ML23156A468

PR-MISC - 59FR37269 - Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety: Draft Policy

ML23156A468
Person / Time
Issue date:	07/21/1994
From:	Hoyle J NRC/SECY
To:
References
PR-MISC, 59FR37269
Download: ML23156A468 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 07/21/1994 TITLE: PR-MISC - 59FR37269 -ADEQUACY AND COMPATIBILITY FOR NRC AND AGREEMENTSTATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFETY; DRAFT POLICY CASE

REFERENCE:

PR-MISC 59FR37269 KEYWORD: RULEMAKJNG COMMENTS

- Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-MISC OPEN ITEM (Y/N) N RULE NAME: ADEQUACY AND COMPATIBILITY FOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFETY; DRAFT POLICY PROPOSgD RULE FED REG CITE: 59FR37269 PROPOSED RULE PUBLICATION DATE: 07/21/94 NUMBER OF COMMENTS: 47 ORIGINAL DATE FOR COMMENTS: 10/19/94 EXTENSION DATE: 12/19/94 FINAL RULE FED. REG. CITE: 62FR46517 FINAL RULE PUBLICATION DATE: 09/03/97 NOTES ON: COMMENT PERIOD EXTENDED BY~FEDERAL REGISTER NOTICE PUBLISHED ON 10 STATUS /17/94 AT 59FR52317. NOTICE OF WORKSHOP ON 11/15/94 PUBLISHED ON OF RULE: 10/17/94 AT 59FR52321. FILE IN 16Hl7.

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HISTO~Y OF THE RULE PART AFFECTED: 'PR-MISC RULE TITLE: ADEQUACY AND COMPATIBILITY FOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND-SAFETY; DRAFT POLICY PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: 93-349 SRM DATE: 04/21/94 SIGNED BY SECRETARY: 07/15/94 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: 97-054 SRM DATE: 06/30/97 SIGNED BY SECRETARY: 08/27/97 STAFF CONTACTS ON THE RULE CONTACT!: CARDELIA MAUPIN MAIL STOP: 0-3D23 PHONE: 504-2312 CONTACT2: MAIL STOP: PHONE:

DOCKET NO. PR-MISC (59FR37269)

In the Matter of ADEQUACY AND COMPATIBILITY FOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFITY; DRAFT POLICY DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 07/15/94 07/15/94 FEDERAL REGISTER NOTICE FOR DRAFT STATEMENT OF POLICY 09/30/94 09/28/94 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS/SOC NUC MED (W. MCCARTNEY/J. CONWAY) ( 1) 10/12/94 10/04/94 COMMENT OF NEVADA NUCLEAR WASTE TASK FORCE, INC (JUDY TREICHEL) ( 2) 10/17/94 08/31/94 COMMENT OF ENVIRONMENTAL COALITION ON NUCLEAR POWER (JUDITH H.JOHNSRUD) ( 3) 10/17/94 10/10/94 COMMENT OF NC SYSTEMS, INC (CHARLES H. ROSE) ( 4) 10/17/94 10/14/94 COMMENT OF WASHINGTON DEPARTMENT OF HEALTH (T. R. STRONG) ( 5) 10/19/94 10/18/94 COMMENT OF KENTUCKY CABINET FOR HUMAN RESOURCES (JOHN A. VOLPE) ( 7) 10/19/94 10/06/94 FRN NOTICE OF MEETING - WORKSHOP TO DISCUSS DRAFT POLICY STATEMENT ON NOV 15, 1994 10/19/94 10/17/94 DRAFT STATEMENT OF POLICY: EXTENSION OF COMMENT PERIOD TO DEC 19 1994 10/24/94 10/17/94 COMMENT OF TENNESSEE DEPARTMENT ENVIRON & CONSERVATION (MICHAEL H. MOBLEY) ( 8) 10/24/94 10/19/94 COMMENT OF CENTRAL INTERSTATE LOW-LEVEL RADIO WASTE COMM (A. EUGENE CRUMP) ( 9) 10/24/94 10/29/94 COMMENT OF TEXAS NATURAL RESOURCE CONSERVATION COMMITTEE (SUSAN S. FERGUSON) ( 10) 10/26/94 10/18/94 COMMENT OF PORTSMOUTH/PIKETON RES FOR ENV HEALTH (DIANA SALISBURY) ( 6)

DOCKET NO. PR-MISC (59FR37269)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 10/26/94 10/19/94 COMMENT OF TEXAS DEPARTMENT OF HEALTH (RICHARD A. RATLIFF) ( 11) 10/27/94 10/26/94 COMMENT OF SOUTHERN CALIFORNIA EDISON CO (WALTER C. MARSH) ( 12) 10/28/94 10/17/94 COMMENT OF ARKANSAS DEPARTMENT OF HEALTH (GRETA J. DICUS) ( 13) 11/02/94 10/29/94 COMMENT OF NEIGHBORS IN NEED (VELMA M. SHEARER) ( 14)

- 11/04/94 10/21/94 COMMENT OF AMERICAN ASSOCIATION FOR NUCLEAR CARDIOLOGY (CLYDE E. PEARCE) ( 15) 11/10/94 11/01/94 COMMENT OF ARIZONA RADIATION REGULATORY AGENCY (AUBREY V. GODWIN) ( 16) 11/14/94 11/02/94 COMMENT OF NEW MEXICO ENVIRONMENT DEPARTMENT (JUDITH M. ESPINOSA) ( 17) 11/15/94 11/03/94 COMMENT OF MARK ROTMAN ( 18) 11/22/94 11/18/94 COMMENT OF NEW YORK DEPARTMENT OF LABOR (RITA ALDRICH) ( 19) 11/25/94 11/22/94 COMMENT OF NEW YORK STATE (EUGENE J. GLEASON) ( 20)

- 12/07/94 11/30/94 COMMENT OF OREGON DEPARTMENT OF HUMAN RESOURCES (RAY D. PARIS) ( 21) 12/09/94 12/01/94 COMMENT OF GEORGIA DEPARTMENT OF NATURAL RESOURCES (THOMAS E. HILL) ( 22) 12/13/94 12/08/94 COMMENT OF PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL RESOURCES (RICHARD R. JANATI) ( 23) 12/16/94 12/15/94 COMMENT OF NEBRASKA DEPARTMENT OF HEALTH (HAROLD R. BORCHERT) ( 24) 12/16/94 12/19/94 COMMENT OF AMERICAN MINING CONGRESS (JAMES E. GILCHRIST, VICE PRES.) ( 25) 12/16/94 12/15/94 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (THOMAS W. ORTCIGER, DIRECTOR) ( 26) 12/19/94 12/14/94 COMMENT OF KANSAS, STATE OF (GERALD W. ALLEN) ( 27) 12/19/94 12/16/94 COMMENT OF ENVIROCARE OF UTAH, INC (CHARLES A. JUDD) ( 28)

DOCKET NO. PR-MISC (59FR37269)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 12/19/94 12/15/94 LTR FM T.R. STRONG SUPPLEMENTING COMMENTS OF THE STATE OF WASHINGTON DEPT OF HEALTH (COMMENT #5) 12/19/94 12/19/94 COMMENT OF NEW JERSEY DEPARTMENT OF ENVIRONMENTAL PROTECTION (JILL LIPOTI) ( 29) 12/19/94 12/17/94 COMMENT OF OHIO CITIZENS FOR RESPONSIBLE ENERGY, INC (SUSAN L. HIATT, DIRECTOR, OCRE) ( 30) 12/19/94 12/19/94 SUPPLEMENTAL COMMENTS (NO. 30) OF OHIO CITIZENS FOR RESPONSIBLE ENERGY (OCRE) 12/19/94 12/15/94 COMMENT OF COLORADO, STATE OF (ROBERT M. QUILLIN, DIRECTOR) ( 31) 12/19/94 12/12/94 COMMENT OF ALLEN H. HUM ( 32) 12/19/94 12/14/94 COMMENT OF E. I. DUPONT DE NEMOURS & CO (LEONARD R. SMITH, CHP) ( 33) 12/19/94 12/19/94 COMMENT OF KERR-MCGEE CORP (HERBERT ESTREICHER) ( 34) 12/19/94 12/19/94 COMMENT OF DECOMMISSIONING COMMENTERS (WILLIAM A. HORIN) ( 35) 12/19/94 12/19/94 COMMENT OF CORAR (BRYAN W. BAKER, PH.D.) ( 36)

- 12/20/94 12/17/94 COMMENT OF PSLAC/COUNTY OF CHATHAM, NORTH CAROLINA (MARY MACDOWELL) ( 37) 12/20/94 12/19/94 COMMENT OF AMERSHAM HOLDINGS, INC (BRYAN W. BAKER, PH.D.) ( 38) 12/22/94 12/19/94 COMMENT OF AMERICAN COLLEGE OF RADIOLOGY (ANN W. RpSSER) ( 39) 12/22/94 12/22/94 COMMENT OF NUCLEAR ENERGY INSTITUTE (FELIX M. KILLAR, JR.) ( 40) 12/23/94 12/19/94 COMMENT OF NUCLEAR INFORMATION & RESOURCE SERV ( 41) 12/27/94 12/16/94 COMMENT OF WASTE AWARENESS AND REDUCTION NETWORK (JIM WARREN, EXECUTIVE DIRECTOR) ( 42) 12/28/94 12/19/94 COMMENT OF LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY (RONALD L. WASCOM) ( 43) 12/28/94 12/21/94 COMMENT OF AMERSHAM CORP (CATHLEEN ROUGHAM) ( 44)

DOCKET NO. PR-MISC (59FR37269)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 01/03/95 12/27/94 COMMENT OF 3M HEALTH PHYSICS SERVICES (ROBERT G. WISSINK) ( 45) 01/12/95 11/17/95 COMMENT OF DAVIDS. GOODEN, PH.D., J.D. ( 46) 01/13/95 01/05/95 COMMENT OF KANSAS, STATE OF (ROBERT C. HARDER, SECRETARY) ( 47) 08/28/97 08/27/97 FEDERAL REGISTER NOTICE ON FINAL POLICY STATEMENTS

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NUCLEAR REGULATORY CO~Q)Nc; :(" SERVICF 8!--4~1:H Statement of Principles and Policy for the Agreement State Program; Policy Statement On Adequacy and Compatibility of Agreement State Programs AGENCY: Nuclear Regulatory Commission.

ACTION: Final policy statements.

SUMMARY

The Nuclear Regulatory Commission (NRC} is publishing two final policy statements: the "Statement of Principles and Policy for the Agreement State Program," and "Policy Statement on Adequacy and Compatibility of Agreement State Programs."

~ 31 lc/1 '7 EFFECTIVE DATE: (Ypgn pt:tbtiea:tion iR the Federal Register.)--

ADDRESSES: Documents referenced in this notice are available for inspection in the Public Document Room, 2120 L Street, NW {Lower Level), Washington, DC, between 7:45 am and 4:15 pm.

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FOR FURTHER INFORMATION CONTACT: Ms. Cardelia Maupin, Sr. Project Manager, Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-2312.

SUPPLEMENT ARY INFORMATION:

I. BACKGROUND A. Statement of Principles and Policy for the Agreement State Program On August 25, 1993, the Commission requested the NRC staff to recommend improvements to the NRC's Agreement State Program to assure adequate protection of public health and safety. The draft Policy Statement was published in the Federal Register on August 5, 1994 (59 FR 40058). At the Commission's request, the public comment period scheduled to end on October 4, 1994, was extended to December 19, 1994 (59 FR 52316).

A final Policy Statement was prepared based on the 'public comments, other activities and issues before the Commission, e.g., the "Policy Statement on Adequacy and Compatibility of Agreement State Programs," issues discussed at public briefings of the Commission by the Organization of Agreement States (OAS), and the Commission's deliberations on the Integrated Materials Performance Evaluation Program. On May 5, 1995, the NRC staff submitted to the Commission the "Final Statement of Principles and Policy for the Agreement State Program" and "'Procedures for Suspension and Termination 2

of an Agreement State Program" (SECY 95-115) that contained the full analysis of comments. By Staff Requirements Memorandum dated June 29, 1995, the Commission provided comments on the Statement of Principles and Policy for the Agreement State Program and directed staff to develop procedures for placing an Agreement State in probationary status and for implementing the phase-in of a new Agreement State program.

On October 3, 1996, the NRC staff submitted to the Commission the Statement of Principles and Policy for the Agreement State Program that had been modified as directed by the Commission (SECY 96-213). Further revisions were made to ensure consistency with the revised Policy Statement on Adequacy and Compatibility of Agreement State

',.'t Programs: The procedures for suspension, emergency suspension and termination of

• an Agreement agreements were finalized on April 25, 1996, and the procedure for placing State in probationary status was finalized on July 3, 1996.

B. Statement on Adequacy and CompatlbDlty of Agreement State Programs.

On July 21, 1994 (59 FR 37269), the Commission published in the Federal Register, for public comment, B draft Policy Statement regarding the adequacy of Agreement State programs to protect public health and safety and compatibility with NRC regulatory programs. The comment period for the draft Policy Statement was scheduled to expire on October 19, 1994, but was extended to December 19, 1994 (59 FR 52317). In

\addition, a public workshop was held on November 15, 1994 (59 FR 52321) to provide an opportunity for Agreement States and interested members of the public to provide comments on th,e draft Policy Statement.

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A final "Policy Statement on Adequacy and Compatibility of Agreement State Program" was prepared based on the public comments and other activities and issues before the Commission. On May 3, 1995, the NRC staff submitted to the CommiJsion the

.,Final Policy Statement on Adequacy and Compatibility of Agreement State Programs" (SECY 95-112) that contained the full analysis of comments.

C. Status of the Policy Statements The Commission approved both policy statements in principle with a Staff Requirements Memorandum dated June 29, 1995, but deferred their implementation until all implementing procedures were completed and approved by the Commission. On August 2, 1995 (60 FR 39463), the Commission published in the Federal Register the status of

• these two policy statements and a notice of their availability.

NRC staff also prepared draft implementing procedures for phased implementation of a new Agreement State program that contained language for a standard agreement (Management Directive 5.8 and its associated handbook). Comments on the dr~ft implementing procedures for phased implementation of new agreements* and the standard agreement were requested from the Agreement States on November 15, 1996. The complete analysis of these comments is included in *Final Recommendations on Policy Statements and Implementing Procedures for: Statement of Principles and Policy for the Agreement State Program and Policy Statement on Adequacy and Compatibility of 4

Agreement State Programs" (SECY 97-054, dated March 3, 1997) that is available for inspection at the-NRC Public Document Room. A summary of the comments appears with the text of the final policy statement in this notice.

In October 1995, a Working Group consisting of representatives of Agreement States and the NRC was formed to develop implementing procedures for the "Policy Statement on Adequacy and Compatibility of Agreement State Programs." The formation of this Working Group was announced in the Federal Register on December 1, 1995 (60 FR 61716). A notice announcing availability of the initial Working Group report (August 21, 1996) and implementing procedures was published in the Federal Register on Sep1ember

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19, 1996 (6 f FR 493 5 7). Comments also were requested specifically from Agreement States and panelists who participated in the November 15, 1994, public workshop. The analysis of State and public comments is part of the supplemental report of the Working Group dated January 27, 1997, that is available for inspection at the NRC Public Document Room. A summary of the comments appears with the text of the final_policy statement in this notice.

r II. STATEMENT OF PRINCIPLES AND POLICY FOR THE AGREEMENT STATE PROGRAM A. Comment Summary Comment letters were received from twelve Agreement States on the implementing

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procedures for phased agreements (Management Directive 5.8). There was strong opposition from the Agreement States on the inclusion of mandatory phased agreements 5

for states seeking Agreement State status. Staff analyzed the comments and agreed with the concerns associated with the use of phased agreements. Changes were made to the Policy Statement to remove the phased agreement concept and to include revisions offered by the Agreement States, as appropriate. The Policy Statement was also edited to conform it to the position that Agreement States have flexibility to impose legally binding requirements on its licensees through mechanisms other than rules.

The text of the final policy statement follows.

B. The Commission Polley STATEMENT OF PRINCIPLES AND POLICY FOR THE AGREEMENT STATE PROGRAM

1. PURPOSE.

The purpose <;>f this Statement of Principles and Policy for the Agreement State Program is to clearly describe the respective roles and responsibilities of the U.S. Nuclear Regulatory Commission (NRC) and States in the administration of programs carried out under Section 274 of the Atomic Energy Act of 1954, as amended. Section 274 provides broad authority for the NRC to establish Federal and State cooperation in the administration of regulatory programs for the protection of public health and safety in the industrial, medical, and research uses of nuclear materials.

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This Policy Statement addresses the Federal-State interaction under the Atomic Energy Act to: (1) establish and maintain agreements with States under Section 274(b) that provide for discontinuance by the NRC, and the assumption by the State, of responsibility for administration of a regulatory program for the use of byproduct, source, and small quantities of special nuclear material; and (2) ensure that post-agreement I

interactions among the NRC and Agreement State radiation control programs are coordinated and compatible and that Agreement State programs continue to provide

-adequate protection of public health and safety.

This Policy Statement establishes principles, objectives, and goals that the Commission expects will be reflected in the implementing guidance and programs of the NRC and Agreement States to meet their respective program responsibilities and that should be achieved in the administration of these programs.

This Policy Statement is intended solely as guidance for the Commission and the Agreement States in the implementation of the Agreement State program. This Policy Statement does not itself impose legally binding requirements on the Agreement States. In addition, nothing in this Policy Statement expands the legal authority of Agreement States beyond that already granted to them by Section 274 of the AEA and other relevant legal authority. Implementation procedures adopted pursuant to this Policy Statement shall be consistent with the legal authorities of the Commission and the Agreement States.

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2. STATEMENT OF LEGISLATIVE INTENT.

The Atomic Energy Act of 1954 did not specify a role for the States in regulating the use of nuclear materials. Many States were concerned as to what their responsibilities in this area might be and expressed interest in seeing that the boundaries of Federal and State authority were clearly defined. This need for clarification was particularly important in view of the fact that although the Federal government retained sole responsibility for protecting public health and safety from the radiation hazards of byproduct, source, and special nuclear material, the responsibility for protecting the public from the radiation

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hazards of other sources such as x-ray machines and radium had been borne for many years by the States.

Consequently, in 1959 Congress enacted Section 274 of the Atomic En~rgy Act to establish a statutory framework under which States could assume certain regulatory jurisdiction over byproduct, source, and special nuclear material in quantities less than a critical mass. The primary purpose of the legislation was to authorize the Commission to discontinue its regulatory authority over the use of these materials and for assumption of .

this authority by the States. The Commission retained regulatory authority over the licensing of certain facilities and activities such as nuclear reactors, larger quantities of special nuclear material, end the export and Import of nuclear materials.

In considering the legislation, Congress recognized that the Federal government would need to assist the States to ensure that they developed the capability to exercise their regulatory authority in a competent and effective m::mner. Accordingly, the legislation 8

authorized the Commission to provide training and other services to State officials and employees. However, in rendering this assistance, Congress did not intend that the Commission would provide any grants to a State for the administration of a State regulatory program. This was fully consistent with the objectives of Section 274 to qualify States to assume independent regulatory authority over certain defined areas of regulatory jurisdiction and to permit the Commission to discontinue its regulatory responsibilities in those areas.

In order to relinquish its authority to a particular State, the Commission must find that the program is compatible with the Commission's program for the regulation of radioactive materials and that the State program is adequate to protect public health and safety. In addition, the Commission has an obligation, pursuant to Section 274(j) of the Act, to review existing Agreement State programs to ensure continued adequacy and compatibility. Section 274(j) of the Act provides that the NRC may terminate or suspend all or part of its agreement with a State if the Commission finds that such termination is necessary to protect public health and safety or that the State has not complied with the provisions of Section 2740,. In these cases, the Commission must offer the State reasonable notice and opportunity for a hearing. In addition, the Commission may temporarily suspend all or part of an agreement in the case of an emergency situation.

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C. PRINCIPLES OF PROGRAM IMPLEMENTATION.

1. Good Regulation Principles.

In 1991, the Commission adopted "Principles of Good Regulation" to serve as a guide to both agency decision making and to individual behavior as NRC employees.

Adherence to these principles has helped to ensure that NRC' s regulatory activities have been of the highest quality, appropriate, and consistent. The "Principles of Good Regulation" recognize that ~rong, vigilant management and a desire to improve performance are prerequisites for success, for both regulators and the regulated industry.

The Commission believes that NRC's implementation of these principles has served the public, the Agreement States, and the regulated community well. The Commission further believes that such principles may be'useful as a part of a common culture that NRC and the Agreement States share as co-regulators. Accordingly, the Commission encourages each Agreement State to adopt a similar set of principles for use in its own regulatory program.

Regulatory decisions and actions should be developed and implemented in an open and publicly credible manner and should be able to withstand scrutiny. Such scrutiny should be welcomed by the regulator. The regulator should be independent and impartial in its actions, and this should be clearly evident. Regulations and regulatory decisions should be based on assessments of the best available information from affected and interested individuals and organizations, as well as on the best available knowledge from research and operational experience. Significant decisions, for example, a change in enforcement policy, 10

should be documented explaining the rationale for such decisions. The public should have an opportunity for early involvement in significant regulatory program decision~. Where several effective alternatives are available, the alternative that best assures safety- while

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considering differing views should be adopted, considering the resources needed to implement that alternative. Regulations should be necessary, and appropriate, to assure safety, and should be clear, coherent, logical, and practical. Regulatory actions should be fully consistent with regulations or other legally binding requirements and good public policy and should lead to stability and predictability in the planning and implementation of radiation control programs.

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Failure to adhere to these principles of good regulation in the conduct of operations should be a sufficient reason for a regulatory program to self.initiate program changes that will result in needed improvements. All involved should welcome expressions of concern that indicate a program may not be operating in accordance with these principles and revise their program to more completely reflect these principles.

It is not intended that these principles of fiJOOd regulation be established as formal

,.criteria against which NRC and Agreement State programs would be assessed. Rather, the expectation is that these principles will be incorporated into the day-to-day operational .

fabric of NRC and Agreement State materials programs. These principles should be used in the formulation of policies and programs, implementation of those policies and programs, and assessments of program effectiveness. Application of these principles will ensure that complacency will be minimized,. that adequate levels of protection of public health and safety are being provided, end that government employees tasked with the responsibility 11

for these Federal and State regulatory programs serve the public in an effective, efficient, and responsive manner. These principles are primarily for the use of NRC and Agreement State materials program managers and staff in the self assessment of their respective programs and to use in the establishment of goals and objectives for the continual improvement of their respective programs. Deficiencies identified during the conduct of NRC Region and Agreement State formal program performance reviews may indicate that the program is not adhering to these principles of good regulation. The organization being assessed should factor the need for these principles into its actions to address identified deficiencies.

2. Coherent Nationwide Effort.

The mission of the NRC is to assure that civilian use of nuclear materials in the United States is carried out with adequate protection of public health and safety. NRC acknowledges its responsibility, shared with the Agreement States, to ensure that the regulatory programs of the NRC and the Agreement States collectively establish a coherent nationwide effort for the control of AEA materials. The basic elements of such regulatory programs include ability to ensure adequate protection of public health and safety, compatibility in areas of national interest, sufficient flexibility to accommodate local needs and conditions, ability to assess program performance on a consistent and systematic I

basis, and principles of good regulation in program administration.

Each of these elements is reflected and addressed in specific sections of this Policy Statement.

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3. Adequate to Protect Public Health and Safety.

NRC and the Agreement States have the responsibility to ensure adequate

• protection of public health and safety in the administration of their respective regulatory programs controlling the uses of AEA materials. Accordingly, NRC and Agreement State programs shall possess the .requisite supporting legislative authority, implementing organization structure and procedures, and financial and human resources to effectively administer a radiation control program that ensures adequate protection of public health

• and safety.

4. Compatible in Areas of National Interest.

NRC and the Agreement States have the responsibility to ensure that consistent and compatible radiation control programs are administered. Such radiation control programs should be based on a common regulatory philosophy including the common use o!

definitions and standards. They should be not only effective and cooperatively implemented by NAC and the Agreement States, but also should provide uniformity and consistency in program areas having national significance.

Such areas include those affecting interstate commerce, movement of goods and provision of services, and safety reviews for sealed source devices sold nationwide. Also necessary is the ability to communicate using a nationally accepted set of terms with common understanding, the ability to ensure an adequate level of protection of public health and safety tha,t is consistent and stable across the nation, and the ability of NRC 13

and each Agreement State to evaluate the effectiveness of the NRG and Agreement State programs for the regulation of agreement material with respect to protection of public health and safety.

5. Flexibility.

With the exception of those compatibility areas where all prograr:ns should be essentially identical, to the extent possible, Agreement State radiation control programs for AEA materials should be provided with flexibility in program implementation to accommodate individual State preferences, State legislative direction, and local needs and conditions. However, the exercise of such flexibility should not preclude, or effectively preclude, a practice authorized by the Atomic Energy Act, and in the national interest.

That is, a State would have the flexibility to design its own program, including incorporating more stringent, or similar, requirements provided that the requirements for adequacy are still met and compatibility is maintained,* and the more stringent requirements do not preclude or effectively preclude a practice in the national interest without an adequate public health and safety or environmental basis related to radiation protection.

D. NEW AGREEMENTS.

Section 274 of the Atomic Energy Act requires that once a decision to seek Agreement State status is made by the ~tate, the Governor of that State must certify to the NRC that the State desires to assume regulatory responsibility and has a program for the control of radiation hazards adequate to protect public health and safety with respect 14

to the materials within the State covered by the proposed agreement. This certification will be provided in a letter to the NRC that includes a number of documents in support of the certification. These documents include the State's enabling legislation, the radiation control regulations, a narrative description of the State program's policies, practices and procedures, and a proposed agreement.

The NRC has published criteria describing the necessary content these documents are required to cover. The NRC reviews the request and publishes notice of the proposed agreement in the Federal Register to provide an opportunity for public comment. After consideration of public comments, if the Commission determines that the State program is adequate and compatible, and approves the agreement, a formal agreement document is signed by the Governor and the Chairman of the NRC.

E. PROGRAM ASSISTANCE.

NRC will offer training and other assistance to States, such as assistance in developing regulations and program descriptions to help individual States prepare for entrance into agreements and to help them prior to the assumption of regulatory authority.

Following assumption of regulatory authority by a new Agreement State, to the extent permitted by resources, NRC can provide training and other assistance such as review of proposed regulatory changes to help States administer their regulatory responsibilities.

NRC would also use its best efforts to provide specialized technical assistance to Agreement States to address unique or complex licensing, inspection, and enforcement issues. In areas where Agreement States have particular expertise or are in the best 15

position to provide immediate assistance to the NRC, the Agreement States are encouraged to do so. In addition, NRC and Agreement States will keep each other informed about relevant aspects of their programs. NRC will provide an opportunity for Agreement States to have early and substantive involvement in rulemaking, policy, and guidance development activities. Agreement States should provide a similar opportunity to the NRC to make it aware of, and to provide the opportunit~ to review and comment on, proposed changes in regulations and significant changes to Agreement State programs, policies, and regulatory guidance.

If an Agreement State experiences difficulty in program administration, the Commission would use its best efforts to assist the State in maintaining the effectiveness of its radiation control program. Such assistance could address an immediate difficulty or a chronic difficulty affecting the State's ability to discharge its responsibility to continue to ensure adequate protection of public health and safety.

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F. PERFORMANCE EVALUATION.

Under Section 274 of the Atomic Energy Act of 1954, as amended, the Commission retains ~uthority for ensuring that Agreement State programs continue to provide adequate protection of public health and safety. In fulfilling this statutory responsibility, NRC will provide oversight of Agreement State radiation control programs to ensure that they are adequate and compatible prior to entrance into a Section 274(b) agreement and that they continue to be adequate and compatible after an agreement is effective. The Commission, in cooperation with the Agreement States, will establish and 16

implement a performance evaluation program to provide NRC and Agreement State management with systematic, integrated, and reliable evaluations of the strengths and weaknesses of their respective radiation control programs and identification of areas needing improvement.

As a part of this performance evaluation process, the Commission will take any necessary actions to help ensure that Agreement State radiation control programs remain adequate and compatible. These actions include: (1) period_ic assessments of Agreement

- State radiation control programs against established review criteria; (2) provision of assistance to help address weaknesses or areas within an Agreement State radiation control program requiring improvement, to the extent permitted by NRC resources; (3) placing a State on a probationary status for serious program deficiencies that require heightened oversight; (4) temporary suspension of an agreement and reassertion of NRC regulatory authority in an emergency if an Agreement State program experiences any immediate program difficulties preventing the State from \

continuing to ensure adequate protection of public health and safety; and (5) suspension or termination of an agreement and reassertion of NRC regulatory authority if the Agreement State program experiences difficulties that jeopardize the State's ability to continue to ensure adequate protection of public health and safety or to continue to maintain a compatible program. The basis for NRC's actions will be based on a well defined and predictable process and a performance evaluation program that will be consistently and fairly applied.

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G. LEVELS OF AGREEMENT STA TE PROGRAM REVIEW FINDINGS.

The following discussion outlines the nature of NRC findings regarding the NRC' s Agreement State review process.

FINDING 1 - ADEOUATE TO PROTECT PUBLIC HEALTH AND SAFETY AND (OR NOT)

COMPATIBLE If the NRC finds that a State program has met all of the Agreement State program review criteria or that only minor deficiencies exist, the Commission would find that the State's program is adequate to protect public health and safety. If the NRC determines that a State program contains all required NRC program elements for compatibility, or only minor discrepancies exist, the program would be found compatible. If the NRC determines that a State has a program that disrupts the orderly pattern of regulation among the collective regulatory efforts of the NRC and_ other Agreement States, i.e., creates conflicts, gaps, or duplication in regulation, the program would be found not compatible.

FINDING 2 - ADEQUATE, BUT NEEDS IMPROVEMENT AND (OR NOT) COMPATIBLE If the NRC finds that a State program protects public health and safety, but is deficient in meeting some of the review criteria, the NRC may find that the State's program is adequate, but needs improvement. The NRC would consider in its determination plans that the State has to address any of the deficiencies noted during the review. In cases

) where less significant Agreement State deficiencies previously identified have been 18

uncorrected for a significant period of time, NRC may also find that the program is adequate but in need of improvement. If the NRC determines that a State program contains all required NRC program elements for compatibility, or only minor discrepancies exist, the program would be found compatible. If the NRC determines that a State h~s a program that disrupts the orderly pattern of regulation among the collective regulatory efforts of the NRC and other Agreement States, i.e., creates conflicts, gaps, or duplication in regulation, the program would be found not compatible.

FINDING 3 - INADEQUATE TO PROTECT PUBLIC HEALTH AND SAFETY AND (OR NOT)

COMPATIBLE If the NRC finds that a State program is significantly deficient in some or all of the review criteria, the NRC would find that the State's program is not adequate to protect public health and safety. If the NRC determines that a State program contains all required NRC program elements for compatibility, or only minor discrepancies exist, the program would be found compatible. If the NRC determines that a State has a program that disrupts the orderly pattern of regulation among the collective regulatory efforts of the NRC and other Agreement States, i.e., creates conflicts, gaps, or duplication in regulation, the program would be found not compatible.

19

r H. NRC ACTIONS AS A RESULT OF THESE FINDINGS.

The following discussion outlines the options available to the NRC as a result of making any of the above findings. The appropriate action will be determined on a case-by-case basis by NRC management.

LETTERS In all cases, subsequent to an Agreement State program review, the findings would be recounted in a letter to senior level State management. In the event that the NRC finds that a State program is adequate and compatible, no further action would be required, except a response by the State to any suggestions or recommendations. In the case where minor deficiencies are noted or areas for improvement are identified, the State would be requested to describe their proposed corrective action. If the corrective action appears appropriate, no further NRC action is required. If additional clarification of the corrective actions is needed, additional correspondence may be necessary.

FOLLOW-UP REVIEWS In the event that deficiencies are noted during the program review, NRC may

/

increase the frequency of contacts with the State to keep abreast of developments end conduct onsite follow-up reviews to assure that progress is being made on correcting program deficiencies. If, during follow-up reviews, it is shown that the State has taken corrective actions, a letter finding the State id"!quate and compatible would be provided.

20

PROBATIONARY STATUS There are three circumstances that can lead to an adequate but needs improvement or incompatible State program being placed in a probationary status: (1) there are cases in which program deficiencies may be serious enough to require immediate heightened oversight; (2) in other cases, Agreement State program deficiencies previously identified may have been uncorrected for a significant period of time; and (3) if the NRC determines that a State P.rogram has been late in adopting required compatibility program elements and

- significant disruption in the collective nationwide efforts to regulate AEA materials has occurred. If the NRC was not confident that the State would address the program deficiencies in an expeditious and effective manner, the Commission would place the State program on probation.

J As a result of placing a State program on probation, the NRC would communicate

,,[,

its findings to a higher level of State management. Notice of such probationary status would normally be addressed to the Governor of the State. Notice would also be published in the Federal Register. A copy of the letter to the Governor would be placed in the Public Document Room and a press release would be issued.

Once a State program is placed on probation, the NRC would heighten its oversight of the program. This would include obtaining commitments from the State in the form of a management plan to describe actions to be taken by the State to address the program deficiencies, including specific goals and milestones. The NRC would increase observation of State program activities under the agreement to assure adequate protection of public 21

health and safety. If requested and in accordance with terms agreed to by the parties, the NRC would consider providing technical support for the maintenance of the regulatory program. The probationary period would last for a specified period of time. This period would not normally be more than one year, but could be extended based on extenuating circumstances. At the end of that time, if the State has not addressed the deficiencies, the NRC would institute suspension or termination proceedings.

SUSPENSION Section 274j of the Atomic Energy Act gives the Commission authority to suspend all or part of its agreement with a State if the suspension is required to protect public health and safety, or if the State has not complied with one or more of the requirements of Section 274 of the Act. In cases where the Commission finds that program deficiencies related to either adequacy or compatibility are such that the Commission must take action to protect public health and safety, or if the program has not complied with one or more of the requirements of Section 274 of the Act, the Commission would suspeJld all or part of its agreement with the State. In cases where a State has failed to respond in an acceptable manner during the probationary period, suspension would be considered. If the situation is not resolved, termination will be considered.

Before reaching a final decision on suspension, the Commission will notify the State and provide the State an opportunity for a hearing on the proposed suspension. Notice of the proposed suspension will also be published in the Federal Register. Suspension, rather 22

than termination, would be the preferred option in those cases where the State provides evidence that the program deficiencies are temporary and that the State is~committed to correcting the deficiencies that led to the suspension.

In addition to the normal suspension authority, Section 274j.(2) of the Act also addresses emergency situations and gives the Commission authority to temporarily suspend all or part of its agreement with a State without notice or hearing if an emergency situation exists requiring immediate action to protect public health and safety, and the State has failed to take necessary action within a reasonable time.

TERMINATION Section 274j of the Atomic Energy Act gives the Commission authority to terminate its agreement with a State if such termination is required to protect public health and safety, or if the State pr*ogram has not complied with one or more of the requirements of Section 274 of the Act (e.g., is found to be not compatible with the Commission's program). When the Commission finds such significant program deficiencies, the Commission would institute proceedings to terminate its agreement with the State.

In cases where a State has failed to respond in an acceptable manner during the probationary period and there is no prospect for improvement, termination will be considered. Before reaching a final decision on termination, the Commission will notify the State and provide the State an opportunity for a hearing on the proposed termination.

23

Also, notice of the proposed termination will be published in the Federal Register,. There may be cases where termination will be considered even though the Sta,te program has not been placed on probation.

I. PROGRAM FUNDING.

Currently, Section 274 does not allow federal funding for the administration of Agreement State radiation control programs. Section 274 permits the NRC to offer training and other assistance to a State in anticipation of entering into an Agreement with NRC, however, it is NRC policy not to fund the establishment of new Agreement State programs. -

Regarding training, given the importance in terms of public health and safety ,of having well trained radiation control program personnel, the NRC offers certain relevant training courses and notifies Agreement State personnel of their availability.

J. REGULATORY DEVELOPMENT.

NRC and Agreement States will cooperate in the development of new regulations and policy. Agreement States will have early and substantive involvement in the development of new regulations affecting protection of public health and safety and of new policy affecting administration of the Agreement State program. Likewise, the NRC expects to have the States provide it with early end substantive involvement in the development of new Suggested State Regulations. NRC and Agreement States will keep each other informed about their individual regulatory requirements (e.g., regulations or 24

license conditions) and the effectiveness of those regulatory requirements so that each has the opportunity to make use of proven regulatory approaches to further the effective and efficient use of resources.

K. PROGRAM EVOLUTION.

The NRC-Agreement State program is dynamic and the NRC and Agreement States will continue to jointly assess the NRC and Agreement State programs for the regulation of AEA materials to identify specific changes that should b~ considered based on experience or to further improve overall performance and effectiveness. The changes considered may include possible legislative changes. The program should also include the formal ~haring of information and views such as briefings of the Commission by the Agreement States.

111. POLICY STATEMENT ON ADEQUACY AND COMPATIBILITY OF AGREEMENT STATE PROGRAMS A. Comment Summary Ten comment letters were received, one from the Organization of Agreement States, six Agreement State program directors, two industry organizations and one environmental group. The Joint NRC-Agreement State Working Group for Development of Implementing Procedures for the Final Policy Statement on Adequacy and Compatibility of Agreement State Programs analyzed the comments and changes were made to the Policy Statement (1) to add additional clarifying language for the terms "adequacy" and *compatibility* and the 25

cooperative nature of the NRC - Agreement State relationship; (2) to confonn It to the position that Agreement States have flexibility with respect to the legally binding mechanism by which regulatory requirements needed for adequacy or compatibility are adopted; and (3) to simplify the language describing compatibility categories. Changes also were made in response to the June 30, 1997 Staff Requirements Memorandum. These changes (1) reflect that program eJe,ments for compatibility also impact public health and safety and may also be considered program elements for adequacy; (2) clarify the definition of basic radiation protection standard; and (3) clarify that States may not adopt program elements reserved exclusively to NRC. The implementing procedures were changed to reflect the final Policy Statement.

• ' '1 One Agreement State specifically commented that it did not believe that Section 274 of the AEA required compatibility of programs or program elements after an agreement is effective except for requirements pertaining to the Uranium Mill Tailings Radiation Control Act in section 274(0). This position also was reflected in the reco~mended changes to the Policy Statement submitted by the Organization of Agreement States.

The Commissio,n does not agree with this interpretation of the AEA. Both Sections 274d.(2) and 274g. indicate that the Commission must find a State program to be compatible with that of NRC in order to enter into a Section 274b. agreement with the State. It is the Commission's view that, pursuant to Section 274, an Agreement State's program should be compatible with NRC's program for the duration of the Agreement for the following reasons:

Subsection 274g. authorizes and directs the Commission to cooperate with the 26

States in the formulation of radiation protection standards to assure that the State and Commission programs for the protection against hazards of radiation will be coordinated and compatible." This provision demonstrates Congress' intention that the compatibility between the NRC and Agreement State programs should be maintained on a continuing basis.

Section 274j.(1) calls on the Commission to suspend or terminate an Agreement State's program if the State has not complied with one or more of the requirements" of the Section 274. The Commission believes that this phrase "one or more of the requirements," encompasses all requirements of Section 274, including the requirement for compatibility.

Under subsection 274d.(2), the Commission is authorized to enter into an agreement with a State if the Commission makes both requisite findings that the State program is compatible with the NRC's program and adequate to protect public health and safety. Absent a continuing compatibility requirement, an Agreement State could divert from having a compatible program the day after any agreement is signed with NRC. This would render the Commission's initial compatibility finding required by Section 274d.(2) meaningless.

/

Therefore, the Commission does not believe that Congress intended such meaning for the compatibility requirement and no changes were made to the Policy Statement in response to this comment.1 27

/

The text of the final policy statement follows.

B. The Commission Policy POLICY STATEMENT ON ADEQUACY AND COMPATIBILITY OF AGREEMENT STATE PROGRAMS PURPOSE Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, provides for a special Federal-State regulatory framework for the control of radioactive materials under which the NRC, by agreement with a State, relinquishes Its authority in certain areas to the State government as long as the State program is adequate to protect public health and safety and compatible with the Commission's program. Section 274 further directs the Commission to periodically review State programs to ensure compliance with provisions of Section 274. This Policy Statement presents the Nuclear Regulatory Commission's policy for determining the adequacy and compatibility of Agreement State programs establist;led pursuant to Section 274. This Policy Statement clarifies the meaning and use of the terms "adequate to protect public health and safety" and "compatible with the Commission's regulatory program" as applied to the Agreement State program. The Policy Statement also describes the general frary,ework that will be used to identify those program elements 1 that 1

For the purposes of this Policy Statement, "program element" means any component or function of a radiation control reaulatory program, including regulations and/or other legally binding requirements imposed ol'l regulated persons, that contributes to 28

Agreer'!lent State programs should Implement to be adequate to protect public health and safety and to be compatible with the Commission's regulatory program. Finally, the Policy Statement reflects principles discussed in the Commission's Statement of Principles and Policy for the Agreement State Program which should be considered in conjunction with this Policy Statement.

This Policy Statement is solely guidance for the Commission and the Agreement States in the implementation of the Agreement State program. This Policy Statement does

- not itself impose legally binding requirements on the Agreement States. In addition, nothing in this Policy Statement expands the legal authority of Agreement States beyond that already

'1 granted to them by Section 274 of the Atomic Energy Act and other relevant legal authority.

Implementation procedures adopted pursuant to this Policy Statement shall be consistent with the legal authorities of the Commission and the Agreement States.

BACKGROUND

• The terms "adequate" and "compatible" represent fundamental concepts in the Agreement State. program authorized in 1959 by Section 274 of the Atomic Energy Act of 1954, as amended (AEA). Subsection 274d. states that the Commission shall enter into an Agreement under subsection b., discontinuing NRC's regulatory authority over certain materials in a State, provided that the State's program is adequate to protect public health and safety and compatible, in all other respects, with the Commission's regulatory program.

Subsection 274g. authorizes and directs the Commission to cooperate with States in the 29

formulation of standards to assure that State and Commission standards will be coordinated and compatible. Subsection 274j.(1} requires the Commission to review periodically the Agreements and actions taken by States under the Agreements to ensure compliance with

\

provisions of Section 274. In other words, the Commission must review the actions taken by States under the Agreements to ensure that the programs continue to be adequate to protect public health and safety an~ compatible with- the Commission's program.

Section 274 of the AEA requires that Agreement State programs be both "adequate to protect the public health and safety" and "compatible with the Commission's program."

These separate findings are based on consideration of two different objectives. First, an Agreement State program should provide for an acceptable level of protection of public health and safety in an Agreement State (the "adequacy" component). Second, the Agreement State should ensure that its program serves an overall nationwide interest in radiation protection (the "compatibility" component). As discussed in more detail below, an "adequate" program should consist of those program elements necessary to maintain an acceptable level of protection of public health and safety within an Agreement State. A "compatible" program should consist of those program elements necessary to meet a larger nationwide interest in radiation protection generally limited to areas of regulation involving radiation protection standards and activities with significant transboundary Implications. Program elements for adequacy focus on the protection of public health and safety within a particular State, whereas program elements for compatibility focus on the Impacts of an Agreement State's regulation of agreement material on a nationwide basis or its potential effects on other

/

jurisdictions. Many program elements for compatibility also impact public health and safety; therefore, they may also be considered program elements for adequacy.

30

In identifying those program elements for adequate and compatible programs, or any changes thereto, the Commission will seek the advice of the Agreement States and will consider such advice in Its final decision.

ADEQUACY An Agreement State's radiation control program is adequate to protect public health and safety if administration of the program provides reasonable assurance of protection of public health and safety in regulating the use of source, byproduct, and small quantities of

/"'

special nuclear material (hereinafter termed "agreement material"} as identified by Section

\

274b. of the AEA. The level of protection afforded by the program elements of NRC's

\

materials regulatory program is presumed to be that which is adequate to provide a _

reasonable assurance of protection of public health and safety. The overall level of protection of public health and safety provided by a State program should be equivalent to, or I

greater than, the level provided by the NRC program. To provide reasonable assurance of

, protection of public health and safety, an Agreement State program should contain five essential program elements, identified below, that the Commission will use to define the scope of its review of the program. The Commission also will consider, when appropriate, other program elements of an Agreement State which appear to affect the program's ability to l

provide reasonable assurance of public health and safety protection. Such consideration will occur only if concerns arise.

31

A. LEGISLATION AND LEGAL AUTHORITY State statutes should:

Authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under an Ag~ment with the Commission:

Authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of protection of public health and safety; Authorize the State to license, inspect, and enforce legally binding requirements such as regulations and licenses: and Be otherwise consistent with Federal statutes, as appropriate, such as Public Law 95-604, The Uranium Mill Tailings Radiation Control Act {UMTRCA).

In addition, the State should have existing legally enforceable measures such as generally applicable rules, license provisions, or other appropriate measures, necessary to allow the State to ensure adequate protection of public health and safety in 'the regulation of agreement material in the State. Specifically, Agreement States should adopt a limited number of legally binding requirements based on those of NRG because of their particular health and safety significance. In adopting such requirements, Agreement States should adopt the essential objectives of those of the ".°'.l'lmmission.

32

B. LICENSING The State should conduct appropriate evaluations of proposed uses of agreement materiat before issuing a license, to assure that the proposed licensee's operations can be conducted safely. Licenses should provide for reasonable assurance of public health and safety protection In relation to the licensed activities.

C. INSPECTION AND ENFORCEMENT The State should periodically conduct inspections of licensed activities involving agreement material to provide reasonable assurance of safe licensee operations and. to detennine compliance with its regulatory requirements. When determined to be necessary by the State, the State should take timely enforcement action against licensees through legal sanctions authorized by State statutes and regulations.

D. PERSONNEL The Stafe should be staffed with a sufficient number of qualified personnel to Implement its regulatory program for the control of agreement material.

E. RESPONSE TO EVENTS AND ALLEGATIONS The St~~e. should respond to and conduct timely inspections or investigations of incid3nt~, r-..po, l;J ,vents, and allegations involving agreement material within the State's 33

jurisdiction to provide reasonable assurance of protection of public health and safety.

COMPATIBILITY An Agreement State radiation control program is compatible with the Commission's regulatory program when its program does not create conflicts, duplications, gaps, or other conditions that would jeopardize an orderty pattern in the regulation of agreement material on a nationwide basis. For purposes of compatibility, the State should address categories A, B, and C identified below:

A. BASIC RADIATION PROTECTION STANDARDS For purposes of this Policy Statement, this category includes "basic radiation protection standards" meaning dose limits, concentration and release limits related to radiation protection in 10 CFR Part 20 that are generally applicable, and the dose limits in 10 CFR 61.41 2* Also included in this category are a limited number of definitions, signs, labels and scientific terms that are necessary for a common understanding of radiation protection principles among licensees, regulatory agencies, and members of the public. Such State standards should be essentially identical to those of the Commission, unless Federal statutes provide the State authority to adopt different standards. Basic radiation protection standards do not include i:onstraints or other limits below the level associated with "adequate 2

The Commission will implement this category consistent with Its ear1ier decision In the LLW area to allow Agreement States flexibDity to, establish pre-closure operational release* limit objectives, ALARA goals or design objectives at such levels as the State may deem necessary or appropriate, as long as the level of protection of public health and safety Is at least equivalent to that afforded by Commission requirements.

34

protection" that take into account permissible balancing considerations such as economic cost and other factors.

B. PROGRAM ELEMENTS WITH SIGNIFICANT TRANSBOUNDARY IMPLICATIONS The Commission will limit this category to a small number of program elements (e.g.,

I transportation regulations and sealed source and device registration certificates) that have significant transboundary implications. Agreement State program elements should be essentially identical to those of the Commission.

" , r C. OTHER COMMISSION PROGRAM ELEMENTS These are other Commission program elements (e.g., reciprocity procedures) that are Important for an Agreement State to have in order to avoid conflicts, duplications, gaps, or

• }'

other conditions that would jeopardize an order1y pattern in the regulation of agreement material on a nationwide basis. Such Agreement State program elt;,ments should embody the essential objective of the corresponding Commission program elements.

D. PROGRAM ELEMENTS NOT REQUIRED FOR COMPATIBILITY An Agreement State has the flexibility to adopt and implement program elements based on those of the Commission (other than those identified in A, B, and C above) or other program elements within the State's jurisdiction that are not addressed by NRC.

35

All,program elements of an Agreement State relating to agreement material should:

Be compatible with those of the Commission (i.e., should not create conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis);

Not preclude, or effectively preclude, a practice 3 in the national interest without an adequate public health and safety or environmental basis related to radiation protection; or Not preclude, or effectively preclude, the ability of the Commission to evaluate the effectiveness of the NRC and Agreement State programs for agreement material with respect to protection of public health and safety.

E. AREAS OF EXCLUSIVE NRC REGULATORY AUTHORITY These are program elements that address areas of regulation that cannot be relinquished to Agreement States pursuant to the AEA or provisions of Title 10 of the Code of Federal Regulations. However, an Agreement State may inform its licensees of certain of these NRC provisions through a mechanism that is appropriate under the State's administrative procedure laws as long as the State adopts these provisions solely for the 3

• Practice" means a use, procedure, or activity associated with the application, possession, use, storage, or disposal of agreement material. , The term "practice" is used in a broad and encompassing manner In this Policy Statement The term encompasses both general activities Involving use of radioactive materials such as Industrial and medical uses and specific activities within a practice such as Industrial radiography and brachytherapy.

36

purposes of notification, and does not exercise any regulatory authority pursuant to them.

SUMMARY

AND CONCLUSIONS To foster and enhance a coherent and consistent nationwide program for the regulation of agreement material, the Commission encourages Agreement States to adopt and implement program elements that are patterned after those adopted and implemented by the Commission. However, the fact that an Agreement State's program is compatible with that of the Commission does not affect that State's obligation to maintain an adequate program as described in this Policy Statement.

By adopting the criteria for adequacy and compatibility as discussed in this Policy Statement the Commission will provide Agreement States a broad range of flexibility in the administration of individual programs. In doing so, the Commission allows Agreement States to fashion their programs so as to reflect specific State needs and preferences, recognizing the fact that Agreement States have responsibilities for radiation sources in addition to agreement material.

The Commission will minimize the number of NRC regulatory requirements that the I

Agreement States will be requested to adopt in an identical manner to maintain compatibility.

At the same time, requirements in these compatibility categories will allow the Commission to ensure that an orderly pattern for the regulation of agreement material exists nationwide.

The Commission believes that this approach achieves a proper balance between the need for Agree, nent State flexibility and the need for coordinated and compatible regulation of 37

agry9ement material across the country.

I PAPERWORK REDUCTION ACT STATEMENT These final policy statements do not contain new or amended Information collection I

requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Existing requirements were approved by the Office of Management and Budget, approval number 3150-0183.

PUBLIC PROTECTION NOTIFICATION The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB control number.

38

SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACT In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has detennined that this action is not a major rule and has verified this detennination with the Office of lnfonnation and Regulatory Affairs of 0MB.

Dated at Rockville, Maryland, this /21 -rJi..- day of August, 1997.

For the Nuclear Regulatory Commission.

ission.

39

State of Kansas DOCKETED Joan Finney Governor ustrnc 95 JAN 13 P2 .z 4 Department of Health and Environment Robert C. Harder, Secretary January 5, 1995 **-_,,,.~

DOCKET NUMBER p --.. . . __ _

PROPOSED RULE ffi\~c...

Samuel J. Chilk, Secretary

(_sq r~310. 69)

Office of the Secretary of the Commission Nuclear Regulatory Commission Attention: Docketing and Services Branch One White Flint North Building 11555 Rockville Pike Rockville MD 20555

Dear Secretary Chilk:

In response to the call for comments on the Commission's draft statement of policy on adequacy and compatibility for Agreement States.

The State of Kansas has enjoyed a very productive relationship with NRC since 1965 when the agreement was signed and hopes to continue that joint program. The draft policy as proposed, however, contains provisions which would be disruptive:

1) The redefinition of the term compatibility to mean essentially "identical to NRC."

2) The treatment of states as something other than co-regulators.

The Atomic Energy Act (ATA) Agreement States program has clearly been one of cooperation with the States in the formulation of standards to assure that States and Commission programs 11 * * *

• will be coordinated and compatible. " It has not been one where NRC established standards which the states must or shall adopt in identical form. This has been a strong part of the program because it allowed the states to develop unique approaches, some of which NRC later adopted.

It is suggested that the policy statement and the companion umbrella policy be referred to the Organization of Agreement State's (OAS) for review and recommendations. The OAS's goal should be to develop a policy document which -permits flexibility for Agreement States to negotiate and develop individual state programs which still maintain compatibility with NRC programs.

,FEB 2 4 1995 900 SW Jackson Street, Suite 620, Topeka, KS 66612-1290 Acknowledged by card ..........................- "fttepbone: (913) 296-0461 Fax Number: (913) 296-1231 Printed on Recycled Paper

u.S. tJUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date # - -----

Copies Received_....__ _ _ _ __

Adct'I Copies Reproduced ____;o Special Distri~tion '31?e 1 &ft:;6,

If the proposed draft compatibil i ty language is adopted and implemented, the burden on the States will be significantly increased. The additional recordkeeping and reporting is also significant. If funding is not included, this becomes another unfunded federal mandate. Federal funding is imperative if the States are to provide NRC with the program additions and data collection being requested in the policy statements.

The Commission's focus should continue to be the evaluation of adequacy of state programs to protect health, safety, and the environment and the way the State chooses to meet that goal need only be compatible (identical or essentially identical) in those instances such as interstate transportation of radioactive materials where compatibility is needed to avoid conflict with the free flow of interstate commerce.

I hope you will give serious consideration to these concerns.

Sincerely,

Saif Francis Hospital DOC .ETl: ~t,CL-1~ I'"' Ptlk--:

s'e-D

• 95 J~N i 2 1\1 1 :45 C. LI h1 November 17, 1994 rJ 1* 1

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Mr. Richard L. Bangart, Director DOCKET NUMBER Office of State Programs PROPOSED RULE...;;..;;.::;..............,_

U.S. Nuclear Regulatory Commission ( ::f\ ~R.31~~H)

Washington, D.C. 20555

Dear Richard:

Thank you for inviting me to participate in the NRC's Workshop on Adequacy and Compatibility. I was honored to serve. I think you, Cardelia Maupin, and Paul Lohaus did a good job in presenting your ideas. I hope the Workshop was of some value in your important and difficult undertaking. If I can be of additional service please let me know.

I wrote other panel members to express my enjoyment in working with them and to encourage them to give you their written perspectives. I enclosed a copy of the letter I sent to each. In my letter to them I detailed the same thoughts I wish to submit to the NRC as a Comment. These are given below.

There is a great need for a definition of "public health and safety" that would serve as a guide for Federal (and State) regulations developed under "public health and safety" enabling legislation. This fundamental requirement is extremely important and quite urgent. Possibly an appropriate convening body could be assembled quickly to address this matter. For consideration, I would suggest CIRRPC.

I think that there are strong arguments that can be made for identical regulations in some areas. These indude areas of:

1. Interstate commerce,

2. Terminology, and

3. Dose limits and release limits.

At the workshop there appeared to be near consensus on tne first two. The third had wide support, but there were significant and persuasive arguments against identicalness here. I thought the best arguments were that this meant Part 20 and I

other parts of 10 CFR must be represented identically in State regulations. Some

"{

were opposed to this (or, at a minimum, thought some Parts, or sections thereto,

~fEB 2 4 1995 A kn I 6161 South Yale Avenue FOll!ded by The C ow edged by card ........................... ...J.~lsa, Oklahoma 74138 WOiiam It Warren Foundation 918 494-2200

U.S. NUCLEAR REGULATORY COMMISSIOM DOCKETING & SERVICE SECTK)N OFFICE OF THE SECRETARY OF THE COMMISSION Document Statislicl Postman< Date ~.Q.,a),L..wip:i.c:acr:.....;;;;11;..._

Copies Recei Add'l Copies Re Special DistJ;ibuti

Mr. Richard Bangart November 17, 1994 Page2 were not candidates for identical treatment). The second argument was that this would minimize the ability of States to promote radiation safety through minimizing, eliminating or modifying certain practices. Shallow land burial was given as an example.

I think that these are very good arguments but that they address questions different from whether or not there should be a reasonable an~ identical set of dose limits and release limits across the country. I strongly support such limits because I think this gives the people of the United States the widest opportunity to receive the wonderful benefits of radiation and radioactive materials while assuring the greatest value for our limited public health and safety dollars.

On a more global note, an identical set of reasonable national dose limits and release limits move us one step closer to uniform treatment of all radiation and radioactive materials, not just byproduct and special nuclear materials. It also starts us down a path of addressing the unreasonable fear of radiation that exists among the public and even some scientists and legislators. Radiation is run the terrible cancer killer some fear. Even the large acute radiation exposures at Hiroshima and Nagasaki resulted in only a few percent of exposed people contracting radiation induced cancer. Natural cancers occur in over 30% of the people. Radiation induced cancer has never been identified at low radiation doses (say about 0.1 Sv (10 rads]). It is unfair to let our people live in fear of something that we know can be effectively regulated and used and enjoyed safely. We, as scientists, must come to some consensus regarding dose limits and release limits before we can hope to address unreasonable fears among other groups. We must assure that we do not play to, nor promote, these fears for personal gain.

Perhaps concerns about the requirements of state regulations being identical to parts of 10CFR and the fear of the loss of State control over certain practices can be addressed elsewhere. Though Part 20 and other parts of 10 CFR would likely comprise the acceptable standard in the short run, a longer term solution might use parts of 10 CFR as a starting point in the creation of reasonable national standards for radiation protection involving input from the States, EPA, FDA and others. In addition, possibly the States could maintain the right to eliminate any practice within their boundaries that did not affect interstate commerce. If a practice was allowed, however, national dose limits and release limits would act as the standard.

Mr. Richard Bangart November 17, 1994 Page3

• I found the *compatibility criterion* (#4 Appendix C) of assisting the Commjssjon in evaluating effectiveness to be particularly troublesome. As defined, this criterion would allow the NRC to indiscriminately impose a compatibility requirement on any regulation. No court would find against the NRC based on the wide latitude of this definition. For example, this would be the criterion under which the NRC would require States to be compatible with (identical to) the medical (Part 35) Quality Management Rule.

This is not to suggest an intent to abuse by the NRC, but merely to point out that this criterion effedively make findings of compatibility a discretionary fundion of the NRC. To address this possible offense, I would suggest for consideration that Criterion #4 be modified to require assisting the Commission in evaluating effectiveness only in matters of 1) interstate commerce, 2) terminology, and 3) dose limits/release limits.

Richard, thanks again for inviting me to participate. I look forward to working with you and your people on this matter and other important issues.

Sincerely, n, Ph.D., J.D.

Director, Biomedical Physics DSG/jml xc: Cardelia H. Maupin PaulH. Lohaus Martin. G. Malsch

Slitt Francis' Hospital November 17. 1994 Mr. Richard D. Dicharry, President SPEC, Inc.

113 Teal Street St.Rose, LA 70087

Dear Donnie:

I enjoyed working witt, you as a panel member at*the AK:ent NRC Workshop on Adequacy and Compatibility. Hopefully, some value came from the meeting. The primary thoughts that I came away wfth are given below.

There is a great need for a definition of *public health and safety" that would serve as a guide for Federal (and State) regulations developed under *public health and safety" enabling legislation. This fundamental requirement is extremely important and quite urgent. Possibly an appropriate convening body could be assembled quickly to address this matter. For consideration, I would suggest CIRRPC.

I think that there are strong arguments that can be made for identical regulations in some areas. These indude areas of:

1. Interstate commerce,

2. Terminology, and

3. Dose limits and release limits.

At the workshop there appeared to be near consensus on the first two. The third

• had wide support, but there were significant and persuasive arguments against identicalness here. I thought the best arguments were that this meant Part 20 and other parts of 10 CFR must be represented identically in State regulations. Some were opposed to this (or, at a minimum, thought some Parts, or sections thereto, were not candidates for identical treatment). The second argument was that this would minimize the ability of States to promote radiation safety through minimizing, eliminating or modifying certain practices. Shallow land burial was given as an example.

1111 Scull Yale Awenue FOlllded by The r-. Otlllloma 1114"*2200 74138 w*m 1t Warren Foundation

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November 17, 1994 Page2 I think that these are very good arguments but that they address questions different from whether or not there should be a reasonable and identical set of dose limits and release limits across the country. I strongly support such limits because I think this gives the people of the United States the widest opportunity to receive the wonderful benefits of radiation and radioactive materials while assuring the greatest value for our limited public health and safety dollars.

On a more global note, an identical set of reasonable national dose limits and release limits move us one step doser to unifonn treatment of an radlatiot;1 and radioactive materials, not just byproduct and special nudear materials. It also starts us down a path of addressing the unreasonable fear of radiation that exists among the public and even some scientists and legislators. Radiation is nm. the terrible cancer killer some fear. Even the large acute radiation exposures at Hiroshima and Nagasaki resulted in only a few percent of exposed people contracting radiation induced cancer. Natural cancers occur in over 30°k of the people. Radiation induced cancer has never been identified at low radiation doses (say about 0.1 Sv

[10 rads)). It is unfair to let our people live in fear of something that we know can be effectively regulated and used and enjoyed safely. We, as scientists, must come to

• some consensus regarding dose limits and release limits before we can hope to address unreasonable fears among other groups. We must assure that we do not play to, nor promote, these fears for personal gain.

Perhaps concerns about the requirements of state regulations being identical to parts of 10 CFR and the fear of the loss of State control over certain practices can be addressed elsewhere. Though Part 20 and other parts of 10 CFR would likely comprise the acceptable standard in the short run, a longer term solution might use parts of 10 CFR as a starting point in the creation of reasonable national standards for radiation protection involving input from the States, EPA, FDA and others. In addition, possibly the States could maintain the right to eliminate any practice within their boundaries that did not affect interstate commerce. If a practice was allowed, however, national dose limits and release limits would ad as the standard.

I found the *compatibility criterion* (#4 Appendix C) of assisting the Commjssjon io evaluating effectiveness to be particularly troublesome. As defined, this aiterion would allow the NRC to indiscriminately impose a compatibility requirement on any

November 17, 1994 Page3 regulation. No court would find against the NRC based on the wide latitude of this definition. For example, this would be the aiterion under which the NRC would require States to be compatible with (identical to) the medical (Part 35) Quality Management Rule.

This is not to suggest an intent to abuse by the NRC, but merely to point out that this criterion effectively make findings of compatibility a discretionary function of the NRC. To address this possible offense, I would suggest for consideration that Criterion #4 be modified to require. assisting the Commission in evaluating effectiveness only in matters of 1) interstate commerce, 2) terminology, and 3) dose limits/release limits.

You may or may not see the issues as I see them. I have detailed my perspective primarily to stimulate thought. I encourage Y(?U to give the NRC the benefit of your written perspectives. The NRC must have thought we had something to contribute when we were asked to participate. I am eager to see that the NRC receive as much input as possible in this important matter.

I look forward to working with you again some time.

Sincerely, David S. Gooden, Ph..D., J. D.

Director, Biomedical Physics DSG/jml

3M Health Physics Services 3M Center, Building 220-3W-06 St. Paul, M 55144- 1000 6 12 736 0498 612 736 2285 Fax DOCKETED U RC DOCKET NUMBER p C/5 @-

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• Secretary, U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Services Branch

Subject:

Comments on NRC "Adequacy and Compatibility for RC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy" published in Federal Register Volume 59, No. 139 pp 37269-37274.

Dear Sir or Madam:

Introduction Following are 3M comments on the propo ed draft statement of policy. These comments are based on our corporate wide radiation safety program which is associated with the use of commercially available gauging ystems containing sealed sources of radioactive material. Although most of these devices are authorized for use as generally licensed devices, 3M has chosen to specifically license their use in 3M facilities. This provides both greater control and more flexibility in the use of the gauges. We are presently authorized to use these gauges in accordance with NRC byproduct material license 22-00057-03 and 17 individual licenses in agreement states.

3M Program At its headquarters, 3M has a health physics staff which is responsible for establishing and maintaining a corporate wide program for ali 3M facilities. The staff includes nine individuals having academic degrees in health physics, six of whom are certified by the American Board of Health Physics. An additional staff member who performs internal auditing functions, has health physics experience from the U.S. Navy and specialized training in quality control. Health Physics Services also has a well equipped laboratory which is staffed with two technicians who have many years of experience working with radioactive materials.

Comments The draft policy addresses, in a very general way, adequacy and compatibility issues for NRC and agreement state radiation control programs. However, it does not deal with the ifEB 2 4 1~95 Acknowledged by card ...............................~

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USNRC Page2 December 27, 1994 specific issues which are troublesome to licensees who conduct business in both non-agreement and agreement states. For example, the draft policy does not mention training for users of radioactive materials in terms of either adequacy or compatibility. To illustrate how an undefined issue can become a problem, the following paragraphs summarize our experience with training.

Our NRC license allows 3M Health Physics Services staff to use radiation survey instruments to perform radiation surveys, to perform leak tests, to perform source removals in selected gauges and to supervise installation, relocation and removal of gauges from service. It also allows the Health Physics Services staff to train individual facility radiation safety officers (RS Os) to perform all the same functions except source removal. This training consists of an initial intensive 16 hour1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> training course which in addition to lectures gives the RSO "hands-on" experience with survey meters and typical gauges. This is supplemented by a Health Physics staff member visiting an RSO's facility and providing several more hours of training which is specific to the gauges used there.

In addition, 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> of refresher training is provided every three years. All training takes into account information received from the gauge vendors by Health Physics Services staff members.

In recent licensing actions in two agreement states the 3M Health Physics Services staff has been authorized to perform the functions stated above. However, the Health Physics Services' training program for facility RSOs has not been accepted to permit our facility RSOs to perform the same functions as those permitted by RSOs in non-Agreement States. Both agreement states have informed us the only training programs they will accept for RSOs are those provided by the gauge manufacturers. In discussing this matter with gauge manufacturers, we have learned that their radiation safety training is not as extensive and thorough as that provided by 3M and that their programs are designed for explaining maintenance functions, not radiation safety. In these two situations the lack of adequacy and compatibility criteria has led to what appears to be arbitrary decisions which involve less radiation safety training for RSOs, increased costs to 3M and no value added service.

Although we have used training as an example of an adequacy and compatibility issue between non-agreement states and agreement states, another matter which should be addressed is the adequacy and compatibility within the regulations themselves. To illustrate, general licensees are exempt from having to perform receipt radiation surveys on generally licensed devices. However, licensees receiving the same generally licensed devices under a specific license are required to perform receipt surveys.

USNRC Page3 December 27, 1994 Summary & Recommendation We have identified two matters which we believe should be addressed by the NRC in its deliberations concerning adequacy and compatibility between NRC and agreement state radiation control programs. We encourage the NRC to address these as well as others in an effort to promote consistency in NRC and agreement state licensing and regulations.

J/fdJ~

Robert G. Wissink, Manager Health Physics Services nrcagrst.doc

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• 94 Off 28 P5 l 2 Amersham Corporation 40 North Avenue Burlington, MA 01803 tel (617) 272-2000 tel (800) 225-1383 21 December 1 994 fax (617) 273-2216 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Compatibility of Agreement States Program with USNRC Programs

Dear Secretary,

I am writing to you on behalf of Amersham Corporation's Burlington Massachusetts facility in response to your call for comments on the above policy statement.

Amersham Corporation's Burlington, MA., facility is primarily responsible for the manufacture, service, and distribution of Radiography Sources, Exposure Devices, and accessories. We support a nation wide, as well as world wide, customer base, which requires our knowledge and involvement in virtually all Agreement State and NRC programs that relate to industrial radiography.

Our comments pertaining to various aspects of the compatability issue are given below.

We feel that a uniform and comprehensive national approach or policy to radiation safety matters is very important. A national approach needs to be developed for the core requirements for radiation safety in order to protect the general public and radiation workers. This set of core requirements should be established by a group of experts made up of NRC personnel, Agreement State personnel and the regulated community. Some of the practical reasons for having a uniform approach include:

- Our experience with the distribution of NRC approved sources and devices clearly demonstrates the complexities involved in dealing with differing regulations among Agreement States . Our 6608 System was the first radiography device to be approved by the NRC in compliance with the new 10 CFR Part 34 regulations. In spite of this we had difficulty shipping this product to customers in many of the Agreement states because of their independent programs. A significant effort from our regulatory group was ffEB 2 4 1995 Acknowledged by card ................................

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required to resolve this situation.

- License verification is a particularly costly and time consuming effort due to the many variations among the NRC, and different state programs.

- As a manufacturer we find it difficult to discontinue the manufacture of certain products that the NRC no longer considers compliant, since most Agreement State programs still consider them to be acceptable. This allows certain devices and source assemblies to conti nue to be used even though there may be more up to date NRC compliant alternatives. This makes it difficult to obsolete old designs.

- With the NRC's cost recovery program, we have experienced a substantial increase in our regulatory costs. Companies located in most Agreement States benefit from a much less severe financial impact, and in fact benefit from the fees that we pay as they support Agreement State activities.

- Several specific issues for industrial radiography licensees highlight the unfair competition that can result from inconsistent rulemaking:

- NRC requires one person radiography teams, while many Agreement States require two person teams to perform the same work.

- Training and certification of industrial radiography needs to be uniform since radiographers frequently perform procedures at temporary job sites in several different NRC or Agreement States. With the use of the high activity sources in radiography, t here need to be a consistent minimum of train ing and enforcement.

- We have experienced different standards for review of device and sealed source registrations between Agreement State and NRC. This has resulted in additional testing, documentatio n, and costs.

In addition, some specific comments on the proposed policy and discussion from the workshop held in Washington, DC on 15 November 19941 are given below.

B. Elements of an Adequate Program Regulations The regulations in 10 CFR part 21 should be listed as being necessary for Agreement states to ad opt. Part 21 requires certain notifications to a regulatory agency if a defect exists in a product containing licensed material that could create a substantial safety hazard. As this applies to all distributors of radioactive material to ensure the safety of the general public it should be a requirement for all Agreement states, yet

it is not required.

Enforcement Enforcement criteria differ from state to state, this results in significant disparities in fines imposed and actions allowed against individuals.

Staffing We have seen significant differences in personnel qualifications between NRC and the Agreement states, with NRC having the best qualified personnel in most cases. This is a result of the money available to pay regulatory personnel and the states with the most money tend to have the most qualified personnel. This aspect of adequacy needs to be addressed to ensure that the state can competitively hire qualified personnel and keep them on staff.

Licensing For products containing radioactive material the regulations dealing with interstate commerce must be identical and not just have a high degree of uniformity, for the reasons listed above.

D. Compatability Criteria

1. Avoids a significant burden on interstate commerce, should be more descriptive, ie all product standards should be identical and implemented simultaneously. We have experienced problems with the various requirements for radiographic equipment as the states have not adopted these simultaneously with the NRC rules. This has caused difficulties as equipment that is not authorized in one state can legally be used in another state. This requires us to always be knowledgable of when the states change their regulations. This is very difficult in most states as the mechanisms for new and proposed rulemaking is not readily apparent to licensees not located within that state. In the interest of public health and safety equipment standards should be identical if the product is to be used in different states.

The flexibility allowed for an agreement state that do not meet the described criteria will create more problems for interstate commerce. This flexibility has resulted in the incompatible programs that we are now dealing with. If this is allowed, then governing standards including, but not limited to, those for equipment and devices, certification, training, and time frames for implementation, must be made more comprehensive and stringent.

However, we are most in favor of a uniform, comprehensive, national program. From a radiation safety standpoint, it is difficult to imagine any area of radiation protection and control that should need to allow significant variance from a national set of approved guidelines.

As we have described in the sections above, we do not feel it is reasonable to allow significant flexibi lity from a national program. Not only is such flexibility difficult to work with, it also gives mixed signals to radioactive material users and the general public.

Some areas that the Agreement states should adopt similar rules or practises include the following:

New Rule Making-We feel that the current NRC process for proposed and final rulemaking is benefi cial to the licensees and the regulators. However it is difficult for a licensee operating in many different Agreement states to learn of proposed changes in the regulations . There needs to be a more consistent approach in how regulatory changes are made and how affected licensees are notified. This would increase the level of complia nce with the regulations, as affected licensees would be aware of the regulatory requirements and could make the necessary changes.

Sealed Source and Device Reviews There needs to be a consistent unifrom approach to the technical and safety review of products contain ing radioactive material being distributed throughout the United States. The staff performing these reviews has to be technically competent in many disciplines ie engineering, health physics, Over the years, Amersham Corporation has learned to work with over thirty different regulatory programs relating to industrial radiography. In some cases we have found certain Agreement State programs easier to deal with than the equivalent function in the NRC, in these cases, the smaller groups at times can process registration or licensing procedures more quickly. However, the significant administrative effort required to interact with the various programs, as well as the periodic financial/competitive advantages or disadvantages that arise, combine to support a uniform and comprehensive national approach to radiation safety matters.

If you require additional information, or would like to discuss this f urther, please give me a call. I can be reached at (617) 272-2000 extension *210.

Cathleen Roughan Regulatory Affairs Ma

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2 Edwin W. Edwards Governor Secretary U. S. Nuclear Regulatory Commission Washington, D.C. 20555 9 ATTN: Docketing and Services Branch RE: Comments on Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs; Draft Statement of Policy 59, Federal Register, Page 37269 and Comments on Draft NRC Agreement State Policies 59, Federal Register, Page 40058.

Dear Sir:

Thank you for the opportunity to comment on "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety" and the "Draft Policy Statement on Agreement State Program."

As you are aware, the Agreement State Program came into being during a time

• of strong States' Rights sentiment, especially in the south. In fact, Louisiana 's own agreement was delayed because of a dispute between the state and federal government over offshore oil revenues, and a supplementary agreement was executed. Suffi ce it to say, however, in the agreement, each party agreed to exercise its best efforts to be compatible with the other . This implies a partnership between the NRC and state, but unfortunately, there seems to be more of a one-way street in recent years. For additional back-ground, your consideration of the Topical Discussion of the NRG/Agreement State Program, prepared this year (1994) under the direction of G. Wayne Kerr for the Organization of Agreement States, is recommended.

It is important to establish, in writing, the agreement state program principles and describe the respective roles and responsibil iti es of the NRC and states in the administration of this program. Likewise , the clar i f ication of the meaning and use HEB 2 ~ 1995 Acknowledged by card ...............................~

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of the terms "adequate" and "compatible," as applied to the Agreement State Program, is a necessary action. However, upon review of the documents it appears that there are other terms that require clarification of their meaning and use. The first that comes to mind is the concept of a "larger national interest in radiation protection" or "overall national program for radiation protection."

An "overall" national program for radiation protection should take into consideration the total radiation exposure to the public including machine made radiation, naturally occurring radioactive material and accelerator produced radioactive material. It might be argued that any effort to evaluate a program's adequacy to protect publ i c health and safety should consider all of these activities.

- It also might be argued that if a state diverts resources because of the stigma attached to being "declared" inadequate or not compatible and allows this to take resources from other activities such as diagnostic x-ray inspections, the "overall" national program for radiation protection is being affected.

There is, and rightly so, an argument for consistency in basic radiation protection standards, such as dose limits and release limits as put forth in the draft documents. It may be that the largest source of inconsistency in basic dose limits in radiation protection standards i s not between the NRC and the agreement states but among federal agencies. The logical place to begin in an attempt to define the national radiation protection program would be by obtaining agreement among the federal agencies and states as to the basic dose limits.

The phrases "adequate to protect public health and safety" and "acceptable level of protection for the public health and safety" are not defined. It is suggested that with input from the agreement states, these be defined, so that we do not find ourselves in the same debate over these phrases as we now do over the terms "adequate" and "compatibl e."

In addition, the phrase "considered necessary by the commission,"

appears in several places. It seems that the spirit of Section 274 of the Atomic Energy Act is one of cooperation and consul-tation . Perhaps this should be revised to read, "considered necessary by the commission and the agreement states." There is much expertise in the agreement states that may be of value in addressing the "overall" national program for radiation protection.

It is suggested that the commission reconsider the proposed "marginally adequate" category of findings. Instead, states

should be either found adequate or inadequate, compatible or not compatible, and these determinations should be based upon elements considered necessary by the commission and the agreement states to effectively implement a radiation protection program.

'Any evaluation of a state radiation protection program should also be made in light of the fact that there are other radiation-related responsibilities and when the NRC requires a state to be essentially identical without factoring in these other responsibilities, the effectiveness of the "overall national program for radiation protection may be impacted. One example of this is the frequency of inspections. The minimal inspection frequency, including initial inspection, should be no less than the NRC inspection frequency. To the best of our knowledge NRC inspection frequencies are established without consideration of the other types of inspections an agreement state may have to conduct, such as diagnostic x-ray. We are not suggesting that inspection frequency is not an important aspect of an adequate and compatible program, but when the frequency of inspections is being established, the NRC should consult with the agreement states so that other inspection needs may be factored into any decisions.

Thank you for this opportunity to comment.

Very truly yours,

~w~

Ronald L. Wascom, Deputy Secretary Office of Air Quality and Radiation Protection

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• 94 Off 27 P6 :48 Jim Warren, Executive _Director 2009 Chapel Hill Road P.O. Box 61051 Durham, NC 27715-1051 OFFIC ,.. :-- SECRETARY Telephone and Fax: (919) 490-0747 DECEMBER J.l){}C ~41 " ,~ ~:rRVICE BRt, lCH SECRETARY OF THE COMMISS ION U.S. NUCLEAR REGULATORY COMMISSION DOCKET & SERVICE BRANCH WASHINGTON, DC 20555 RE: COMPATIBILITY OF AGREEMENT STATE PROGRAMS I REQUEST THAT YOU EXCEPT THESE COMMENTS AS PART OF THE FORMAL RECORD ALTHOUGH THE OFFICIAL COMMENT PERIOD HAS EXPIRED.

YOUR -DRAFT POLICY STATEMENT ON AGREEMENT STATE ADEQUACY AND COMPATIBILITY SHOULD BE REJECTED FOR VARIOUS REASONS. PRIMARILY; THE VERY NOTION . OF USURPING CONTROL REGARDING HEALTH _AND SAFETY FROM LOCAL CITIZENS IS ENTIRELY .UNACCEPTABLE. LOCAL AND STATE GOVERNMENTS HAVE AN . INHERENTLY HIGHER LEVEL OF IN'l'EREST AND

• RESPONSIBILITY -FOR THEIR CITIZENS THAN. DOES A FEDERAL BUREAUCRACY WHICH IS BY NATURE * 'DISTANT FROM THE AFFECTED PARTIES BOTH _

. PHYSICALLY AND .IN TERMS OF ACCOUNTABILITY. LOCAL CONTROL ENSURES CITIZENS :THE RIGHT AND RESPONSIBIL°ITY TO. REGULATE THEIR DESTINY.

ALSO, . THE *TIMING OF THE PROPOSED CHANGES SEEMS CAPRICIOUS.

NATIONALLY, THE COMPACT SYSTEM rs . TEETERING, WHICH PUTS ADDITIONAL PRESSURE ON COMMUNITIES WHICH ARE FACING THE PROSPECT OF .A "LOW-LEVEL" DUMP. .

• YOUR

• DRAFT'S REFERENCE TO "INTERSTATE COMMERCE" IS EXTREMELY CONCERNING IN LIGHT OF THE PROFANE USE OF THAT JUSTIFICATION BY THE WASTE INDUSTRY TO . FORCE .MASSIVE CHEMICAL AND SOLTIY"'W.ASTE ~DFILLS ON NUMEROUS -C0MMUNI41.'lES,--ESPJre-I-ALLY IN THE SOUTH. IT IS CLEAR TliAT YOUR PROPOSAL WOULD . INCREASE THE LIKELIHOOD THAT OUR STATE WOULD BECOME A NATIONAL DUMP SITE FOR RADIOACTIVE WASTE.

WE HAVE RECENTLY SEEN THE FEDERAL GOVERNMENT FORCING HIGH LEVEL FUEL RODS ON SOUTH CAROL'rNA. FOR .THOSE WHO WOULD ARGUE THAT THE COMPACT LAWS WOULD PROTECT NORTH CAROLINA FROM WASTE FROM OUTSIDE THE EIGHT STATES, I WILL QUOTE THE DIRECTOR OF THE NC DIVISION OF RADIATION PROTECTION, . WHO HAS CALLED THE PROTECTION OF THE EIGHT STATE COMPACT "VERY THIN". .

_LOCAL CITIZENS HAVE THE RIGHT TO PROTECT THEMSELVES TO THE FULLEST EXTENT THEY DEEM NECESSARY. YOUR PROPOSAL TO CHANGE THAT FURTHER DAMAGES OUR TRUST IN THE FEDERAL BUREAUCRACY.

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Comments on NRC Draft Statement of Policy on Adequacy and Compatibility for NRC and Agreement State Programs Necessary to Protect Public Health and Safety 59 FR 139; 37269-37274, 7/ 21/94 December 19, 1994 The Nuclear Information and Resource Service supports the authority of state and local governments to set stricter (more protective) than federal standards for radiation protection of the public, workers and the environment.

This authority should not be contingent upon state or local governments having to prove the inadequacy of federal standards or proving that there is "an adequate public health and safety or environmental basis" for their provisions. Such unnecessary legal thresholds could cost state and local governments undue technical and litigation expenses. The authority to set stricter than federal standards should be unconditional, clear, independent and unaffected by potential determinations that. the local or state provisions i*preclude or effectively preclude a practice within the national interest."

In a free market economy, the* entity applying for a license to carry out a practice should be fully responsib]e for meeting the local, state and federal regulations. If it meets federal standards, but cannot meef the standards of public, worker and environmental protection in a given state or locality, it can revise its operations to meet those requirements or move to another locality with less stringent standards. The federal government does not have the right to preempt state and local governments (that go to the trouble of setting stricter standards) by forcing states/localities to accept facilities that contaminate at higher levels than the state/community is willing to accept:

The federal government does not have the right to force localities to accept higher levels of radioactive contamination or involuntary risks; but) l_iis draft policy would have that effect. NIRS opposes these provisions of the proposed policy.

From the liability and health perspective, the local and state governments and residents will effectively bear the risks (no matter how great or small). There is no reason to preempt those entities from protecting themselves, fiscally and radiologically, to a greater extent than the federal regulations.

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The "low-level" radioactive waste siting efforts which will essentially shift liability for "low-level" radioactive waste from generators to dumpstates are clear examples of situations in which states should be free to set stricter standards than federal. Some state and local governments, in unison with their citizens, are requiring stricter-than-federal standards (less radioactive leakage and lower dose than NRC allows, prohibitions on burial in soil trenches, etc.). Many environmental and governmental-organizations believe that state and local governments have the power to set more protective standards. This proposed policy is a an attempt by NRC to make preemption a fait-a-compli, in an era when it is completely unjustified.

On the other hand, it is incumbent upon the NRC to prevent any facilities from operating at less protective than federal standards. Agreement States must be prohibited from setting weaker (less protective) than federal provisions for public and worker health and safety and environmental protection, for public participation in licensing and rulemaking and for access to information.

The NRC should enforce its own standards, if more stringent, and such licensees should comply with the standards and procedures providing greater hearth and environmental protection and public participation (such as an adjudicatory hearing in licensing of facilities).

Similarly, as the NRC moves ahead setting its ERORR (Enhanced Rulemaking on Residual Radioactivity) standards for decommissioning, clean-up and radioactive deregulation (BRC by

.its new name), and attempts to involve local communities in Site-Specific Advisory Boards, it appears disingenuous to be preempting local authority in this proposed policy.

State and lo~al struggles against the NRC's BRC (deregulation ofradioactive waste, materials, emissions and practices) policies resulted in Congressional revocation of those NRC policies.

Now this NRC draft policy would essentially preempt state and local governments from providing greater protection the health and safety of their citizens. This is apparent in the "Criteria for Compatibility" which would require state standards to be "essentially identical" to NRC if they involve:

1) radiation dose limits and release limits in 10 CFR 20 and 10 CFR 61, the regulations setting allowable contamination of air, water, workers, the public and land disposal facilities.

NIRS opposes this criterion.

• 2) interstate commerce, even though the big carrot (for states to join compacts) in the "Low-Level" Radioactive Waste Policy Act is touted as states' exemption from and authority over the Interstate Commerce Clause of the Constitution. Now, NRC is reaffirming its existing policy that all state regulations involving interstate commerce be "essentially identical" to the NRC federal regulations. NIRS opposes this criterion;

3) radiation protection terminology

4) assisting NRC in evaluating effectiveness of the overall national radiation protection program.

According to these criteria, states may set stricter-than-NRC standards only when they do not apply to the above four compatibility criteria AND they "do not preclude or effectively preclude a practice within the national interest without an adequate public health and safety or

environmental basis." This sets a much higher legal threshold for local and state governments, which could result in expensive local litigation.

The first criterion essentially forces states to allow contamination of air and water, workers and the public at unenforceable levels set by the NRC. It is an attack on the backbone of environmental and human health protection. NRC has recently increased the allowable concentrations of many radioactive elements in air and water for workers and the public in

. its "new" 10 CFR 20 standards. Clearly states ought to be able to set more protective standards and should not be required to accept higher levels of contamination. In this instance, they would be forced to accept some contamination levels that are higher than NRC had allowed for decades.

As for 10 CFR 61 , many states have challenged the NRC's 100 millirem allowable leak rate and the assumption of shallow land burial. Especially since states will end up liable fotthe sites, they ought to be able to set stricter standards.

NIRS opposes the provision in which local government authority is dismissed, i.e.:

preempted, in a footnote! (59 FR 37273) The limited (potentially meaningless) state authority (allowed under the draft policy) to set stricter-than-federal standards would be denied to local governments, the very entities that will be immediately impacted (in fiscal and health terms). It has always been up to the states how much authority various local jurisdictions have. Now NRC is proposing that localities simply have no authority over radioactivity unless they enter into an Agreement which .would be based on the same troublesome compatibility criteria that apply to Agreement states. NRC is treading on the rights of states regarding state/local jurisdictional authority.

This draft policy threatens state and local government authority to protect the health and safety of their present and future citizens. That authority to set more protective standards must be retained by those governmental entities. This is especially important now as NRC is developing its ERORR Standards, which will permit radioactively contaminated sites to be released from regulatory control and radioactive polluters to be relieved of liability.

NIRS calls on NRC to revise the draft policy to do away with preemption, to require states to meet minimum federal public participation, hearing, and health and safety standards but to respect state and local authority to set more protective standards if they so choose.

DOCKET NUMBERp PROPOSED RULE 0\\SC-DOC KF TE D (59F~-51~9)

US 1(RC NUCLEAR ENERGY I NSTITUTE

• 94 Q[r 22 p J :4alix M. Killar, Jr.

DIRECTOR, MATERIAL LICENSEES PROGRAMS on 1Cl ~-

V oocKEri*, ,

HI\, r December 22, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Services Branch

Reference:

Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy, 59 - Federal Register 37269 (July 21, 1994),

Request for Comments

Dear Sir:

These comments are submitted by the Nuclear Energy Institute (NEI) 1 on behalf of the Nuclear Industry, in response to the U.S. Nuclear Regulatory Commission's (NRC) request for comments, on the draft statement of policy for Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary. to Protect Public Health and Safety. The industry encourages the NRC to aggressively pursue Agreement State status with all 50 states and the District of Columbia.

The industry believes that Agreement States should regulate the users of source and byproduct materials. This is the most effective way to regulate small users and companies.

The NRC should focus its attention on the Part 50, 70, 72, and 76 licensees. It should also continue to license the major material licensees under Parts 30 and 40.

1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry.

lfEB 2 4 1995 Acknowledged by card .........................,"*m 1776 I STREET , NW SUITE 400 WASHINGTON , DC 20006-3708 PHONE 202 .739 8000 FAX 202 785.4019

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTICW OFFICE OF THE SECRETARY OF THE COMMISSION Document Statisticl Postmar1c Date ......L!..!.l..Wlit....l,~ liil'lliWilllli~ -

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N .R. C. Docketing and Services Branch December 22, 1994 Page 2 Based on the review of the proposed policy statement, discussion with our members, and participation in the November workshop on the issue, we have drawn three basic conclusions. First, the NRC needs to clarify the definitions of adequacy and compatibility; we are providing suggestions below. Second, the concept of the Policy Statement is sound; however, without the clear definition of adequacy and compatibility, it may not be effective.

Finally, the NRC needs to clarify how it intends to work with Agreement States, i.e. , is an Agreement State a special form of licensee, or is an Agreement State a comparable regulatory body that the NRC interacts with and overlaps with, similar to the working relationship the NRC has with the Environmental Protection Agency (EPA). Our thoughts on this relationship are discussed below.

The industry believes that the key to the success of the Agreement State Policy lies in the understanding of what is adequate and what is compatible. Licensees expect that no matter who issues the license, i.e., whether it is the NRC or an Agreement State, there should be no change in the level of protection from radiation for the public, workers, or the environment. The core of regulations and terminology which address radiation protection, must be compatible between the NRC and the Agreement State. These regulations should be identical in terms of specific regulatory standards being set, i.e., limit of exposure/dose and use of terminology. However, while it may be desirable, they do not have to be word-for-word, or text-to-text identical. But, they must be exposure-to-exposure or dose-to-dose identical.

The radiation limits and terminology, as established in 10 CFR Parts 20, 61, and 71, must be identical between the NRC and the Agreement State in order to be compatible, assure transparency for a licensee, and ensure that the public has confidence that the standards are appropriate for its protection. This would meet the intent of compatibility criteria in the policy statement, by avoiding burdens on interstate commerce, ensuring uniform definitions and use of fundamental radiation protection terminology, and establishing uniform dose limits and radiation-protection related limits in 10 CFR Parts 20, 61, and 71.

We disagree with the proposal in the compatibility criteria to afford states the flexibility to design their own programs incorporating more stringent requirements. The NRC regulations for radiation protection are established based on recommendations by the National Council on Radiation Protection and Measurements (NCRP) and the International Commission on Radiological Protection (ICRP). These are national and international scientific bodies that develop consensus and provide advice as to appropriate standards for radiation protection. In developing these recommendations, the NCRP and ICRP use very conservative assumptions. Therefore, there are no health and safety reasons to establish more stringent requirements. These conservative standards along with the implementation of the "as low as reasonably achievable" (ALARA) principle clearly provide more than an adequate level of protection from radiation for the public, workers, and the environment. Conversely, because of the inherent conservatism in the NRC limits, if a state would like to establish a less conservative limit specifically for a medical application, the state should be able to do that after consultation with the NRC.

N.R.C. Docketing and Services Branch December 22, 1994 Page 3 For a state program to be adequate, the NRC must be confident that the state program includes all of the functions necessary to fulfill its responsibilities. This program would include; funding, staffing, training, enforcement, record keeping, and reciprocity. The NRC would evaluate the state's program to ensure that the radiation protection levels and terminology are being effectively imposed and enforced.

In the August 5, 1994 Federal Register, the NRC requested comments on how to determine if an Agreement State Program is adequate, marginally adequate or inadequate. The industry believes an Agreement State Program is either adequate or it is not. Once the NRC has granted Agreement State status it is incumbent on the NRC to assure that the state's program remains adequate. The NRC would be able to accomplish this through the same methods used to assure that a licensee continues to operate in a manner that protects the public's and the environment's health and safety. If an Agreement State Program begins to deteriorate, and the state fails to improve its program, it should lose its Agreement State status, and all of the state's licensees would automatically become NRC licensees. This is another reason why it is important that the standards being implemented by the regulatory body be consistent between the NRC and the Agreement States.

Finally, the industry believes that the NRC should work with the Agreement State regulatory bodies as peers rather than licensees. It is important for the NRC to realize that working with the state agency needs to be conducted on a professional government-to-government arrangement. This is similar to the FBI working with state police. They are both working to the same end. The NRC and the Agreement State regulatory bodies are working to the same end - the use of radioactive materials for social benefit, while adequately protecting the health and safety of the public, workers, and the environment.

The policy statement is intended to be broad and all encompassing, however, we would like to point out some specific areas of concern. First, the radiological health and safety standards for the disposal of low level waste should be uniform across the country. Second, when a license is terminated and the site released for unrestricted use by the NRC, there should not be new and different radiation controls imposed by the state. Third, in order to avoid interstate commerce problems, Agreement State programs that issue general licenses must be designed to ensure that reciprocity will be provided. Fourth, the NRC's program for the review, approval, monitoring, and enforcement of radiation protection requirements must be measured against the same variables used in the review of an Agreement State Program. Finally, the NRC should make it clear that this policy statement does not change the provision of federal law that preempts from state regulation the activities performed under NRC licenses for nuclear power reactors and other NRC licensees.

A key NRC objective in establishing a policy for compatibility of Agreement State low-level waste disposal regulatory programs should be the timely development of new disposal facilities. The agency has a sound health and safety based justification for promoting this objective, since permanent disposal of low-level waste is preferable to extended storage at thousands of generator sites throughout the country.

N.R.C. Docketing and Services Branch December 22, 1994 Page 4 The industry believes that, in most cases, it is preferable for Agreement States to closely adhere to the existing technically sound federal regulatory program for low-level waste disposal and that even if a particular proposed state requirement is technically "compatible," the NRC should use its influence and technical experience to work with state officials to minimize disparities between NRC and state requirements. The licensing of new disposal facilities by Agreement States is proving to be a significant institutional challenge. Proposed disposal sites and facility designs are subjected to exhaustive technical, public, political, and legal scrutiny. In this environment, the Agreement State review of low-level waste disposal facility license applications has become a very time-consuming and costly process that requires an extraordinary degree of highly specialized technical expertise.

The above difficulties are exacerbated when states impose various nonuniform low-level waste regulations that deviate from the provisions of 10 CFR Part 61. This ultimately causes further delays in new disposal site development. For instance, state regulations that are supposedly "more stringent" than Part 61 may introduce unwarranted complexity and uncertainty into the licensing process, as a result of the potential need to prove the safety of a proposed site to an unreasonable or unachievable technical standard.

Also, nonuniformity among state low-level waste regulations degrades the public's confidence in state and federal regulatory programs. Differing state standards for disposal facility siting, design, and operations understandably raises questions about whether government regulators really know how to safely control the disposal of low-level waste.

For example, NRC requirements limit a member of the public's radiation exposure from a low-level waste disposal facility to 25 millirem per year. This limit was established as part of an extensive federal rulemaking process involving exhaustive technical review and public comment. However, for members of the public living in Illinois, the applicable Agreement State limit is 1 millirem per year. Not surprisingly, members of the public outside Illinois are likely to wonder why they are subjected to an apparently "lesser" standard. Which regulator is right? Public understanding and confidence in the integrity of the federal regulatory program for low-level waste - an essential ingredient in successful disposal facility siting - is needlessly damaged by such nonuniform regulations.

The industry recognizes, however, that allowing some limited flexibility for Agreement States to depart from the NRC's regulatory program may, in certain cases, advance the development of new disposal facilities. In those cases, flexibility should be permitted.

However, such flexibility can also hinder new site development in many cases, with no commensurate benefit, since existing federal regulatory requirements are already fully protective of public health and safety. Therefore, the NRC's final compatibility policy statement should allow flexibility in the area of low-level waste disposal only on a case-by-case basis, after careful review by the NRC staff in consultation with the Agreement State and other affected parties. Where it is reasonably concluded that allowing flexibility will promote, rather than hinder, overall implementation of the Act, we believe the NRC should permit such flexibility.

N.R.C. Docketing and Services Branch December 22, 1994 Page 5 The industry also believes the NRC should require Agreement State regulations governing manifesting and reporting of radioactive waste shipments to be in accord with the national standard. Nonuniform reporting regulations burden interstate commerce. Waste generators have grown increasingly dependent upon the services of centralized waste processors, located in only a few states, who provide important environmental and economic benefits by reducing waste volumes and enhancing final waste forms. To make use of these services, low-level waste and radioactive materials must be transported across many state and compact boundaries. If each such state and compact were to impose its own manifesting and reporting requirements, shippers, carriers and processors would be adversely impacted. The confusion created by numerous duplicative and conflicting reporting requirements could also jeopardize the objective of reporting requirements in the first place - clear communication of the contents of a shipment. The NRC is presently finalizing its rulemaking intended to establish a uniform manifest system. This rulemaking effort has involved extensive consultation with the states. We urge the NRC to

- ensure that the Agreement States do not depart from this national standard.

Finally, the NRC must assure that Agreement States do not attempt to impose regulatory authority over low-level waste management practices within the exclusion area of Part 50 licensee sites. This is consistent with the position expressed by the NRC staff in October 1994, after reviewing proposed regulations of the South Carolina Department of Health and Environmental Control claiming state regulatory authority over low-level waste storage, characterization, packaging and other practices at NRC-regulated reactor facilities.

Various states have developed, or are considering, regulations that would require state inspection or regulation of reactor on-site storage, treatment or packaging activities, some of which go well beyond federal statutory limitations. Motivated by a desire to either assure the safety of storage activities or to verify compliance with disposal site waste acceptance criteria, states are crossing the boundary between legitimate state regulation and areas that are preempted by the Atomic Energy Act. Such requirements are also technically unnecessary. NRC guidelines on verification of compliance with disposal facility waste acceptance criteria (NUREG 1200, Chapter 4.1) make clear that onsite inspection at generators' facilities is not required to provide adequate assurance that waste acceptance criteria are achieved. We urge the NRC to clearly communicate to all states that they may not regulate such onsite activities.

The Atomic Energy Act and applicable regulations clearly provide that regulatory control over such practices is within the exclusive purview of the NRC. The Low-Level Radioactive Waste Policy Amendments Act grants no additional authority to the agreement states in this regard.

N.R.C. Docketing and Services Branch December 22, 1994 Page 6 The attachment provides responses to the specific questions raised. If you have any questions concerning these comments or the responses to the specific questions, please contact me at 202-739-8126.

Sincerely,

1-~ t;af4J Felix M. Killar, J r.

Attachments

Attachment U.S. Nuclear Regulatory Commission December 22, 1994 Specific Questions for Public Comment

1. Under what circumstances should Agreement States be permitted to establish more stringent requirements, for their licensees, than those established by the Commission? Should this also include the ability to establish stricter dose limits for particular classes of licensees?

Agreement States should have the discretion to establish more or less stringent requirements for licensees in the areas other than the core compatibility areas of terminology, dose and exposure limits, provided the NRC believes these areas are adequately covered and that they do not contradict the terminology, dose and exposure requirements of 10 CFR 20, 61, and 71. The requirements, however, must be uniformly applied. No class of licensees should be treated preferentially with relaxed regulations, nor discriminated against with stricter regulations.

Low level radioactive waste disposal regulations should be reviewed on a case-by-case basis as discussed in the cover letter.

2. Are the four criteria in the proposed policy statement for determining whether a Commission regulation or other program element should be adopted in a manner essentially identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? What examples could be used to illustrate how each criterion would be applied?

Criterion number one needs to be expanded to include 10 CFR 71 terminology, dose, and exposure limits to ensure uniform packaging and transportation requirements are established, which protect public health and safety. The fourth criterion should be deleted.

The example that best illustrates compatibility is the adoption of 10 CFR 20, 61, and 71, verbatim, by the Agreement State. The NRC should review the Agreement State's program to assure it is meeting the intent, if not the letter, of these regulations. The NRC should be looking for any interstate commerce issues raised by the licensees of the state as well as any raised by licensees outside of the state. In addition, the NRC should ensure that the radiation terminology being used by the state and its licensees is consistent with Part 20.

3. What are some examples of State action to establish stricter requirements than those established by the Commission, or establish requirements where the NRG has not?

An example of state actions to establish stricter requirements, or requirements where the NRC has not, is occurring in the area of reciprocity. As an example, a nuclear device that has been approved for use by the NRC, or an Agreement State, is not allowed to be employed in another state without additional certification and justification. Specifically, Illinois approved a device for use and both Texas and Oregon required additional certification and justification. This has also occurred in byproduct materials and radiopharmaceuticals, between New York and Texas. A third example is under the general licensed devices. Some states are placing additional restrictions on their applications.

Finally, as the NRC is aware, Pennsylvania and Illinois have both established performance standards for low-level waste disposal facilities that are "stricter" than NRC's requirements in 10 CFR 61.

4. What limits, if any, should be placed on the power of a State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice?

As discussed in the response to the first question, all licensees and all practices should be treated uniformly. Neither the NRC nor the Agreement State should preclude, by exceptionally stringent and not technically/scientifically justified, regulations, a particular practice. To the same extent, no class of licensees should be given preferential treatment through reduced or lax regulations.

5. Are there any other dose or radiation-protection related release limits in the Commission's regulations which should be included under criterion 3 of the compatibility criteria? Should the dose limits contained in 10CFR61 be included under this criterion?

Criterion number three does not include the terminology, dose and exposure limits for transportation. These are contained in 10 CFR 71. Therefore, criterion number three needs to be expanded to include 10 CFR 71 or, as we suggested above, criterion number one be expanded to include 10 CFR 71.

The industry believes that strict compatibility with 10 CFR 61 is very important. This is especially true as the nation attempts to site and license new low-level waste disposal facilities. Therefore, it is important that the terminology, dose and exposure limits contained in 10 CFR 61 be included under this criterion.

6. Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-case basis?

Low level radioactive waste disposal should be addressed on a case-by-case basis.

7. Are there currently areas or situations in Agreement State regulations or other Agreement State requirements that would not meet the proposed policy statement?

There are interpretations of the regulations by some Agreement States that may not meet the proposed policy statement. These are primarily in the areas of reciprocity and, to a limited extent, in the area of licensing new low-level waste disposal facilities. The NRC needs to review these two specific areas in relation to the policy and the comments offered elsewhere in this submittal. These differences are on the interpretation of the regulation rather than the regulation itself. The policy statement may be adopted as written, however, it must also be interpreted as intended.

8. Should States be permitted to establish more stringent standards for radiation-protection related release limits?

States should not be permitted to establish more stringent standards for radiation protection-related release limits. The existing NRC and EPA requirements provide for the safety of the public and the environment. There is no technical, scientifically-based reason for more stringent standards. At the same time, to ensure uniformity, states should not be permitted to establish less stringent standards for radiation protection-related release limits. A state should not establish standards which are not as strict as the NRC's to attract a class of licensees, as an example.

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• 94 ocr. 22 I\~, *. J2 December 19, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Secretary:

On behalf of the over 29,000 members which comprise the American College of Radiology (ACR), following are comments on the Adequacy and Compatibility for NRC and Agreement State Programs; Draft Statement of Policy (59 FR 37269, July 21, 1994).

Responses to the specific questions for public comment posed on page 37271 are as follows:

1.) States should not be given a great deal of flexibility to establish more stringent requirements than those set by the NRC--particularly in the areas of reporting requirements, exposure limits and leak testing. Also, states should not be able to establish stricter dose limits for particular classes of licensees beyond those dose limits set by the NRC.

2) Yes, the four criteria are sufficient to ensure protection of the national interest in radiation protection.

3) There are numerous examples of states which either have established or have sought to establish stricter requirements than those set by the Commission, or have established requirements where the NRC has not. These would include:

• States with requirements for X-ray services;

• States which have developed a quality management program for linear accelerators; and

• Specifically, involving the State of Minnesota, a proposal was recommended to impose lower dose limits of approximately .054 mrem/year.

4) Substantial limits. States should not be able to preclude particular practices.

5) No comment.

6) No. Questions of compatibility in the low level waste area should continue to be considered on a case-by-case basis.

COL L EGE OF Acknowledged by card .......

RADI OLOGY

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AMERICAN 1891 Preston White Drive, Reston, Virginia 22091 (703) 648-8900

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7) No comment.

8) No. There exists no scientific justification for more stringent standards in the area of radiation protection-related release limits.

The ACR would also like to make the following points with regard to the Policy Statement:

• Section B, Paragraph 5. Staffing and Personnel Qualifications "Agreement State staff shall be qualified using criteria no less stringent than criteria used for NRC staff." The ACR would support the implementation and enforcement of this statement.

-

• Section B, Paragraph 11. Budget

The State radiation control program (RCP) shall have adequate budgetary support to implement an effective program." This requirement should be met if states are to continue Agreement state status.

The ACR appreciates the opportunity to comment on this matter.

-~

Ann W. Rosser Director, Government Relations

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• 94 0[" 20 A1 1 :04 December 19, 1994 Amersharn Holdings, Inc.

2636 S. Clearbrook Drive Arlington Heights, IL 60005 Secretary tel (708 ) 593-6300 U.S. Nuclear Regulatory Commission 115 5 5 Rockville Pike Rockville, Maryland 20852

,..Amersham The Health Science Group Re: Agreement State Programs I am writing in response to the recent publications in the Federal Register concerning Agreement State Programs, Volume 59, No 139, dated July 21 , 1994 and No. 150, dated August 5, 1994.

Amersham is a major manufacturer of radiopharmaceuticals, radioactive sources and radiochemicals that are used for therapeutic and diagnostic medical applications, for industrial, environmental and biomedical quality control and research.

We still maintain that there should be a uniform national approach to radiation safety matters and the regulations for the manufacture and supply of radioactive materials as we had expressed in our letter dated March 18, 1992, (copy enclosed). The following are the areas we had identified in that letter where lack of uniform regulations increases the complexity of our business and leads inevitably to increased costs to the users of our products.

Customer License Verification Operations in different states Competitive disadvantages Licensing Fee Registration of Sealed Sources/Devices Inspections Different regulations/fees for reciprocity concerning temporary job sites lfm 2. 4 i995 Acknowledged by card ..........................."...

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• U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics 4 ~.... '

Postmar1t Data ~ &):S) ,.,e?:e&l 1m s::i Co~esReceived,__.__ _ _ _ _ __

Add'I Copies Reproduced ____ _ __

U.S. Nuclear Regulatory Commission December 19, 1994

, Page 2.

Implementation /

Differences in implementation dates for new regulations Emergency Preparedness Incident Notification 10 CPR Part 21 Notifications Generally Li~ed Devices Since that letter was written on March 18, 1992, we have experienced additional problems as a result of differences in regulations/implementation between the USNRC and Agreement States and between Agreement States.

Medi-Physics receiv:ed approval from the Food and Drug Administration for its NDA on Metastron (Strontium-89) for the palliation of pain in patients with bone cancer and the*

Illinois Department of Nuclear Safety then approved distribution of the NIST-traceable unit dose to medical licensees. However a number of Agreement states imposed additional requirements for its use by their medical licensees, e.g., further measurements on that NIST-traceable dose prior to administration. These-requirements are quite unnecessary, as now exemplified by NRC Information Notice 94-70: "Issues Associated with the Use of Strontium-89 and other Beta Emitting Radiophannaceuticals". These additional requirements by some states led to delays in the availability of Metastron for use in tliose states. Furthermore, having to clear products for distribution in individual states clearly leads*to increased costs and ultimately increased costs to patients, as well as delaying the availability of products to doctors and their patients. ,

• Medi-Physics, Amersham Health Care has ~ntly become aware of a change in California's licensing of users of Metastron, without distributors being notified by the state. Our customers informed us of the change. Previously they were allowed to use Metastron if they were authorized for *therapeutic use of radiopharmaceuticals. Now we understand 'that Metastron has to be

. specifically listed on the user's license.

While we recognize that the USNRC does not regulate Naturally Occurring and Accelerator-Produced Radioactive Material'(NARM) or non-radioactive products.used in conjunction with NARM, we do consider' it relevant to inform you that we have also encountered difficulties distributing these products because of the different requirements from one state to another.

U.S. Nuclear Regulatory Commission December 19, 1994 Page 3.

Although beyond the terms of the Federal Register publication, we believe that there is a much more basic question that needs to be addressed, but one that when answered would resolve many of the issues that are currently being considered. We are firmly: of the opinion that there needs to be one body within the government that establishes radiation standards for all types of radiation whether it be by-product material, NARM or machine produced. Given two samples of Cadmium-109, one produced in a nuclear reactor and the other in a cyclotron, there is no way to differentiate between the two, and yet they are subject to different regulations.

Furthermore, there needs to be_a separate body within the government to implement and enforce those regulations. It is not appropriate for the same body to establish and enforce standards. It is reminiscent of the days of the USAEC promoting and regulating the use of radioactive waste materials.

Our answers to the specific questions raised on Page 37271 are as follows:

1. Under what circumstances should Agreement States be permitted to establish more stringent requirements, for their licensees, than those established by the Commission?

Should this also include the ~bility to establish stricter dose limits for particular classes of licensees?

Under no circumstances should Agreement States be permitted to establish more stringent requirements that those established by the USNRC. Stricter dose limits for particular classes of licensees should not be established by Agreement States.

2. Are the four criteria in the proposed policy statement for determining whether a Commission regulation or other program element should be adopted in a manner essentially identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? What examples could be used to illustrate how each criterion would be applied?

The four criteria in the proposed policy statement provide the basis for an Agreement State program but need to be expanded to provide uniformity in regulations in the areas previously mentioned in this letter.

3. What are some examples of State action to establish stricter requirements than those established by the Commission, or establish requirements where the NRC has not?

We consider it neither nec~ssary nor desirable for states to establish stricter requirements than those established by the USNRC, nor to establish requirements where USNRC has none.

• U.S. Nuclear Regulatory Commission December* 19, 1994 Page 4.

4. What limits, if any, should be placed on the power of a State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice?

States should not effectively preclude a particular practice permitted in USNRC regulated states.

5. Are there any other dose or radiation-protection related release limits in the Commission's regulations which should be included under the criterion number 3 of the compatibility criteria? Should the dose limits contained in 10 CPR Part 61 be included tmder this criteria?

All USNRC dose limits should be items ofstrict compatibility including those of 10 CFR Part 61. (We have already seen variation in Agreement States adopting dose limits different from those in 10 CFR Part 61.)

6. Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-case basis?

Applying a uniform policy to the regulation of/ow-level radioactive waste disposal would not only facilitate implementation but would also accelerate the process for establishing low-level radioactive waste disposal sites.

/

7. Are there currently areas of situations in Agreement State regulations or other Agreement State requirements that would not meet the proposed policy statement? \

There are a number of areas of non-compatibility at present. These include standards for sealed source and device evaluations, reciprocity arrangements, standards for waste disposal sites, sewer disposal limits, requirements for "Part 21" notifications and implementation dates for new regulations. Also, license fees vary appreciably between Agreement states, and between those state~ and the USNRC.

8. Should states be permitted to establish more stringent standards for radiation-protection related release limits?

States should not be permitted to establish more stringent standards for radiation-protection related release limits.

U.S. Nuclear Regulatory Commission December 19, 1994 Page 5.

Under III, Policy Statement and Implementation (Page 37273) there is the statement "In order to permit the NRC to provide early coordination and oversight of any proposed more stringent regulations or requirements, NRC will request Agreement States t<;> identify any such regulations or requirements and provide opportunity for NRC to review before publication as a draft rule for comment or before the institution of the requirement as a legally binding measure". We would strongly urge that licensees conducting business in*these states and suppliers of radioactive materials including sealed source and devices, also be provided the opportunity to cpmment. This could be by NRC publishing the proposed change in the Federal Register. Earlier this year, the state of Oregon proposed a new regulation that would have virtually precluded the distnbution and use of any generally licensed devices within the state. Tuey were unaware of the implications of their proposed new rule, and did not proceed with it when they became aware of those implications. It is extremely difficult for a licensee distributing products in all 50 states to keep abreast of changes as well as proposed changes in state regulations. The mechanism varies considerably from one state to another.

Another area of concern is that of an Agreement State's financial ability to operate an effective program. We see examples where an Agreement State does not implement regulations adequate and compatible with those of NRC and as required by NRC, because of a lack of financial resources.*

For example, we understand that California has added a condition to licenses that licensees must conform to the requirements of the new 10 CFR P3:ft 20, since the state does not have the resources to amend their regulations.

Tue July 21, 1994 Federal Register publication gave 3 examples where NRC felt that more stringent requirements by individual states were justified. Iri the first, Florida was allowed to be more stringent for the disposal of small quantities of radionuclides because of the high grolJild water level in that state. However, I would suspect that there are parts of other states that have a similar high ground water level. Presumably these states will be permitted to set their own standards which may then be different from those in Florida Why not have a national uniform standard for all areas with high ground water levels?

In the third example, we understand that there is much industrial radiography within the state of Texas, but if the standards established in Texas are appropriate, why not implement them nationwide?

• I -

There are examples where individual states established stricter standards before NRC did so, and where it was clearly appropriate. A more collegial approach by NRC to the Agreement States would enable their more appropriate standards to be established simultaneously within all states.

U.S. Nuclear Regulatory Commission December 19, 1994 Page 6.

We do appreciate the opportunity to comment on the proposed draft and would be pleased to discuss with NRC any aspects of the Agreement Statement program and our recommendations. My phone number is 708/593-6300, extension 379.

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Corporate Manager, Nuclear Licensing and Industrial Liaison BWB:bcb Enclosure

AJ:nersham Corporation 2636 South Clearbrook Drive Arlmgton Heights. lllll'lOIS 60005-4692 (312) 593-6300 March 18, 1992 Amersham Secretary U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, MD 20852 Compatibility of Agreement States Programs with NRG: Regulatory Programs

Dear Sir:

I am writing on behalf of Amersham/Medi + Physics in response to your call for comments on the above topic published in the Federal Register, December 23, 1991, FR .§6.. No.

1 246, 66457-66459. Amersham Corporation supplies a wide variety of radioactive materials throughout the United States to Life. Science Customers in universities, research institutes and industry and for numerous industrial applications: Amersham Corporation has facilities in_ Illinois, Massachusetts and Louisiana. Medi+ Physics is an Amersham Company that supplies Health Care products such as radiopharmaceuticals and sealed radioactive sources for diagnostic and therapeutic applications. Medi+ Physics has production facilities in Illinois and New Jersey and 18 nuclear pharmacies throughout the United States.

• The following are our responses to the specific questions in the Federal Register.

1 Uniform National Approach to Radiation Safety Matters For Amersham/Medi + Physics tQere would be several advantages to a uniform national approach since we supply products/services to customers in all states.

These advantages are as follows:

1.1 Advantages 1.1.1 ucense verification Verifying that customer is licensed to receive a radioactive material frequently requires reference to the regulations applicable to that customer. Wrth uniform national regulations, there could be one single set of licensing regulations, Instead

• of so individual state regulations plus NRC regulations.

(

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Secretary March 18, 1992 Page 2*

The following are some examples of variation in regulations affecting license verification:

a) Some states issue licenses which are very specific for sealed sources and list Model Numbers and even Product Codes as well as total activity. Other states will list just the nuclide(s) and total activity for possession of sealed sources.

b) The regulatory process for naturally occurring and accelerator produced materials (NARM) varies widely

• c) between states and Is essentially unregulated in some states.

Distribution, receipt and use of in vitro diagnostic kits containing radioactive material. NRC and some states require users (without a radioactive materials license) to file for a registration certificate. In California these kits are 'generally licensed.

To achieve a single set of regulations there is an additional change that would be required and that would be for one Federal Agency to be responsible for the regulatiori of. all discrete sources of radioactive materials - naturally occurring and accelerator produced materials (NARM) as well as by-product. We strongly favor and recommend the establishment of such an agency.

1.1.2 Operations In Different_ States

\

A uniform approach would again facilitate regulatory

, compliance for companies with operations in different states, and offering services in different states, since again there could be a, single set of regulations Instead of many as stated in 1.1.1.

• Secretary March 18, 1992 Page 3

, I 1.1.3 Competition Variation in regulations from state to state can place a company In one state at a competitive disadvantage with that In another. Some examples are as follows:

a) Licensing fees There was some variation prior to the Implementation of NRC User Fees, but those fees have exacerbated the difference. The user fee~ Impact only licensees in NRC-regulated states and not those, In Agreement States. One licensee was abl~ to move operations from an NRG-regulated state to an Agreement State to avoid the user fees, but that Is not possible for all licensees who are then faced with higher, and sometimes very consid~rably higher costs than those in Agreement States, and could lead to some licensees having to terminate their business. The fees affect both manufacturers and users.

Amersham's facility at Burlington, Massachusetts, found It necessary to inactivate several sealed source and device registrations because of the signjficant financial impact of the annual fees imposed by NRC.

However, competitors in Agreement States are not subject to these fees, and consequently continue to supply their entire product line-without any additional costs resulting from annual fees.

b) Registration of Sealed Sources/Devices The time taken for a review varies according to the state, and thus a company may be able to launch a new product nation-wide earlier than another company with a similar product in another state, when the submissions had been made at the same time. This may result from the differences in the resources available in different Agreement States and between.

Secretary March 18, 1992 Page 4 those states and the NRC. Differences may become accentuated as several states are having to curtail severely their budgets. Again, fees charged for registration of sealed sources/devices vary from state to state. There also appear to be differences, state to

• state, in the amount and detail of information required to be submitted for the safety evaluation and review before a registration is issued.

c) Temporary Job Sites There is a lack of consistency In state regulations concerning reciprocity over work by licensees at temporary Job sites.

d) Inspections There is variability in the frequency and scope of

. inspections from state*to state. Also fees are charged for Inspections* in some states but not in others.

e) Industrial Radiographer Certification The proposal by NRC to require third party certification of industrial radiographers will result in different standards, since Agreement States may administer their own tests and impose different enforcement rules regarding the certification. A radiographer certified in one state rriay not be acceptable for certification In another state because of the different standards adopted by that state. Also, a state may not recognize certification by another state.

1.1.4 Implementation A uniform approach should provide for the simultaneous implementation of new or additional regulations. Variability in implementation dates, state to state can lead to inequities.

_,.,pa1nrc

Secretary Marcil 181 1992 Page 5 a)

Many Agreement States have not even determined yet the implementation date for this part, although they have already been Implemented by NRC. The implication is that some products covered by this part are acceptable In some states but not in others. A manufacturer of radiography .devices has then to cileck each order to determine its destination, before the product is manufactured to ensure that It will meet the specifications established by the state where the customer is located.

b) 10 CFR 20 Dtfferences in implementation dates for the new 10 CFR 20 between Agreement States will lead to inequities.

c) Emergency Preparedness Differences between states result in some licensees being required to have a radiological contingency plan while a licensee with comparable activities in another state is not subject to that requirement.

. d) Incident Notification Licensees in some states will be subject to these additional requirements before those in other states.

e) 10 CFR Part 21 Notifications To my knowledge only licensees In NRC-regulated states are required to comply with 1o CFR 21, Reporting of Defects. I am not aware that any of the Agreement States have a similar reporting requirement.

~

Secretary March 18, 1992 Page 6 This then is an additional requirement dn NRC licensees who must have the necessary procedures established and documented to comply with 10 CFR

21. For some depending on the type of license, these*

could be very extensive.

• 1.1.5 GENERALLY LICENSED DEVICES There is considerable variation state-to-state in the regulations controlling generally licensed devices. Some states require the recipient of a generally licensed device to report to the state within 1O days the fact that they have received such a device. Some states charge the general licensee a fee, some annual, some a one-time fee; other states do not charge a fee.

This variation in the regulations makes it extremely difficult for a nation-wide supplier of generally licensed devices to provide general licensees with advice on their responsibilities as general *licensees. With uniform regulations, suppliers could and would provide specific and definitive advice.

In summary for this section, Amersham/Medl + Physics Is strongly in favor of a uniform national approach to radioactive materials regulations.

• 1.2 Scope For the reasons stated above we are in favor of the scope of uniformity being comprehensive: -

2 Tiered Approach The tiered approach leads to variability of regulations between NRC and Agreement States and between Agreement States. This is a severe disadvantage for Amersham/Medi + Physics for the reasons stated in 1.

Secretary March 18, 1992 Page 7 I

a) Therefore we do not consider that a tiered approach is reasonable b) All areas should be identical c) None 3 Mechanisms to allow Agreement States Rexlblltty None /

4 Low Level Radioactive waste I

The compacts add yet a third level of regulation. We understand that representatives of the compacts do meet from time_ to time in an attempt to .

achieve compatibility, but we have seen very little published as to their discussions.

We are concerned about the impact their decisions might have on our business.

• lndMdual states/compacts doI seek input from licensees, but licensees do not have direct input to the inter-compact discussions.

Some of the specific issues we are concerned about are as follows:

a) Import/Export I

Any variation in the rules on import/export of radioactive waste from one compact to another could place some licensees at a disadvantage.

b) Costs Costs of waste disposal could vary significantly from one compact to another.

c) Standards Some compacts may accept some* forms of waste for disposal that would not be accepted in another compact.

Secretary March 18, 1992 Page 8 d) When is a product designated as Radioactive waste?

Any differences In answers to this question by compacts could have a significant impact on licensees both In costs and feasibility of dlsposaljrecycling.

• Amersham/Medl + Physics Is convinced that the appropHate regulatory position should be that unwanted radioactive materials are not classified as waste when they are to be reprocessed or recycled. This should be untforrn throughout all states, otherwise there will be a disincentive to recycle/reprocess sµch materials in some states and resulting in negative ecological impact.

Again, a lack of consistency between tf:ie regulations of different compacts could place a company at a competitive disadvantage. Consequently, we do not 'agree that Agreement States should be given a greater degree of flexibility In developing their own standards for low level radioactive waste disposal.

5 Rule-Making Notices ,

We believe that the current process is adequate.

6 Exemption No exemptions should be granted.

41 Amersham/Medi + Physics experience in operating In an Agreement State has been that we usua11y* obtain quicker responses to our inquiries, license appllcations/rerlf::lwals, registration of sealed sources and devices than when dealing with the NRC. Since there is a smaller number of employees in an Agreement State Agency than in NRC, It is easier to establish channels of communication.

In summary, despite our usually more favorable experience In working with an Agreement State, Amersham/Medi + Physics is very much in favor of a uniform national approach to radiation safety matters and regulation of radioactive materials.

• Secretary March 18, 1992 Page 9 Please let us know should you have any questions conceming the information we nave provided. We shall be pleased to discuss them with you, and I may be reached by phone at 708/593-6300 1 extension 379 ,

In addition we would be willing to participate in any meetings or discussions on this topic.

. Sincerely, Bryan . a er, Ph.D.

Man{:lger, Environmental and Safety Regulatory Affairs BWB/cem c: Steven C. Collins; Chief Pivision of Radioactive Materials

• 10NS I

DOCKET NUMBER p PROPOSED RULE..:...::-l-!,.\,~ ---

COUNTY OF CHATH 2 3 CS9rR~1~9J COMMISSIONERS HENRY DUNLAP, JR., Chairman ounty Manager MARY HAYES HOLMES R BERT L. GUNN UVA HOLLAND ounty Attorney MARGARET BRYANT POLLARO E.T. HANNER P. 0. BOX 87 PITTSBORO, N. C. 27312 ORGANIZED 1770 707 SQUARE MILES Preferred Site Local Advisory Committee December 17, 1994 Secretary of the Commission US Nuclear Regulatory Commission Attention: Docket & Service Branch Washington, DC 20555 RE: Comments on Copatibility of Agree ent State Progra s I attended the day long workshop the Nuclear Regulatory Commission held on November 15 in Rockville on compatibility of agreement state rules with federal rules for low-level radioactive waste.

Some of my concerns were expressed verbally, but I also want to put our committee's comments on the written record. We were not able to do this by the deadline of December 2, but request that you extend the comment period to accept these comments.

Our primary interest is naturally in protecting the health and safety of citizens. We see the following problems with your Draft Policy Statement on Agreement State Adequacy and Compatibility: 59 FR 139:37269-74,7/21/94.

1. Your definition of the word "compatible" as "essentially identical" twists the meaning of the word "compatible". According to Webster's 9th Collegiate Dictionary compatible means, "capable of existing or operating together in harmony" which is not the same as identical. We do not feel your definition is an accurate reflection of the law.

2. Your guidance that rules on doses of radiation allowed the public at the fence line must be "essentially identical" to federal rules and no stricter to be "compatible" is unacceptable to us.

Local and state governments should have the right to be more protective of their citizens. North Carolina or local governments may want to consider factors not yet taken into account by federal rules, but known to be significant risks to health, such as the synergistic effect of toxic and radiation exposures in cancer development. State or local governments whose citizens will be at risk from such facilities may be motivated to move more quickly in keeping rules up to date with new scientific findings than the federal government.

lfEB 2 4 1995 Acknowledged by card ...................................

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION lloalment Statisb Postmar1': Date ,.\94 Copies Received _ _ _ _ _ _ __

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Add'I Copies Reproduced _____;L - -_ __

Special Distri~tion~e,~ '21l2$ >

Secretary of the Commission December 17, 1994 (Compatibility)

Page 2

3. Your guidance that rules that could have the effect of interfering with "interstate commerce" or "precluding a practice within the national interest" must be "essentially identical" with federal rules, is vague and very broad. Almost any rule could be construed to have an effect on interstate commerce or the national interest. This effectively prevents states from being more protective of their citizens' health than the federal government by opening the door to virtually any claim from any interested party with an economic interest. It gives us no security that the limited protection the interstate compact system gives a host state would be upheld once the army of corporate lawyers examines this new policy. Nor does it assure us that the stricter statutes that North Carolina has enacted would not be challenged on the basis of these two broad concepts.

Though the assistant director of the NC Radiation Protection Division has told me that he feels secure that these guidelines will not threaten existing North Carolina statutes, we do not share his confidence that lawyers for those with economic interests may not use this broad, vague policy to challenge North Carolina's laws.

These proposed interpretations of compatibility will further decrease public confidence in our state's ability to protect its citizens under the rules that are now in place in North Carolina.

Mary MacDowell, Research Coordinator Preferred Site Local Advisory Committee

Henry H. Kramer, Ph.D., FACNP

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DOCKETED 3911 Campolindo Drive Moraga, CA 94556-1551 510/283-1850 Fax:510/283-1850 Executive Director D..:r.c*' ~ ~

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Ei"'l 1~Cc: SFl,\NCH December 19, 1994 Secretary

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U.S. Nuclear Regulatory Commission 115 55 Rockville Pike Rockville, Maryland 20852 Re: Agreement State Programs I am writing on behalf of The Council on Radionuclides and Radiopharmaceuticals, Inc.

(CORAR), a trade association representing major manufacturers of radiopharmaceuticals, radioactive sources and radiochemicals that are used for therapeutic and diagnostic medical applications, for industrial, environmental and biomedical quality control and research.

We are responding to the recent publications in the Federal Register concerning Agreement State Programs, Volume 59, No 139, dated July 21, 1994 and No. 150, dated August 5, 1994.

I appreciated the opportunity to participate in the NRC Workshop on November 15, 1994, and to hear the views of others. It was particularly encouraging to hear some of the state regulators stating that there needs to be some uniformity between Agreement State and NRC programs, e.g., sealed source and device evaluations.

We still maintain that there should be a uniform national approach to radiation safety matters and the regulations for the manufacture and supply of radioactive materials, as we had expressed in our letter dated March 18, 1992, (copy enclosed). The following are the areas we had identified in that letter where lack of uniform regulations increases the complexity of our businesses and leads inevitably to increased costs to the users of our products.

ifEB 2 4 1995 Acknowledged by card.........................¥ ..... ~

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmar1< Date .-J:Sf §,.<y ..~,9 "tb Sf>

Copies Received~\_ _ _ _ _ __

Add'I Copies Reproduced ____ _ __

Special Dis~ibution 3?P12,, RJDSJ O&i D9 ~q.O \l'O :::pg. - rn,t:,Q (5°'E&t-kn~)

U.S. Nuclear Regulatory Commission December 19, 1994 Page 2.

Customer License Verification Operations jn different states Competitive disadvantages Licensing Fee Registration of Sealed Sources/Devices Inspections Different regulations/fees for reciprocity concerning temporary job sites Implementation Differences in implementation dates for new regulations Emergency Preparedness Incident Notification 10 CFR Part 21 Notifications

'Generally Licensed Devices Since that letter was written on March 18, 1992, our companies have experienced additional problems as a result of differences in regulations/implementation between the USNRC and Agreement States and between Agreement States.

Medi-Physics received approval fro~ the Food and'Drug Administration for its NDA on Metastron (Strontium-89) for the palliation of p~ in patients with bone cancer, and the Illinois Department of Nuclear Safety then approved distribution of the NIST-traceable unit dose to medical licensees. H~wever a number of Agreement states imposed additional requirements for its use by their medical licensees, e.g., further measurements on that NIST-traceable dose prior to administration. These requirements were quite unnecessary, as now exemplified by NRC Information Notice 94-70: "Issues Associated with the Use of Strontium-89 and other Beta Emitting Radiopharmaceuticals". These additional requirements by some states led to delays in the availability of Metastron for use in those states. Furthermore, having to clear products for distribution in individual states clearly leads to increased costs and ultimately increased costs to patients, as well as delaying-the availability of products to doctors and their patients.

U.S. Nuclear Regulatory Commission December 19, 1994 Page 3.

While we recognize that the USNRC does not regulate Naturally Occurring and Accelerator-Produced Radioactive Material (NARM) or non-radioactive products used in conjunction with NARM, we do consider it relevant to inform you that several of our companies have also

• experienced differing requirements state-to-state for the distribution of these products.

These experiences strengthen our position that there needs to be one Federal Agency, and only

~one, that regulates all discrete sources of ionizing radiation irrespective of its source - by-product, NARM or machine. There is also a problem that there is no independent national standard that can be used by federal, state and local agencies in promulgating regulations. Consequently these agencies establish their own standards, again resulting in lack of uniformity. Hence we believe that one group within the Executive Branch of Government should be responsible for establishing radiation standards, but that another body, e.g., a federal agency should be responsible for enforcement of those standards.

Our answers to the specific questions raised on Page 37271 are as follows:

1. Under what circumstances should Agreement States be permitted to establish more stringent requirements, for their licensees; than those established by the Commission?

Should this also include the ability to establish stric!ef dose limits for particul~ classes of licensees?

Under no circumstances should Agreemeni States be permitted to establish more

• stringent requirements that those e_stablished by the USNRC. Stricter dose limits for particular classes of licensees should not be established by Agreement States.

2. Are the four criteria in the proposed policy statement for determining whethe; a Commission regulation or other program element should be adopted in a manner essentially identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? What examples could be used to illustrate how each criterion would be applied?

The four criteria in the proposed policy statement provide the basis for an Agreement State program but need to be expanded to provide uniformity in regulations in the areas previously mentioned in this letter. '

3. What are some examples of State action to establish stricter requirements than those established by the Commission, or establish requirements where the NRC has not?

We consider it neither necessary nor desirable for states to establish stricter requirements than those established by the USNRC, nor to establish requirements where USNRC has none.

U.S. Nuclear Regulatory Commission December 19, 1994 Page 4.

4. What limits, if any, should be placed on the power of a State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice?

States should not effectively preclude a particular practice permitted in USNRC regulated states.

5. Are there any other dose or radiation-protection related release limits in the Commission's regulations which should be included under the criterion number 3 of the compatibility criteria? Should the dose limits contained in 10 CFR Part 61 be included under this criteria?

All USNRC dose limits should be items ofstrict compatibility including those of 10 CFR Part 61. (We have already seen variation in Agreement States adopting dose limits different from those in JO CFR Part 61.)

6. Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-case basis?

Applying a uniform policy to the regulation of/ow-level radioactive waste disposal would not only facilitate implementation but would also accelerate the process for establishing low-level radioactive waste disposal sites.

7. Are there currently areas of situations in Agreement State regulations or other Agreement State requirements that would not meet the proposed policy statement?

Some of the areas/situations where we currently find lack of compatibility are sealed source and device evaluations, reciprocity arrangements, waste disposal site standards, implementation dates for new regulations, "Part 21 "notifications and sewer disposal limits.

Also, there is considerable variation in licensing fees between NRC and Agreement States and between states.

8. Should states be permitted to establish more stringent standards for radiation-protection related release limits?

States should not be permitted to establish more stringent standards for radiation-protection related release limits.

U.S. Nuclear Regulatory Commission December 19, 1994 Page 5.

Under ill, Policy Statement and Implementation (Page 37273) there is the statement "In order to permit the NRC to provide early coordination and oversight of any proposed more_ string~nt regulations or requirements, NRC will request Agreement-States to identify any such regulations or -*

requirements and provide opportunity for NRC to review before publication as a draft rule for comment or before the institution of the requirement as a legally binding measure". We would strongly urge that licensees conducting business in these states and suppliers of radioactive materials inciuding sealed source and devices, also be provided the opportunity to comment This could be by NRC publishing the proposed change in the Federal Register. Earlier this year, the state of Oregon proposed a new regulation that would have virtually precluded the distribution and use of any genera.Ily licerised devices within the state. They were unaware of the implications of their proposed new rule and fortunately did not proceed with it when iliey became aware of those implications. It is extremely difficult for a licensee distributing products in all 50 states to keep informed of proposed changes in state regulations. The mechanism varies considerably from one state to another.

Another area of concern is that of an Agreement State's financial ability to ,operate an effective program. We see examples where an Agreement State does not implement regulations adequate and compatible with those of NRC and as required by NRC, because of a lack of financial resources.

For example, we understand that California has added a condition to-licenses that licensees must conform to the recpJirements of the new 10 CPR Part 20, since the state does not have the resources to amend their regulations.

We have been privileged to read the letter submitted by ANCP/SMlvl on the subject of Agreement States Compatibility. While it may appear that superficially our recommendations are different from theirs, we do not believe that they are necessarily so in practice. Our perspectives and areas of concern are different We appreciate the opportunity to comment on the proposed draft ~d would be pleased to discuss with NRC any aspects of the Agreement Statement program and our recommendations. Please contact me should you have any questions. My phone number is 708/593-6300, extension 379.

• Regards, ,

Bryan W. Baker, Ph.D.

Chairman, Subcommittee on NRC/

Agreement State Compatibility BWB:bcb Enclosure

USCEA U.S. CotllClkx EnergyAwafeness Sul!e-400 17761 Slreel. N W

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- (202)293-CmO March 18, 1992 FAX {202) 7854019 (202) 785-4113 Secretary U.S. Nuclear Regulatory Commission One White Rint North l 11555 Rockville Pike RockvlUe, MD 20852 CompatJblllty of Agreement States Programs with NRC Regulatory Programs

Dear Sir:

I am writing on behalf of the Committee on Radionuclides and RadiopharmaceuticaJs, U. S. Council for Energy Awareness to respond to your request for comments on

• Compatibility of Agreement States Programs with NRC Regulatory Programs* published in the December 23, *1991, issue of the Federal Register,..§§ No 246, 66457-66459. The Committee on Radionucfides and RadiopharmaceuticaJs is comprised of members of U.

S. and Ganadian manufacturers and distributors of radiopharmaceuticaJs. radionuclides, radi~micals and other radioactive products.

The following are our responses to the specific questions raised in the above publication in the Federal Register.

1 Uniform National Approach to Radiation Safety Matters For the members of the Committee on Radlonuclides and RadiopharmaceuticaJs there would be many advantages to a uniform national approach since we supply products/services to our customers in all states. These advantages are as follows:

1.1 Advantages 1.1.1 Ucense Verification Verifying that customer is licensed to receive a radioactive material frequently requires reference to the regulations applicable to that customer. With uniform national regulations,1 there could be one single set of licensing regulations, instead of 50 individual state regulations plus NRC regulations as at present.

Secretary March 18, 1992 Page 2 The following are three examples where there is varlablllty in regulations affecting Ucense verification:

a) Some states issue Hcenses which are very specific for sealed sources and list Model Numbers and even Product Codes BS well BS total activity. Other states will list just the huclide{s) and total activity for possession of sealed sources.

b) The regulatory process for naturally occurring and accelerator pn,duced materials (NARM) varies widely between states and ls essentially unregulated in some

-* c) states.

Distribution, receipt and use of in vitro diagnostic kits containing radioactive material. NRC and some states require users (without a radioactive materials license) to file for a registration certificate. In California these kits are generally licensed.

To achieve a single set of regulations there ls an additional change that would be requir ~d and that- would .be for one Federal Agency to be responsible for the regulation of all discrete sources of radioactive materials - naturally occurring and accelerator produced materials {NARM} as well as by-product materials. We strongly favor and recommend the establishment of such an agency.

1.1.2 Operations In Different States A uniform approach would again facilitate regulatory compliance for companies with operations in different states, and offering services in different states, since again there could be a single set of regulations instead of many as stated ,

in 1.1.1.

Secretary March 18, 1992 Page 3 1.1.3 CompetHton When there are differences in regulations from one state to another, that can place a company in one state at a competitive disadvantage with that in another state. Some examples are as follows:

a) Licensing tees There was some variati0n prior to the implementation

, of NRC User f?'ees, but those fees have exacerbated the difference. Th,e user fees Impact only licensees in NRG-regulated states and not those in Agreement

, States. One licensee was able to move operations from an NRC-regulated state to an Agreement State to avoid the user' fees, but that is not possible for all licensees who are then faced with higher, and sometimes very considerably higher costs than those in Agreement States. This could result in some licensees having *to terminate their business. The fees affect both manufacturers and users. '

Some manufacturers have found It necessary to withdraw sealed source and device registrations because of the significant financial impact of the annual fees imposed by NRC. Competitors in Agreement States are not subject to these fees, and consequently continue to supply their entire product line without any additional costs.

b) . Registration of Sealed Sources/Deyfces The time taken for a review varies aooording to the state, and thus a company may be able to launch a new product nation-wide earlier than another company with a similar product In a different state, when the submissions had been made at the same time. This may be the result of differences In the resources available in different Agreement States and between I

Secretary March 18, 1992 Page 4 those states and the NRC. Differences may become accentuated as several states are having to curtail severely their budget$. Again, fees charged for registration of sealed sources/devices vary from state to state. There also appear to be differences, between Agreement States and between these states and NRC-regulated states, in the amount and detail of information required to be submitted for the safety evaluation and review be-fore a registration is issued.

c) Temporary Job Sites There Is a lack of consistency in state regulations concerning reciprocity over work by licensees at, temporary job sites.

• cf) Inspections There is variability in the frequency and scope of inspections from state to state. Also fees are charged for inspections in some states but not in others.

1.1.4 Implementation

, A uniform approach should provide for the simultaneous .

implementation of new or additional regulations. Variability In imple,:nentatlon dates, state to state can lead to inequities.

a) 10 CFR 34 Many Agreement S, ates have not even determined yet the implementation date for this part, although they have already been implemented by NRC. The implication is that some products covered by this part-are acceptable In some states but not in others. A manufacturer of radiography devices has then to check each order to determine its destination, before the product is manufactured to ensure that It wUI meet the specifications established by the state to which the shipment is being made.

Secretary March 18, 1992 Page 5 b) 10 CFR 20 Differences in Implementation dates for the new 10 CFR 20 between Agreement States will lead to inequities.

c) Emergency Preparedness Differences between states result in some licensees being required to have a radiological contingency plan while a Hcensee with comparable activities In another state is not subject to that requirement d) Incident Notification Licensees in some states will be subject to these additional requirements before those In other states.

e) 10 CFR Part 21 Notifications To our knowledge only Ucensees In NRC-regulated states are required to comply with 10 CFR 21, Reporting of Defects. I am not aware that any of the Agreement States have a similar ~eporting requirement.

This then ls an additional requirement on NRC

- licensees who must have the necessary procedures established and documented to comply with 10 CFR

21. For some depending on the type of license, these procedures could be very extensive.

1.1.5 GENERALLY UCl;HSED l2EVICES There Is considerable variation state-to-state In the regulations controlling generally Hcensed devices. Some states require the recipient of a generally licensed device to report to the state within .1 O days the fact that they have received such a device. Some states charge the general licensee a f~, some anrtual, some a one-tlrrie fee; other states do not charge a fee.

Secretary March 18, 1992 Page 6 This variation in the regulations makes It extremely dlfficult for a nation-wide supplier of generally licensed devices to provide general Hcensees with advice on their responsibilities as general Ucensees. Wrth unlform regulations, suppliers could and would provide specific and definitive advice.

In summary for this section, the Committee on Radionuclides and Radiopharmaceuticals is strongly in favor of a uniform national approach to radioactive materials regulations.

1.2 scope For the reasons stated above we are In favor of the scope of uniformity being comprehensive.

• 2 Tiered Approach The tiered approach leads to variability of regulations between ~RC and Agreement States and between Agreement States. This is a severe disadvantage for the companies represented on the Committee on Radionuclides and Radiopharmaceuticals for the reasons stated In 1.

a) Therefore we do not consider that a tiered approach is reasonable b) All areas should be Identical c) None We do realize that a uniform approach may be difficult for some Agreement States depending upon the state legislation and

• the extent of their resources.

Nevertheless as nationwide suppliers of radioacdve materials we consider that a uniform approach Is appropriate and highly desirable.

3 Mechanisms to allow Agreement States Flexlblllty None 4 Low Level Radioactive Waste The compacts add yet a Jhlrd level of regulation. We understand that representatives of the compacts do meet from time to time In an attempt to achieve compatibility, but we.have* seen very little published as to their discussions.

'Secretary Marcil 18, 199~

Page7 We are concerned about the impact their decisior. 1 might have on our business.

lndMdual states/compacts do seek input from licensees, but licensees do not have direct Input to the inter-compact discussions. 1 Some of the specific .issues we are concerned about are as follows:

a) Import/Export Any variation lfl the rules on import/export ~f radioactive waste from. one compact to another could place some licensees at a disadvantage.

• b) -Costs ,

Costs Of waste disposal *could vary significantly from one compact to another.

C) Standards Some compacts may* accept some forms of waste for disposal that would

~ not be accepted in anotner compact.

d) When is a product designated as fladioactlye waste?

Any differences in answers to this question by compacts could have a significant impact on Hcensees both in costs and feasibility of

• disposal/recycling. '

Again, a lack of consistency between the regulations of different compacts could place a company at a competiWe disadvantage. Consequently, we do not agree tnat Agreement States should be given a greater degree of flextbHity In developing their own standards for low level radioactive waste disposal.

5 Rule-Making Notices We beBeve that the current process Is adequate.

6 Exemption No exemptions should be granted.

,

• p Secretary March 18, 1992 Pages In summary, the Committee on Radionucfldes and Radiopharmaceuticals 'is, very much in favor of a uniform national approach to radiation safety matters and regulation of radioactive materials.

Please let us know .should you have any questions concerning the information we have provided. We shall be pleased to discuss them with you, and I may be reached by phone at 708/593-8300, extension 379 -

In addition we would be willing to participate in any meetings or discussions on this topic.

• Sincerely, Bryan W. Baker, Ph.D.

Chairman, Subcommittee on NRC/ Agreement State Compatibility Committee on Radlonuclides and Radioph~aceuticals BWB/cem

DOCKET NUMBER p WINSTON & STRAWN PROPOSED RULE..:..::....,:..y~-

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35 WEST WACKER DRIVE 1400 L STREET, N.W. 43, RUE DU RHONE 35 CHICAGO, ILLINOIS 60601-9703 WASHINGlON, D.C. 20005-3502 1204 GENEVA, SWITZERLAND (312) 658-5600 (4122) 7810506 FACSIMILE (312) 558-5700 FACSIMILE (4122) 7810361 (202) 371-5700 175 WATER STREET SULAYMANIYAH CENTER NEW YORK, NY 10038-4981 FACSIMILE (202) 371-5950 P.O. BOX 22166 (212) 269-2500 RIYADH 11495, SAUDI ARABIA FACSIMILE (212) 858-4700 (9661) 4826866 FACSIMILE(9661)4629001 December 19, 1994 O()Ot(EtED OEC , S 1994 Mr. Samuel J. Chilk, Secretary [)OCKETING &

U.S. Nuclear Regulatory Commission SERVICE BAANCH SECV-Nf\C ~

Washington, D.C. 20555 ~

Attn: Docketing and Services Branch SUBJ: Comments on NRC Draft Policy statement re Adequacy and Compatibility for Agreement State Radiation Control Programs

Dear Sir:

The Nuclear Regulatory Commission {"NRC") has proposed to revise its general statement of policy which establishes the criteria used by the NRC for determining whether an Agreement State program meets federal statutory requirements in the Atomic Energy Act of 1954, as amended {"AEA"). In particular, the NRC has proposed substantially new interpretations of the statutory phrases "adequacy" and "compatibility," which will be central to any determination that a state agreement satisfies the Act. 59 Fed.

Reg. 37269 {July 21, 1994). The NRC's decision to formulate a new policy on compatibility issues is the latest in a series of agency responses to aggressive Agreement State initiatives for more autonomy under the Agreement States program.

The following comments on the Commission's draft Policy Statement are submitted on behalf of several members of the Nuclear Utility Decommissioning Group {"Decommissioning Commenters").

These members of the Group appreciate the opportunity to have their views concerning the NRC's compatibility requirements incorporated into the Commission's policy-making process.

In general, the Decommissioning Commenters are concerned that, if adopted as proposed, the draft policy statement's definitions of "adequacy" and "compatibility" will almost certainly lead to less uniformity between state and NRC requirements, giving Agreement States more authority and autonomy in their regulatory areas. Such a policy will facilitate greater state intrusion into ifEB 2 4 1995, Acknowledged by card .................................

U.S. NUCLEAR REGULATORY COMMISSIOM DOCKcTING & SERVICE SECTION (

OFFiCE OF THE SECRETARY OF THE CO~lMlSSION **

Docum"n! ~tatistics Postmark D~te slo,r_s)_ s-~J::i -s;\)4) ..~

Copies RoCB1vcJ_"---- - - - - -

Add'I Copies R:::produced _,0______

Special Distribution~ \ &,:ns.,

Mr. Samuel J. Chilk December 19, 1994 Page 2 the regulation of nuclear power plants. More specifically, the Decommissioning Commenters would oppose any statement of policy (or other NRC efforts) that supports or facilitates state attempts to regulate power reactor decommissioning, either directly or indirectly, including through the regulation of "LLW disposal. 11 Accordingly, we urge the NRC to consider the clarifications and modifications discussed below as the agency finalizes the Policy Statement.

I. COlllJlents on Proposed Policy statement The NRC has established a comprehensive regulatory scheme for assuring the protection of the public health and safety with respect to the decommissioning of NRC-licensed facilities, including nuclear power reactors. (See 53 Fed. Reg. 24018 (June 27, 1988).) This regulatory scheme addresses both technical and financial aspects of decommissioning. The draft agreement state policy statement appears to create the potential for State intrusion into several related regulatory arenas that could produce incompatibilities with the NRC's decommissioning regulations. As a consequence, licensee planning and funding for decommissioning could be significantly affected, leaving uncertainty and inconsistency regarding licensee decommissioning obligations.

Addressed below are those aspects of the draft policy statement with which we are concerned in this regard and which we urge the NRC to modify.

A. Basis for Ahandomaent of spectrum Approach Of initial concern is the proposal to abolish the "spectrum" approach to compatibility that the NRC has used for years in reviewing Agreement state programs for compliance with Section 274 of the AEA. Under this existing approach, the NRC divided Agreement State regulations into Divisions I, II and III, with Division I requiring identity to NRC regulations and progressively more flexibility for the other two divisions in order to satisfy the statutory term "compatibility." This approach appears to have accommodated the interests of both the NRC and the states reasonably well, and no experience points to a compelling need, whether from a public health and safety, economic or other standpoint, for its modification. We would therefore urge

Mr. Samuel J. Chilk December 19, 1994 Page 3 retention of this mechanism because of its relative ease of implementation and clarity.

B. Radioloqical criteria for Deoommissioninq Although Agreement States may not regulate the "operation" of nuclear power plants, the development of an NRC policy on compatibility is very important for NRC power reactor licensees because it could affect states' inclinations to attempt to regulate decontamination and decommissioning of nuclear facilities. A threshold legal question is whether Agreement States may regulate nuclear power plant decommissioning at a11.V Section 274.c of the AEA provides in part that the NRC shall retain authority and responsibility with respect to regulation of "the construction and operation of any production or utilization facility." 42 u.s.c. S 2021.c(l) (emphasis added). It is debatable whether this provision leaves open the possibility that Agreement States can regulate plant decommissioning or whether, on the other hand, the conduct of decommissioning ( ~ , the termination of licensed "operation") is included within the scope of this provision. We believe that the latter interpretation is more consistent with the Congressional intent behind Section 274.

Specifically, it is the position of the Decommissioning Commenters that states, including Agreement States, are preempted from regulating any aspect of nuclear power plant decommissioning.

The term "operation" as used in Section 274 of the AEA should be read to include reactor decommissioning activities. The purpose of that provision is to preempt from state regulation the activities performed under NRC licenses for nuclear power reactors. Nuclear power reactor decommissioning is conducted under the NRC Part 50 operating license although the authority to actually operate the facility has been removed. Thus, for example, states should be precluded from applying radiological criteria to nuclear plant decommissioning regardless of whether those criteria would be considered "adequate" or "compatible" under NRC Agreement State policy. The Decommissioning Commenters urge the NRC to revise the draft policy to stipulate that Agreement State policy does not affect the NRC-regulated activities -- including decommissioning --

of power reactor licensees, since regulatory responsibility for such matters cannot be delegated to the states by the NRC.

V In this context "decommissioning" is intended to include those activities within the scope of the definition of that term in 10 CFR S 50.2.

Mr. Samuel J. Chilk December 19, 1994 Page 4 The importance of this issue is illustrated by the NRC's pending proposed rule on radiological criteria for decommissioning of NRC-licensed facilities. In the supplementary information accompanying the proposed rule, the NRC notes that it is seeking comments on the draft Agreement state compatibility policy and states further:

The compatibility determination for the radiological criteria for decommissioning will be considered in regard to the implementation of the new compatibility policy. Therefore, the Commission believes that it would be premature to make a proposed compatibility determination on the radiological criteria for decommissioning at this time. However, for the purpose of facilitating the ultimate resolution of the compatibility determination for the radiological criteria for decommissioning, the Commission welcomes any comments on this issue. In particular, the Commission invites comments on to what extent and under what circumstances should an Agreement state be authorized to establish more stringent requirements than those set forth in NRC radiological criteria for decommissioning.

59 Fed. Reg. 43,200, 43,226 (Aug. 22, 1994)

• The NRC does not provide assurances that its compatibility determination will be limited to materials licensees.

Further, license termination and release of a site containing residual radioactivity levels that are acceptable to NRC does not constitute "LLW disposal" for purposes of Section 276 of the AEA, and may not be regulated by the states.Y In our view the Through the Energy Policy Act of 1992, Congress added Section 276 to the AEA, which provides in Section 276a:

No provision of this Act, or of the Low-Level Radioactive Waste Policy Act, may be construed to prohibit or otherwise restrict the authority of any State to regulate, on the basis of radiological hazard, the disposal or off-site incineration of low-level radioactive waste, if the Nuclear Regulatory Commission, after [October 24, 1992) exempts such waste (continued *** )

Mr. Samuel J. Chilk December 19, 1994 Page 5 proposed rule on radiological criteria for decommissioning does not exempt from NRC regulation residual radioactivity below the limits necessary to achieve license termination.

Accordingly, the NRC should eliminate the resulting ambiguity by revising the draft policy statement to specify that Agreement State programs may not address radiological criteria for power reactor decommissioning.

c. Low-Level Radioactive waste Issues In view of the potential for states to assert jurisdiction over power reactor decommissioning under the guise of LLW disposal regulation, as discussed above, we address below those aspects of the draft policy that deal with LLW disposal and which we believe could result in state-imposed burdens on power reactor decommissioning.

As a general matter, the final policy statement should clarify the extent to which it will cover LLW issues. The draft policy states at one point that the Commission directed the Staff to develop a compatibility policy "for all program areas other than low level radioactive waste" (59 Fed. Reg. at 37270). Although it appears that the Commission originally instructed the NRC staff that the policy should not address Agreement State regulation of LLW disposal,¥ the draft policy does in fact address LLW disposal in several respects.~ The NRC specifically requests comments on

'll( *** continued) from regulation.

42 u.s.c. S 2023 (1992).

See 59 Fed. Reg. at 37,271 n.2 (the Commission "is revisiting its earlier decision to review compatibility of Agreement State programs in the low level radioactive waste area on a case-by-case basis.").

For example, the draft policy defines the "practices" to which it applies as including not only "very general activities involving radioactive materials such as industrial radiography, low-level waste disposal, nuclear medicine procedures, and well logging, but also includes specific activities conducted within these very broad activities, such as shallow land burial . . * . " 59 Fed. Reg. at 37,272 (emphasis added). Similarly, the draft policy includes as an example of acceptable Agreement State requirements that are (continued *.. )

Mr. Samuel J. Chilk December 19, 1994 Page 6 whether the final policy should apply to LLW disposal regulation or whether, on the other hand, the NRC should continue its past practice of considering questions of compatibility in this area on a case-by-case basis. 59 Fed. Reg. at 37,271 (Question 6).

The Decommissioning Commenters urge the NRC to retain in the final policy statement the provisions concerning LLW disposal.

In addition, the Decommissioning Commenters urge the Commission to clarify (1) that the provisions of the policy statement do not apply to residual radioactivity at decommissioned power reactor sites; and (2) that Agreement States must adopt dose limits and radiation protection release limits associated with LLW disposal that are identical to those promulgated by the NRC.

The final policy statement should also clarify what --

if any -- remaining areas of LLW disposal the states may regulate and impose more stringent regulatory standards. In our view, state flexibility to regulate in this area should be minimal, and should be subject to a "rebuttable presumption" that the NRC standard is adequate.l' In this regard, at a minimum, the NRC should not permit a scenario in which a state could totally prohibit the disposal of LLW within its boundaries, even if it asserts the existence of a "special public health and safety or environmental basis for this action." See 59 Fed. Reg. at 37274.

In our view, the potential- imposition of State requirements on LLW disposal that are more restrictive than NRC requirements could lead to substantial uncertainty as to the ultimate costs of decommissioning power reactors. NRC decommissioning funding requirements that are intended to provide reasonable assurance of the protection of the public and safety§/

i'( *** continued) more stringent than NRC requirements, state prohibitions on shallow land burial of LLW. See 59 Fed. Reg. at 37,274.

~ We recognize that Section 276(a) of the AEA provides that the States are not prohibited from regulating the disposal or off-site incineration of LLW on the basis of radiological hazard, if the NRC "exempts such waste from regulation. 11 See 42 u.s.c. S 2023.a.

~ See 53 Fed. Reg. 24018, 24037 (June 27, 1988).

The NRC has also determined that the public health and safety can best be protected by promulgating a rule requiring reasonable (continued ..* )

Mr. Samuel J. Chilk December 19, 1994 Page 7 could be materially compromised if wholly independent State regulation of LLW disposal were permitted. Given the significant effect that LLW disposal costs have on decommissioning funding estimates, the potential for inconsistent state regulation of LLW disposal would introduce inconsistencies and uncertainties into the overall decommissioning planning and funding scheme, undermining the NRC's responsibility to assure the protection of the public health and safety.

D. General comments Regarding Draft Policy statement

1. Definition of an "Adequate" state Program.

The draft policy statement contemplates that separate findings of "adequacy" and "compatibility" would be made with respect to Agreement State programs, and that these findings would be based upon different considerations. The NRC proposes that a state program will be "adequate" if it consists of those attributes considered necessary by the NRC to maintain an acceptable level of protection of public health and safety within the Agreement state.

By contrast, a program would be "compatible" if the effect of Agreement state action or inaction on other states would not interfere with the "larger national interest in radiation protection as defined by the NRC." 59 Fed. Reg. at 37270. The NRC proposes to identify what is needed for an "adequate" Agreement State program before determining what will ultimately be required for compatibility. ~

The proposed definition of "adequacy" deviates from the well-known statutory test of "reasonable assurance of adequate protection of public health and safety. 11 Instead, adequate performance would be measured by a new test of "acceptable" level of protection. No reason has been given for inventing a new standard. No problems with the familiar standard have been identified. It would be simpler, and more consistent with NRC historical practice, to define "adequate protection" not in terms of what is "acceptable," but in terms of whether or not the state program provides reasonable assurance that public health and safety will be protected.

§'( *** continued) assurance that at the time of termination of operations adequate funds are available so that decommissioning can be carried out in a safe and timely manner and that lack of funds does not result in delays that may cause potential health and safety problems.

Mr. Samuel J. Chilk December 19, 1994 Page 8 The NRC has long equated the need for "adequate protection" of public health and safety with a demand for "reasonable assurance" of that protection; and the U.S. Supreme Court has squarely sustained the NRC's administrative construction.1' The NRC's regulatory process "turns upon the concept of reasonable assurance to public heal th and safety. "1' Moreover, application of a "reasonable assurance" standard would allow reliance upon the body of NRC case law which interprets this term. This substantial body of regulatory interpretation would implicitly be abandoned if the NRC adopts the new standard. The results will be a legal basis for Agreement States to demand greater autonomy by showing that their more stringent standards clearly are acceptable. For these reasons, the Decommissioning Commenters oppose this new criterion.

2. specific compatibility ouestions Posed by the pc The NRC has solicited answers to several questions that raise significant legal and policy issues, such as whether (and, if so, when) Agreement States should be permitted to establish more stringent requirements, or more stringent radiation-protection related release limits, for their licensees.

In our view, the "compatibility" requirement of Section 274 should not be read to allow Agreement states to establish requirements for their licensees, or for particular classes of licensees, that are more stringent than those established by the NRC. Uniformity (or, more precisely, lack of conflict) between the Federal and state programs regulating nuclear materials was, and still remains, the primary consideration underlying Section 274.~

11 Power Reactor Development co. y. International Union of Electrical. Radio and Machine workers, 367 u.s. 396, 407-16

( 1961) .

Nader v. Nuclear Regulatory Comm'n., 513 F.2d 1045, 1052 (D.c.

Cir. 1975).

SECY-93-290, "Draft Policy Options on Compatibility," states:

the legislative history [of the AEA] indicates that the general concept of uniformity and avoiding conflicts and overlaps between the Federal program regulating nuclear materials and the proposed State programs were a prime consideration during the development of this legislation. This led to the adoption of the language requiring that proposed (continued ... )

Mr. Samuel J. Chilk December 19, 1994 Page 9 Accordingly, there should be a presumption in favor of national uniformity in the NRC' s compatibility policy, and the agency should not be reluctant to say so. Under this interpretation, for example, a "compatible" Agreement State program would include all elements of the NRC's program for the same material. It would also be presumed that (absent express Congressional intervention), a state may not adopt more stringent regulations than the NRC and still be found "compatible."

At a minimum, an alternative position on more stringent state standards would be that (1) Agreement States should not be allowed to impose more stringent radiation-protection related release limits than the NRC; and (2) Agreement States that wish to establish more stringent requirements in other areas must affirmatively rebut the presumption that the NRC's standards are adequate to protect public health and safety. This presumption could be rebutted only by a clear and convincing showing by the state that local conditions require the adoption of a stricter standard.

The principle of "compatibility" should not allow an Agreement State to preclude (or effectively preclude) a particular practice that is permitted by the NRC. If the NRC has determined that a specific activity or practice under its jurisdiction is acceptable, there can be no justifiable technical basis for a state to reach a different conclusion. (While political considerations could certainly motivate a state to preclude certain activities permitted by the NRC, the Atomic Energy Act does not contemplate that such factors may provide the basis for a state's decision.)

compatibility criteria Consistent with the suggested answers regarding adequacy, we also propose that Section D of the draft policy statement 2' ( *** continued)

State programs be 'compatible' with the Commission's program. (p. 2)

See also the NRC's State Agreements Program Internal Procedure B.7 (provided as an attachment to SECY-93-290), which states (p. 1) that although the Commission has never formally defined compatibility, "The basic objective has been to achieve uniformity among the various regulatory programs to the maximum extent practicable recognizing that the states must be allowed some flexibility to accommodate local conditions."

(emphasis added).

Mr. Samuel J. Chilk December 19, 1994 Page 10

{Compatibility Criteria) be modified. First, the text of the policy should be revised to state more clearly that, to achieve compatibility, a state regulation or program element must be adopted by an Agreement state in a manner essentially identical to that of the NRC if any one of the four criteria listed in Section D (p. 37273, col. 3) is met. Only if the regulation in question meets none of these criteria may the state have the flexibility to include more stringent requirements.

Moreover, if, under these circumstances, the state chooses to adopt more stringent requirements, it will shoulder the burden of demonstrating that: (1) the requirements for adequacy are still met; and (2) the more stringent state requirements do not preclude or effectively preclude a practice within the national interest. The existing provision which would allow states to adopt more stringent requirements that effectively preclude a practice within the national interest if they can show an "adequate public health and safety or environmental basis" should be deleted.

Implementation of Policy statement Section E (Implementation). This section, as drafted, provides that:

In order to permit the NRC to provide early coordination and oversight of any proposed more stringent regulations or requirements, NRC will request Agreement States to identify any such regulations or requirements and provide opportunity for NRC review before publication as a draft rule for comment or before the institution of the requirement as a legally binding measure.

This language should be changed to read as follows:

In order to permit the NRC to provide early coordination and oversight of any proposed more stringent regulations or requirements, NRC will require Agreement states to identify any such regulations or requirements and provide opportunity for NRC review, including public comments, before publication as a draft rule for comment or before the institution of the requirement as a legally binding measure.

Mr. Samuel J. Chilk December 19, 1994 Page 11 i:v. conclusions In our view, national uniformity is the most effective way of standardizing requirements and optimizing regulatory resources and ensuring predictability and uniformity in regulation of licensees' decommissioning activities and finality of license termination. We believe such uniformity is essential to the maintenance of a decommissioning regulatory scheme that assures the adequate protection of the public health and safety. Accordingly, we urge the adoption of the specific and general comments provided above in the finalization of the Draft Policy Statement.

Respectfully submitted, Joseph a.Knotts, Jr.

William A. Horin Anne w. Cottingham Winston & Strawn Counsel to the Decommissioning Commenters

COVINGTON & BURLING 1201 PENNSYLVANIA AVENUE . N . w . OQCV r_ TED P . 0 . BOX 7566 us PC WASHINGT ON , D .C . 20044- 7566 LECONFIELO HOUSE (202 ) 662 - 6000

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• LONDON WIY B AS ENGLAND T ELEX : B9 - 593 ICOVLI N G W S H l HERBERT ESTREICHER TELEPHONE : 071-495- 54555 DIRECT DIAL NUM B ER CAB L E : COVLING

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&rl.!S§E'LS CORRESPON DENT OFFICE 44 AVENUE DES ARTS BRUSSELS 1040 BELGIUM TELEPHONE. 32-2-512-9890 T ELEFAX: 3Z*2-502- 15 98 December 19, 1994 DOCKET NUMBER p PROPOSED RULE r<\\~

• Cardelia Maupin State Agreements Program (5\ f'R~T\~~

Office of State Programs U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, Maryland Re: Comments on "Agreement State Programs Adequacy to Protect Public Health and Safety and Compatibility With the NRC Regulatory Program; Draft Statement of Policy"

Dear Ms. Maupin:

Enclosed for filing please find three copies of Kerr - McGee Chemical Corporation's {"Kerr-McGee") comments on the "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy," 59 Fed. Reg. 37,269 (July 21, 1994). The comment period, which was originally scheduled to end on October 19, 1994, has been extended to December 19, 1994. See 59 Fed. Reg. 52,317 {Oct. 17, 1994)

Kindly arrange to have the comments deposited with the Docketing and Services Branch. Also, I enclose one copy to b e date-stamped and returned with our messenger.

Thank you for your assistance i n this matter.

Yours very truly, Herbert Estreicher FEB 2 4 1995 Acknowledged by card ........................... """'

LI. S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF Tl-iE SECRETARY /

Of THE COMMISSION DoaJment Stattslial Postmarl( Date ~ ~r>),:

Copies Received_\.,____ _ _ _ __

,stwP °;:R' Add'I Copies Reproduced __..o.....____

Special Distri~tion :J?'ve., &, P ~ 1

I COVINGTON & BURLING 1201 PENNS YLVANIA AVENUE . N W P 0. BOX 7566 WASHINGTON , O.C. 20044-7566 1202 ) 662-6000 LECONFl[LO HOUSE CURZON STR((T LONDON WIY 8AS TELEF'AX , li!Oi!I eez-ezg, TELEX ,89-593 ICOVLING WSHI HERBERT ESTREICHER T[LEPMON[. 071 95*58!55 OIA'ECT DIAL NUM8£R CABLE, COVLING T[L[F'AJ<: 071 95*3101 12021 ee2-557e BRUSSELS CORRESPONDENT OFF'ICE 44 A'v[NUE 0£5 ARTS BRUSSELS 1040 atLGIUM TELEPHONE 32*2*!512-9890 December 19, 1994 TC.LEF'AA 32*t?-!50Z-1!588 By Hand Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Services Branch Re: Comments of Kerr-McGee Chemical Corporation on the "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety: Draft Statement of Policy," 59 Fed. Rei. 37,269 {July 21, 1994).

Dear Secretary:

These comments are submitted by Kerr-McGee Chemical Corporation

("Kerr-McGee") concerning the draft document entitled "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy" (hereinafter "draft policy statement") that was published by the Nuclear Regulatory Commission (NRC") at 59 Fed. Reg. 37,269 (July 21, 1994). The comment period, which was originally scheduled to end on October 19, 1994, has been extended to December 19, 1994. See 59 Fed. Reg. 52,317 (Oct. 17, 1994). Kerr-McGee has an interest in the matter as a result of the fact that it is subject to regulation by an Agreement State.

The draft policy statement would provide guidance to Agreement Stat~s.

NRC staff, and the public on the criteria the NRC intends to use in evaluating the adequacy and compatibility of Agreement State programs. Kerr-McGee agrees that specific criteria are needed in order to guide Agreement States in the development of regulatory programs and to provide a clear basis for the Commission to exercise its

COV I NG TON & BUR LI NG Secretary U.S. Nuclear Regulatory Commission December 19, 1994 Page 2 responsibility for oversight of Agreement State programs. Kerr-McGee has submitted comments in response to the NRC's "Draft Policy Statement on Agreement State Program," 59 Fed. Reg. 40,058 (Aug. 5, 1994), which address a number of our concerns with respect to specific NRC proposals for revising the Agreement State program review criteria. See Comments of Kerr-McGee Corporation on the "Draft Policy Statement on Agreement State Program" (Dec. 19, 1994). Many of the points made by Kerr-McGee in those comments apply with equal force to this draft policy statement and hence we request that these other comments also be considered here. These comments respond to a number of the specific questions for public comment which the Commission has raised.

See 59 Fed. Reg. 37,271 .

More Stringent State Requirements The Commission has asked whether Agreement States should be permitted to establish more stringent requirements, for their licensees, than those established by the NRC. 59 Fed. Reg. 37,271 (Specific Question Nos. 1 and 8). Kerr-McGee does not believe that there are any circumstances under which a more stringent State requirement could be justified.

In Kerr-McGee's comments on the "Draft Policy Statement on Agreement State Program," we demonstrated that NRC lacks the authority to allow Agreement States to establish more stringent radiation-protection standards than those established by the Commission. As discussed, the statutory scheme reflects Congress' recognition of, and intent to guard against, the enormous problems that would be created for the regulatory community and the public if the various States were allowed to enact conflicting, overlapping, and inconsistent radiation standards. Section 274(g) of the Atomic Energy Act -- which requires that a uniform set of radiation standards be applied at both the federal and state level -- was enacted specifically for the purpose of preventing the States

COVI NG TO N & B U R LIN G Secretary U.S. Nuclear Regulatory Commission December 19, 1994 Page 3 from imposing radiation standards that differ (either more or less stringent) from the Federal standards.

Providing flexibility to the States to depart from the Federal standards is both unnecessary and contrary to sound regulatory policy. The States have adequate opportunity to present their views on the appropriate level at which radiation standards should be set during the NRC rulemaking process. Once a standard is set at the national level, however, an Agreement State should not be permitted to deviate from the NRC requirements. To permit States to impose more stringent standards would serve to undermine the credibility of the national standards.

The NRC standards are fully protective of the public health and safety, and there thus can be no legitimate health or safety rationale for a more stringent standard at the state lc:vel. In setting standards, the NRC draws on the recommendations of international and national expert bodies. And guided by extensive input from a broad spectrum of industry, federal, state, local and environmental interests, the NRC is able to forge a national consensus on the appropriate level of protection of public health and the environment. The NRC also conducts a comprehensive environmental impact statement in connection with every major rulemaking. In short, the NRC standards reflect the best available data on the appropriate level of protectiveness.

A decision by a State to impose standards that are more stringent than the national standard would lack the benefits of the NRC consensus building and of the expert analysis conducted by the NRC staff. The States are more likely to be influenced by local partisanship and narrow parochial interests than by a legitimate concern for the health and safety of the public. In short, more stringent State standards would lack ari adequate technical basis and should not be permitted.

The same rationale should apply to substantive standards outside of the radiation-protection area. There are strong benefits in a uniform set of requirements throughout the Nation so that entities regulated by various different States are confronted

COVI NG T ON & BUR LI NG Secretary U.S. Nuclear Regulatory Commission December 19, 1994 Page 4 by consistent rules. The need for a uniform and coherent national body of regulation should not be undercut by parochial or politically motivated state action.

2. Compatibility Criteria The Commission has asked whether the four compatibility criteria in the draft policy statement provide sufficient guidance for determining whether an NRC standard must be adopted verbatim by the States. 59 Fed. Reg. 37,271 (Specific Question No. 2). Kerr-McGee agrees that the four compatibility criteria provide an appropriate starting point for making a compatibility determination. In addition, the Commission should consider whether the proposed State requirement imposes burdens on Agreement State licensees that are disproportionate to those faced by licensees in other Agreement States or in NRC-regulated States.

3. Limits On State Authority to Prohibit Licensing Practices The Commission has asked whether the States should be permitted to preclude or, by exceptionally stringent regulation, effectively preclude an Atomic Energy Act ("AEA")-authorized practice in the State. 59 Fed. Reg. 37,271 (Specific Question No. 4). Kerr-McGee does not believe that Agreement States should have authority to bar a practice that is permitted in the NRC-regulated States. Indeed, any such effort by a State should constitute a basis for the withdrawal of Agreement State authority.

The AEA reflects Congress' recognition that the use of atomic energy for both military and peaceful purposes is "vital" to the common defense and the national security. See 42 U.S.C. § 2012(a). The Act thus establishes a federal program for ,

• regulation of nuclear materials that serves among other things "to encourage widespread participation in the development and utilization of atomic energy for peaceful purposes to the maximum extent .... " Id. § 2013(d). Although Section 274 of the AEA authorizes the NRC to enter into an agreement ~lowing a State to assume regulatory authority over

COVI NG TON & B U R LIN G Secretary U.S. Nuclear Regulatory Commission December 19, 1994 Page 5 certain nuclear materials, the overall purpose of the federal program must nonetheless still be served.

If the NRC were to permit Agreement States (potentially all fifty states) to pick and choose those AEA-authorized activities that are to be permitted within the State, the Federal program for regulation of nuclear materials could be destroyed. The Commission should not countenance a State' s attempt to place its parochial interests above the national interest.

4. Standards Subject To The Compatibility Requirement The Commission has asked whether compatibility should be required for NRC regulations other than those already listed under criterion number 3 of the proposed compatibility criteria. 59 Fed. Reg. 37,271 (Specific Question No. 5). The Commission currently requires that States adopt, essentially verbatim, into their regulations some 50 NRC provisions that are found in parts 19, 20, 30, 40, 61 , 70, 71 , and 150 of the NRC regulations. These NRC requirements, called "Division 1 Rules" (see Appendix A to SECY-93-290)~ are basic to the regulatory program for nuclear materials and their modification by a State should not be permitted.

There also are some 150 NRC regulations -- called Division 2 Rules (~

SECY-93-290, App. A, A-2 to A-5) -- which in Kerr-McGee's view are also necessary for a coherent national program for regulation of nuclear materials. Kerr-McGee urges that the Commission require extraordinary showings before authorizing an Agreement State to depart from any of these Division 2 rules. A request by a State to depart from any of these rules should be reviewed by the NRC, subject to public comment, before'the NRC grants the State's request.

COVI NG TO N & BUR LI NG Secretary U.S. Nuclear Regulatory Commission December 19, 1994 Page 6 In light of the foregoing, Kerr-McGee urges that the Commission limit the flexibility that would be offered to the States under the draft policy statement. We urge substantial revision of the statement and then reissuance for further public comment.

Respectfully submitted, Richard A. Meserve Herbert Estreicher Counsel to Kerr-McGee Chemical Corporation

DOCKET NUMBER PROPOSED RULE pl .~N\ 6 c...

E.I. DU PONT DE NEMOURS & CO. (INC.)

MEDICAL PRODUCTS DEPARTMENT (6~F~o'1&.(p9)

• 94 ff 19 r 2 :17 Secretary U. S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch

Reference:

Adequacy and Compatibility for NRC and Agreement State Radiation Protection Control Program Necessary to Protect Health and Safety; Draft Statement of Policy. Federal Register Vol. 59, 139 Thursday, July 21, 1994. Page 37269.

Dear Sir,

These comments are submitted on behalf of NEN Products, Medical Products/Imaging Systems, DuPont de Nemours and Company and the DuPont Merck Pharmaceuticals Company (DMPC). NEN Products is a major manufacturer and supplier of radioactive materials for biomedical, environmental and industrial research applications and quality control. DMPC is a major manufacturer and supplier of radioactive sources and radiopharmaceuticals for nuclear medicine applications. NEN Products and DMPC distribute radioactive materials worldwide and to licensees in every State.

To ensure availability of these beneficial products, it is essential that the federal regulations to protect health and safety are uniform and compatible with those in each State.

NEN Products and DMPC are members of the Council on Radionuclides and Radiopharmaceutical, Inc. and endorses the comments they have issued on the above referenced subject. We have provided some additional comments that we hope are of use to you.

We appreciate the opportunity to comment on this subject and would be glad to provide further information or clarification if needed.

Sincerely, yours,

~

Leonard R. Smith, CHP Radiation Protection Consultant FEB 2 4 1995 Acknowledged by card .........................., .......

MEDICAL PRODUCTS DEPARTMENT 549 Albany Street, Boston, Massachusetts 02118 Telephone 617-482-9595 Fax (617) 542-8468

U.S. NUCLEfR REGULATORY COMMISSIO:

D0C f<ET'1'-IG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COM ISSION Document Statislias Postman< Dal8 _ IO:\-,L-...q.;.L-L-- - - -

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COMMENTS OF DRAFT STATEMENT OF POLICY; ADEQUACY AND COMPATIBILITY FOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFETY.

The world community is increasingly dependent on international standards in radiation protection and quality assurance. The establishment of international standards involves a concentration of effort from the worlds best qualified experts. Because of this practice, international standards enjoys the highest level of public confidence. This confidence transfers to Federal and State regulations when they are strictly compatible with the international standards.

To implement this process there should be one federal agency that establishes national standards to be compatible with international standards . This standard setting agency should not have any responsibility for promulgating or enforcing regulations.

Responsibility for promulgation and enforcement belong to federal and state regulatory agencies and their regulations should be uniformly compatible with the national standards.

The advantages of this proposed system are significant and numerous including.

a. Maximize public confidence.

b. Reduce the costs of essential health care services and products, and biomedical environmental and industrial research.

c Promote US involvement in setting international standards.

d Promote a better understanding of fewer regulations.

e. Simplify and enhance compliance with regulatory requirements.

f. Avoid the cost of promulgating, enforcing and complying with duplicate regulations.

g. Avoid the liability of conflicting regulations.

h. Simplify the accreditation of radiation protection and quality assurance programs and the certification of radiation protection professionals.

i. Enable more in depth training of professionals in regulatory affairs.

j. Facilitate the transfer of experienced and qualified professionals between states.

k. Facilitate international commerce in radioactive materials that benefit society.

I. Facilitate emergency assistance from groups outside the state or country.

m. Enable manufacturers to take a more active role in assisting smaller licensees (often customers) in safe handling techniques, training and regulatory compliance.

For these reasons it is essential that state regulations that concern dose and release limits, transportation, license verification and waste disposal and processing be strictly compatible with the national and international standards.

1.

SPECIFIC QUESTIONS FOR PUBLIC COMMENT

1. Under what circumstances should Agreement States be permitted to establish more stringent requirements, for their licensee, than those established by Commission? Should this also include the ability to establish stricter dose limits for particular classes of licensees?

Agreement States should not be permitted to establish more stringent requirements than those of the NRC. All licensees should be subject to the same dose limits. Radiation protection can be enhanced by there being one set of national standards that all federal and state regulators must adopt which are compatible with international standards.

2. Are the four criteria in the proposed policy statement for determining whether Commission regulation or other program element should be adopted in a manner essentially identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? What examples could be used to illustrate how each criterion would be applied Criteria I needs to be expanded to include IO CFR 71 requirements.

Criteria 2 should include the requirement that licenses must use identical terminology to ensure communication . For example there is a need for a nationally acceptable definition of a "sealed source".

Criteria 3 should ensure that dose limits and release limits in 10 CFR 20, 6 I and 71 are identical in all federal and state regulations.

We disagree that states should be permitted the flexibility to promulgate standards different from the NRC. In general the above mentioned requirements should be strictly compatible. In rare exceptions, when a state can demonstrate a substantive benefit in health and safety, the NRC should have the flexibility to grant a variance. However, this variance should only be granted provided that it does not deprive the nation of a beneficial practice and provided that the cost of maintaining stricter requirements is borne by the state and not the license. States should not be permitted to apply stricter requirements on a class of licensees for political reasons.

2.

3. What are some examples of State action to establish stricter reqllirements than those established by the Commission, or establish reqllirements where the NRC has not?

Several States have established stricter requirements than the NRC for the use of devices and sealed sources and the application of generally licensed devices. Certain States require stricter emission standards than the NRC or require that licensees must reduce residual contamination to "below background" prior to releasing a site for unrestricted use. Several states are incorporating more restrictive requirements on waste disposal sites than required by 10 CFR 20. A commonly occuring situation is that local communities will attempt to prohibit the transportation of radioactive material and the disposal of radioactive materials in the sanitary sewer. The recent increase in these activities has been agrivated by the Environmental Protection Agency offering financial assistance to States that promulgate regulations more restrictive than the NRC. In most cases these initiatives are promoted for political reasons and have no technical merit.

4. What limits, if any should be placed on the power of a State to preclllde or, by exceptionally stringent regulation, effectively prechlde a particular practice?

States should be prohibited from precluding practices that are permitted by the NRC and that are in the national interest.

5. Are there any other dose or radiation protection related release limits in the Commission's regulations which should be included under the criterion number J of the compatibility criteria? Should the dose limits contained in 10 CFR Part 61 be included under this criterion?

Criterion number 3 needs to be expanded to included 10 CFR 71 . It is essential that the dose limits in 10 CFR 61 be included in criterion 3 to facilitate the development of low level radioactive waste disposal sites by compacts.

6. Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-case basis?

State regulations must be strictly compatible with 10 CFR 61 to ensure continued progress in the compact process and to avoid the proliferation of unnecessary low level radioactive waste sites.

3.

7. Are there cu"ently areas or situations in Agreement State regulations or other Agreement State requirements that would not meet the proposed policy statement.

As indicated in our response to specific question 3, above, State regulations and practices that are not compatible with NRC regulations include:

a. decommissioning release standards.

b. emission standards.

c. reciprocity arrangements.

d. waste disposal site requirements.

e. sewer disposal considerations.

Other areas of incompatibility include:

a. licensing fees.

b. inspection and enforcement practices.

c. different implementation dates for new regulations.

d. incident notifications.

e. notification of defects.

f emergency preparedness.

g. waste storage fees.

h. interpretation of regulatory requirements.

1. inconsistent regulatory treatment of byproduct material and NARM.

j. inconsistent regulatory treatment of radioactive sources

8. Should States be permitted to establish more stringent standards for radiation protection related release limits.

States should not be permitted to establish standards for radiation protection release limits that are neither more restrictive or less restrictive than those of the NRC.

4.

DOCKET NUMBER PROPOSED RULE p ff\~

27 Lum Road Cincinnatus, N Y 13040 [O (ii)

Dec. 12, 1994 oocU~~t C (59 FR. ~1~~9)

To Whom it may Concern RE: NAS Reviews LLRW

• 94 er 19 P2 :16 The panel has several biased persons or conflict oflodm1 eJilfs .--r \~f. TAR n- _, RVICE I contacted the LLRW Office in Cortland regarding t iq~~[l A CH decision would be suspect by the public and the process suspect or favor the nuclear industry , if not personal interests .

The NAS Review Panel violated N.Y . S, law by holding secret or closed door sessions . Yet the Citizens Advisory Commission (NYS) was unable to prevent this. Citizens were not present at all NAS Meetings to hear why the panel would or would not answer public questions. The review has become a farce and not even all the essential documents were reviewed as far as the public knows.

I am greatly concerned for the safety of people and the enviornment as the DOE atates in EM-0216: contamination of non-arid SRS a plume larger than 3 square miles; Hanford Site 7 aquare miles plume, Nevada Test Site over 5 aquare miles of soil and over 220 sites with VOC (Volatile Or anic Compound) contamination in arid enviornments within the no~ Complex . The above exhibit high concentration levela, high mobility and high toxicity. The federal government and industry is developing technology solutions to address common waste stream problems .

I doubt that any community knowing a portion of truth and the risk involved with LLRW facility being attempted to be sited would ever do it vo}untarilly. The records of experience are too risky.

Qtates should be able to pass more restrictive regulations than federal rules for they are too open to misunderstanding and risky or we wouldn ' t have s~ -many hazardous waste sites across the nation.

I hope good statesmanship and common sense will p.ers e vere and that sound technology and science will be used to ~r'f; c* pise solutions *

~irrcerely yours, CC: G*O, Wash. DC ... ..,. !,.:,,J/ f i ~r~../,,__

NIRS, " " Alleen n ' ~,. *G:tr.:~~r.--z.

I I U. S. Senate "

U.S. House NYS 9enate, Albany ifEB 2 4 1995 LLRW Office, Cortland, NY NCNY Conf. UMC, Cicero, J.JY Acknowledged by card "'"*-m-*-*tnllllf

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r U.8.NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date --L~ .LSl..µ.;;;;i__ __

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STATE 0Fo@t0RADO '

Roy Romer, Governor Patricia A. Nolan, MD, MPH, Executive Director Dedicated to protecting and improving the health and environment of the people of Colorado

• 94 (~ 19 P 2 :14 4300 Cheny Creek Dr. S. Laboratory Building Denver, Colorado 80222-1530 4210 E. 11th Avenue Phone (303) 692-2000 Denver, Colorado 80220-3716 (303) 691-4700 Of *C.otorado Department 00 of Public Health and F.nvironment DEC 16 1994 DOCKET NUMBER Pl PROPOSED RULE.!.!!-~ ~"'!

(SC\~=>'1 ~!cf\)

Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555

- ATTENTION: Docketing and Service Branch This letter is in regard to 59 FR 37269, The Commission's "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy" While the draft policy statement contains many appropriate elements for an adequate radiation control program, the policy too* often points to procedures and "standards" that are not necessarily essential for a partnership between the NRC and Agreement States.

GENERAL COMMENT

S:

1. The Policy Statement Should Focus on Those Factors That Are Essential For The Protection of Public Health And Safety.

Many of the items in the draft policy statement are substitutes for determining whether a state or the NRC adequately protects the public and the environment. While it is difficult to determine what is an acceptable level of protection within a particular state, the NRC should not impose its assumptions and procedures in lieu of that determination.

Colorado agrees with the statement that "adequate [should] focus on those elements of a State program that are necessary to provide a level of protection to the public health and safety within the State that is equivalent to, or greater than, that provided by the NRC ..* 11 However, all too often the NRC has mistakenly imposed regulations that were not necessary to provide the same level of protection. This is especially critical as the Commission does not intend to allow States to deviate from the program elements that the Commission requires.

Likewise, for compatibility the NRC should focus on insuring that the respective programs are not in conflict. Compatibility does not mean the NRC and States need to be identical .

2. A Final Policy Statement Must Have The Concurrence Of The Agreement States.

As partners who are required by law to cooperate, a policy as important as the relationship between the NRC and the States must be entered into as an agreement between partners.

£FEB 2 4 1995 Acknowledged by card .. " .............................,,

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date _,._...,_._,,.""'t"-_ _ __

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Secretary, U.S. Nuclear Regulatory Commission Pae 2 After evaluating the comments received on this draft policy, the NRC should convene a workshop with the Agreement States in order to reach concurrence on those specific regulations that are necessary for an adequate and compatible Agreement State Program.

3. NRC Mus t I mprove The Quali ty And Accuracy Of Its Regu lat ions Before They Are Considered Matters Of Adequacy And Compatibility.

NRC has required Agreement States to adopt regulations that are not based on sound information. Before any regulation that might be a matter of adequacy or compatibility is adopted by the Commission, NRC's procedures for performing a regulatory analysis must be improved. NRC at times adopts regulations that are based on staff's beliefs of what occurs, or what they think will occur.

This is unacceptable. There must be data to justify those assumptions. For example, the Quality Management rule has been assigned a Division 1 matter of compatibility. However, data has not been presented that the rule actually reduces exposures commensurate with the effort involved.

Another example is the propos al for record re t ention. The NRC's a n aly sis estimates that it will cost Agreement States $750,000 per year. The analysis states this is necessary based upon one (1) facility for which NRC could not find adequate information. This analysis fails to either justify the expense in terms of benefit, or provide obvious alternatives that could be considered at less cost.

RESPONSE TO SPECIFIC QUESTIONS :

1. States Should Be Permitted To Establish More Stringent Requirements.

Including Stricter Dose Limits.

Agreement States should be permitted to adopt stricter standards including dose limits. The NRC should set minimal standards based on risk in those areas. Where required by law, NRC should adopt, and require states to adopt the EPA standards. Scientists can determine the risks associated with a particular hazard, but it is a political, not technical, decision as to what level of risk a government will permit its citizens to be exposed. Beyond ensuring the very basic exposure limits are enforced, the NRC should give deference to States that want to make this decision themselves.

The NRC must also separate dose limits and risks from procedures. Colorado recognizes the federal government's responsibility of setting basic, maximum dose limits, but the federal government should not dictate how those limits are reached.

The final policy should identify the criteria in such a way that State's do not have to apply to the NRC for exemptions.

2. Interstate Commerce And The Evaluation Of Trends Should Not Be A Requirement For An Adequate and Compatible Program.

Agreement States should be required to abide with those factors that affect public health and safety. The NRC is responsible for radiation safety. A State is responsible for the welfare of its citizens. To imply that either the NRC or a State should exceed its authority is inappropriate. For example, if a State Radiation Control Program adopts a regulation that is in conflict with interstate or international commerce, there are remedies that do not involve the NRC to correct that conflict.

Secretary, U.S. Nuclear Regulatory Commission Page 3 In regard to reports required for NRC surveys, it may be desirable for States to participate, and States may want to participate. However, before NRC can require States to participate in any survey or report, it must demonstrate that the NRC cannot obtain sufficient information itself in order to take a required action.

The concepts regarding interstate commerce and the study of trends are valid, and States should participate. But if they do not, they can still have an adequate program that is compatible with the NRC.

3. Examples Of State Action To Establish Stricter Requirements Than Those Established By The Commission.

Two examples where the NRC should favor this concept are the new 10 CFR 20, and the Clean Air Act. The revised dose limits for the general public and the embryo/fetus have been recommendations by national and international organizations for many years. In fact, NRC spent many years trying to adopt these standards. If the NRC recognized that the dose to the embryo/fetus should be limited to 5 mSv, and the annual dose to a member of the public should be 10 msv, why shoul d NRC have a problem if a State a dopted thes e standards prior to the NRC?

In regard to the Clean Air Act, EPA, as required, established a national standard - 1 mSv. EPA also said the NRC's regulations are not adequate to implement this standard. If a State adopted EPA's national standard, how could NRC find the State inadequate or incompatible based on the State not complying with NRC's standard that has been determined by EPA to be unacceptable?

4. The NRC Should Not Place Limits On A State's Ability To Preclude A Particular Practice.

In order for a State to adopt regulations, it must follow its administrative procedures, hold a hearing and respond to comments from citizens, environmental groups and industry. If it is state policy that a type of practice should not occur within its borders because that practice is too hazardous, than the NRC should not interfere. Each state has a right to make public policy as long as it is not contrary to law.

Further, it is unrealistic for the NRC to believe that a particular practice will not be precluded just because radiation protection regulations permit the practice. The local community can still preclude activities through zoning and occupancy requirements. The NRC should not waste its time or a State's time trying to ensure operations, such as waste disposal and incineration, can be permitted in every state.

5. The Criteria For Adequacy And Compatibility Should Be Only The Basic Standards.

As stated above, States should be given flexibility. Basic exposure limits and release limits must be met. However, how they are met, and the ability to set more protective limits should not be a concern of the NRC.

Occasionally, industry claims that a State is making it hard for them to do business. It is not NRC's role to ensure that industry can make a profit.

Secretary, U.S. Nuclear Regulatory Commission Pa e4

7. There May Be Cur rent Regulati o n s That Would Not Meet The Proposed Policy Sta t ement.

Colorado believes that all of its regulations would be acceptable under the proposed policy statement. However, certain regulations have been modified to permit licensees flexibility in meeting the basic radiation protection standards. While Colorado believes that public health and safety are adequately protected, the NRC, under the proposed policy, could argue that we are inadequate merely because the regulations are not identical.

8. States Should Be Permitted to Establish More Stringent S tandards.

See response to Specific Question 1 above.

DEFINITIONS:

1. The Definition Of Adequate Is Ge n e rally Acceptable With Reservations.

Colorado agrees that adequa t e r elates to the acceptable level of protection.

This basic level of protection is embodied in exposure limits and release rates. A state that imposes stricter standards still provides adequate protection for its citizens.

2. An Adequate Agreement State Program Is One That Adequately Protects The Public And The Environment.

Colorado cannot agree with the proposed definition of an adequate program as one that has "effectively implemented regulatory program containing elements considered necessary by the Commission" because all too often the Commission adopts, as a Division 1 level of compatibility, "elements" of a program that are either not directly related to radiation safety, or for which other procedures are equally effective.

An example of this is the requirements for emergency notification. Colorado agrees that an adequate program will have requirements for emergency notification. However, there is nothing sacred about the release limits that separate a 4 hour4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> report from a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> report. A State might require a 4 hour4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> report for an exposure of 0.20 Sv, and require that a qualified expert, rather than the State, respond when an individual is taken to a medical center with contamination. That State could be considered adequate and compatible, but not under the proposed policy because of NRC's historic insistence that regulations be identical.

Determinations of "adequate" and "compatible" are harder to perform than determining "identical", but that is no reason to not do the job right.

3. Compatible.

Interstate commerce and the evaluation of trends should not be a requirement for an adequate and compatible program. See response to Specific Questions.

5. Elements Must Be Limited And Necessary.

The elements that are essential should only relate to those necessary to protect public health and safety. The NRC should have concurrence by the Agreement States on what those elements are.

Secretary, U.S. Nuclear Regulatory Commission Page5 ELEMENTS OF AN ADEQUATE PROGRAM:

1. Protection.

Agree.

2. Regulations.

Colorado agrees that an Agreement State program should adopt dose limits and radiation protection related release limits that meet the minimum standards established by NRC or the EPA. It is inappropriate to require as an essential element "any subsequent amendments" to Parts 20 or 61. States cannot be expected to accept unknown, future standards. If the intent is to limit the policy to the dose and release limits in Parts 20 and 61, then the policy should so state.

There is no reason for the NRC to take away from the States their statutory authority to set standards unless such standards are less protective of public health and safety than those of the NRC. Again, it must be noted that many NRC "st andards" a re secondary standards relat ing to dose. These secondary standards should permit flexibility as long as the primary dose and release standards are met.

3. Inspections.

The inspection element does not need to be so rigid; there is no reason why the States cannot use judgment in setting the frequency. An example of where less frequent inspections might be warranted is a small State with only a few medical physicists that serve the hospitals in that State. Such a State may have routine contact with these physicists relative to both the licensing and the x-ray programs. Because of this frequent contact, these physicists may establish safety programs that result in few items of noncompliance. If this State has data to show that compliance at these hospitals exceeds that in NRC-regulated hospitals, the State should be permitted to extend the inspection frequency.

s. Staffing And Personnel Qualification The first sentence in this element relative to sufficient and adequately trained personnel is appropriate. The requirement that the staffing requirements be no less stringent than criteria used for NRC staff is not acceptable. Rather this element should specify training and/or experience that is necessary to perform functions.

9. Licensing The criteria is generally acceptable, with the exception of the statement regarding staff. See above.

ELEMENTS OF A COMPATIBLE PROGRAM:

2. Uniform Manifest.

A uniform manifest is desirable. However, host states, not the NRC, should be able to require additional, necessary information.

Secretary, U.S. Nuclear Regulatory Commission Page 6

3. Trans p ortation Regulation.

States should have regulations essentially verbatim with those of the Department of Transportation (DOT). Should DOT amend its regulations, States should not have to wait for NRC to be compatible with DOT. The requirement should be for compatibility with DOT.

4. Event Reporting.

Event reporting should not be a matter of compatibility unless the NRC demonstrates that a state's information is essential to set a basic radiation protection standard. Too often the NRC requires reports for the development of secondary standards or for procedural requirements. These are not a matter of compatibility.

IMPLEMENTATION:

1. Neither The NRC Nor A State Should Adopt Any Regulation Without An Adequate Safety Or Environmental Basis.

NRC at times adopts regulations that are based on staff's beliefs of what occurs, or what will occur. There should be data to justify those assumptions. For example, the Quality Management rule has been assigned a Division 1 matter of compatibility. However, data has not been presented that the rule actually reduces exposures commensurate with the effort involved.

2. Agreement States Should Be Permi tted To Adopt Al ternat ive Regulations Without First Contacting The NRC.

The criteria should be clear and specific so that States can determine if it has authority to deviate from federal regulations. Should NRC adopt a policy that deviations be approved by the NRC, then the policy must state that NRC shall provide comments within 30 days of receipt, and that a State cannot be found inadequate or incompatible because of any regulation for which NRC failed to provide timely comment.

Robert M. Quillin, Director Radiation Control Division cf: Richard Bangart Agreement States

Secretary, U.S. Nuclear Regulatory Commission Page6

3. Transportation Regulation.

States should have regulations essentially verbatim with those of the Department of Transportation (DOT). Should DOT amend its regulations, States should not have to wait for NRC to be compatible with DOT. The requirement should be for compatibility with DOT.

4. Event Reporting.

Event reporting should not be a matter of compatibility unless the NRC demonstrates that a state's information is essential to set a basic radiation protection standard. Too often the NRC requires reports for the development of secondary standards or for procedural requirements. These are not a matter of compatibility.

IMPLEMENTATION:

1. Neither The NRC Nor A State Should Adop t Any Regulation Without An Adequate Safety Or Environmental Basis .

NRC at times adopts regulations that are based on staff's beliefs of what occurs, or what will occur. There should be data to justify those assumptions. For example, the Quality Management rule has been assigned a Division 1 matter of compatibility. However, data has not been presented that the rule actually reduces exposures commensurate with the effort involved.

2. Agreement States Should Be Permitted To Adopt Alternative Regulations Without First Contacting The NRC.

The criteria should be clear and specific so that States can determine if it has authority to deviate from federal regulations. Should NRC adopt a policy that deviations be approved by the NRC , then the policy must state that NRC shall provide comments within 30 days of receipt, and that a State cannot be found inadequate or incompatible because of any regulation for which NRC failed to provide timely comment.

Robert M. Quillin , Director Radiation Control Division cf: Richard Bangart Agreement States

DOCKET NUMBER pg M f sc-.

December 19, 1994 PROPOSED RULE -

(5t!f Fl< 3126lf)

,r" SUPPLEMENTAL COMMENTS OF OHIO CITIZENS FOR RESPONSIBL INC. ("OCRE") ON "ADEQUACY AND COMPATIBILITY FOR NRC A MENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTE ,

HEALTH AND SAFETY: DRAFT STATEMENT OF POLICY," 59 FED. REG.

(JULY 2 1 , 19 94)

OGRE would supplement its previous comments with these additional statements.

1. Need for independence of the State regulatory program OCRE believes that the NRC should add to its list of elements of an adequate Agreement State program a new element:

Independence The State regulatory program shall be independent from, and shall not be subject to any authority or jurisdiction of, or control by, any function, agency, or element of State government which is also a licensee or license applicant, or which seeks to develop or promote any licensed activities.

The need for this new element is apparent when one considers the enabling legislation which has been introduced into the Ohio General Assembly. This legislation would establish the statutory basis of Ohio's Agreement State program, amend state law estab-lishing the Midwest Compact, and would establish a process for siting and developing the LLRW disposal facility in Ohio, which is the host state of the Midwest Compact.

OGRE finds some provisions of this legislation objectionable from an independence standpoint:

- the director of health's review of the LLRW license application must be completed within 24 months (proposed Sec. 3748.09(A)(l));

the license application review by an independent entity (if utilized) must be completed within 12 months (proposed Sec.

3748. 09 (A) (2));

1

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the license review board's review of the license application must be completed within 6 months (proposed Sec. 3748.09(B)(5));

the adjudicatory hearing conducted by the license review board must be completed within 6 months (proposed Sec.

3748.09(d)).

- if the director cannot complete the license application review within 24 months, the director is to request an extension of time from the Authority, which may grant an extension of not more than 6 months (proposed Sec. 3748.09(A)(2) (see also Sec.

3747.06(A)(20));

if the director contracts with an independent entity to com-plete the license application review, the Board of the Authority shall approve or disapprove that entity. (proposed Sec.

3748(A)(2) (see also Sec. 3747.06(A)(21)));

if the director fails to appoint the license review board within 30 days, the Board of the Authority shall appoint a li-cense review board (proposed Sec. 3748.09(B)(4)).

Clearly, this legislation contains some serious separation of powers conflicts between the Authority, which will be a new state agency created to oversee the siting and development of the LLRW disposal facility, and the Department of Health, the regulator under the Agreement State program. [The license review board is analogous to the NRC's Atomic Safety and Licensing Board in that it conducts the adjudicatory hearing on the licensing of the LLRW facility, but is appointed by the Director of Health and exists only for that purpose.] While the contractor will be the actual licensee of the LLRW facility, the Authority is largely analogous to a licensee and therefore should not have any control over the regulator's activities. While all of these provisions are highly improper if the Ohio Department of Health is to have an independent regulatory program compatible with that of the NRC, the last is clearly the most odious. A licensee does not appoint its own panel of administrative law judges, for obvious reasons.

While the LLRW disposal facility is the probably the largest and most obvious situation where such a conflict of interest could occur, there are other circumstances where state entities are materials licensees, e.g., state universities. It is essential that the independence of the regulator be established and main-tained for all such situations. Again, if a state can't do the Job right, then the NRC should do it.

2

2. Clarification OCRE would clarify our earlier comments with regard to compati-bility. OCRE completely supports the elements of a compatible program, item 1, Radiation Labels, Signs, and Symbols, through item 7, Radiation Protection Terminology. OCRE recommends that item 8, Radiation Protection Standards, be revised to read:

The State regulatory program shall adopt dose limits and radia-tion protection related release limits identical to or more protective than those in 10 CFR Part 20 and 10 CFR Part 61 ap-plicable to all licensees, or any subsequent amendments thereto.

Respectfully submitted, Susan L. Hiatt Director, OCRE 8275 Munson Road Mentor, OH 44060-2406 (216) 255-3158 3

December 17, 1994 COMMENTS OF OHIO CITIZENS FOR RESPONSIBLE ENERGY, INC.

ON "ADEQUACY AND COMPATIBILITY FOR NRC AND AGRE EMENT STATE TION CONTROL PROGRAMS NECESSARY TO PROTECT PUBL I C HEALTH SAFETY: DRAFT STATEMENT OF POLICY," 59 FED. REG. 37269 (JOLY 21, 1994)

1. Adequacy OCRE supports the part of the policy statement pertaining to adequacy. OCRE finds all of the listed elements for an adequate program to be necessary.

2. Compatibility OCRE supports compatibility in areas such as units of measure and placarding of vehicles transporting radioactive materials. OCRE is also concerned that an Agreement State not enact regulatory measures merely as a method of revenue enhancement. And, states should not be permitted to have standards less stringent or protective than the NRC*s. But the floor must not become the ceiling. The NRC's standards represent the floor, the minimum requirements for adequa te protection. If an Agreement State wishes to exceed that level of safety, due to the scientific uncertainties and differences of expert opinion regarding the hazards of ionizing radiation, it should have that power, includ-ing the power to set more stringent dose and release limits than those set forth in 10 CFR Parts 20 and 61 ..

a) Preclusion of a practice The policy statement would prohibit Agreement States from adopt-ing "more stringent regulations or requirements as a means to bar or preclude a practice without an adequate safety or environ-mental basis, or bar a practice needed in the national interest."

But what if the citizens of a state decide that such a practice is not in their best interests? The legislation enacted by about a dozen states regarding the NRC's now-withdrawn Below Regulatory Concern policy is a good example of this. These states felt compelled to preclude practices which the NRC in the BRC policy had authorized (and were thus presumably authorized by the AEA) to protect the health of their citizens. Would the enactment of 1

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such a law render an Agreement State's program incompatible?

In those instances where Agreement States have precluded prac-tices, there was good reason to do so. Two such examples were given in the Federal Register notice: Florida's banning of radio-active waste burials allowed by 10 CFR 20.304, and the banning of shallow land burial of low-level radioactive waste by several states. Another other example was given at the November 15, 1994 NRC Workshop on this policy statement: the banning by Texas of cesium chloride sources for use in pool irradiators. Rather than placing the burden on the Agreement States to justify their actions in such cases, the burden should be on the NRC: why shouldn't a State be allowed to ban a practice, as long as public health and safety are not being decreased? If the Agreement State program is to have any meaning and value at all, then the states should be permitted to set more stringent requirements and to ban practices.

b) 10 CFR Part 61 The policy statement would require that the dose and release limits in 10 CFR Part 61 be adopted identically by Agreement States. OCRE has strong opposition to this provision of the policy statement.

Under the Low-Level Radioactive Waste Policy Act of 1980 and the Low-Level Radioactive Waste Policy Amendments Act of 1985, the states have been made responsible for the disposal of low-level radioactive waste. If states have this responsibility, they should have commensurate authority to protect their citizens from the inherent hazards. Furthermore, any claim that interstate commerce is involved is without merit, at least for those states which belong to a compact, because compacts have the power under these statutes to prevent the importation of out-of-compact waste.

OCRE agrees that it is in the national interest to develop dis-posal capacity for low-level waste. However, requiring the states to enact LLRW regulations identical to the NRc*s is likely to frustrate, rather than achieve, this national interest. New disposal facilities will not be developed without public confi-dence in their safety. Public confidence will be enhanced if states set more stringent dose and release limits than those in Part 61. We will be better off to let the states experiment on this issue.

OCRE does not believe that setting more stringent dose and re-lease limits for LLRW disposal will result in the preclusion of 2

disposal. It is likely that stricter limits can be achieved through the use of better waste treatment and packaging and engineered barriers for the facility itself.

3. Administrative procedures OCRE strongly believes that administrative procedures must be considered an element of both adequacy and compatibility. The term "administrative procedures" should encompass rulemaking, hearings, licensing and license amendments, enforcement actions, and public notice and access to information.

If a state is not an Agreement State, then its materials licen-sees are regulated by the NRC, which has well-defined, open, and liberal practices in this regard, as required by the Administra-tive Procedure Act and Section 189 of the Atomic Energy Act.

OCRE believes that Agreement States should have procedures which are comparable to the NRC's with regard to openness and partici-pation rights for both licensees and the general public.

For example, consider the licensing of an LLRW disposal facility.

If done by the NRC in a state which is not an Agreement State, members of the public whose interest may be affected would have the right to request an adjudicatory hearing on the LLRW facility licensing. This is a full, formal evidentiary hearing conducted by an Atomic Safety and Licensing Board pursuant to Subpart G of 10 CFR Part 2. OCRE believes that an Agreement State which is licensing an LLRW disposal facility uw.a.t. offer the same type of formal adjudicatory hearing to its citizens.

Another advantage conferred by the NRC's Rules of Practice is contained in 10 CFR 2.713(b), which permits persons who are not attorneys to represent their own organizations in NRC proceed-ings. This provision is extremely advantageous to small enti-ties, both licensees and public interest organizations. Small licensees who are regulated by the NRC and fined (on the order of

$1000 to $5000) for violations can challenge the enforcement action in a hearing without the need to hire legal counsel, which would not be cost-effective for that small a civil penalty. OCRE believes that this provision must also be a matter of compatibil-ity for Agreement States.

With regard to rulemakings and public notice and access to infor-mation, OCRE finds the circumstances which prompted the Measurex Corporation to file PRM-150-3 to be of utmost concern. OCRE finds it deplorable that the petitioner has had such difficulty obtain-ing notice of what should be readily available public records.

3

If a company has this much trouble trying to become aware of and to participate in Agreement State rulemaking actions, it must be even more difficult for members of the public.

OCRE is also concerned that the difficulties encountered by the petitioner may stem from state government favoritism toward in-state businesses, to the detriment of out-of-state entities who are nonetheless affected by the state's actions. Such favoritism should have no place in the behavior of a regulatory body.

OCRE finds the comments made at the November 15, 1994 NRC Work-shop on this policy statement by Mr. Aubrey Godwin of Arizona on the availability of state regulations to be rather disturbing:

(Businesses] "can get a copy for a small fee - of course, some-times it isn't that small - that you do business. In many cases, they have to appoint an agent within the state to represent them . . . If a citizen wants to do business before any of our regulatory bodies, they come to us and do it just like the indus-try does. There's no problem. 1f you want to do business with it, you inform yourself how to do it, and then you proceed. I'm sure the local attorneys would be happy to take your money and lead you right through it."

OCRE would hope that Agreement States are not deliberately creat-ing closed and arcane regulatory systems for the purpose of establishing a local lawyers* full employment program. There is a compelling need for the NRC to establish adequacy and compati-bility standards for Agreement State administrative procedures to prevent this type of abuse. Agreement States should not be allowed to erect barriers to public participation.

OCRE feels very strongly that if a state can't do the job right, then it should not be doing it at all; the NRC should do it. And part of the job of Agreement States is meaningful public partic-ipation and due process of law.

Respectfully submitted, Susan L. Hiatt Director, OCRE 8275 Munson Road Mentor, OH 44060-2406 (216) 255-3158 4

Chr istine Todd Whitman Department of Environmental Protection Go v ernor Division of Environmental Safety, Health and Analytical Programs Radiation Protection Programs CN 4Ei Trenton, N.J. 08625-0415 Tel (609) 987-6389 Fax (609) 987-6390 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Services Branch Re: Comments on Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy

Dear Mr. Chilk:

I had the opportunity to attend the NRC Workshop on the proposed new policy statement on adequacy and compatibility of Agreement State radiation control programs. After hearing the comments of other states, members of the regulated community, and selected environmental groups, and reflecting on their content, I offer the following comments.

No one likes to have their performance graded, but people will accept a performance appraisal if (1) they know the parameters against which they will be measured, (2) they perceive these parameters as fair, and (3) they respect those issuing the grade.

Over the years the radiation control programs who chose to become agreement states were graded for their adequacy and compatibility without fully defining these terms, or obtaining outside input into the rating mechanism. Nonetheless, NRC staff performed the reviews, rationally and intelligently. You are now proposing to correct the situation with the draft statement of policy and I support your efforts.

It is not a unique NRC function to issue "grades" to states.

The Federal Emergency Management Agency (FEMA) grades states on their emergency preparedness through their observation of nuclear power plant exercises. As the Food and Drug Administration's (FDA) program of allowing states to be certifying states under the Mammography Quality Standards Act (MQSA) gets underway, they will be grading states. The Environmental Protection Agency (EPA) performs program reviews annually and grades a state's performance under the New Jersey is an Equal Opportunity Employer iFEB 2 4 1995 Recycled Paper Acknowledged by card ...........................,.,....,,

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State Indoor Radon Grants program and will be grading a state's performance of NESHAPs work when delegated.

A performance review can and should be useful to the state being reviewed as well as to the reviewer. If a state program director is having difficulty getting high enough on the priority list to get assistance from the Attorney General's office with regulation writing, for example, a report to the governor explaining the importance of that function can assist the program. If additional resources are necessary to perform inspections or if equipment is lacking, the "grade" can elevate the priority of the program within the administration to get the resources they need.

However, in grading a state on adequacy, the NRC is determining whether the state program provides an acceptable level of protection for the public health and safety from radiation hazards associated with source, byproduct, and special nuclear material. I believe that only a Governor can make a decision about the public health and safety of the citizens of their state. Ray Paris made this observation at the workshop. That is why the decisions about protective _actions for citizens surrounding nuclear power plants are left to the Gove rnor, even though the NRC can give input to the recommendation.

If the NRC is going to make a determination about the level of protection afforded the public, there must be a definition of what it will find acceptable. Is a level of one in a million risk of cancer acceptable? One in 10,000? One in 10? Is NRC the appropriate body to determine acceptable levels of risk from radioactivity? Shouldn't that be a Congressional decision? And if Congress has not spoken on the issue, isn't that really a state's right?

The decision about what is an acceptable level of risk from AEA materials is analagous to the decision about what is an adequate margin of safety for nuclear power plants. NRC has never defined adequate "margin of safety" for nuclear power plants although they are getting closer through the use of probabilistic risk assessment. It is difficult to determine if the margin of safety has narrowed if you have never defined the margin of safety. It is difficult to determine if the level of risk from exposure to source, by-product, or special nuclear material is unacceptable if you have n~ver defined an acceptable level of risk.

From the policy statement, NRC seems to imply that acceptable is equal to the level of protection offered if the NRC were the regulatory agency. The radiation standards, frequency of inspection, qualifications of inspectors, rigor of inspection, enforcement, and licensing review seem to be defined using NRC as a yardstick. That is a useful comparison for the Governor of a state when deciding whether to have the state program regulate users of radioactive material or return the program to the NRG. It is not a measure of acceptable risk.

To make a statement about a state program's acceptable level of protection to a Governor, information should be provided on the

total radiation control program including radioacitve materials -

both AEA and NARM , machine sources of radiation, radon, emergency preparedness, air permitting, technologist certification, etc.

Otherwise the Governor will get piecemeal information that does not reflect the true protection afforded the people of that state.

It is the position of the Conference of Radiation Control Program Directors (CRCPD) that a state radiation protection program should be located in one agency. There are many reasons for this position, including consistency of standards, consistency of policies, reduced chance of duplication or missing issues, cross training and improved ability to shift resources to needed programs. An overall audit will not just point out the shortcoming of the AEA radioactive material program but will give the Governor a complete picture of the protection afforded the citizens of that state. Otherwise, there could be a tendency to assign available resources to the part of the program which has been brought to the Governor's attention. Accoriing to BIER V, the nuclear medicine exposure of citizens makes up just 4% of their overall annual radiation exposure. Consumer products make up another 3%, which could be in the manufacture, as well as in the use of these products. The Governor needs to put the entire rad iation protection program in perspective and consider exposure to radon, machine sources, etc. The Governor also needs to understand the probabilistic risk from nuclear power. Although *the risk is just 0.1% from the nuclear fuel cycle, the consequences if something does go wrong are quite significant.

An overall program evaluation can put all of these things in perspective. Although a political firestorm was touched off when Congress decided to look into misadministration of nuclear medicine, it is clear that misadministrations constitute a very small portion of the overall radiation exposure of the public. Only by looking at the big picture can the risks for various radiation sources be put into perspective. As Aubrey Godwin once said to me, "A rem is a rem is a rem." It is essential that the AEA radioactive materials program be placed in exactly the risk perspective it deserves, and not afforded special attention just because of an NRC evaluation.

There is a need for constructive discussion at the governor's level. The current structure of auditing piecemeal encourages political over reaction.

Risk-based decision making can "have the added benefit of raising the stature of the radiation control program within state government since the radiation risks dwarf the risks of chemical hazards by comparison.

The issue of compatibility is really one of providing enough uniformity in regulation that there is not a significant burden on interstate commerce. Certainly, using the same definitions for fundamental radiation protection terminology is essential and would be good practice by any agency regulating a physical phenomenon.

Using different definitions would be silly. Similarly, the signs and symbols for radioactivity should be uniform to assist individuals in recognizing them.

But what is so magical about dose limits or release limits that they should be uniform throughout the country? Certainly it would lessen the economic burden on industry to have only one standard that they would need to comply with, but as Marty Malsch pointed out, that is not part of the criteria for consideration of restriction of interstate commerce. If the standards were so diverse that interstate commerce were impossible, the standards would be preempted.

Medical devices and the use of radioactive materials in the health field are evolving at a rapid pace. States like New Jersey, with its numerous research and medical facilities, are in a better position than federal agencies to develop cutting edge standards for the use of this equipment and these materials. The way that the Suggested State Regulations for the Control of Radiation (SSRCR)s are developed by the Conference of Radiation Control Program Directors (CRCPD) is to gather input from several states who have developed expertise in particular radiation source hazards, and then craft SSRCRs based upon the best thinking from those states. For the SSRCRs to remain current, they must be continually updated based on experience in enforcing the regulations and considering the new products that are available for medical use .

I realize that there is concern in the regulated community about the diversity of regulation of ionizing radiation in medicine, and that industry would prefer federal r*egulation since that would mean one standard with which they would need to comply rather than the possiblity of 50 different standards. That is a legitimate concern. However I think the concern can be abrogated with good communication between states since the transfer of information about any innovative program would lead to greater reciprocity among states. Unlike a forced uniformity when the federal government is in charge, which as Ed Bailey pointed out, could lead to mediocrity and stagnation, this is a uniformity which grows out of consensus, and includes the involvement and experience of the regulated community.

If a state has taken into consideration the overall radiation exposure of its citizens and believes that there is a need for restricting dose from a particular source to provide adequate public health protection, that is the purview of the state, and should not be a consideration of the NRC in making a compatibility decision.

NRC does not have a nat:ic,nal radiation protection program, they only regulate AEA materials. If, as Judith Johnsrud suggested, it is necessary to look at the totality of personal dose, and include the contributions from all the various sources such as x-rays, nuclear medicine procedures, radon, clean-up standards for contaminated sites, and nuclear power plants, to make adequate restrictions in the dose to protect public health,

• this can only be done at the state level. NRC should not restrict a state in making that decision.

Although Chip Cameron made it clear that no decision has been made on whether the site clean-up standards would be included as an area of compatibility for agreement states, I think this is a

particularly important issue to leave to the states to determine if they wish to be more stringent. In referencing 10 CFR Part 20, you lead to the conclusion that the clean-up standards would be a matter of compatibility. In New Jersey, the state legislature has spoken on acceptable risk for clean-up of contaminated sites, and if this were an area of strict compatibility, it may preclude New Jersey from ever becoming an agreement state. The New Jersey legislature has determined that all contaminated sites should be cleaned up to a risk level of one in a million, or, if that is not possible, to background.

Underlying the discussion was a question about whether a change in the adequacy and compatibility policy would make it easier or more difficult for a non-agreement state to become an agreement state. It is my opinion that there are two reasons that would drive a governor to express a desire to sign an agreement with the NRC to regulate AEA materials. The first reason would be if it were perceived that the NRC mlght be doing an inadequate job of regulating AEA materials within the state. This perception could arise from a finding by the General Accounting Office or other auditing agency, or through an investigative press report. The public perception may become mor e important to the decision to s eek agreement status than the actual risk to the public. The other reason would be based on economics. Industry will begin to compare the costs for licensing fees charged by NRC vs the probable costs charged by a state agency, and will find that in general the fees charged by agreement states are 50% or less than the comparable fees charged by the NRC. This can lead to an industry group approaching the Governor and requesting an investigation as to the cost savings that may incur if the state were to become an agreement state. If the savings were substantial, the Governor would choose to seek agreement state status rather than risk losing an important industrial base from the state.

In implementing the revised adequacy and compatibility policy, NRC should work with the CRCPD, and other federal agencies to coordinate its program review. If every state program director were involved in one review each year of another state program, they would learn valuable information on how that state manages its radiation protection program and could apply lessons learned to their own situation, thereby improving the overall program to protect public health and safety. Additionally, this type of information exchange would lead to more uniform standards in the future since it would facilitate the transfer of information about any innovative program, and that would lead to greater reciprocity among states. This type of review would be a true peer review, not just a grade issued by an oversight agency, and the input would be much more welcome. I believe this is a win-win-win strategy - with the regulated community winning greater uniformity and reciprocity -

with environmental

• groups winning their point of a more global look at true radiation exposure - with the radiation control programs

winning some constructive feedback on their overall program - and with the public winning the benefit of improved health and safety.

Thank you for the opportunity to participate in the workshop, and I hope my comments are constructive.

Sincerely, Jill Lipoti, Ph.D.

Assistant Director

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• Olympia, Washington 98504-78 DEC 19 199 DOCKETING &

December 15, 1994 RVICE BAANC ECY-NRC Secretary Attn: Docketing and Services Branch U .S. Nuclear Regulatory Commission Washington, D.C. 20555 To the Commission:

This is a followup letter to our October 14, 1994 letter commenting on 59 FR 37269, the Commission's Draft Statement of Policy. This letter reflects our participation in the November 15th public workshop on Adequacy and Compatibility. The following comments are in addition to, and not a replacement for, our October 14th letter.

It is our concern, having heard a variety of opinions on the subject, that our contribution, at this point, be one that will serve the public good and unify the nation's radiation control programs in their interpretation of the terms "adequate" and "compatible" as found in Section 274 of the AEA.

Therefore, to overcome most of the concerns ( and still encompass the work going into the current draft policy) we propose that the Commission:

1. Acknowledge that the dictionary definition of "compatible" is not how NRC has come to view the term.

2. Agree that "compatibility" should have as its common sense meaning "that which fits together, works together, does not conflict."

3. Establish three levels of "adequacy" needed to demonstrate that a radiation control program is "adequate". These three levels would be: 1) Items that must be identical to NRC's program (but don't r~fer to them using the term "compatible"), 2) Items that must be at least as stringent as NRC, and 3) Items (regulations, program elements, etc.) that must be addressed but can be either more or less stringent than NRC's.

This means that the NRC's review of Agreement State Programs should focus on adequacy.

Compatibility (or lack thereof) would become a rarely exercised determination reserved for "out and

• out conflicts" between NRC and State Programs.

0

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Page Two December 15, 1994 Essentially, all the elements identified in the proposed policy would be retained in the final policy but there would be a logical shift to a single question "Is the program adequate to protect public health and safety". In our estimation there would be few items requiring strict identicality: Scientific definitions, the radiation symbol, certain transportation requirements (packaging, marking, labeling, shipping papers, etc), and information to be reported to NRC (not how the state collects it, just the ability to relay essential information meeting NRC's data needs). Most requirements for an adequate program would fall in the realm of minimum standards. The state should always have the right to set stricter standards. These minimum standards include basic dose limits as well as virtually every other regulation. These minimum requirements would cover many of the program elements as well.

There was much discussion by industry concerning the impact of differing regulations on interstate commerce (or more to the heart of their problem, the economics of doing business). We believe the ability of the states individually to enforce more strict standards than those deemed minimal should be left to the states and the differences become "the cost of doing business" from one state to the next. In the final analysis, it is best that the citizens of the state determine whether the actions of their state government reflect their wishes, even if those actions prohibit certain activities from taking place in their state.

NRC should not interfere with the states' right to place further restrictions on any aspect of radiation protection even ifit precludes a certain activity or practice. For instance, if the citizens of the state, through whatever means, choose to set a lower (therefore, more restrictive) dose limit, even under the guise of radiation safety, that does not mean that the Commission standards is not safe or is inadequate; it simply means the citizens of the state have chosen a more conservative risk factor.

If this precludes a certain practice it becomes the apparent will of the citizenry that this be so. In the hand ringing over the preclusionary practice, keep in mind that for every action there eventually comes a reaction. In other words, the citizens of the state also accept the consequences of getting too far out of line with the "accepted" NRC minimum standard. If setting a 2 rem annual occupational dose limit causes industry to move out of state, the consequences of the state's setting such a limit are clear to all.

Other examples of minimum requirements include: 1) information required in the uniform manifest (a particular low level waste site could legitimately want more information on the manifest form used for its site), 2) records and reports, 3) wording on labels and signs (there is no reason to disallow multi-lingual signs), 4) most standards in the regulations, 5) ways to enforce the standard, such as licensing program, inspection program, legal sanctions, etc. and 6) methods of assuring quality of licensing and inspection (staff training and experience and so forth). The focus here should be minimal requirements for a system to assure certain actions are accomplished rather than the details of the action. Where appropriate the standard should be "similar to NRC" for program requirements.

For instance, it is more important that the quality of work be acceptable than that the individual performing the work meet some specific or unique qualification.

Page Three December 15, 1994 The final level of adequacy concerns whether a program element is covered in some manner. The absence of an administrative procedures act would be a fatal flaw to the radiation control program's "adequacy". However, as long as the state provides the mechanism for public involvement (comment periods, hearings, adjudicatory proceedings, etc.) then it should be up to the state (citizens) to determine how it wants that process to work. NRC should never be in a position of forcing the state to change the way it administers its own laws, procedures, employment practices, etc. Other aspects where a program element should be in place include budget and lab support. Regulations not directly related to the basic radiation standard and reporting of incidents could fit into this category as well.

In summary, the emotion and disagreement over the issue of "compatibility" can be readily resolved if the Commission will allow the term to resume its dictionary meaning and by focusing on defining what 1s required to be implemented in an adequate radiation control program for the purposes of the Atomic Energy Act. The principle of "identicality" can be retained in defining adequacy and a determination of compatibility can still be made. However, it would be a simple matter: A state that is found to be inadequate would automatically be incompatible with NRC. For instance, a state that defined 11 sievert 11 incorrectly would be incompatible and so would a state that did not have any administrative procedures. On the other hand, a state that restricted occupational dose to 4 rem a year would not be incompatible (nor inadequate); but relaxing the occupational dose to 12 rem a year

( as was allowed not so long ago) would indeed warrant a finding of incompatibility ( along with inadequacy).

While we recognize that this represents a significant change in the NRC's and Agreement State Programs' mind set of how to view "adequate" and "compatible", we believe it would be a worth-while and beneficial move. We believe a radical change of this sort is necessary for NRC to demonstrate its willingness to work with the state radiation control programs in resolving what now constitutes a national program.

Thank you for the opportunity to participate in the public workshop, we look forward to your response to this and the other comments received.

Sincerely,

~!!:,

Division of Radiation Protection TRS:TCF:amw CC: Dick Bangart, Office of State Programs Agreement States

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December 16, 1994 ' 1 The Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D .C. 20555 Attention: Docketing and Services Branch RE: Envirocare of Utah, Inc. Comments On Nuclear Regulatory Commission Draft Statement of Policy on Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety (59 Fed. Reg. 37269 (July 21, 1994)}

Dear Secretary:

1. Introduction Envirocare of Utah, Inc. (Envirocare) submits these comments on the Nuclear Regulatory Commission's (Commission) Draft Statement of Policy on State Radiation Control Programs Necessary to Protect Public Health and Safety, 59 Fed. Reg. 37269 (July 21 , 1994).

Envirocare owns and operates a treatment and disposal facility at Clive, Utah, for NORM, NARM, l le.(2), and mixed waste. Envirocare is thus a licensee both of the State of Utah, which runs a radiation control program as an Agreement State under the Agreement State Program, and of the Commission, which regulates l le.(2) materials in Utah. Because of this regulatory posture, Envirocare believes that its views will be beneficial to the Commission as the Commission finalizes its Policy Statement. Envirocare commends the Commission for its efforts to establish a Policy on adequacy and compatibility in radiation control programs.

2. Compatibility and Adequacy Generally There is no question that "compatibility" and "adequacy" of radiation control programs are foundations of the Agreement State Program under Section 274 of the Atomic Energy Act, as amended. A state's radiation control program must be adequate, as written and as applied, to be compatible with the Commission's regulatory program.

Thus, there is a strong relationship between the concepts of adequacy and compatibility.

ifEB 2 4 1995 Acknowledged by card ..........................,"'"""

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• SALT LAKE CITY. UTAH 84101

• TELEPHONE (801) 532-1330

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3. The Commission Should Allow States To Adopt Requirements That Are More Stringent Than Commission Requirements.

Envirocare agrees with the Commission's historical practice of encouraging the maximum practicable uniformity in Agreement State radiation control programs.

Envirocare believes, however, that an Agreement State should be allowed to adopt more stringent regulations, if the state believes that it is necessary to adequately protect public health and safety. For example, although the State of Utah and the Commission have approved Envirocare for shallow land burial (SLB) oflow-level waste, some states have prohibited such SLB. The Draft Policy Statement approves this scheme. Envirocare agrees. SLB may not be appropriate in all states for environmental or other local reasons.

4. The Policy Statement Should Be Extended To Low-Level Waste Regulation According to the Federal Register notice, "on April 2, 1993, the Commission directed Staff to develop a compatibility policy for all program areas other than low-level radioactive waste." 59 Fed. Reg. 37270, col. 1. Questions regarding compatibility of the regulation of low-level waste disposal would continue to be considered on a case-by-case basis. Id. at 37271, col. 3. Envirocare believes the Policy Statement should cover all elements of a radiation control program, including low-level waste regulation. Such consistency is necessary to protect public health and safety, to promote public confidence in the radioactive waste disposal industry and Agreement State Program, and to give a degree of certainty to the regulated community. Envirocare believes that the issue of regulation of low-level waste disposal is national in scope and interest, and that minimum compatibility requirements in this area should be generically established that would apply in all Agreement States. Compatibility requirements should extend to the siting and licensing of waste disposal facilities, as well.

5. Effective Implementation is Critical to the Integrity of the Agreement State Program Envirocare agrees with the Commission that an Agreement State's radiation control program should be adequate and compatible not only on paper, but in practice. If regulations are ignored or otherwise not implemented, the integrity of the program is challenged, and public health and safety may be compromised. This principle applies with particularity to the siting and licensing of waste disposal facilities, regardless of whether the Commission addresses compatibility questions under a Policy Statement or on a case-by-case basis.

ENVIROCARE

6. Conclusion Envirocare appreciates the opportunity to comment on the Commission's Draft Policy Statement, and looks forward to working with the Commission to further strengthen the Agreement State Program to assure protection of public health and safety.

Sincerely, (JidacµJ Charles A Judd

State of Kansas ri ,, ...,. - *rt. f)

L.-.,; .J ,._ .1 Joan Finney Governor  ! ,~ 'Jl\ :

Department of Health and Environment *94 \lC 19 P4 ...:, J Robert C. Harder, Secretary December 14, 1994 SECRETARY ATTENTION DOCKETING AND SERVICES BRANCH US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555 To the Commission:

This is a response for the call for comments on the Commission's draft statement of policy on adequacy and compatibility for Agreement States. The State of Kansas finds the draft policy as proposed disturbing for the following reasons:

1. The redefinition of the term compatibility to mean essentially "identical to NRC".

2. The treatment of states as something other than co-regulators.

Section 274g of the Atomic Energy Act (ATA) upon which the status of each NRC agreement state is based is clearly directing the NRC to " **.* cooperate with the State in the formulation of standards .... " to assure that State and Commission programs

" ..** will be coordinated and compatible." It does not say NRC will establish standards which the states must or shall adopt.

The terms "adequate" and "compatible" were not defined in the original ATA because the authors of the amendments in 1959 were using the dictionary meaning of those terms. The term compatible for example is defined as"**** getting along well together; in agreement." The term adequate is defined as "... sufficient; suitable". Neither is defined as identical or essentially identical.

The policy statement and the companion umbrella policy should be ref erred to the Organization of Agreement States for a redraft which should be done with the mandate that the issue is development of proper language and outcome rather than meeting of a specific deadline.

If NRC wishes to add the burden of identical program components and record keeping and providing of extra data to NRC by the agreement states, it must be prepared to fund what is at this point an attempt to add unfunded mandates to agreements signed over two decades ago by both the State and NRC. Such funding is imperative Division of Environment, Bureau of Air and Radiation IFEB 2 4 1995 Telephone: (913) 296-1560 Forbes Field, Building 283, Topeka, KS 66620-0001 ACknowIedged bYcard.................... "X . ..{913) 296-0984 or (913) 296-1545 Printed on Recycled Paper

• • , V ' ,,.h.,lc:AR REGULA fORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date I a-\ s \94 1

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if the states are to provide NRC with the addition of staffing and data collection being requested in the most recent of the "compatibility" determinations made without agreement state input.

We feel the Commission's focus should continue to be on the evaluation of adequacy of state programs to protect heal th and safety and the environment and the way the state chooses to meet that goal need only be compatible in those instances such as interstate transportation of radioactive materials where compatibility is needed to avoid conflict with the free flow of inters t te commerce.

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r~ l a w. Allen, Chief Rad i oactive Mater ials & X-ray Section Bureau of Air and Radiation Radiation Control Program GWA/psw

• 94 0[" 16 p l :S 7 Jim Edgar Governor December 15, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attn: Docketing and Services Branch Re: NRC Draft Statement of Pol icy, "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety;" 59 Federal Register 37269-37274 (July 21, 1994).

The Illinois Department of Nuclear Safety (Department) hereby submits comments on the subject draft policy statement appearing in the Federal Register on July 21, 1994.

We have reviewed this document in conjunction with the draft policy statement of Principles and Policy for the Agreement State Program which appeared in the Federal Register on Aug. 5, 1994. Our comments on that document were submitted on Sept. 21, 1994. In addition, we have considered information discussed at the public workshop held on Nov. 15, 1994 in Rockville, Maryland on the Adequacy and Compatibility draft policy.

As a general statement, this draft policy accomplishes a part of what was requested by the Organization of Agreement States (OAS) in a letter from Mr. Thomas Hill to former Chairman Carr dated Jan. 24, 1991 and in the report of the OAS Task Force on Compatibility dated March 7, 1991 transmitted to Chairman Carr by Mr . Hill with letter dated March 13, 1991. Recommendation No. 4 of the Task Force report states, in part, "The Task Force believes that there should be better and more clearly defined criteria for determination of compatibility of regulations and that Agreement States should be actively involved in the development of such criteria. These criteria should be clearly related to adequacy ... " Further, the Task Force expressed its view that the legislative record 1indicated the Congress was concerned about "reasonable compatibility."

We reiterate our position that Section 274 of the Atomic Energy Act (AEA) does not require "compatibility" be maintained after an agreement is effective. We recognize and support the concept of continued compatibility as 1

Pages 16 and 17 of the Task Force Report .

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Secretary of the Commission December 15, 1994 Page 2 contained in Article VI of the agreement that Illinois entered into with the NRC on June 1, 1987. However, the Federal Register notice, particularly Section II.B., indicates that compatibility becomes more important than adequacy. The essentially identical standard may be appropriate for some of the elements of a compatible program, principally in the area of regulations (e.g. labels, signs, and symbols; transportation regulations; terminology; and some parts of the radiation protection standards), but there are many other elements of regulations that do not require the same level of uniformity.

Finally, the statement indicates what elements need to be compatible and therefore nearly identical. It would seem the opposite approach would be more appropriate where one determines, after careful consideration, that for regulations only, a specific regulation needs to be nearly identical, then it becomes a matter of compatibility. There should be good justification and full documentation of the reasons why a regulation needs to be nearly identical. We believe that for non-regulation program elements, near identicality can never be achieved since they involve use of judgment, implementation of procedures and policies, and other human factors. If these elements are made matters of compatibility, they should allow for considerable flexibility.

We have noted ~ith interest an article entitled "EPA Moves to Revamp Oversight of State Environmental Programs" appearing in the Oct. 14, 1994 issue of Inside E.P.A. Weekly Report. This article indicates a joint EPA/state steering committee proposed that the EPA focus its oversight efforts on states' program-wide performance rather than reviews of individual actions.

The apparent purpose is to create a more effective partnership between the EPA and state environmental agencies. It appears to us that the NRC is trying to move in the opposite direction to a more prescriptive oversight program. We believe the position of the EPA committee would be well worth consideration by the NRC.

Our specific comments on the draft policy statement are attached. If you have any questions regarding the comments, please contact Wayne Kerr at (217) 785-9918.

Q Y,~iar.,.,.,-., ,.,:1Jc-.. . . _

Thomas W.

Director TWO:gas

Attachment:

Specific Comments cc: Jim Lynch, NRC, Region III

Illinois Department of Nuclear Safety Coll'lllents on Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy; 59 Federal Register 37269-37274; July 21, 1994

1.Section II., second paragraph - The words "national interest" appear here and similar phrases such as national program and national radiation protection program are used in this and other NRC documents. We are unaware of any statutory mandate for such programs and, as several participants at the July 12-14, 1994 Workshop for Program Managers and the November 15 workshop indicated, this does not characterize the situation accurately. A national radiation protection program would include many other sources of radiation such as x-ray machines ,

accelerators, naturally occurring and accelerator-produced material (NARM), and even non-ionizing radiation to some extent. If the NRC persists in using such terms, they should be clearly defined and the basis for their use stated. The NRC also should take into account the provision in Sec. 3(b)(l) of Executive Order 12612 dated Oct. 26, 1987 which states that "It is important to recognize the distinction between problems of national scope (which may justify Federal action) and problems that are merely common to the States (which will not justify Federal action because individual States, acting individually or together, can effectively deal with them)."

2.Section II.B. - The words "or any subsequent amendments" in the third sentence are too all-encompassing. At least the words "significant technical" should be inserted after the word "subsequent" in this sentence.

3.Section II.B., footnote 2 - This footnote indicates the NRC is revisiting the case-by-case approach for low-level radioactive waste regulations.

We gained the impression at the November 15 workshop that these would remain case-by-case issues. If the iss ue is revisited, we urge the NRC not to revisit those cases that have been decided previously. This would be extremely disruptive to the efforts of Illinois to site and license a low-level radioactive waste disposal facility under provisions of the Low-Level Waste Policy Amendments Act of 1985. Further, such an action would remove the flexibility needed by a state for a fixed facility that has essentially no impact on interstate commerce . As a general statement, we oppose most requirements for nearly identical standards for fixed facilities.

4.Section II.D. - As indicated in our cover letter, we disagree on the issue of termination based on incompatibility. In regard to the last sentence of this section, please refer to Comment 1 above. The words "national program" and "national interest" are not defined.

5.Section II.E., Questions Under what circumstances should Agreement States be permitted to establish more stringent requirements, for their licensees, than those established by the Commission? Should this also include the ability to establish stricter dose limits for particular classes of licensees?

Answer:

As long as the more stringent requirement does not preclude reasonable alternatives, such requirements should be permitted. An example would be the prohibition of conventional shallow land burial, since other reasonable alternatives are being developed. Stricter dose limits (or presumably effluent limits) for classes of licensees should be allowed.

Are the four criteria in the proposed policy statement for determining whether a Commission regulation or other program element should be adopted in a manner essentially identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? What examples could be used to illustrate how each criterion would be applied?

Answer:

More than sufficient.

What are some examples of State action to establish stricter requirements than those established by the Commission, or establish requirements where the NRC has not?

Answer:

Section III.G. gives some good examples of more stringent requirements that have not been detrimental to the NRC's regulatory program. Other examples are as follows:

A. Texas, Louisiana, Mississippi and Illinois requirement for two radiographers at temporary job sites.

B. New York Department of Labor requirement for disposal of source material wastes from general licensees to be performed by a specific licensee.

C. New York Dept. of Environmental Conservation requirement to meet effluent release limits at the stack rather than at the restricted area boundary.

D. New York City Health Department did not adopt the biomedi cal waste rule.

E. Adoption by Illinois of a 1 mrem per year standard for external exposure of members of the public from a low-level radioactive waste disposal facility.

F. Adoption of what is, in effect, a zero release standard for a low-level radioactive waste site by Pennsylvania in preparation for a Section 274 agreement with NRC. (Specifically, see subparagraph 3 on page 2 of Additional Views of Commissioner Curtiss attached to memo from Samuel J. Chilk to James M. Taylor dated Jan. 22, 1993.)

There have also been regulations adopted by Agreement States that are less restrictive than the NRC's with no adverse impact. Examples are:

A. Addition of iodine-125 to the biomedical waste rule by Kentucky, Louisiana, North Carolina and Illinois.

B. State of New York dose limits allowing occupational exposures of 3 rem per 13 weeks instead of 11/4 rem per quarter for persons with no prior history form.

Such less restrictive variations should be allowed.

What limits, if any, should be placed on the power of a State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice?

Answer:

We are not confident such conditions can be predicted. We believe any such proposals might involve unique circumstances and should be handled on a case-by-case basis.

Are there any other dose or radiation-protection related release limits in the Commission's regulations which should be included under criterion number 3 of the compatibility criteria? Should the dose limits contained in 10 CFR Part 61 be included under this criterion?

Answer:

None of which we are aware. We presume the dose limits referred to in Part 61 of the second question are those in 61.41. They should not be included in this criterion for two reasons:

A. These limits apply to a fixed facility in a given state and have very little relation to products in interstate commerce or mobile licensees. It is a matter between a state and its licensee or applicant.

B. In light of pending actions by the USEPA, the NRC limits are likely to become irrelevant.

Should the draft adequacy and compatibility policy statement be appli-cable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-case basis?

Answer:

Based on the precedents previously set, no change should be made.

Are there currently areas or situations in Agreement State regulations or other Agreement State requirements that would not meet the proposed policy statement?

Answer:

This question is difficult to answer, but we suspect there could be several, particularly if the criteria are applied too literally. The following are examples where the Illinois Department of Nuclear Safety differences could be deemed incompatible by an overzealous NRC reviewer:

A. When the IDNS receives a phone call from a licensee of an incident in progress (within the 24-hour notification rule), we do not require the confirmatory notice in writing at that time.

B. The NRC has three-year record retention requirements for the most part, whereas the IDNS has a five-year requirement.

C. The NRC uses the term "misadministration" for certain medical events whereas the IDNS uses the term "reportable event" and the definitions are identical. The IDNS incorporated this term based on a draft NRC proposal developed in workshops with Agreement States and affected licensees. The NRC changed the term when t he final rule was prepared in response to unilateral direction of the Commission.

D. The IDNS uses the term "reclamation" in our requirement for financial surety whereas NRC uses the term "decommissioning."

The intent of both are the same, but the IDNS term is based on a statutory requirement.

E. The IDNS rules require licensees to adopt additional exposure restrictions for an occupational worker who is a declared pregnant woman when it becomes known to the licensee even in the absence of the estimated date of conception. The NRC rules do not require this.

Should States be permitted to establish more stringent standards for radiation-protection related release limits?

Answer:

Yes. This question is somewhat duplicative of question I. See reply in Item 5, question #1.

6. Sections 111.A.2., 4, & 5 - The words "considered necessary by the Commission" should have the words "and generally agreed to by the Agreement States" added to reflect the intent of the best efforts article of each agreement. The words "considered necessary by the Commission" are too open-ended.

7.Section III.A.3. - See Comment I.

8.Section III.A.7. - See Comment 2.

9. Section 111.B.2. - See Comment 2.

10. Section 111.B.3. - We disagree with the statement, "The mini mum inspection frequency, including initial i nspect ions, shall be no less than the NRC inspection frequency." In spection priority systems are based in part on the subjective j udgement of NRC and Agreement State staff and managers. We do not believe the NRC could detect a significant difference in compliance rates when a priority system is modified slightly. In many respects, these systems are a planning tool used by managers to determine how resources should be allocated within the inspection function, and therefore are inappropriate for judging Agreement State performance. If such stringent criteria are to be used, then the frequency should be determined by consensus of the NRC and Agreement States, since the states regulate more than two-thirds of the licensees.

11. Section 111.B.5 - The last sentence should be deleted. Agreement States have administrative codes and practices as well as union contracts which impact on this element, and the NRC should not intrude in this area. Our employees are not NRC employees. We believe the existing policy statement on personnel qualifications is adequate.

12. Section 111.B.6 - We interpret the words "where appropriate" to be a determination made by the individual Agreement State. If this interpretation is incorrect, then the NRC is going far beyond its authority by imposing its will on the administrative procedures of each Agreement State.

13. Section 111.C.2. - We expect to adopt a manifest system that will include all the elements of the NRC manifest, but may also include additional elements which should be allowed.

14. Section 111.C.8. - See Comment 2.

15. Section 111.D.3. - See Comment 2.

16. Section 111.D.4. - See Comment 1.

17. Section 111.D., paragraph following D.4. - This statement lends support to the argument presented in our cover letter, namely, that adequacy is what is most important.

18. Section 111.F.3. - See Comment 2.

19. Section 111.F.4. - See Comment 1.

Additional Co11111ents Resulting From November 15, 1994 Workshop Participants at the workshop were invited to submit specific comments on items presented or raised at the workshop. Ours are listed here:

1. We suggest the definition of an adequate program contained in Attachment A to the agenda be worded as follows:

"An effective implemented regulatory program containing elements that are necessary to provide an acceptable level of protection for the public health and safety from potential radiation hazards associated with the use of source, byproduct, and special nuclear materials."

In regard to the elements of an adequate program listed in Attachment A, we believe that although administrative procedures, laboratory support and budget are all necessary elements, they are secondary to, and supportive of, the other listed elements.

2. We believe the definition of compatible in the Federal Register notice and as shown in Attachment B to the workshop agenda needs to be significantly modified. Many representatives at the Nov. 15 workshop suggested the definition be similar to the dictionary definition.

Second, we believe the theme for compatibility should be taken from Section 274a. of the Atomic Energy Act which states:

"It is the purpose of this section --

(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;".

Therefore, we believe the definition should read:

"Compatibility means the capability of the NRC and Agreement States to carry out their respective regulatory responsibil-ities in an orderly, efficient and harmonious manner ."

The supporting explanatory statement could read as follows:

"Compatibility shall be aimed at ensuring that interstate commerce is not impeded, that effective communication in the radiation protection field is maintained, that dose limits and radiation protection related release limits are based on national {NCRP} and international {ICRP} recommended limits, and that significant information needed for the study of radiation protection issues is maintained and shared among the regulatory entities."

During the Nov. 15 workshop, Mr . Bangart elaborated on NRC's intent with regard to some of the compatibility criteria. For example, in regard to the criteria of avoiding burden on interstate convnerce, he stated the intent was that states not take action bordering on prohibition (emphasis added} of interstate commerce. It would be useful to include such statements of intention in the policy statement as explanatory material.

On pp. 44-45 of the transcript of the Nov. 15 workshop, Mr. Bangart clarified what the NRC meant when it drafted the definition of an adequate program. He stated that "acceptable level was meant simply only to mean that an acceptable level would be achieved when each of the elements was present in a radiation control program, and each of those elements were being adequately implemented in accordance with your own

[Agreement State] procedures, and the guidance that the NRC provides."

This type of explanatory information should be included. However, we do not believe Agreement States need to follow NRC guidance explicitly.

Guidance documents should be treated as guidance for Agreement States to use as they deem appropriate.

On pp. 193-194 of the transcript, Mr. Bangart clarified what the NRC meant when it defined compatibility. He stated, "[b]ut on the compatibility side, I think it probably was a mistake for us, after listening to the conversation and seeing some of the written comments, to equate our definition of compatible to the word identical. We did it, but I don't think we really meant it that way." The NRC should more clearly state its intentions in the policy statement.

3.Section III.C. of the policy statement (and Attachment C to the workshop agenda) listed eight possible program elements for compatibility.

A suggestion was made to add a ninth - Evaluation of Products for Distribution and Licenses Authorizing Such Distribution. We generally agree with the nine elements, although we have made specific comments on some of them elsewhere in this document. We do recommend that the elements be separated into two categories - those affecting regulations (1, 2, 3, part of 4, part of 5, part of 6, 7, and 8) and those affecting program operations (part of 4, part of 5, part of 6 and 9). Those elements involved in program operations should not require the degree of uniformity as those affecting regulations.

4. The workshop agenda included a discussion of three (later four) administrative-type program elements that were not included in the draft policy statement. Our comments on them are as follows:

a. Opportunity for Hearings - Any statement of compatibility on this item should include the phrase "generally consistent with state law." Agreement States should not have to follow the NRC's hearing requirements.

b. Environmental Assessments - Any statement of compatibility on this item should include the phrase "when required by law, e.g., Section 2740 of the Atomic Energy Act related to uranium and thorium mills."

c. Criminal Sanctions - There should be no compatibility requirement for criminal sanctions through the NRC/

Agreement State program. States generally have such statutory provisions. Further, any reciprocity of criminal or civil sanctions raises due process concerns. In Illinois, respondents must be given an opportunity to be heard.

d. Public Access to Documents - Any statement of compatibility on this item should include the phrase "consistent with existing state law."

~~ DOCl~ETED DOCKET NUMBER PR AMERICAN MINING PROPOSED RULE ffi \SC- ~

CONGRESS FOUNDED 1697 ( 59 fR_3ri~b9) *94 DEC 16 A11:5Q~

1920 N Street NW, Suite 300 Washington, DC 20036-1662 202/ 861-2800 OF.-' ~

Fax: 202 / 861 -7535 DOC, Officers December 19, 1994 Chairman: Richard de J. Osborne Vice Chairman and Chairman, Finance Committee:

Douglas C. Yearley Vice Chairmen:

BY HAND DELIVERY Allen Born*

Milton H. Ward Harry M. Conger Gordon R. Parker Mr. Samuel J. Chilk M. Thomas Moore lie B. Turner Secretary rry G. McGrath

• Burgess Winter U.S. Nuclear Regulatory Commission John M. Piecuch Bob E. Cooper 11555 Rockville Pike President: John A. Knebel Rockville, MD 20852 Secretary: Michael J. Chakarun Treasurer: Clarence L. Smtth Att ention: Docketing and Services Branch Directors Calvin A. Campbell Jr., Chicago Harry M. Conger, San Francisco Re: Adequacy and Compatibility for NRC and Milton _H. Ward, Englewood CO Agreement State Radiation Control Allen Born, Norcross GA R. Gene Dewey, Los Angeles Programs Necessary to Protect Publ ic Richard de J. Osborne, New York Gordon R. Parker, Denver Health and Safety - Draft Statement o f W. R. Stamler, Paris KY M. Thomas Moore, Cleveland Pol icy Arthur Brown, Coeur d'Alene ID John D. Janak, Dallas

Dear Mr. Chilk:

Wm. G. Mulligan, Woodcliff Lake NJ Billie 8. Turner, Northbrook IL Dana S. Getman, Bangor Ml The American Mining Congress (AMC) submits these A Burgess Winter, Tucson W"1 L. White-Thomson, Los Angeles comments in respons~ to the Nuclear Regulatory Glen A. Barton, Peoria Karl E. Elers, Houston Commission's (NRC) draft statement of policy for the Robert M. Smith, Toronto review of Agreement State radiation control programs.

Marc F. Wray, Pittsburgh Robert P. Larkins, Houston 59 Fed. Reg. 37,269 (July 21, 1994) .u NRC is revising Thomas W. Garges Jr., Indiana PA Anthony G. Fernandes, Denver its general policy to clarify the meaning of the terms Barry G. McGrath, Englewood CO Gerard E. Monera, Englewood CO "adequate" and "compatible." .I.d,.

Merle D. Wolfe, Knoxville John A. Wright, St. Louis Jerry K. Ellis, San Francisco AMC is a national trade association of mining and Douglas C. Yearley, Phoenix Bruce E. Grewcock, Omaha mineral companies whose membership encompasses: (1 )

John M. Piecuch, Reston VA producers of most of the United States' metals, Robert C. Scharp, Oklahoma City James A. Todd Jr., Birmingham uranium, coal and industrial and agri cultural minerals; John M. Willson, Vancouver BC Jeffrey L. Zelms, St. Louis (2) manufacturers of mining and mineral processing R. Thomas Green Jr., Cleveland machinery, equipment and supplies; and (3) engineering George A. Mealey, New Orleans Bob E. Cooper, Salt Lake City and consulting firms and financ i al institutions that David D. Eckert, Shelton CT J. Brett Harvey, Salt Lake City serve the mining industry.

Werner G. Nennecker, Spokane Richard T. Zitting, Albuquerque 11 The comment period was extended to December 19, 1994. 59 Fed .

Sir Ian MacGregor, New York+

N. T. Camicia, Greenwich+

Reg. 52,317 {October 17, 1994).

Charles F. Barber, New York+

Ralph E. Bailey, Stamford +

• Immediate Past Chairman IFEB 2 4 1995

+ Honorary Acknowledged by card ................................" ...

j U.S. NUCLEAR REGULATORY COMMISSIOtl DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmarl< Date ~ ~ S ) H w heP Copies Received_ ql...

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These comments raise several questions and concerns that AMC has with the draft policy statement on Agreement State programs.

1. Adequate Programs The draft policy defines "adequate" as" [t]he acceptable level of protection for the public health and safety from the radiation hazards associated with the use of byproduct, source, and special nuclear material." 59 Fed. Reg. at 37,272. The draft policy, however, does not define what is an "acceptable level of protection." In terms of specific dose limits, the obvious ly "adequate/acceptable" level of protection is provided by the 100 mrem/yr dose limit 10 C.F.R. § 20.1301.u This limit accounts for doses from licensed activities from all pathways and is consistent with the recommendations of the National Council on Radiation Protection (NCRP) and the International Commission on Radiological Protection (ICRP) .u The more difficult issue, however, may be how to define what will constitute an adequate/acceptable Agreement State program.

The simplest answer is a program that unambiguously adopts and enforces NRC radiation protection standards. While it is appropriate to consider site-specific and local factors in licensing sites, there need to be some clearly stated parameters that NRC considers fundamental and essential to providing "acceptable levels of protection." Allowing Agreement States too much leeway is asking for inconsistent and duplicative regu l atory requirements. NRC has not set forth any parameters and, instead, has relied on soft and fuzzy rhetoric to explain what constitutes an "adequate" program. NRC should set priorities in terms of the

~ Robert Bernero, Director of the Office Nuclear Material Safety and Safeguards, has stated that when "push comes to shove 100 millirem a year to a member of the public is safe." Transcript of NRC public meeting on "Briefing on Status of Efforts for Risk Harmonization," {May 26, 1993), p.

59.

NCRP, "Limitation of Exposure to Ionizing Radiation," Report No. 116 (March 1993); ICRP, "1990 Recommendations of the International Commission on Radiological Protection," Pub. 60 (November 1990).

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various elements of an adequate program and address how they would work together.

2. Compatible Programs NRC states that 11 [t]he guiding concept over the years since the beginning of the Agreement State program in the area of compatibility has been to encourage uniformity to the maximum extent practicable while allowing flexibility, where possible, to accommodate local regulatory concerns." 59 Fed. Reg. at 37,270.

This guiding principle must consider the direct and indirect impacts on the public health and safety if uniformity across the states is not required.u Conflicting requirements for similar facilities should not be acceptable to NRC under almost any circumstances. While allowance for site specific factors makes good regulatory sense, allowing any state to impede the licensing or license termination process would represent a failure on NRC's part to fulfill its responsibility as the primary implementer and enforcer of the AEA.

NRC lists four goals for the "compatibility" concept. 59 Fed. Reg. at 37,272. AMC strongly agrees with NRC that one important goal is to assure that the various Agreement State programs do not impede interstate commerce. This is particularly crucial for a company that has facilities in a number of states and must comply with conflicting or inconsistent requirements.

Effective communication in the radiation protection field is also essential and should mean that Agreement States communicate with NRC and that NRC shares information with them and with the Environmental Protection Agency (EPA) and the Department of Energy (DOE) to maintain consistent requirements that reflect the latest scientific developments in the field. In this light it is indeed imperative, as NRC notes, that compatibility ensure that If NRC requires compatibility for Agreement States, it should also do so for non-agreement states and not allow non-agreement states concurrent jurisdiction over the nonradioactive components of lle. (2) byproduct material.

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"information needed for the study of trends in radiation protection and other national program needs is obtained." 59 Fed. Reg. at 37,272.

Finally, AMC agrees that dose and release limits must be maintained for all licensees so that the system is a fair and impartial one that does not favor one licensee over another or the licensees of one Agreement State over the licensees of another state.

3. Management Review Board AMC supports the establishment of a Management Review Board (MRB) to determine the adequacy of an Agreement State program.

To maintain its objectivity and impartiality, however, the MRB should not consist of members of the regulated community (i.e.,

Agreement States). Moreover, in reviewing a program, the MRB should adhere to the principles of excellence spelled out by the Commission in its August draft statement of policy for Agreement States. 59 Fed. Reg. 40,058 (August 5, 1994). Failure to terminate an Agreement State program that does not meet these principles of excellence undermines the purpose of the MRB and undercuts the philosophical underpinnings of NRC's entire regulatory program.

4. Low-Level Radioac t ive Waste AMC believes that NRC should apply the draft adequacy and compatibility policy statement to the regulation of low-level waste (LLW) disposal rather than continue to review questions of compatibility on a case-by-case basis. A uniform approach to LLW disposal would provide consistent protection of the public health and safety, whereas the current ad hQQ system subjects facilities to requirements of varying degrees of stringency depending in which state the facility is located.

4

5. Local Government Entities The draft policy statement notes that "[l]ocal government entities are not usually authori z ed by the NRC under Section 274 to regulate radiological safety. " 59 Fed. Reg. at 37,273. AMC urges the Commission to adhere to this policy of prohibiting local government entities from setting their own standards.

Authorizing local governments to establish protection standards for AEA materials could create inconsistent and duplicative requirements that do not significantly reduce the potential health risks to the public but could make compliance overly burdensome and virtually impossible to achieve. The purpose of the NRC and the Agreement State program is to provide a consistent approach to radiological safety based on sound science and not the current political agenda of local communities.

6. Oversight of Agreement State Programs As AMC has commented in the past, it is not appropriate or fair for NRC to use the fees collected from NRC licensees to oversee Agreement State licensees. It is particularly egregious to fund Agreement State programs out of the pockets of non-Agreement State licensees where NRC will not require the rigorous adherence to the performance criteria as it does for non-Agreement State licensees.

7. NRC Guidance It is unclear from the draft policy what weight will be given to NRC guidance, Branch Technical Positions, and the like in the implementation and oversight of the Agreement State programs. Would licensees in non-Agreement States be subject to the Commission's guidance while those in Agreement States are exempt? If so, such an approach would lead to inconsistent and inequitable programs across the country.

5

If you have any question or if we can be of assistance, please contact me at (202) 861-2876, or AMC's counsel for this matter, Anthony J. Thompson of Shaw, Pittman, Potts & Trowbridge at (202) 663-9198.

James E. Gilchrist Vice President 6

STATE OF NEBRASKA l>EMRTMENT OF HEAi.Ili Mark B. Horton, M.D., M.S.P.H.

Dllector December 15, 1994 E. Benjamin Nelson Secretary Governor U.S. Nuclear Regulatory Commission Attention: Docketing and Services Branch Washington, D.C. 20555 Re: Adequacy ~d Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy (Federal Register Vol.

59, No. 139, July 21, 1994, Notices)

To the Commission:

Common usage of the terms "adequate" and "compatible" has withstood the test of more than 30 years of regulatory interaction between NRC and Agreement States. One cannot argue that the positive consequence of having "adequate" and "compatible" standards has been a successful national program of radiation protection. I believe these terms should continue to be used and, in general, I feel the draft policy is acceptable if the application and administration of the policy are coordinated with Agreement States. Specifically, my comments on the policy are as follows:

"Adeqyate"

1. As noted in the NRC Overview for the workshop, controversy has not erupted over II adequacy" . As dedicated health physics professionals, there is agreement as to what is "sufficient or suitable, competent, and capable" to protect public health and safety.

"Compatible"

1. In the past, NRC has developed national standards and assigned a level of compatibility to each one. It is my opinion that states should be involved in the regulatory development process from the very beginning. That is, states should be involved in decisions regarding what regulations are necessary and what level of compatibility should be assigned to each. Too often, states feel that the NRC dictates (with the governing ideology of identicality) to states, treating them the same as licensees.

2. The compatibility standard should continue to mean "capable of existing together in harmony". This determination is based on professional judgement.

3. Compatibility criteria 1, 2, and 3 appear to be straightforward. Criteria 4 should 301 Centennial Mall South

• P.O. Box 95007

• Lincoln, Nebraska 68509-5007 FAX (402) 471-0383

• TIY 471-6421 FEB 2 4 1995 An Equal Opportunity/Affirmative Action Employer Printed with &Oy ink on recycled paper Acknowledged by card .........................,..,....,..

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be placed in the context of the Agreement State Program.

4. In the past, there have been deviations from the standard regulatory template by Agreement States which have been accepted by NRC. Ifit is the intent of the compatibility policy to identify a standard to handle all of these unique and varied deviations (or, conversely, to focus only on what must be identical) then we have eliminated the "compatibility" concept. I believe these deviations can enrich and strengthen the national radiation protection program through a constructive interaction between Agreement States and NRC.

Thank you for the opportunity to comment.

Sincerely,

(\.o;.._ C t ~ ~

~ ; ~ Borchert, Director Division of Radiological Health HRB/CKR/ JAP

DOCKETED COMMONWEALTH OF PENNSYLVANIA US RC DEPARTMENT OF ENVIRONMENTAL RESOURCES PENN SYL VAN IA

• 94 0[C 13 A7 :41 DEw P.O. Box 8469 Harrisburg, PA 17105-8469 December 8 , 1994 OFF 1Cf o: :ECR[TARY OOCKF. I !'ff~ ,t <*i:R ICF.

Bureau of Radiation Protection BR I\ tit'~~

DOCKET NUMBER PROPOSED RULE...::..::.:~.....a...---

Mr. John C. Hoy le (5"'1 FfZ 37261}

Secretar y of the Commission U. S . Nuc lear Regulatory Commissio n Washington , D. C . 20555

Dear Mr. Hoy le :

Enc l osed are our comments o n the NRC Proposed Adequacy and Comp at i bility Policy , published in the Federal Register on July 21 , 1 9 94 .

I would like to thank you for t he oppor t unity to comment on the propo sed p olicy statement .

I f y o u should have any questions or require f u rther informa t ion r e gar ding this submittal, please contact me at (717) 787-2 1 63 .

Sincerely, Q_. ~~

Richa.{j_ R . Janat i Chief Division of Nuclear Safety Enclosure FEB 2 4 1995 Acknowledged by card .............."""""""""

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• S. Nu1,,_.=:_ _ , v :~*1'-;:,.:SSION oov;:: * *,_  ::.r.1/;LE SECT 10N OFriCL 1.)f- Hil SECRET ARY Of fHE COMMISSION D rr\,nt Stanstics

COMMENTS ON NRC PROPOSED ADEQUACY AND COMPATIBILITY POLICY Policy Statement : "The inspection staff technical expertise should be similar to NRC staff qualification. "

Comment : How does a person compare "expertise" to "qualificaion? "

Exactly how similar must these qual i fications be between the Agreement State inspectors and the NRC inspectors?

Policy Statement : "Agreement State staff shall be qualified using criteria no less stringent than criteria used for NRC staff . "

Comment : Does this mean that state inspectors need B. S . , M. S . , and Ph.D . degrees? Pennsylvania's hiring practices including educational requirements are established by the State Civil Service Commission, and may not necessarily be as stringent as the NRC requirements.

Policy Question : "Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-case basis?"

Comment : Yes . It should be applicable to the regulation of low-level waste disposal .

Georgia Department of Natural Resources 4244 International Parkway, Suite 114, Atlanta, Georgia 30354 Joe D. Tanner, Commissioner oor,'<ET NUMBER HROPOSED RULE p ( Environmental p~~er:~

Harold F. Rehels. Director

( >"q FR ?.>72-61 December 1, 1994 DOCKETED ~

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U.S. Nuclear Regulatory Commission *94 DEC - 9 A9 :34 ATTN: Docketing & Services Branch Washington, D.C. 20555 OFFI CE OF SECRETARY DOCKETING ,S: :ERV!Cf RE: Federal RegisterNol.59, No. 139/July 21, 1994/Notices BRA~4CH Gentlemen:

This letter is to respond to the July 21, 1994 Federal Register Notice on "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy and the November 15, 1994 Compatibility Workshop.

1. In Section II. Discussion; E. Specific Questions for Public Comment, Question 4. ask "What limits, if any, should be placed on the power of a State to preclude or, by exceptionally stringent regulation, effectively preclude a particular practice?" Answer, None.

2. In Section Ill. Statement of Policy; A. Definitions; 3. Compatible: In defining the term Compatible the phrase "administration of the national radiation protection program" is used. This phrase is inappropriate since NRC, in defining the terms "Adequate" and "An Adequate Agreement State Program" in the two preceding definitions, addresses only the uses of byproduct, source and special nuclear materials. The States, including Agreement States, also regulate Naturally Occurring Radioactive Material (NORM),

Accelerator produced Radioactive Material (NARM), radiation producing machines (X-ray) and laser radiations. It is not appropriate for NRC to imply in its policy statement that any possible future finding of inadequacy or incompatibility with NRC extends to the State's radiation protection program for NORM, NARM, X-ray and laser regulatory programs.

NRC should define what it means by the national radiation protection program." In defining the national radiation protection program, NRC should specify the interface with the radiation programs of the States an of DOE, EPA, FDA, DOD, USDOT, and other federal agencies.

3. In Section Ill. Statement of Policy; B. Elements of an Adequate Program: Eleven different program elements are listed. All except inspection, licensing and enforcement should be deleted. All of the remaining listed elements, except statutes, are indicators of problems if the three elements of licensing, inspection and enforcement are deficient. The Agreement State's statutes are reviewed by NRC before NRC and the state signs an agreement. It would be acceptable for NRC to have guidelines for training of Program staff who have been hired by the state. It would not be appropriate for NRC to specify the criteria for the state to use in hiring staff. That is a function in Georgia of the State Merit System. To summarize, if an Agreement States' licensing, inspection and enforcement program are protecting the public health and safety why should NRC care how many staff the program has, or its budget or administrative procedures etc.?

FEB 2 4 1995 1 Acknowledged by card ..........................::::-,.

S. NUCLF.:~rl ~L*.;_.. ,,.. \TORY COMMISSION DOCKET. ~G & SERVICE SECTION Offir;E OF TH E SECRETARY Of THE COMMISSION

U. S. Nuclear Regulatory Commission Page Two November 28, 1994

4. In Section Ill. Statement of Policy; C. Elements of a Compatible Program: Eight different program elements are listed. Six of the eight address rules: Radiation Labels, Signs, and Symbols; Uniform Manifest; Transportation Regulations; Records and Reports; Radiation Protection Terminology; and Radiation Protection Standards. Event Reporting and Reciprocity to the degree that the Agreement State provides information to NRC on events and whether Agreement States reciprocally recognize sanctions can be interpreted as Program Elements. This implies that Compatibility will continue to be related exclusively to rules adoption.

5. In Section Ill. Statement of Policy; D. Compatibility Criteria: Item 1. states that "avoids a significant burden on interstate commerce." This is appropriate as long as significant is interpreted as bordering on prohibiting interstate commerce.

NRC, under Section 274 of the Atomic Energy Act has a responsibility to periodically review Agreement State Programs. NRC, under the Atomic Energy Act has a responsibility to regulate its licensees. Reviewing an Agreement State's Program for radiation protection is not the same as regulating a licensee. With a small amount of effort NRC could draft policy statements and other documents that do not convey the message that NRC is attempting to regulate Agreement States. Phrases included in this policy statement that convey that message include: (1) "elements considered necessary by the Commission," (2) "or any other component or function that the Commission considers necessary," (3) "incorporates all the elements of the NRC Program identified by the Commission .. .. " and (4) "shall be provided to NRC .... " The message conveyed by the phrases is that NRC will unilaterally modify the policy statement as it deems appropriate without Agreement State input. Although this may not be the case, the tone is not in keeping with the tone of the Agreement entered into between the Commission and Georgia. The Agreement uses such phrases as "best efforts to cooperate," "best efforts to keep each other informed," and the State and the Commission recognize the desirability and importance of cooperation .... " A removal of the regulatory blinders and conscious effort to address the tone of documents that address the NRC and Agreement State relationship could go a long way toward rebuilding the trust of the Agreement States and result in a less adversarial relationship between NRC and the States.

I look forward to continuing to work with the NRC as co-regulators in protecting public health and safety.

Sincerely, Thomas E. Hill, Manager Radioactive Materials Program TEH:klc c: Paul H. Lohaus, Deputy Director, OSP i:\wp51 \nrc\letters\adq_com.ltr

n (503) 731-4014 FAX (503) 731 -4081 TDD-Nonvoice (503) 732-4031 DOC KETED DOCKET NlJABER , , ~ Us ~~f-: c PROPOSED R~LE ,-i iJ&C - -

November 30, 1994 ( S Cf R 3 7 2 Cf} .94 DEC - 7 P1 :38 DEPARTMENT OF HUMAN OFFlc** 0,. .:U;f{[ fARY RESOURCES Secretary DO C~\ t. ~ i;: ~: ,_ [,l ' I : i' c-U.S. Nuclear Regulatory Commission 6f1AiH,i Washington, D.C . 20555 HEALTH DIVISION ATTN: Docketing and Services Branch Re: Federal Register, Vol. 59, No. 139, July 21, 1994, 37269-37274 Federal Register, Vol. 59, No. 150, August 5, 1994, 40058-40068 The following are comments relating to the Nuclear Regulatory Commission's (NRC)

Draft Statement of Policy for Adequacy and Compatibility and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety. They are also applicable to the Draft Policy Statement on Agreement State Programs.

The Atomic Energy Act (AEA) of 1954, as amended, in 1959 did not clearly define the terms "adequacy" and "compatibility" under Section 274. This is has caused controversy over the years. The NRC under the auspices of the Statute has tended to embellish or add criteria for each term in order to give them more meaning. This was done many times without the input of Agreement States (i.e. their "partners" and "co-regulators ").

Since there is still so much controversy over these terms today, it seems appropriate to go back into the Congressional records and seek the .iiilimt_of the AEA. It is my understanding that the intent of the AEA was to encourage states to become Agreement States in order to regulate radioactive material under State authority. This was subject to the Atomic Energy Commission (AEC), now the NRC, finding a State adequate and compatible; where adequate implied no undue risk to public health and safety, and compatible implied the State would use basic radiation standards not in conflict with federal standards. Thus when a State was deemed to have met this general criteria, the AEC, (now NRC) would turnover regulatory authority to the State. The Governor of the State by signing the Agreement in essence was saying to Congress that he/she was assuming oversight responsibility. The problem today appears to be that the NRC is having difficulty in accepting the concept of relinquish-ing this authority without a lot of II strings attached 11

• Barbara Roberts Adequacy focuses on public health and safety. The Governor in a State has ultimate Governor authority for determining public health and safety. Therefore, once NRC and a State have signed an Agreement for the state to regulate radioactive material, determination of public health and safety is the Governor's responsibility. How then does the Governor proceed in determining such adequacy?

800 NE Oregon Street # 21 The following are suggestions for that determination: Portland, OR 97232-2162 (503) 731-4030 Emergency (503) 252-7978 TDD Emergency fE8 2 4 19954-26 (Rev. 1-92)

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Letter to Secretary November 30, 1994 Page2

1) The Governor could designate an internal management team to periodically review the Radiation Control program to insure all public health and safety aspects are being met. The team would report the results to the Governor, who in tum would report to the NRC the findings.

2) The Governor could invite a third party to conduct a public health and safety review.

• One option for this third party review would be to use the Conference of Radiation Control Program Directors (CRCPD). The CRCPD is an organization with members from all 50 states, the District of Columbia, New York City, and Puerto Rico. It was formed in 1968 with objectives to promote radiological health in all aspects and phases and to encourage and promote cooperative enforcement programs with federal agencies and between related enforcement agencies within each state. A team from the CRCPD would conduct a public health and safety review and report the results to the Governor, who again would pass the results on to NRC.

Another option would be for the Governor to invite the NRC to do this review.

The first option is recommended because the CRCPD is an independent organization and would not be biased one way or the other. More information about the CRCPD is available from Office of Executive Director, CRCPD Inc., 71 Fountain Place, Frankfort, Kentucky 40601.

Compatibility focuses on radiation protection standards. The Congressional intent of the term compatibility was used in a limited sense and was proposed to maximize state autonomy. It was recognized that basic radiation protection standards should be uniform in the Federal agencies and Agreement States. State radiation standards for the protection against radiation hazards, in most cases, should be identical to federal standards. If this is done, compatibility is achieved.

Compatibility issues were not intended to go beyond radiation protection standards, (i.e. they were not intended to include inspection, enforcement, reporting, ... etc.) How then is the Governor of an Agreement State to determine compatibility?

The following are suggestions for that determination:

1) Since NRC knows their regulations better than anyone else, it would be appropriate to have their representatives periodically review state programs to determine compatibility. This would be within the scope as noted above relating to basic radiation protection standards.

2) Another option would be for the CRCPD to review state programs, report the results to the Governor, who would as with adequacy report back to the NRC.

There is nothing in the Atomic Energy Act that requires the NRC to be directly responsible to review state programs. The CRCPD could certainly fulfill this role and report to the NRC the status of adequacy and compatibility for Agreement States.

Letter to Secretary November 30, 1994 Page 3 In summary, the following are specific recommendations relating to the Draft Statement of Policy for Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety:

1) Leave the responsibility to determine adequacy (i.e. public health and safety issues) with the Governor. The Governor can deceide the best methodology and report the results to NRC. The elements identified under "B.Elements of an Adequate Program in the Federal Register could be used as guidelines to assist in such determination.

2) Allow the Governor to deceide the best way to determine compatibility. It would be recommended that the Governor have NRC conduct periodic reviews of their Radiation Control programs. However, the Governor should be given the option to have a third party, such as the CRCPD, conduct the reviews with follow up reports submitted as appropriate.

If it is determined, after all comments to this Federal Register Notice have been considered, that NRC still must be the determinant for adequacy and compatibility, then the following must be done:

1) Define clearly "public health and safety". If this is not done, controversy will still reign because the two issues "public health" and "safety" are too subjective.

2) Limit compatibility to that intended by Congress, i.e. basic radiation protection standards only. Have only one level of compatibility. Specifically identify the standards through a synergistic decision maldng process, seeking input from federal, state and regulated communities.

3) Under "D. Compatibility Criteria", eliminate the 4 criteria listed in the Federal Register.

4) Redraft the Policy Statements mentioned in the first paragraph of this letter accordingly.

Your careful consideration of the above comments and suggestions is appreciated.

Sincerely, 121/~

Ray o'taris, Manager Radiation Protection Services RDP/tm c: Mr. Charles M. Hardin, Executive Director CRCPD

(Ofi__ N_E_w_v_o_R_K_s_T_A_T_E_E_N_E_R_G_v_o_F_F_1c_E_o_o-nct-5K r'rEtt1T

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November 22, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Acting Secretary Hoyle:

New York State appreciates the opportunity to offer comments on the draft statement of policy regarding "Adequacy and compatibili-ty for NRC and Agreement state Radiation Control Programs Necessary to Protect Public Health and Safety" as published in 59FR 37269 dated July 21, 1994.

New York State has a long record of safely regulating radioactive materials. In addition to our Agreement materials, New York has exclusive regulatory jurisdiction over naturally occurring radioactive materials, accelerator produced radioactive materials and machine sources of ionizing radiation (such as x-ray machines and medical therapy

_ accelerators). This broad base of experience has provided us with a thorough understanding of the arcane principles of radiation safety and protection. We, therefore, understand and appreciate the NRC staffs concerns in this area and are eager to work together to develop a policy that will enhance public health and safety and the environment. Indeed, that goal is paramount in New York State.

While we recognize the effort expended by the NRC staff to date in developing a policy on adequacy and compatibility, the draft document is fundamentally flawed. It fails to recognize that Agreement States are independent, parallel regulators, and that our programs are parallel regulatory operations. While the concepts of adequate and compatible are declared to be "core concepts" in the draft policy, the elements by which they are judged are not objective. We believe that the word "compatible" was never intended to mean "identical." For example, if a state regulatory program lacks a specific parallel to an NRC regulation but accomplishes the same effect through license conditions, the intent should be recognized and deemed compatible. Also, not all regulations promulgated by the NRC are necessary to the Agreement State programs. An Agreement State may have none or perhaps only one or two licensees to which a lengthy NRC regulation would apply. If the state can accomplish the same level of control without the expense and substantial effort of a rulemaking, this should be acceptable.

FEB 2 4 1995 Acknowledged by card ......nmotltttftNtltff ... ~

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• ALBANY, NEW YORK 12223 518-4 73-4375

'1Ji.NUCLE<\fT REC" .JLATORY COMMISSION DOCKETH~G & SERVICE SECTIONi OFFICE 0~ THE SECRETAR'f OF THE COMMISSION Docume t Statistics Postmark Date / I/-,_ 1 /q'f Copies Received _ _ _/_ _ _ __

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Further, the definition of adequacy has similar problems. We feel if there is a deviation in the manner in which our program addresses a situation but it is acceptable and adequately protects public health, safety and the environment then it should be judged as adequate. Diversity should not be punished.

New York believes the idea of a policy statement is needed but that the current draft should be reconsidered in light of its flaws.

Additional comments have been developed by the New York State Departments of Health, Environmental Conservation and Labor and these are attached for your review.

EJG:DR:sd I ,

New York State'* Bespow to Dnlt Statement of PoJlq llegardlag "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Sqfety" Octobers, 1'.994

NEW YORK STATE DEPARTMENT OF LABOR COMMENTS ON: July 1, 1994 Federal Register Notice on "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety."

This draft statement of policy begins with a background statement declaring that the terms "compatible" and "adequate" are "core concepts" in the Atomic Energy Act section on Agreement States, but are not defined in the Act. It is further stated that the "guiding concept over the years since the beginning of the Agreement State program in the area of compatibility has been to encourage uniformity to the maximum extent practicable while allowing f 7 '=Xibility, where possible, to accommodate local regulatory concerns." we would take issue with this statement and question its basis. New York State's Agreement with the NRC contains an article pledging the best efforts of both NRC and New York State to maintain compatible programs. Furthermore, when New York State's regulations were assessed by NRC prior to finalizing this Agreement, several differences between State and NRC regulations were noted and accepted. One of these related to the calculation of occupational dose, and not only differed from 10 CFR Part 20, but differed between the regulations of the three New York State agencies that were party to the Agreement. Other instances were noted by NRC where a New York State agency lacked a specific parallel to an NRC regulation, but accomplished the same intent through licensing. The latter was not only accepted by NRC at the time our Agreement was signed, but during subsequent periodic program reviews conducted by NRC staff. Only in the last few years has NRC advanced the concept that the Atomic Energy Act requires "uniformity to the maximum extent practicable" when it states that an Agreement State's program must be "compatible" with the Commission's program at the time a State enters into an Agreement. This concept is not supported by the Act, nor is it supported by the wording in New York's, and the other Agreement States', agreements with NRC.

The approach to defining "adequacy" in this draft policy is similarly flawed. Rather than developing an objective definition based on a program's (NRC's or an Agreement State's) likelihood to protect public health and safety, or its actual performance in doing so, a completely subjective approach is taken. The measure of adequacy is proposed to be the extent to which it contains "elements" considered "necessary" by the Commission.

This draft policy is built on the erroneous concept that the Agreement States are sub-contractors to the NRC, rather than the independent, parallel regulators that Chairman Selin has acknowledged they are. It basically defines adequacy and compatibility as the extent to which a State program is identical to NRC's. This is the antithesis of independence. Rather,

adequacy and compatibility should be defined in terms of objective capability to protect public health and safety in the first instance, and the concordance between NRC and Agreement State requirements (not just regulations) in the second.

Comments on specific sections of the draft policy follow:

A. Definitions:

Definition number two defines "An Adequate Agreement State Program" as one containing "elements" considered necessary by the Commission to provide an acceptable level of protection. Definition number five defines "element" as "any aspect of a radiation protection program that is necessary to implement a program that is adequate to protect public health and safety." Furthermore, the term "element" may include "organizational structure, staffing level, inspection frequency, regulations, policies and procedures or any other component or function that the Commission considers necessary."

This is circular reasoning (an "adequate" program contains the "elements" necess.ary to make it "adequate"),

and totally lacking in objectivity (the necessary "elements" include any component or function the Commission considers essential).

Definition number three defines "Compatible" as the consistency needed to assure an orderly and effective regulatory pattern in the administration of the "national radiation protection program." I do not know what the latter is. The States {Agreement or not) regulate non-AEA radioactive materials and machine sources of radiation independent of NRC, and Agreement States regulate AEA materials also. It would be less grandiose and more accurate to refer to the "regulatory program for AEA materials." However, the equating of "compatibility" with "consistency" is a good beginning. Also acceptable are the stated goals that interstate commerce not be impeded, that effective communication in radiation protection is maintained and that dose limits and release limits be consistent. The last goal, ("that information needed for the study of trends in radiation protection and other national needs is obtained") however, seems to have no relationship to compatibility and should be deleted from the definition.

Definition number four unaccountably redefines "compatibility" by stating that a "compatible Agreement State program" is one which contains "elements considered necessary by the Commission." In the discussion of

definition nwnber two, above, we have already remarked upon the lack of objectivity this introduces. Since an element is "any component or function which the Commission considers necessary" we have gone from the reasonable equating of compatibility and consistency in definition nwnber three, to an unreasonable and subjective dictum that the commission can condition a finding of compatibility on the presence or absence of any II element'.' it thinks a program should have.

B. Elements of an Adequate Program Element nwnber two, Regulations, states that except for certain regulations which must be "essentially identical,"

an Agreement State "shall" adopt regulations "or other legally binding measures," equivalent to, or more stringent than, those designated by the NRC.

The meaning of "other legally binding measures" should be defined. In the absence of a definition telling us what this encompasses, it appears that the Agreement States could be required to adopt every regulation which NRC adopts, either identically or more stringently. There is nothing in this policy to suggest what specific criteria NRC will use to decide which regulations it will require the states to adopt. Definition nwnber three suggests that it would only be those regulations "aimed" at certain stated goals, while definition nwnber four suggests that virtually any regulation could constitute an "element" the Commission thinks is necessary.

Also, the Agreement S'tates would have only two options in adopting regulations: "essentially identical;" or "equivalent to, or more stringent." We need further explanation of the second option in order to comment. What does "equivalent" mean? What about NRC regulations which States feel should not be adopted at all, or that only certain components should be adopted.

Element nwnber three, Inspection, requires Agreement States to adopt NRC inspection frequencies for each type of licensee, as minimum frequencies. This is unacceptable. As independent, parallel regulators, the Agreement States must be accorded more flexibility than this. It is perfectly possible that a State will have more stringent frequencies than NRC for many or most types of licensees, but will decide that some types of licensees need to be inspected less frequently. To require unthinking conformity to NRC frequencies interferes with a State's need and responsibility to use its resources as efficiently as possible to provide maximum protection of public health and safety. It also ignores the reality that a State program

regulates other radiation sources not subject to the AEA, which it may judge should have a higher priority than some AEA materials.

This may be a convenient requirement for NRC to impose, since it eliminates the need for any judgement, but it is inappropriate and counterproductive.

C. Elements of a Compatible Program Element number four, Event Reporting, states that Agreement States "shall" require licensee reporting of events in a manner consistent with NRC reporting requirements. It further states that "this information shall be provided to the NRC." Does this mean that every report received from licensees must be forwarded to NRC?

This makes Agreement States little more than middle-men. It is our understanding that as independent, parallel regulators, we are responsible for receiving and responding to licensee reports, and that only reports with special significance (such as those meeting Abnormal Occurrence criteria) were to be reported to NRC.

D. Compatibility Criteria This section lists criteria to be applied to program "elements" and regulations to determine whether an Agreement State must adopt them in a manner "essentially identical" to that of NRC.

The criteria re-state the goals of definition number, three "compatible", and as discussed above, the fourth goal has no reasonable relationship to compatibility as it is equated with "consistency." In this section the fourth goal is given as assisting the Commission in "evaluating the effectiveness of the overall national program for radiation protection." Please see our discussion of definition number three above; the same comments apply here.

At the end of this section it is stated that "if none of the above criteria is met" the State could "design its own program including incorporating more stringent requirements." This needs to be expanded upon since it again suggests only two choices: adopting everything NRC wants adopted identically, or more stringently. That is not an adequate range of choices.

SUMMARY

In Part E of the "Discussion" section preceding the draft policy statement, eight specific questions are posed

for public comment. These primarily relate to whether Agreement States should be permitted to adopt more stringent requirements than NRC, or to preclude practices allowed by NRC. In answer to this, we believe that all basic radiation protection definitions should be identical; as should all dose limits, discharge limits and related standards which are based on the recommendations of accepted national and international radiation protection bodies. All other regulations and criteria should be up to the discretion of the States; whether to adopt a regulation or standard at all, or to adopt one in a more or less stringent form.

NEW YORK STATE DEPARTMENT OF HEALTH COMMENTS ON THE US NRC'S DRAFT POLICY STATEMENT ON ADEQUACY AND COMPATIBILITY PUBLISHED IN THE FEDERAL REGISTER ON JULY 21, 1994 New York State Department of Health staff has reviewed the proposed NRC Draft Statement of Policy on Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs necessary to protect public health and safety published in the Federal Register on July 21, 1994.

We would like to offer the following comments:

1. Section m.E. "Implementation" focusses on-the states' responsibilities and the need for them to share with NRC their proposed regulations or requirements which are more stringent than NRC's at an early stage in developing such a regulation or requirement.

This section also should include the statement that NRC will involve the states in the early review of its proposed regulations and programs, including the intended compatibility requirements and the rationale for such compatibility requirements.

2. Item m.C.4. "Event Reporting" requires the states to impose reporting requirements on their licensees in a manner so that information on identical type events is consistent with the reporting established by the NRC. It is important that any reporting requirement established by NRC is justified on the basis of need to protect public health and safety, and that licensees and state programs not be burdened with reporting data of little or no value in advancing public health and safety. For example, in the past, NRC required its licensees to report diagnostic nuclear medicine misadministrations, the value of which was never adequately justified. A mechanism should be in place for clearly justifying a reporting requirement prior to its imposition and for allowing the states to have input into the requirement prior to its imposition.

3. Item m.C.5. "Reciprocity". We see the'reason for, and accept the need for reciprocity.

However, the states should have the flexibility to impose additional requirements on specific groups of licensees that desire to practice within their jurisdiction, provided that these additional requirements do not conflict with the four criteria listed under Item "ill.D. Compatibility Criteria". For example, New York State Department of Health requires a specific license for each location of use to conduct nuclear medicine or nuclear cardiology procedures, and we should be able to continue this policy.

The policy statement also requests comments on specific questions listed under Item 11.E.

The following are our comments. The numbers listed refer to the question numbers in the policy statement.

1. We agree, in general, with NRC that states may develop more stringent requirements as long as they do not conflict with the four compatibility criteria listed under Item 111.D.

States also should be able to establish stricter discharge limits if it is found that discharges consistent with the existing regulations lead to observed contamination in the environment that approaches the criteria for requiring the imposition of controls to meet the decommissioning rule. It is to be noted that the radioactivity in many of the environmentally contaminated sites currently under remediation, or investigation to determine if remediation is warranted, was placed there at one time in the past in accordance with existing regulations. These regulations included the sewage discharge limits, burial of small quantities of radionuclides, or thorium obtained under a general license. States should have the ability to impose more strict requirements, if similar situations are identified in the future without having to wait for NRC's action.

2. The four criteria are sufficient However it should be noted that program compatibility can be accomplished through license conditions and not necessarily always through the adoption of regulations. Also, as stated above, states should have the flexibility to restrict certain discharges beyond the NRC discharge limits if the released materials are found to accumulate in the environment at a level that threatens to cause a need for remedial action.

3. Examples of requirements in New York State Department of Health regulations that are not in the NRC rules include:

a. Requirement of external audits of radiation therapy facilities.

b. Requirement for reporting therapy misadministrations where the delivered dose for a fraction of a fractionated treatment differs by 50% or more from prescribed.

4. State programs are subject to State Administrative Procedure Acts which inhibit them from adopting arbitrary and unjustifiable rules. In addition there is always the court system to which facilities or licensees can resort. We believe NRC's role should be limited to determination or compatibility according to the four criteria stated in the Policy Statement.

5-7. No comment.

8. As stated above, states need to have the flexibility to set more stringent standards for release of radionuclides to the sewer systems or to the environment if they find it necessary to prevent the accumulation of the radionuclides in the environment to levels which approach those that require remedial action or special management of the contaminated substances for radiation protection purposes.

New York State Department of Environmental Conservation 50 Wolf Road, Albany, New York 12233-7260 518-45 7-6934 FAX 518-45 7-0629 Langdon Marsh Comm1ss10ner Bureau of Radiation Division of Hazardous Substances Regulation New York State Department of Environmental Conservation Comments on NRC Draft Policy Statement on Adequacy and Compatibility September 9, 1994 Comment on Title of Federal Register Notice Add the phrase 11 and the environment" after the phrase "public health and safety. 11 COJDJDents on Section II, Discussion D. Termination of Agreements

. . . In some situations, individual indicator weakness(es) could result in a "marginal" finding by the .MRB calling for Agreement State improvement and the State program may be placed on probation . . . .

The concept of probation neids to be clarified. Probation can mean to subject a program to a period of testing and trial to ascertain fitness, or it can mean the action of suspending the sentence of a convicted offender.

E. Specific Questions for Public Comment

1. Under what circumstances should Agreement States be permitted to establish more stringent requirements, for their licensees, than those established by the Commission? Should this also include the ability to establish stricter dose limits for particular classes of licensees?

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Agreement States should be allowed to establish more stringent requirements in all areas other than those where essentially identical rules are required for compatibility (i.e.,

dose and release limits). The State should be able to set more stringent requirements when such requirements are (1) needed to comply with State laws and policies and (2) consistent with the ALARA principle.

Agreement States should not be allowed to establish stricter dose limits for particular classes of licensees. This is not necessary, and would introduce confusion and uncertainty from State to State. Stricter dose limits can be set on a case-by-case basis, through application of the ALARA principle.

NRC should clarify the status of its current system of making "Division of Compatibility" determinations for the provisions in its regulations. If the current system would remain in effect after the proposed policy is finalized, it should be the prerogative of States to determine if they need to further restrict any practice for which the applicable regulation is not a Division I rule. Under the proposed policy, it appears that Agreement States would be authorized to do just that for any regulation not listed under the "Elements of Compatible Program."

2. Are the four criteria in the proposed policy statement for determining whether a Commission regulation or other program element should be adopted in a manner essentially identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? What examples could be used to illustrate how each criterion would be applied?

No comments.

3. What are some examples of State action to establish stricter requirements than those established by the Commission, or establish requirements where the NRC has not?

In regulating radioactive discharges to the environment from effluents to air and water, the New York State Department of Environmental Conservation sets stricter requirements, on a case-by-case basis, via permit conditions. Rather than automatically allowing maximum discharges, DEC authorizes an applicant's requested discharge level only if the applicant (1) demonstrates that radiation dose limits will be met and that radiation doses and radioactive discharges to the environment will be maintained ALARA, and (2) provides an adequate justification for the requested level of discharge. This approach has been ,_implemented Page 2 of 9

at DEC to assure that doses to the public received as a result of radioactive discharges to unrestricted areas in the environment are ALARA.

4. What limits, i f any, should be placed on the power of a State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice?

No comments.

5. Are there any other dose or radiation-protection related released limits in the Commission's regulations which should be included under the criterion number 3 of the compatibility criteria? Should the dose limits contained in 10 CFR Part 61 be included under this criterion?

The NRC should consider including the biomedical waste rule, which has been a Division 3 rule and, therefore, optional for Agreement States.

The dose limits in 10 CFR Part 61 should be included under this criterion. There is no basis for concluding that these dose limits should be treated any differently than the dose limits for releases from any other facility.

6. Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-caae basis?

Yes, it should be applicable to the regulation of LLRW disposal. The case-by-case approach has added confusion and inconsistency to an already highly controversial issue. It has been difficult for States to explain compatibility requirements to the public when the NRC has given different compatibility advice to different States. For example, New York State was led to believe by NRC staff that the dose limits in Part 61 were Division I rules, and that New York State did not have the discretion to adopt lower dose limits. We referred to this compatibility requirement in response to demands from the public for lower, or even zero, dose limits. Subsequently, the NRC found compatible other State's regulations that set lower dose limits for LLRW facilities. Such inconsistency does not serve anyone well. It casts doubt on both the validity of the dose limits themselves and the need for consistent radiation protection standards across the country.

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7. Are there currently areas or situation in Agreement State regulations or other Agreement State requirements that would not meet the proposed policy statement?

No comments.

8. Should States be permitted to establish more stringent standards for radiation-protection related release limits?

See response to Question El.

Comments on Section III, Policy Statement A. Definitions

1. Adequ2te The acceptable level of protection for the public health and safety from tbe radiation hazards associated with the use of byproduct, source, and special nuclear material.

This proposed definition does not include the sense of "sufficient for," which is part of the standard, dictionary definition of "adequate." The proposed definition should be revised. As now drafted, it only redefines "adequate" to mean "acceptable," which then leads to a need to define "acceptable level of protection."

This draft definition of "adequate" appears to be designed to acknowledge that an adequate program will not eliminate all risks from the use of radioactive material. It is important to make that point; however, as an alternative to redefining "adequate," the NRC could address the concept of acceptable risk in a definition of the term, "protection of the public health and safety." '

In the definition of "adequate," the phrase "and the environment" should be added after the phrase "protection of the public health and safety."

2. An Adequate Agreement State Program An effectively implemented regulatory program containing elements considered necessary by the Commission to provide an acceptable level of protection for the public health and safety from the use of byproduct, source, and special nuclear materials.

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This definition also uses the word "acceptable" to define "adequate." See our comment on the definition of "adequate."

The phrase "and the environment" should be added after the phrase "protection of the public health and safety."

B. Elements of an Adequate Program

1. Protection The Agreement State program shall be designed and administered to protect the public health and safety of its citizens against radiation hazards.

Add the phrase "and the environment" after the word "citizens."

2. Regulations Except for dose limits and radiation-protection related release limits in 10 CFR Part 20 and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto, or other regulations which are required to be essentially identical for compatibility purposes, an Agreement State program shall adopt regulations or other legally binding measures, equivalent to, or more stringent than, those designated by the NRC.

This makes no reference to regulations that would be optional for Agreement States (Division 3 rules) or those that Agreement States are not to adopt (Division 4 rules). NRC should clarify whether or not they are abandoning the compatibility divisions. If they are, this paragraph should be revised to allow some discretion by the States for certain rules. As it is written, it implies that Agreement States must adopt all NRC regulations (or, where allowed, more stringent provisions).

3. Inspection

. The State inspection of licensee facilities, equipment, procedures and use of materials shall provide reasonable assurance that the public health and safety is being protected.

Add the phrase "and the environment" after the phrase "public health and safety."

. Frequency of inspection shall be related directly to the hazards associated with amount and kind of material and type of operation licensed. The minimum inspection frequency, including initial inspections, shall be no less than the NRC inspection frequency.

Page 5 of 9

NYSDEC may not be able to comply with this requirement.

Because we regulate releases of radioactive material to the environment, our inspection priorities are based on the potential for release to the environment, not the total amount of material on site. As a result, we may not assign as high a priority as NRC would assign in certain situations, if the use of the material does not lead to a release to the environment.

Conversely, we may give a high priority to a small operation that has the potential for a significant release to the environment.

5. Staffing and Personnel Qualifications

. Agreement State staff shall be qualified using criteria no less stringent than criteria used for NRC staff.

It is difficult to comment on this issue, without knowing the criteria used for qualifying NRC staff and managers.

9. Licensing The State regulatory program review of license applications for the purpose of evaluating the applicant's qualifications, facilities, equipment, procedures and use of materials shall provide reasonable assurance that the public health and safety are being protected.

Add the phrase "and the environment" after the phrase "public health and safety."

C. Elements of a Compatible Program

- 1. Radiation Labels, Signs, and Symbols States must have radiation labels, signs, and symbols identical to that of the national standard.

\

This is requirement is not clear. The word "states" appears to mean something different from "state regulatory programs" (used in item C.2). The term "national standard" is not defined.

We assume what is meant is that Agreement States should set, in their regulations, the same requirements for radiation labels, signs, and symbols as the NRC has in its regulations. If that is correct, DEC agrees. The statement should be rewritten to clearly define what is being required.

Page 6 of 9

2. Uniform Manifest State regulatory programs shall establish a manifest system in accordance with 10 CFR Part 20.

NYSDEC has such a program already in place pursuant to 6 NYCRR Part 381.

7. Radiation Protection Terminology The State regulatory program shall adopt fundamental radiation protection terminology in a manner essentially identical to NRC definition of these terms to ensure clear communication about radiation protection.

We recommend changing the word "ensure" to "promote." We have found that the use of identical terms does not necessarily ensure clear communication about radiation protection.

D. Compatibility Criteria The following criteria shall be applied to program elements and regulations . . for the purposes of compatibility:

1. avoids a significant burden on interstate commerce;

2. ensures clear communication on fundamental radiation protection terminology;

3. ensures the establishment of the dose limits and radiation-protection related release limits in 10 CFR Part 20 and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto;

4. assists the Commissiontin evaluating the effectiveness of the overall national program for radiation protection.

Since the Elements of a Compatible Program have already been presented in Section C, the purpose of these criteria is not clear. The compatibility elements should be used as the standards against which states are judged. The elements are clear; the criteria are more subjective and the point at which they will be applied to a State's program is not clear. Use of these proposed criteria would allow NRC to be subjective in its reviews of Agreement State programs.

Page 7 of 9

Perhaps NRC has presented the criteria as an additional means to avoid specific types of problems (as is apparent by the nature of the criteria presented). However, if the compatibility elements are instituted by Agreement States, these problems will not occur. The criteria merely repeat much of what has already been covered in the elements.

It is not clear whether NRC is proposing to discontinue its system of Compatibility Divisions I-IV. NRC should clarify its intentions regarding this. If NRC intends to continue the Division I-IV system, the NRC must commit, in this policy, to identifying its proposed Division designations in Notices of Proposed Rulemaking. The NRC's final Division determinations should be published in the Notice of Final Rule. To date, the NRC has not yet provided its Division determinations regarding the provisions of 10 CFR 20, which was finalized several years ago. Agreement States have, therefore, been forced to proceed with promulgating their state regulations without the benefit of knowing NRC's Division compatibility determinations.

The first criterion (avoids a significant burden on interstate commerce) must be placed within the perspective of avoiding a conflict with the State's police powers.

We recommend that the wording of the second criterion be changed to read, "is necessary for clear communication on fundamental radiation protection terminology."

. If none of the above criteria is met, the State would have the flexibility to design its own program including incorporating more stringent requirements provided that:

a. the requirements for adequacy are still met; and

b. the more stringent requirements do not preclude or effectively preclude a practice within the national incerest without an adequate public health and safety or environmental basis Item a refers to "the requirements for adequacy." It is not clear whether these requirements are the same as the Elements of an Adequate Program, presented in section B of the draft policy.

E. Implementation Notwithstanding the provisions above, the Agreement States shall exercise their regulatory authority in a responsible manner and shall not adopt more stringent regulations or requirements as a means to bar or Page 8 of 9

preclude a practice without an adequate safety or environmental basis, or bar a practice needed in the national interest.

New York State already conducts safety and environmental assessments when promulgating regulations via this State's equivalent to NEPA. It is not evident how the NRC will determine the adequacy of such safety and environmental assessments, or determine what constitutes a "practice needed in the national interest." NRC must recognize that states are sometimes forced to promulgate regulations due to a state legislative mandate, regardless of the results of any safety and environmental assessment. In fact, NRC has, in the recent past, found itself in a similar position (i.e., forced to withdraw its draft BRC policy) .

. In order to permit the NRC to provide early coordination and oversight of any proposed more stringent regulation or requirements, NRC will request Agreement States to identify =i11Y such regulations or requirements and provide opportunity for NRC review before publication as a draft rule for comment or before the institution of the requirement as a legally binding measure.

Agreement States request early review of proposed rules for compatibility determinations by NRC. Often, such determinations have not been provided until after the states' regulations have been finalized. In these instances, states have been placed in the position of having to proceed with promulgating their regulations without the benefit of having been provided NRC's compatibility determination for their proposed regulations.

G. Examples of More Stringent Requirements As noted above, i f the State program is equivalent to, or more stringent than, NRC's program to assure the protection of the public an~ safety, Add the phrase "and the environment" after the phrase "public health and safety."

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STATE OF NEW YORK DEPARTMENT OF LABOR DOC ETED DIVISION OF SAFETY AND HEALTH US 1, , C i Radiological Health Unit J Building #12, Room 457 fill State Office Building Campus *94 OV 22 A9 :45 Albany, NY 12240 November 18, 1994 Secretary DOCKET NUMBER B .

U.S. Nuclear Regulatory Commission PROPOSED RULE p f'1 t5 y Washington, DC 20555 (S°! FR 372 01)

Dear Acting Secretary Hoyle:

Enclosed please find the comments of the New York State Department of Labor, submitted in response to 59 FR 37269 seeking comments on a draft statement of policy regarding "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety".

Sincerely, £

~~

Rita Aldrich Principal Radiophysicist RA/fdh Enc.

.FEB 2 4 1995 Ackn wledged by card .........................--........

Telephone: 518-457-1202 FAX: 518-457-5545

W.S. NUCLEPJl ;;[: Li..J.TORY COMMISSION DOCKETiNG & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COM ISSION Docume t Statistics Postmark Date 11 / Iif:: / 9 L/

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NEW YORK STATE DEPARTMENT OF LABOR COMMENTS ON: July 1, 1994 Federa l Register Notice on "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety."

This draft statement of policy begins with a background statement declaring t hat the terms "compatible" and "adequate" are "core concepts" in the Atomic Energy Act section on Agreement States, but are not defined in the Act. It is further stated that the "guiding concept over the years since the beginning of the Agreement State program in the area of compatibility has been to encourage uniformity to the maximum extent practicable while allowing flexibility, where possible, to accommodate local regulatory concerns." We would take issue with this statement and question its basis. New York State's Agreement with the NRC contains an article p l edging the best efforts of both NRC and New York State to maintain compatible programs. Furthermore, when New York State's regulations were assessed by NRC prior to finalizing this Agreement, several differences between State and NRC regulations were noted and accepted. One of these related to the calculation of occupational dose, and not only differed from 10 CFR Part 20, but differed between the regulations of the three New York State agencies that were party to the Agreement. Other instances were noted by NRC where a New York State agency lacked a specific parallel to an NRC regulation, but accomplished the same intent through licensing. The latter was not only accepted by NRC at the time our Agreement was signed, but during subsequent periodic program reviews conducted by NRC staff. Only in the last few years has NRC advanced the concept that the Atomic Energy Act requires "uniformity to the maximum extent practicable" when it states that an Agreement State's program must be "compatible" with the Commission's program at the time a State enters into an Agreement. This concept is not supported by the Act, nor is it supported by the wording in New York's, and the other Agreement States*, agreements with NRC.

The approach to defining "adequacy" in this draft policy is similarly flawed. Rather than developing an objective definition based on a program's (NRC's or an Agreement State's) likelihood to protect public health and safety, or its actual performance in doing so, a completely subjective approach is taken. The measure of adequacy is proposed to be the extent to which it contains "elements" considered "necessary" by the Commission.

This draft policy is built on the erroneous concept that the

~greement States are sub-contractors to the NRC, rather than the independent, parallel regulators that Chairman Selin has acknowledged they are. It basical l y defines adequacy and compatibility as the extent to which a State program is identical to NRC's. This is the antithesis of independence. Rather,

adequacy and compatibility should be defined in terms of objective capability to protect public health and safety in the first instance, and the concordance between NRC and Agreement State requirements (not just regulations) in the second.

Comments on specific sections of the draft policy follow:

A. Definitions:

Definition number two defines "An Adequate Agreement State Program" as one containing "elements" considered necessary by the Commission to provide an acceptable level of protection. Definition number five defines "element" as "any aspect of a radiation protection program that is necessary to implement a program- that is adequate to protect public health and safety." Furthermore, the term "element" may include "organizational structure, staffing level, inspection frequency, regulations, policies and procedures or any other component or function that the Commission considers necessary."

This is circular reasoning (an "adequate" program contains the "elements" necessary to make it "adequate"),

and totally lacking in objectivity (the necessary "elements" include any component or function the Commission considers essential).

Definition number three defines "Compatible" as the consistency needed to assure an orderly and effective regulatory pattern in the administration of the "national radiation protection program." I do not know what the latter is. The States (Agreement or not) regulate non-AEA radioactive materials and machine sources of radiation independent of NRC, and Agreement States regulate AEA materials also. It would be less grandiose and more accurate to refer to the "regulatory program for AEA materials." However, the equating of "compatibility" with "consistency" is a good beginning. Also acceptable are the stated goals that interstate commerce not be impeded, that effective communication in radiation protection is maintained and that dose limits and release limits be consistent. The last goal, ("that information needed for the study of trends in radiation protection and other national needs is obtained") however, seems to have no relationship to compatibility and should be deleted from the definition.

Definition number four unaccountably redefines "compatibility" by stating that a "compatible Agreement State program" is one which contains "elements considered necessary by the Commission." In the discussion of

definition number two, above, we have already remarked upon the lack of objectivity this introduces. Since an element is "any component or function which the Commission considers necessary" we have gone from the reasonable equating of compatibility and consistency in definition number three, to an unreasonable and subjective dictum that the Commission can condition a finding of compatibility on the presence or absence of any "element" it thinks a program should have.

B. Elements of an Adequate Program Element number two, Regulations, states that except for certain regulations which must be "essentially identical,"

an Agreement State "shall" adop t regulations "or other legally binding measures," equivalent to, or more stringent than, those designated by the NRC.

The meaning of "other legally binding measures" should be defined. In the absence of a definition telling us what this encompasses, it appears that the Agreement States could be required to adopt every regulation which NRC adopts, either identically or more stringently. There is nothing in this policy to suggest what specific criteria NRC will use to decide which regulations it will require the states to adopt. Definition number three suggests that it would only be those regulations "aimed" at certain stated goals, while definition number four suggests that virtually any regulation could constitute an "element" the Commission thinks is necessary.

Also, the Agreement States would have only two options in adopting regulations: "essentially identical;" or "equivalent to, or more stringent." We need further explanation of the second option in order to comment. What does "equivalent" mean? What about NRC regulations which States feel should not be adopted at all, or that only certain components should be adopted.

Element number three, Inspection, requires Agreement States to adopt NRC inspection frequencies for each type of licen see, as minimum frequencies. This is unacceptable. As indep endent, parallel regulators, the Agreement States must be accorded more flexibility than this. It is perfectly possible that a State will have more stringent frequencies than NRC for many or most types of licensees, but will decide that some types of licensees need to be inspected less frequently. To require unthinking conformity to NRC frequencies interferes with a State's need and responsibility to use its resources as efficiently as possible to provide maximum protection of public health and safety. It also ignores the reality that a State program

regulates other radiation sources not subject to the AEA, which it may judge should have a higher priority than some AEA materials.

This may be a convenient requirement for NRC to impose, since it eliminates the need for any judgement, but it is inappropriate and counterproductive.

c. Elements of a Compatible Program Element number four, Event Reporting, states that Agreement States "shall" require licensee reporting of events in a manner consistent with NRC reporting requirements. It further states that "this information shall be provided to the NRC." Does this mean that every report received from licensees must be forwarded to NRC?

This makes Agreement States little more than middle-men. It is our understanding that as independent, parallel regulators, we are responsible for receiving and responding to licensee reports, and that only reports with special significance (such as those meeting Abnormal Occurrence criteria) were to be reported to NRC.

D. Compatibility Criteria This section lists criteria to be applied to program "elements" and regulations to determine whether an Agreement State must adopt them in a manner "essentially identical" to that of NRC.

The criteria re-state the goals of definition number three "compatible", and as discussed above, the fourth goal has no reasonable relationship to compatibility as it is equated with "consistency." In this section the fourth goal is given as assisting the Commission in "evaluating the effectiveness of the overall national program for radiation protection." Please see our discussion of definition number three above; the same comments apply here.

At t he end of this section it is stated that "if none of the above criteria is met" the State could "design its own program including incorporating more stringent requirements." This needs to be expanded upon since it again suggests only two choices: adopting everything NRC wants adopted identically, or more stringently. That is not an adequate range of choices.

SUMMARY

In Part E of the "Discussion" section preceding the draft policy statement, eight specific questions are posed

for public comment. These primarily relate to whether Agreement States should be permitted to adopt more stringent re.quirements than NRC, or to preclude practices allowed by NRC. In answer to this, we believe that all basic radiation protection definitions should be identical; as should all dose limits, discharge limits and related standards which are based on the recommendations of accepted national and international radiation protection bodies. All other regulations and criteria should be up to the discretion of the States; whether to adopt a regulation or standard at all, or to adopt one in a more or less stringent form.

DOCKET NUMBER - RECEIVED i.,!0 0 7 1994 1

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(SCf FR 312b1) DOCKETED USHRC Mark Rotman 8585 Mansfield Court *94 NOV 15 P4 :30 Middletown, MD 21769 COMMENTARY ON FEDERAL REGISTER NOTICE , VOLUM...Q~l.J ¥t-i ~ ~~f --; ji ;~i }

7-21-94, DRAFT POLICY STATEMENT: ADEQUACY AND coMP1iiflf:aI~':i\lt:EOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFETY.

As a Board Certified Nuclear Pharmacist, Senior Nuclear Pharmacist in the us Public Health Service, and a former Visiting Medical Fellow at the US Nuclear Regulatory Commission I am compelled to make the following comments:

A major defect in the above FRN is that a number of important parameters are undefined. Without clear definitions much of the draft policy statement is open to any interpretation, thus rendering it useless. The FRN repeatedly holds up the NRC staff, and their qualifications as the standard by which all Agreement State staffs should be judged. Unfortunately, the NRC arrived at its current staff and qualifications by trial, error, and luck of the draw, as they hired who was available at the time to fill each opening. There is no national consensus on training and experience necessary for regulatory agency staff. The FRN takes a giant step away from using the State's performance in protecting the public heal th and safety as the major indicator of ade*quacy, and substitutes prescriptive requirements instead. This giant step is also likely to be a violation of 274(b) of the Atomic Energy Act.

The FRN is highly chauvinistic, and without any proof, in its assumption that if each State is a mini-NRC, performance will be improved.

The FRN does not define what constitutes a risk to the public health and safety. If the elements necessary to produce risk to public health and safety are not defined, then the elements necessary to protect the public health and safety are also undefined.

Chapter 19 of the AEA, Section 274(b), 42 USC 2021, states "During the duration of such an agreement it is recognized that the state shall have authority to regulat e the materials covered by the agreement for the protection of the public health and safety from radiation hazards." Thus it appears that the NRC, in this FRN, is trying to super-regulate the States. This appears to be a violation of t h e AEA.

On page 37270, col umn 3, paragraph 3, the NRC uses the term "overall national interest in radiation protection." However, this is undefined. Later, in the same paragraph, the term "a larger national interest in radiation protection" is used. Again, it is undefined. But it does imply there are major and minor national interests in radiation protection. These should be clearly explained.

Rotman's Commentary on FRN 59(139) 37269, 7-21-94

.FEB 2 4 1995 Acknowledged by card ........................,r- .....,,.

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2 On page 37271, column 1, "C.", the first sentence states "The staff developed a management directive *.* " The implication is that NRC staff determines policy, not NRC management.

Column 2, 11 0. 11 states "Termination of an Agreement can occur when an Agreement State program is either inadequate or incompatible." The key words here are "either inadequate or incompatible". If risk to public health and safety were defined, and if an Agreement State were inadequate to provide the public with radiological health and safety protection, then termination of Agreement state status would be justified. However, Agreement State status can be terminated simply because the state's regulatory language is deemed, by the NRC, to be essentially non-identical. This could be done in the absence of any evidence that the state has been inadequate in the protection of the public heal th and safety. FAILURE OF A STATE TO PROVIDE PROTECTION OF THE PUBLIC HEALTH AND SAFETY SHOULD BE THE ONLY REASON TO TERMINATE AN AGREEMENT!

Column 3, "E. 11 , 11 1. 11 , in answer to the question, State's often are more restrictive than the NRC's regulation, and do so through licensing conditions. *Allowing the States to use licensing conditions to custom design regulatory control to the individual licensee is critical to the allocation of resources. The better equipped, better trained licensees or those performing operations with less risk will need less regulatory oversight than those with lesser training or performing higher risk operations. States need the ability to custom fit regulatory oversight to the licensee.

Page 37272, column 1, "A.", 11 1. and 2. 11 ; Both 1 and 2 talk about "acceptable level", and "elements considered necessary".

Both of these terms are highly prescriptive and seem to disallow any use of performance indicators. The only performance indicator that should be examined is "protection of the public health and safety". If there was a clear definition of protection of public heal th and safety, then a determination of "acceptable level of protection" might be possible.

Under the heading "3. Compatib l e" the policy statement states "information needed for the study of trends in radiation protection and other national programs needs is obtained." The study of radiation protection is a very mature field. I don't believe that any issues, other than time, distance, and shielding, are going to be discovered. However, scientific data is accumulating to support radiation Hormesis, and to date, the NRC has ignored it.

Column 3, "B.", "3.", the policy statement states "Frequency of inspection shall be related directly to the hazards associated with amount and kind of material and type of operation licensed."

This appears to give the states the flexibility necessary to inspect based on risk to the public health and safety. However, the very next sentence takes that flexibility away by stating "The minimum inspection frequency including initial inspection, shall be no less than the NRC inspection frequency. " This is a perfect example of NRC chauvinism and p rescriptionism.

Rotman's Commentary on FRN 59(139) 37269, 7-21-94

t 3

In numbers "3.", 11 5. 11 , and 11 9.", the policy statement states that staff ( inspection and licensing) technical expertise should be similar to NRC staff qualifications. There are major problems associated with this philosophy. First of all, using the NRC staff qualifications as a bench mark is no guarantee of performance. For example, I present Indiana PA. There is ample evid ence that NRC licensing and inspection staff faile d to protect the public health and safety. In general, qualifications alone are not the sole indicator of good performance, indeed motivation and management oversight must be factored in. Secondl y, there does not appear to be any open, peer reviewed, national system for determining the qualifications necessary to be an inspector, reviewer, or administrator. In fact, t h e NRC is full of former us Navy reactor personne l who have oversigh t over much of the non-reactor business of t h e NRC. It appears that even the NRC may not have "appropriately" trained staff for much of its materials program.

For example, the NRC does not have a single nuclear pharmacist to inspect, teach inspection, license, review licensing, write regulatory guidance, or to provide any guidance on the regulation of nuclear pharmacies. The NRC needs to develop, with the help of t he States, the regulated community, and scientific advisors, national qualification standards for inspectors, licensers, and administrators. Then it can judge whether its staff or that of a State is appropriate.

In conclusion, the FRN is deficient in that it fails to clearly define many judgement parameters. The FRN assumes that the NRC and its staff should be used as the benchmark to measure others when there is no established national standard to use. The FRN is proposing a highly prescriptive method for the States to regulate by, when there is no evidence that public health and safety has been jeopardized or that a highly prescriptive method (NRC style) of regulation is better than a performance based regulatory style.

Lastly, at a minimum, this FRN violates the intent of 274(b) of the AEA.

Thank you for allowing my comments.

Ulttd /2~t~~

(1-YlY Rotman's commentary on FRN 59(139) 37269, 7-21-94

State of New Mexico ENVIRONMENT DEPAllTMENT Harold Runnels Building DOCKET E0 1190 St. Francis Drive, P.O. Box 2M~0mc Santa Fe, New Mexico 87502 JUDITH M. ESPINOSA SECRETARY (505) 827-2850 *94 NOV 14 p li :26 BRUCE KING RONCURRY GOVERNOR DEl'UTY SECRETARY November 2, 1994 oocK:;.T, *UMBER PROPOSED RULE PB t-..t - G 1 .,, ._ 5 Mr. Samuel J. Chilk Secretary of The Commission

( 5 q FY<- '31?- {, GJ)

Attn: Docketi ng and Services Branch U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Mr. Chilk:

This letter is in reference to 59FR 37269, the Commission's draft statement of policy on adequacy and compatibility for NRC and Agreement State Radiation Control Programs. While there are very good elements to the draft, the New Mexico Environment Department opposes the U.S. NRC's interpretation of the term "compatibility."

The Department objects to the NRC's interpretation of "compatible" to mean essentially "identical to NRC". The language of the Atomic Energy Act is that a state must have a program that is "adequate to protect the public health and safety" and compatible with the NRC before an agreement may be entered into by the state and the NRC. Protection of the public's health and safety has traditionally been a state responsibility.

When New Mexico became an Agreement State in 1974 it was understood that both the Commission and the state would use their best efforts to keep their programs compatible with each other. This implicitly means that there should be a negotiation between states and the NRC on programs being compatible. Should the NRC look at the definition of compatible, the NRC would find that the strict definition refers to the capability to exist in harmony. Nowhere in the definition does the capability to exist in harmony include language that the entities or objects to be compatible be identical. The NRC must reeval uate its definition of compatibility.

Compatibility requirements imposed under the NRC compatibility definition have increased by leaps and bounds in recent years to a point where the 29 Agreement States are having to devote more and more time and resources to remain compatible with NRC regulations.

The time and resources expended by states in this area detract from program activity implementation.

iffB 2 4 1995 Acknowledged by card .................................."

,$. r ~

* i *- vt; ~ *.*f6~1vN i/:- ECTiON v~ ,*, . :J T1\RY U1 I:*,:.:. N

Mr. Samuel J. Chilk Page 2 November 2, 1994 The Department finds it questionable that the NRC can find an Agreement State adequate t o protect the public health and safety upon a review of its radiation protection program and yet incompatible because of failure to adopt some identical regulation deemed an item of compatibility by NRC. The NMED questions the direct relationship between the implementation of compatibility items and program implementation which affect the public health and safety. The compatibility requirements also fail to take into account differences that exist among the states. The Department beli eves that maximum regulatory flexibility must be allowed for states to achieve a desired goal in ways that best suit their circumstances.

Thank you for the opportunity to comment.

Fife Symington DOCKETED Governor USN:,C Aubrey V. Godwin Director 4814 South 40 Street (602) 255-4845 FAX (602) 437-0705 OFFICt OF SECR~TA.RY DOCK ET! 1G ~~ ~C:P'/ ' C[

November 1, 1994 B~*M,Crl DOCKET NUMBER PROPOSED RULE PB M Is . G.

Secretary, Attention Docketing and Services Branch (Sc, F-'f( 3726:)

U.S. Nuclear Regulatory Commission Washington, DC 20555

Reference:

Draft Policy Statement on Agreement State Compatibility

Dear Sir:

We would like to offer the following comments on the Draft Policy Statement.

1. The first paragraph in "I. Background" is inadequate in that it does not give an appropriate definition of "compatible." This paragraph admits that neither the Act nor the regulations of the Commission define the term yet in the last three sentences of the paragraph the definition of "uniformity" is provided for "compatibility." A glance in almost any dictionary indicates that "uniformity" is not one of the definitions of "compatibility." Indeed, the most common definition is the concept of being able to exist together without discord. This failure to recogniz.e a proper definition of "compatibility" has distracted the Commission and its' staff from the needed clarifications of compatibility. Further, the "Background" information completely misses one of the more important points in the relationship of the Commission with Agreement States, namely, that of a partnership or co-equal regulator. Again not stated in the "Background" information is the clear statement in the Act that an Agreement is to be terminated when " .. (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." It is not likely that the undefined term "compatibility" (i.e. working together) reaches ihe same threshold of significance as that of protecting the public health and safety, therefore it was not intended to be grounds for terminating an Agreement. This point is further supported by the very Agreement with Arizona. In this document the State and the Commission both pledged to have an adequate program to protect the public health and safety but both are only committed to use "their best efforts to maintain compatibility. "

2. The second paragraph under "II. Discussion" states that Section 274 of the Act requires that Agreement State programs be both "adequate to protect the public health and safety" and "compatible with the Commission's program." This is not a proper reading of Section 274. As stated in 1. above, the requirement to terminate or suspend an Agreement is dependant on a finding that the public health and safety is in danger. Only by stretching the point can a reference to compatibility be made. Indeed paragraph o. of Section 274 seems to recogniz.e that only public health and safety are to be considered for termination, by clearly indicating that

,FEB 2 4 1995 !

Acknowledged by card°"""""'"'"~

i.:, ,* . .._,,: ~'COMMISSION

~~ , *::::: .t:CE ... ECTION

( ',- i*,:_:c. ;.J* 1f E SECRETARY Cr-T; , ECO , MISSION

Secretary Page 2 November 1, 1994 a State regulating materials as defined by Section 11 e. (2) of the Act, may adopt more stringent regulatory requirements than the Commission. If we followed the Commission definition of "compatibility" as given in the discussion, we would be restricted from such adoption. Congress appears to have sent a message to both the States and the Commission.

3. Under the "Il. Discussion," B. appears to continue the faulty definitions indicated in 1. and 2.

above. Further, with the assumptions made in the "Background" paragraphs and in the initial portions of the "Discussion," the failure to use a proper definition is compounded and we suggest that the whole issue should be abandoned and a new proposal submitted for comment.

We believe that these sections are so replete with errors that the public is totally misled as to the intent of the proposal.

4. The "Policy Statement" definition more closely approaches the classic dictionary definition of "compatible" than in either the "Background" of "Discussion" portions of the proposal.

Regretfully the earlier material has fatally flawed the proposal. A better term than "consistency" would be "congruous" or "fitting." It must be noted that with the definition and criteria provided, it is very vague as to when an Agreement State has reached or over stepped the requirements to be compatible. This very point was raised to Congress July 17, 1979, by then Governor Babbitt in his testimony regarding American Atomics Corporation (Pages 4-5 of the Subcommittee Report, Serial Number 96-8). Commissioner Gilinsky apparently gave the Commission' s position in his testimony to this Oversight Hearing and stated that an Agreement could be terminated for a failure to protect the public health and safety. He did not say the same for compatibility.

Thank you for the opportunity to comment on this proposal.

Sincerely, U,'

A u ~ Godwin,

- ~

Director

American Association for Nucle~t~~~lology, Inc.

Professionals Dedicated to Diagnostic Accuracy I!" i : @

Richard Bangert, Director *94 t{)V -4 p 3 :J7 Agreement States Programs Safety, US Nuclear Regulatory Commission Third Floor or ,

Mail Stop 3D23 OCL,1 One White Flint North 11555 Rockville Pike Rockville, MD 20852 DOCKET NUMBER -

(301) 504-3340 PROPOSED RULE PR rt l 5 6

{_5qFR.31161)

October 21, 1994 w

Dear Dr. Bangert:

N There have been disturbing trends this past year in the agreement states which adversely affect physician radioactive materials licensing concerns and health care costs. Changes are increasingly being implemented in the states which are incompatible with the Nuclear Regulatory Commission requirements in Part 35, and which interfere with interstate transfer of qualified physicians. These incompatibilities unnecessarily restrict availability of qualified physicians and in doing so involve restraint of trade issues, increase healthcare costs without corresponding benefit and compromise the safety of patients who experience restricted treatment options.

Texas made changes which severely limited the ability of physicians who lack board certification in either radiology or nuclear medicine to become an authorized user in that state.

The changes had no relationship to safety issues. I obtained, through the FOi rules, copies of fines, citations and violations in Texas for the past several years and there was absolutely no safety related basis for these changes. Some of the changes have been reversed, however there are still portions of the training requirements which remain incompatible with NRC and other Agreement State regulations. These changes provide no increase in safety and serve no purpose except to increase restrictive control of the field by a select segment of the physician population.

Georgia has made changes that completely eliminate the second training option accepted by the NRC and other Agreement States. The three options are; board certifications, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> didactic plus 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> clinical and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> work experience, and the third option of 6 months in an ACGME program. A physician can no longer qualify under the 200, 500, 500 option in Georgia. This means a physician meeting that requirement of the NRC regulation in 10 CFR Part 35 is no longer qualified to become an Authorized User in Georgia.

Nebraska has chosen to interpret that same option in a more restrictive manner than the NRC or other Agreement States, in spite the fact that the Nebraska Regulation is phrased similarly to the NRC regulation (Part 35). The regulation appears to be the same, but the interpretation is decidedly different in a more exclusive way. Several other states have made changes that similarly restrict access, with NO evidence of a safety related basis for these chan~s.

Supported by Nuclear Cardiology Systems, Inc.

5171 Eldorado Springs Drive Boulder, CO 80303 Telephone: 303-499-4099 FAX: (303) 499-3999 Toll Free: 1-800-548-4024 Acknowledged by card ..... -~~..:~."~~

In addition, there is a general lack of understanding of the role of the "accreditation" agencies quoted in some of these changes. The Accreditation Council for Graduate Medical Education (ACGME) approves institutions with programs longer than six months. It does not accredit any six month training programs as described in the regulations. Another organization, The Accreditation Council for Continuing Medical Education (ACCME) does not approve curricula. Both of these organizations, and any other used for purposes of determining qualification of a physician for licensing must also be reviewed in terms of governance, who "runs" the organiution, to insure there is not a conflict of interest in enabling a narrow group of physician influenced entities to determine which physicians are allowed access. This is contrary to espoused policies to maximize safety and minimize healthcare costs.

Finally, it is clear that the board certifications allowed in the NRC's own regulations do not guarantee equal training requirements for all physicians. A recent survey demonstrates that a board certified radiologist is exposed (no pun intended) to less than half the amount of didactic instruction required of all others during their radiology residency. Their radiation safety training focusses on diagnostic x-rays, rather than radionuclide concerns. Radiologists do not have sufficient clinical experience during their entire program to meet a fraction of the clinical experience requirements specified in the regulations. To their credit they have recognized this inadequacy in other areas such as cardiac catheterizations in radiology and for some in the performance of radionuclide stress studies. Performance of these studies by a physician without adequate clinical skills creates a very real risk to patients that exceeds even the radiation concerns in terms of magnitude of injury that is likely to occur, and probability of injury occurring. If the interpretation of radionuclide studies is a valid topic under radiation safety issues, is not direct clinical experience and competency with high risk radionuclide studies likewise a legitimate concern of the regulations?

Do you anticipate that the draft Policy Statement on Agreement State Program in the Federal Register, Vol. 59, No. 150, Friday, August 5, 1994 (FR 40058) and the Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft State of Policy as described in the Federal Register, Vol. 59, No.

139, Thursday, July 21, 1994 (FR 37269) will be implemented before the fragmentation of state programs gets totally out of hand?

Please advise me at your earliest opportunity where the NRC will position itself in terms of the increasing trend of states to impose incompatible rules that adversely affect safety, patient care, and physician interstate mobility. Will the NRC act with dispatch to stop these dangerous trends occurring in the states?

t'~

E. Pearce Encl: ACGME letter Radiology survey Supported by Nuclear Cardiology Systems, Inc.

5171 Eldorado Springs Drive Boulder, CO 80303 Telephone: 303-499-4099 FAX: (303) 499-3999 Toll Free: 1-800-548-4024

NATIONAL RADIOLOGY RESIDENCY SURVEY (Training and Experience In Nuclear Medicine)

This survey was completed by mail in May/June 1994, and contacted each senior Radiology Resident in the nation. The sample return was 123 of 807, (15.25%), and represents 45% of all Radiology Resi-dency programs in the United States. The survey categories were derived from the specific Code of Federal Regulations Part 35 requirements for the training of physicians to be qualified for licensure to perform nuclear medical procedures. The three (3) major training categories; Didactic Classroom, Su-pervised Work Experience, and Supervised Clinical Experience are determined by the NRC, and with-out exception, all Agreement States, to be the specific categories of experience that are expected to occur in all training programs including Radiology Residency Programs. All results were tabulated by the average number of hours of experience 00 in each category, and the range of hours from the responses in parenthesis.

Regulatory Texas Nationwide Requirement

- idactic Classroom Exoerience X hrs. /ranae of hrs.' x hrs. /ranae of hrs.

a) Radiation Physics 50 61.7 ( 2,140) 63.0 (0°400) b) Radiation Instrumentation 50 3.3 ( O* 10) 7.8 (0- 52) c) Radiation Protection 30 3.0 ( O* 10) 7.2 (0- 50) d) Mathematics for Radiation Use and Measurement 30 1.1 ( O* 5) 2.9 (0- 30) e) Radiopharmaceutical Chemistry 20 t.3 ca- 5) I 6.9 <a- so) t) Radiation Biology 20 2.8 ( 0- 10) I 9.8 I

(0* 60)

Total Classroom Experience 200 73.2 (10-140) 199.8 (4-510)

Supervised Work Experience xhrs. (range of hrs.) xhrs. (range of hrs.)

a) Ordering~. receiving. unpacking radioactive,materials 0 (O*O.)' 0.61 (0.-210) and performing:related surveys b) Calibrating dose calibrators and diagnostic instruments 0 1.1 (0- 20)

~)) Checking Survey ~ ?~rati,9~: ~lt113!1:1t?' ;.s,1.,~:i~lilt1z:;r~l'.};. o- 0.4-1 (0:- 10),

W Calculating and preparing patient dosages 0.8 3.0 (0- 60) e) Using.adininistrativecont~ts-tci pre,~~rnisad~~~ori~';T!:{>'}?tifr"_, or 2:3 (0:- "50} _*

f) Using decontamination procedures to contain spilled 1.0 0.54 (0- 8) radioactive materials g) Eluting technetium generators;. .Ot2:  :'~lti:t'I~: t ..t h) Measuring and testing eluate ** 0.2 (0-1) 1.0 i) Preparing radiopharmaceuticatkits 0:2: (O~tt ..* ~- . 1'.5. :

Total Supervised Worfc Experience- (~f.>*

- :. if.

Su ervised Clinical Ex erience a) Examining;patients and.case0 historiestodetermine,need.<,

,. for- nuclear diagnosis .,. ., *I;;.,,. **. :_

• b) Selecting radiopharmaceuticals 39.5 (20- 50) _ 26.0 (O* 300) c) Calculati~gand m,easuring_dos,ages* ..:" -~ -* ,,:~,..~".

• u.,... -:. _,,,, *1$0 (Jf~L ,:. ,] :. ,. 4:f: .* lO;.,.tkL:,:~

d) Administering dosages to patients 12.5 ( 0- 40) 12.25 (0- 180) e) Using syringe radiationshieldi' _-,.. .. * ,*. to:o ':f~7~1ti:: . t1.*7 <<>= Jso( ..

f) Collaborating with an authorized user fo interpret test resuits 35.0 ( 0-100) 136.5 (0-1000) g) Patient follow-up 1s.o 't).=:-40f

• 1?.2 :to-16"8r::r Total Supervised Experience 500 359 (90-800) 365 (0-1646) 1276 AANC 8/84

Accreditation Council for Graduate Medical EduCltion Of!lce of tbe Secretary December 3, 1991 515 Norm Smic Sucet Oliago, IL 60610 (312) 464-4920 FAX: (312) 464--4098 Gretchen S. Wheeier Nuclear Cardiology Systems, Inc.

5785 Araphahoe, Suite D Boulder, CO 80303

Dear Ms. Wheeler:

I am responding to your October 18 letter, which .was addressed to Dr..

John Gienapp, Executive Secretary for the ACGME. In response to your request, I can confirm that the statement in the Code of Federal Regulations with regarding to nuclear medicine training is incorrect.

The ACG~E does not accredit a six month training program in nuclear medicine. The Residency Review Committee for Nuclear Medicine accredits residency training in Nuclear Medicine. These programs are of a minimum duration of three years Accredited residency training in diagnostic radiology includes six months of nuclear medicine.

However, that training is an integral part of the diagnostic radiology program and cannot be broken out as a separate training entity.

I hope my response is of assistance to you. If you have further questions, please contact me.

Sincerely yours, Member Cl"'Pntnr!ou American Board of Medic:al

~~

Judith S. Armbruster, Ph.D., Executive Secretary Specialties OneR-,,Center Residency Review Committee for Nuclear Medicine Suire 805 (312) 464-4642 Evanston. IL 60201 American Hospilal Assoc:ialion zj 840 N. Lau Shen 1k Chicaao, IL 60611 American Medical Association 515 Nonb SWc Sirect 0412b-4 Chicaao. IL 60610 Association of American Medical Colleps One 0uPoat C-ll'Cle, N.W.

Suite 200 Wuhinatoa, D.C. 20036 Council of Medical Specialty Societies P.O. Box 70 Lue Forest, lL 60045

DOCKET NUMBER PR M,sG PROPOSED RULE..!._.!!...!.~---

To:

( fd/ FI< 312-6e,)

OOCKr1ED Secretary, U.S. Nuclear Regulatory Commission US1RC (jj)

Washington, D.C. 20555 Attention: Docketing and Services Branch Re: Adequacy and Compatibility for NRC and Agre

• ftten Vsiale 4 :ZL Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Pol

• YlCE OF SEC.' E. lA~'(

DOCKETIHG 6c~ SEP . If , .._

The draft statement of policy unduly limi ts theB f' ens of a State to control their own health and safety destiny.

It should be noted that the citizens earlier defeated an attempt by NRC to deregulate certain radioactive waste, materials, emissions and practices. Citizens and States should be able to participate with NRC in naming protective standards for air, water, environment, workers, and the public. If States and citizens conscientiously request some-what higher standards than NRC -- this should be granted by NRC as a respectful and cooperative measure.

The NRC should be able to recognize that the citizens are much more knowledgeable now about radioactivity than they were in 1954 when the Atomic Energy Act was passed. The States now also have a much greater number of people with the skills needed to participate in site surveillance and regulation. States should be credited and called upon for these skills.

Since the radioactive waste classifications include everything but the spent fuel from nuclear power plants, it is absolutely essential that States have a voice in the compatibility criteria to protect their health and safety.

Regulations for interstate transport of Low-Level Radio-active Waste should allow a community to request that they be by-passed for qualified safety reasons. This is common sense.

Rev. Dr. Velma M. Shearer Neighbors in Need 124 Chestnut st., #210 Englewood, OH 45322 10/29/94 FEB 2 4 1995 Acknowledged by card .............................,.~

i_~AR REGUl. " 1 ..,

DOCKETING OFFlt r

DOCKET NUMBER P""'OPOSED RULE PR r, i5 C (St'f FR 3 72 61)

~ DEPARTMENT Of1uffi~lTH 4815 WEST MARKHAM STREET* LITTLE ROCK, ARKANSAS 72205-3867 TELEPHONE AC 501 661-2000

• 94 OCT 28 A11 :J 6 JIM GUY TUCKER SANDRA B. NICHOLS, M.D.

GOVERNOR DIRECTOR Secretary October 17, 1994 U.S. Nuclear Regulatory Commission Washington D.C. 20555 ATT: Docketing & Services Branch RE : ADEQUACY AND COMPATIBi LITY FOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFETY; DRAFT STATEMENT OF POLICY.

The draft statement of po l icy appeare d in the Federal Register, Vol . 59, No.

139, dated Ju ly 21, 1994. The following comments are made in response to only the specific questions posed in t he Federal Register. General comments regarding the IMPEP will follow at a later date.

Question 1: Under what circumstances shoul d Agreement States be permitted to establi sh more stringent requirements, for their licensees, than those established by the Commission? Should this also include the ability to estab li sh stricter dose limits for particular classes of licensees?

Respons~ Standards, such as dose limits and definitions should be generally uniform. Also, activities associated with interstate commerce should be fairly consistent across the nation. Beyond these considerations, Agreement States shou ld have reasonable flex ib ility to address State and local issues that affect health and safety as well as area concerns . As noted, dose l i mits shou ld be uniform and stricter dose limits should not be assigned to particular classes of licensees. At the same time, States may wish, and shou ld be given the latitude, to set stricter action limiti.

Question 2: Are the four criteria in the proposed pol i cy statement for determining whether a Commission regulation or other program element should be adopted in a manne r essential identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? What example could be used to illustrate how each criterion wou ld be applied?

~PQ!l~: Cr iteria l-3 are acceptab le . Criteria 4 is unacceptable in its present form. It appears to be a "catch-all" criteria and could be exploited to require identical language on every regulation . If this criterion remains in its present form, it will require carefully constructed guidance in order for i t to be properly implemented . I recommend that it be clarified or deleted.

Ex ample s: #1 . Transportation of radioactive waste ; distribution of general and specific licensed gauges, etc .; and some consideration might be ifEB 2 4 1995 Acknowledged by card .......................,,,..,,,,,,t,

given to national companies operating in multiple jurisdictions although this needs to be approached with caution - states still need flexibility in th is area.

1. 2. All basic definitions should be identical.

1. 3. There cou ld be a national standard for release rates or for cleanup criteria, but the Agreement State might set a more stringent action level

• to avoid reaching the national standard.

1. 4 . NA Question 3: What are some examples of State action to establish stricter requirements than those considered by the Commission, or establish requirements where the NRC has not.

R~mn.1~-~ Our requirements are fairly consistent with NRC requirements although our policies vary somewhat . For example, we have a more frequent inspection sc hedule and do not allow one license to cover more than one location of use when that location is a permanent facility. As we also regulate radiation prod ucing machines and non-by-product material, we must insure that a common regulation is appropriate for all sources. Finally, we have established soil concentration limits for both by-product and non-by-product material .

Question 4: What limits, if any, should be placed on the power of a State to preclude or, by exceptionally st ringent regulations, effectively preclude an activity?

B.!tW..<m.S~ A regulatory program should not encourage or discourage a practice but should concentrate its efforts only on ensuring that the practice meets the objectives necessary to protect public health & safety and the environment . I believe it is difficult to set specific limits, thus a regulation may have to be eva lu ated on a case by case basis against this concern. However, there may also be suff i cient State law or policy to prevent this from occurring. Indeed, the process most st ates must use to adopt a new regulation or to amend an existing regulation includes a sometimes extensive public hearing process where an unfair regulation can be called to task.

Finally, there is lega l recourse for the affected community.

Question 5: Are there any other dose or radiation protection related release limits in the Commission's regulations which should be included under the Cr iterion number 3 of the compatibi li ty criteria? Should the dose limits contained in 10 CFR Part 61 be incl uded irr this criterion?

~s.ponse: As dose lim i ts should be standard, release limits based upon the potential for an exposure should be inclu ded in the criterion. 10 CFR Part 61 l imits should also be included in the criterion. However, as previously noted, states should still have the option of selecting a lower limit as an action trigger .

Question 6: Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal instead of continuing to consider questions of compatibility in this area on a case-by-case basis?

Response: Yes.

Question 7: Are there currently areas or situations in Agreement State

regulations or other Agreement State requirements that would not meet the proposed policy statement?

Response: None have been identified in our regulations or requirements, however, that could depend in part upon the final inclusion of Criterion 4 and how it is implemented. Also, future regulations or requirements may not meet the proposed policy statement, again dependent upon its final form and its application in practice.

Question 8: Should States be permitted to establish more stringent standards for radiation protection related release limits.

Besponse: States may need flex ib ility to establish more stringent action levels to avoi d reaching either dose limits or standard release limits. This has been addressed above.

The Division appreciates the opport un ity to comment on the draft policy statement. We remain concerned about the relationship between the Agreement States, the Commission and the regulated community. Our goal should be to ensure the safe use of sources of radiation in the most effective and reasonable way . We should recognize both the need and value of a national standard while accepting the fact t ha t the standard can be reached using multiple paths . We look forward to the resolution of this issue in a manner that achieves what, I hope, is a mutual goal.

Sincerely,

~ -Qi~

~ta K1cus, Director Division of Radiation Control and Emergency Management RADDOC: 1241

~~g~~1~ou~~~: PR ~is '1

~,: OOCl~ETED (S'} Fft 3116'1)

US' f~r, Southern California Edison Company ~

23 PARKER STREET *94 OCT 27 p 3 :4 9 ~

IRVINE, CALIFORNIA 92718 WALTEA C. MARSH October 26, 1994 OF F1l,~- r - '.:~' * *. I TELEPHONE MANAGER OF NUCLEAR REGULATORY AFFAIRS 00 *:1\1:*1, I.-: ~- (714) 454-4403 r , '

U.S. Nuclear Regulatory Commission Secretary Attention: Docketing and Services Branch Washington, DC 20555 Gentlemen:

Subject:

Southern California Edison's {Edison's) Comments on Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Publ ic Health and Safety; Draft Statement of Policy

Reference:

59 Federal Register 37269, "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy," July 21, 1994 In the referenced Federal Register, the NRC requested industry comments on the subject Draft Statement of Policy issue. Attached are Edison's comments on the subject Draft Statement of Policy. In general, Edison supports the two core concepts of adequate {necessary to provide a level of protection of 11 11 public health and safety) and "compatibility" (essentially identical with NRC requirements).

However, Edison believes a national program for regulating radiation protection is desirable and wou l d be most effectively implemented by requ1r1ng Agreement States to develop programs that are, for the most part, essentially identica l with those established by the NRC. In addition to those features currently outlined in the draft Policy Statement, Agreement States should also be required to have compatible low-level waste regulatory programs.

Statements in the draft that could be interpreted as the NRC being philosophically opposed to shallow land burial of low-level waste should be deleted or, as a minimum, amended to reiterate that each proposed disposal facility must satisfy the requirements of 10 CFR Part 61. Accordingly, the NRC would evaluate each proposal on an individual basis and provide technical support to the States.

FEB 2 4 1995 Acknowledged by card ......"'"'"""'""'~'~

Document Control Desk If you have any questions or require additional information, please contact Dr. Eric Goldin at (714) 454-4522.

Sincerely, cc: L. J. Callan, Administrator, NRC Region IV A. B. Beach, Director, Division of Reactor Projects, Region IV K. E. Perkins, Jr., Director, Wal nut Creek Field Office, NRC Region IV M. K. Webb, NRC Project Manager, San Onofre Unit 1 M. B. Fields, NRC Project Manager, San Onofre Units 2 and 3 Louis Carson, Regional Project Inspector, San Onofre Unit 1 J. A. Sloan, NRC Senior Resident Inspector, San Onofre Units 2 & 3 S.S. Bajwa, Section Chief, Decommissioning Section

ATTACHMENT ADEQUACY AND COMPATIBILITY FOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFETY; Draft Statement of Policy COMMENTS:

1. Agreement States should also be required to implement compatible low-level waste regulatory programs.

The licensing of low-level waste dis posal facilities is currently heavily influenced by state and local politics and has become a resource-intensive, time consuming, and financially burdensome process with no en d in sight. As part of the national energy policy, the NRC permits commercial nuclear power production and regulates these facilities at a federal level. Without the requirement for essentially identical low-level waste regulatory programs, the potential exists for States to effectively ban commercial nuclear power by prohibiting shallow land burial of low-level waste.

2. Section 0.4.b. "Compatibility Criteria" says that a State may incorporate more stringent requirements provided that ***

"the mo re stringent requirements do not preclude or effectively preclude a practice within the national interest without an adequate public health and safety or environmental basis. 11 The policy should be rephrased to indicate that the NRC, who ultimately is responsible for radiation protection under the Atomic Energy Act, should be responsible for determining the answers to: 1) who makes the determination that the practice is precluded or effectively precluded, 2) who determines whether a practice is in the national interest, or 3) who determines that a safety or environmental analysis is adequate.

With these three questions open, the policy may allow subjective evaluation by the State. This section of the policy is important to the survival of many businesses that rely on the use of radioactive materials.

If the NRC is assigned responsibility for determining the answers, we can at least be ensured of a consistent policy nationwide.

3. Section G.2 should be reworded to state: "The NRC will review low-level waste disposal facilities on a case-by-case basis for satisfaction of the requirements of 10 CFR Part 61. In doing so, the decision of the enforcing regulatory agency and the critical technical review performed will be considered."

As drafted. Ed i son believes Section G.2. "Shallow Land Burial." is inconsistent with Section A. Definitions, criterion #3. Compatible, 11 11 11 11 name ly that Agreement State programs be essentially identical to the dose l imi ts and release limits in 10 CFR Part 20 and Part 61.

Edison disagrees with the statement in G.2: "There is no overriding national interest in allowing shallow land burial of low-level waste." In certain hydrogeological areas, shallow land burial is appropriate and desirable and the most cost-effective technology. The desert regions of the southwest (i.e., Ward Valley, California) provide a shallow burial site that cannot result in significant offsite migration of waste-associated radionuclides.

4. The Policy Statement should include certain clearly defined tests that must be met prior to a State enacting more stringent regulations.

For example, absent data which clearly demonstrate a significant risk that was not previously considered, or significant improvements in the methods for evaluating risk and/or dose, Edison believes States should not amend regulations to be more restrictive. To allow States unlimited flexibility without requiring demonstration of need defeats the goal of a consistent national radiation protection program.

5. Modify the statement in Section G, pg 37274, "More stringent requirements, other than the above mentioned dose limits and radiation protection release limits should be applicable to all classes of licensees in a State," to clearly identify that NRC licensees are under the sole jurisdiction of the NRC.

Without this clarification, State Regulators who are philosophica l ly opposed to nuclear power may seize this opportunity to impose additional unwarranted regulations that are only achievable at unwarranted financial burden.

IJVv~C: I l'lUMOt:H p PROPOSED RULE R M;s u (5,q FR 371.61) @

DOCKETED DOCKETED USHRC US~RC Texas Department -Qf o!il§fllths2 .94 ocr 26 P 4 2

s David R. Smith, M.D. 1100 West 49th Street Carol S. Daniels Commissioner Austin, Texas 78756-:.3lflCE C ~ECRf_[f¥1? Commissioner for Pro rams (512) 458-7111 UtCKEf l G , l i;iVI FI CE~ er. . S_F,_ PF !'.\RY DO ~ Koy 8t({aJJ I 1t.J _. '- c- f:\,' ICF Radiation Control BRAH C Deputy Comm* s** dministration (512) 834-6688 October 19, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555

. ttn: Docketing and Services Branch

Dear Secretary:

Staff members of the Bureau of Radiation Control have reviewed the draft statement of policy titled, "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety" and offer the following comments for consideration.

1. According to the logic of the draft policy statement, it seems unlikely that an NRC region would be found incompatible since the regulations in 10 CFR are utilized by the regions and the regional regulatory framework is mandated by the NRC headquarters office. However, it is possible for a NRC regional office to be inadequate. If the premise of the draft policy statement is to apply the same performance indicators to the NRC regional offices, then such intent should be noted throughout the document. For example, the title of 11.C. addresses the determination of adequacy and compatibility of Agreement States only. Termination of agreements is discussed in 11.D, yet there is no indication of consequences or corrective actions if a NRC regional office is found inadequate.Section III should also address adequate NRC regional materials programs.

2. Although it has previously been pointed out, it should again be stressed that compatibility is not identicaiity. Many Agreement State programs are able to respond to"' changing and emerging technologies in the use of sources of radiation by modifying or developing regulations in a more timely manner than NRC. Also, discovery of recurring radiation protection problems can usually be addressed by rule development, license condition, or enforcement action more. readily by Agreement State programs. This ability to respond in order to be "adequate" should not be jeopardized by the threat of being "incompatible" with NRC regulations that may be inadequate. It is imperative that Agreement State programs and NRC regional materials programs have early and substantive input to rulemaking and the determination of the degree of compatibility for such rules. Steps have been made towards such a cooperative effort and this trend should be encouraged.

If you have any questions concerning these comments, please contact me at (512) 834-6688. Thank you for the opportunity for input.

,fEB 2 4 1995 An Eq11al Employment Opportunity Employer Acknowledged by card ....""'"'"'"'""~

,:.Si*~* *: .,*, :..:c~ii?*,ilvvlON CfX: ' , ,, r..n::,C.,f:: SECTION Orh1..E (1f- TriE ECRETARY Or THE CO AMIS SiON C:;.;um.-:r:t ~'.:tistic-s

DOCKET NUMBER PB ~

PROPOSED RULE /'-1,f u- ~

John Hall, Chairman Pam Reed, Commissioner (sCff(<37Ui} DOJt,_f};D <!_!:/

Peggy Garner, Commissioner Anthony Grigsby, Executive Director

• 94 OCT 24 P4 :16 TEXAS NATURAL RESOURCE CONSERVATION COMMISSION Protecting Texas by Reducing and Preventing Pollution October 20, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Services Branch Re: Draft Statement of Policy regarding Agreement State Prog rams, 59 FR 37269, et seq

Dear Sir or Madam:

These comments are submitted in response to the Nuclear Regulatory Commission's (NRC) Draft Statement of Policy regarding Adequacy and Compatibility for NRC and Agreement state Radiation Programs which was published in the Federal Register on July 21, 1994. The Texas Natural Resource Conservation Commission is the state agency which has jurisdiction over uranium mining facilities and radioactive waste disposal in Texas.

The Draft Statement of Po l icy implies, but does not expressly state, that the NRC will be reviewing low level radioactive waste programs on a case-by-case basis. For instance, on page 37270, the Draft Statement of Policy includes the sentence: "On Ap ril 2, 1993, the Commission directed the staff to develop a compatibility policy for all program areas other than low level radioactive waste" (emphasis added). However, on page 37271, a footnote states that"* . . the Commission is revisiting its earlier decision to review compatibility of Agreement State programs in the low level radioactive waste area on a case-by-case basis." Lt is unclear whether the NRC now intends to use the compatibility po l icy or case-by-case basis in low level radioactive waste reviews. The TNRCC respectfully requests that the final Statement of Policy include clarifying language.

Along the same vein, it is unclear if this Draft Statement of Policy will apply to uranium programs. Previous information and drafts re l eased by the NRC to Agreement state managers has stated that uranium programs will also be reviewed on a case-by-case basis. The TNRCC also respectfully requests that the final Statement of Policy include clarifying language regarding the uranium programs.

jfEB 2 4 1995 Acknowledged by card ..................." ...'""'"

P.O. Box 13087

• Austin, Texas 78711-3087

• 512/ 239-1000 printed on recyded paper using soy-based ink

\V.5. t!L\~ _[ / *:. , '" .. ;_ i (.:i , *t Cv ~.1!i:iiS~iON DOG>: . i*' & S::AV!CE SECTION OrF'CE Ot= PE SECRETARY OF THE COMMISSION Documer.t Statistics Postmark Date / 0 / :2.LJ/1<-/

Copies Received_ _ _ _ L , ._ _ _ __

Add I Copie;; Rwroduced _ 3_ _,,..,,,.......,..- -

tz.y; VS"

Secretary Page 2 October 20 , 1994 Lastly, if the NRC chooses to review low level radioactive waste and/or uranium programs on a case-by-case basis, the TNRCC urges the NRC to publish guidance on how the NRC would review such programs.

We thank you for the opportunity to comment on this Draft Statement of Policy. If you have any questions regarding these comments, please contact Alice Hamilton Rogers, P.E., Manager, Underground Injection Control, Uranium, and Radioactive Waste Section at 512/239-6846.

Sincerely,

• ~~ F~ s~?:~

Industrial and Hazardous Waste Division Xe: Kevin McLeod, TNRCC Legal Richard Ratliff, P.E., Texas Department of Health Marilyn Preusse, TNRCC, UURW Section Bob Doda, NRC Region IV

Federal Register / Vol. 59, No. 139 / Thursday, July 21, 1994 / Notices 37269 Program: This meeting will review 17. Date: August 19, 1994 programs. This action is necessary to Fellowships for College Teachers Time: a*:oo a.m. to 5:30 p.m. clarify the meaning and use of the terms applications in Political Science Room: 315 "adequate" and "compatible" as and Jurisprudence, submitted to the Program: This meeting will review applied to an Agreement State radiation Division of Fellowships and Fellowships for University Teachers control program. This draft policy Seminars,_ for projects beginning applications in American statement would not be intended to i after.June 1, 1995. Literature, submitted to the have the force and-effect of law or

.1. Date: August 12, 1994 Division of Fellowships and binding effect; it is intended as guidance Time: 8:00 a.m. to 5:30 p.m. Seminars, for projects beginning to the Agreement States, NRC staff, and Room: 315 after June 1, 1995. the public to make clear how the

, Program: This meeting will review David Fisher, Commission intends to evaluate the f Fellowships for University Teachers Advisory Committee Management Officer. adequacy and compatibility of NRC and t

• applications in Classical, Medieval, [FR Doc. 94-17691 Filed 7-20-94; 8:45 am) Agreement State programs. Comments f and Renaissance Studies, submitted f, to the Division of Fellowships and BILLING CODE 7536-01-M are solicited on the draft policy statement and specific questions t - Seminars, for projects beginning contained in this notice.

! after June 1, 1995. NATIONAL SCIENCE FOUNDATION DATES: Comments are due on or before t2. Date: August 15, 1994 October 19, 1994.

i. Time: 8:00 a.m. to 5:30 p.m. Notice of Workshop ADDRESSES: Send written comments to Pl am:

fRoom: 315 This meeting will review owships for University Teachers The National Science Foundation (NSF) will hold a one day workshop on August 1, 1994. The Workshop will take Secretary, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Services plications in Romance Languages place at the Foundation, 4201 Wilson Branch. Deliver comments to: 11555 and Literatures, submitted to the

• Boulevard, Arlington, VA 22230. Rockville Pike, Rockville, Maryland, Dh"ision of Fellowships and Sessions will be held from 11 a.m. to between 7:45 am and 4:15 pin on Semina."S, for projects beginning 3:30 p.m. Federal workdays.

_, after June 1, 1995. The goal of the Workshop is to FOR FURTHER INFORMATION CONTACT:

13. Date: August 16, 1994 provide a forum for gathering the views Cardelia Maupin, State Agreements

• . Time: 8:00 a.m. to 5:30 p.m. of leaders in the higher education Program, Office of State Programs, U.S .

ZRoom: 315 community on the present condition of Nuclear Regulatory Commissfon,

• Program: This meeting will review undergraduate education in science, Washington, DC 20555, telephone (301)

~ _Fellowships for University Teachers mathematics, engineering and 504-2312.

applications in Political Science, technology, and obtain advice about SUPPLEMENTARY INFORMATIOH:

f.:_: Law, and Jurisprudence, submitted how to improve it

-.-_ 'to the Division of Fellowships and The Workshop will not operate as an Table of Contents Seminars, for projects beginning advisory committee. It will be open to I. Background t

• after June 1, 1995. the public. Participants will include Results of Discussions with Various

14. Date: August 16, 1994 approximately 15 leaders in science, Groups mathematics and engineering education. A. States,11 .

"_ Time: 8:00 a.m. to 5:30 p.m. B. Regulated Community For additional information, contact Pl am:

' Room: 415 This meeting will review owships for College Teachers Dr. Robert,Watson, Director, Di~sion of _

Undergraduate Education, 4201 Wilson C. Environmental Group II. Discussion A. Adequate plications in Religious Studies, Boulevard, Arlington, VA 22230, (703) B. Compatibility submitted to the Division of 306-1666. C. Compatibility and Adequacy Fellowships and Seminars, for Dated: July 15, 1994. Determination of Agreement States projects beginning after June 1, Dr. Robert F. Watson, D. Termination of Agreements 1995. - E. Specific Questions for Public Comment Di\'ision Director, Undergraduate Education. III. Policy Statement

5. Date: August 18, 1994 {FR Doc. 94-17727 Filed 7-20-94; 8:45 am] A. Definitions Time: 8:00 a.m. to 5:30 p.m. BILLING CODE 7555-C1-M B. Elements of an Adequate Program Room: 31{> C. Elements c;,f a Compatible Program Program: This meeting will review D. Compatibility Criteria

• Fellowships for University Teachers NUCLEAR REGULATORY E. Implementation _

applications in Religious Studies, COMMISSION . F. Examples for the Compatibility Criteria G. Examples of More Stringent submitted to the Division of Requirements Fellowships and Seminars, for Adequacy and Compatibility for NR~

IV. Paperwork Reduction Act Statement projects beginning after June 1, and Agreement State Radiation Control . ,

e:, 1995. Programs Necessary to Protect Public I. Background

6. Date: August 18, 1994 Health and Safety; Draft Statement of The terms "compatible" and Time: 8:00 a.m. to 5:30 p.m, Polley "adequate" constitute core concepts in Room: 415 AGENCY: Nuclear Regulatory the Commission's Agreement State Program: This meeting will review Commission. program under Section 274 of the

;_Fellowships for College Teachers ACTION: Draft statement of policy. Atomic Energy Act (AEA) of 1954, as

. applications in Classical, and . . . amended, in 1959. Subsection 274d.

Medieval Studies, submitted to the

SUMMARY

The Nuclear Regulatory states that the Commission shall enter

'. Division of Fellowships and Commission is revising its general into an Agreement under subsection b.,

' Seminars, for projects beginning statement of policy regarding the review discontinuing NRC's regulatory

• after June 1, 1995.

• of Agreement State radiation control authority over certain mateii~s in a

. . .., , . . . . -.J .n~uc1eu L\.t:giSter , vol. 5~. No. 139 / Thursday, July 21, 1994 / Notices

'* State, if the State's program is both working group was formed and a draft Agreement State p1ograms is only_

adequate to protect public health and issues paper was developed. The draft applied to program elements in terms of safety and compatible '"-ith the issues paper was discussed *with the their direct or indirect bearing on public Commission's regulatory program. Agreement States in a public meeting in health and safety and compatibility is Subsection 274g. authorizes and directs May 1993 and draft options, SECY only applied to the degree of conformity the Commission.to cooperate with the 290, were discussed in October 1993 at between State regulations and NRC's States in the formulation of standards to the All Agreement States Meeting. The regulations. However, staff believes that assure that State and Commission Agreement and n on-Agreement States, some regulations should be a matter of standards will be coordinated and the regulated community and the adequacy to protect public health and

" compatible." Subsection 274(j)(1) general public participated in a public safety and some program elements requires the Commission to periodically workshop on the final issues paper in should be a matter of compatibility. fa review the Agreements and actiops July 1993. order to fully understand this concept,

. taken by the States under the the relationship between adequacy and Agreements to ensure compliance with Results of Discussions With Various compatibility must be examined.

• the provisions of section 27 4. Although Groups Section 274 of the Atomic Energy Act the terms "compatible" and "adequate" A. States requires that Agreement State programs are fundamental requirements in the be both "adequate to protect the public The States would like to see a health and safety" and '.'compatible Agreement State program under Section minimum number of requirements for 274 of the AEA, these terms are not v.-ith the Commission's program." Thus, compatibility determinations. From the under the proposed compatibility defined in the Act. Neither has the Commission provided a formal comments at the July 1993 public policy, these separate findings must be workshop and during the October 1993 based on consideration of two different definition or formal comprehensive guidance on how the terms should be All Agreement States Meeting in Tempe, objectives; first, providing for an interpreted in implementing Section Arizona, the following positions, though acceptable level of prote-ctlon for public 274. The guiding concept over the years not a formal consensus, emerged: health and safety in an Agreement State The States are in favor of: (the "adequacy" component), and since the beginning of the Agreement i. uniformity of requirements that are State program in the area of second, providing for the overall necessary to assure interstate compatibility has been to encourage national interest in radiation protection, commerce, i.e., labels, signs and uniformity to the maximum extent (the "compatibility" component). An symbols. * * "adequate" program, including practicab_le while allowing flexibility, 2. uniformity of radiation standards where possible, to accommodate local necessary to protect public health and regulations or other legally binding regulatory concerns. This concept has measures (e.g., license conditions) and safety. However, States want the been implemented in case-by-case flexibility to set stricter dose limits ... program elements (e.g., organization and decisions by the Commission and in when local conditions warrant them. resources) should consist of those internal procedures developed by the 3. early and substantive involvement in the attributes considered necessary by the staff to assign designations of degrees of deliberations on the devefopmenr of Commission to maintain an acceptable "compatibility" (i.e. uniformity), from regulations. level of protection of the public health "essentially verbatim" to "no degree of and safety within the Agreement St&te.

unif!=)rmity required," to sections of the B. Regulated Community A "compatible" program, including Commission's regulations. More The regulated community desires radiation protection standards and othe1 recently, the Com!l'.'Jssion has attempted strict adherence to uniform national program elements, should consist of to involve the States earlier in the radiation standards so that.licensees those attributes considered necessary by prqcess of developing new regulations meet the same standards in all States the Commission to meet a larger

. and determining what level of . and will not be subject to different ~ national interest in_radiation protection.

compatibility" (i.e. uniformity) will be regulations in different States. The requirements for adequacy would required of the Agreement States. focus on the protection of public h f'.altb The Commission's approach to C. Environmental Group and safety within a particu!ar State, making compatibility determinations An environmental advocacy group whereas the requirements for has evoh*ed slowly over the life of the indicated that Federal and State compatibility would focus on the

, Agreement State program. At the same regulations should be the minimum extraterritorial effect of State action or time, since 1962, the Agreement State requirements with the proviso that inaction either on other States or on the

. program has expanded and developed communities may have the flexibility to national program for radiation significantly both in the number of go beyond those regulations. protection. As a basis for detennining Agreement States, as well as depth of In the formulation of this draft policy what ultimately will be required for experience and expertise of State statement, the staff has carefully compatibility, the Commission must regulators. T o clarify the matter of considered the views of the Agreement first identify what is necessary for a compatibility, the Commission has States, the regulated community, the State program to be "adequate."

directed the staff to develop a enviro~ental group and other comprehensive interpretation and members of the public.

A.Adequate application of com patibility. Under the draft policy, "adequate;,;

On April 2, 199 3, the Commission II. Discussion would focus on those elements of a directed the staff to develop a The question posed*by the current State program that are necessary to compatibility policy for all program task to develop a compatibility,policy provide a level of protection of the areas other than low level radioactive centers on making a determination of public health &lld safety within the State waste. While developing the policy, the what components or elements of a State that is eduivalent to, = t e r than. that staffparticipated in discussions with radiation control program are needed

• provide by the NRC atory ,

1 the Agreement States, the non- beyond those which establish and program for its licensees. The Agreement States, the regulated - maintain an adequate radiation control requirements for ~*adequate" would n~t community, and the general public. A *program. Presently, adequacy of .

• require that _NRC regulations or other

Federal Register { _Vol. 59, No. 139 / Thursday, July 21, 1994 / Notices 37271 program elements be incorporated in an performance indicators in NRC region E. Specific Questions for Public essentially identical manner. Under the and Agreement State reviews. The staff .Comm*e nt adequate provision, States would also is currently implementing a_pilot

• In responding to this notice, the be allowed to establish requirements program on the common performance following questions should be through measures other than indicators program. The current

• specifically addressed along with any regulations; such as license conditions. proposed common performance additional comments.

B. (!ompatibility indicators program contemplates using a 1. Under what circumstances should Man~gement Review Board (MRB) to Agreement States b~ permitted to

• The "compatibility" requirement make th~ decision on the adequacy of establish more stringent requirements, would focus on those elements of a existing Agreement State programs. The for their licensees, than those State program which would be required

• initial adequacy determination of a established by the Commission? Should to be essentially identical with the NRC proposed new Agreement State program this also include the ability to establish regulatory framework.in order to stricter dose limits for particular classes will be made by the Office of State achieve a larger national interest beyond of licensees?

Programs, rather than the MRB, because that required for adequate protection of 2. Are the four criteria in the the public health and safety within the the adequacy of a proposed new*

program is not dependent on proposed policy statement for State. The draft policy establishes four determining whether a Commission criteria I that the NRC would use to effectiveness of actual program irp.plementation. The staff plans to regulation or other program element determine which elements of the NRC should be adopted in a manner I regulatory program, including specific follow this same split of responsibilities 1¥ essentially identical by the Agreement NRC regulations, that the State would be for the compatibility determination of States sufficient to ensure protection of required to incorporate in an essentially an Agreement State program, with the the national interest in radiation identical manner into its regulatory MRB making the compatibility protection? What examples could be program. The dose limits and radiation* determinations for existing Agreement used to illustrate how each criterion rotection re ate re ease imits

• 10 State programs, and the Office of State Programs making the initial would be applied?

CFR Part 20 and 1 0 CFR Part 61 3. What are some examples of State a p icafile toall licensees, or any compatibility determinations for action to establish stricter requirements su seguent amfil}dments ere o, or proposed new programs. The initial than those established by the other NRC regulations which are - <' adequacy ani:l compatibility Commission, or establish requirements requirml.""1C>be esse11 a Y. 1 ent1 cal for determinations for proposed new where the NRC has not?

compatibi1ity pu..-poses will Agreement State programs are reviewed 4. What limits, if any, should be automaticall be g,l-!ire.d to.be and approved by the Commission. placed on the power of a State to identical. 2 States will nothave the Indicators of compatibility will also be preclude or, by exceptionally stringent flexibi 'ty to deviate from the program developed by the staff. regulations, effectively preclude a elements that the Commission requires particular practice?

for compatibility. D. Termination of Agreements

5. Are there any other dose or C. Compatibility and Adequacy Termination of an Agreement can radiation-protection related release Determination of Agreem_e nt States n ~ occur when an Agreement State limits in the Commission's regulations

' program is either inadequate or which should be included under the The staff has developed a criterion number 3 of the compatibility management directive for the use of incompatible. The proposed MRB, reviewing discrete common criteria? Should the dose limits common performance indicators in contained in 10 CFR Part 61 be included review of the Agreement States and performance indicators, would judge the overall adequacy of an Agreement State under this criterion?

regiopal materials program. The 6 Should the draft ade uac and development of the common program. Similarly, the MRB would review discrete "compatibility com atibilit olic stateme t be performance indicators for the app ica e to the re ulation of low-level evaluation of Agreement States and the indicators" and determine the overall compatibility of an Agreement State was e 1s osa mstea o continuing to NRC regional offices will be directly cons1 er questions of c;:om atibilit in related to adequacy requirements for program. For either of the adequacy or compatibility determination, failure to is area on a case* -case a s.

Agreement State programs, and Are there currently areas or consequently, will need to be closely satisfy an individual indicator may not necessarily result in an overall finding situations in Agreement State coordinated with the staff efforts to regulations or other Agreement State define the elements of an adequate State of inadequacy or incompatibility. In requirements that would not meet the program. In January 1994, the staff some situations, individual indicator proposed policy statement?

provided to the Commission a paper weakness(es) could result in a 8. Should States be permitted to further describing the use of common "marginal" finding by the MRB calling establish more stringent standards for for Agreement State improvements and radiation-protection related release 1 The compatibility criteria are specified in the State program may be placed on limits?

Section lll.D, below. probation. In extreme cases, indiGator(s) 2 In issuing this Draft Policy Statement for faih.u*~ could lead to inadequate or III. Policy Statement comment, the Commission Is revisiting its earlier decision to review compatibility or Agreement State incompatible findings resulting in the The purpose of this Policy Statement programs In the low level radioactive waste area on initiation of program suspension or is to provide a comprehensive a case-by-case basis. The Commission based its earlier decision on a belief that such case-by-case termination. In terms of the inten,retation and application of the

~nsideration could best address the special compatibility evaluation, the terms "adequate" and "compatible" as circumstances that confront Agreement States in significance of performance indicator they apply to the NRC Agreement State that area. Using the case-by-case approach. the "incompatibility" in an individual State regulatory programs.

Commission bas determined that the low level radioactive wute regulations or Pennsylvania and will be judged on the basis of the impact The terms "compatible" and Illinois are compatible. on the national program. "adequate" constitute core concepts in

37272 Federal Register / Vol. 59, No. 139 / Thursday, July 21, 1994 / Notices the Commission's Agreement State 4. A Compatible Agreement State purposes, an Agreement State program program under Section 274 of tho Program shall adopt regulations or other legally Atomic Energy Act (AEA) of 1954, as A regulatory program *containing binding measures, equivalent to, or amended, in 1959. Subsection 274d. elements considered necessary by tho more stringent than, those designated by states thatthe Commission shall enter Commission to effectively implement theNRC.

into an Agreement under subsection b., the tem1 "compatible" as defined above. 3. Inspection discontinuing NRG's regulatory authority over certain materials in a 5. Element The State regulatory program shall State, if the State's program is both "Element" or "'program element" is provide for the inspection of the adequate to protect public health and used to describe any of the essential possession and use of radioactive safety and compatible with the components and functions of a radiaU.on materials by the regulatory authority.

Commission's regulatory program. protection regulatory f. rogram. The term The State inspection of licensw Subsection 274g. authorizes and directs includes any aspect o a radiation facilities, equipment, procedures and the Commission to cooperate with the protection regulatory program that is use of materials shall provide States.in the formulation of standards to necessary to implement a program that reasonable assurance that the public assure that State and Commission is adequate to protect public health and health and safety is being protected.

standards will be coordinated and safety and is compatible with the NRC Inspection and testing shall be "compatible." Subsection 274j(1) regulatory program. T_he term "element" conducted to assist in determining requires the Commission to periodically may include organizational structure, compliance with regulatory review the Agreements and actions staffing level, inspection frequency, requirements. Frequency of inspection taken by the States under the regulations, policies and procedures or shall oo related directly to the hazards Agreements to insure compliance with any other component or function that associated with amount and kind of the provisions of section 274. the Commission considers necessary. material and type of operation licensed.

The minimum inspection frequency, A. Definitions 6. Practice including initial inspections, shall be no For the purpose of evaluating the The term *,.practice" describes a use, less than the NRC inspection frequency.

procedure or activity associated '".;th An adequate inspection program adequacy of Agreement State regulatory programs to protect public health and the application, possession, storage or includes: preparation and use of safety, the following terms are defined: disposal of byproduct, source and procedures and policy memoranda to special nuclear materials. The term assure technical quality in the

1. Adequate "practice" is very broad and inspection program and review of encompassing in nature. For example,

• inspection actions by senior staff or The acceptable level of protection for supervisors. The inspection staff the term "practice," as applied in the the public health and safety from the policy statement, not only applies to technical expertise should be similar to radiation hazards associated with the very general activities involving NRC staff qualifications; use of byproduct, source, and special radioactive materials such as industrial 4. Enforcement Program nuclear materials. radiography, low-level waste disposal, nuclear medicine procedures, and well Licensee noncompliance with

2. An Adequate Agreement State logging, but also includes s~fic requirements necessary for the safe Program possession and use of radioactive activities conducted within these very An effElClively implemented broad activities, such as shallow land materials shall be subject to * .

regulatory program containing elements burial, sanitary sewerage disposal, and

• enforcement through legal sanctions, considered necessary by the incineration of materials, iJI and the regulatory authority shall be Commission to provide an acceptable authorized by law with the necessary level of protection for the public health 7. Radiation Protection Standards powers for prompt enforcement.

and safety from the radiation hazards As used in ~is Policy Statement, the 5. Staffing and Personnel Qualifications

<1ssociated with the use of byproduct, term *"radiation protection standards" source, and special nuclear materials. means dose limits arid radiation- - The regulatory agency shall be protection* related release limits in 10 sufficiently staffed with an adequate

3. Compatible number of qualified personnel to CFRPart 20 and 10 CFRPart 61 applicable to all licensees, or any implement the radiation control The consistency between NRG and program effectively. Agreement State Agreement State regulatory programs subsequent amendments thereto.

staff shall be qualified using criteria no which is needed for the regulation of B. Elements of an Adequate Program less stringent than criteria used for NRG byproduct, source and special nuclear staff.

material which assures an orderly and 1. Protection effective regulatory pattern in the * -The Agreement State program s~all be 6. Administrative Procedures administration of the national radiation designed and administered to protect State practices for,assuring the protection program; Compatibility shall the public health and safety of its effective administration of the radiation be aimed at ensuring that interstate citizens against radiation hazards. control program, including provisions commerce is not impeded, that effective 2. Regulations for public participation where .

communication in the radiation , appropriate, shall be incorporated in protection field is maintained, that dose Except for dose limits and radiation- procedures for:

limits and radiation-protection related protection related release limits in 10 (a) Formulation of rules of general rel~se limits applicable to all licensees CFR Part 20 and 10 CFR Part 61 applicability; .

are maintained, and that information applicable to all licensees, or any (b) Approving or denying applications needed for the study of trends in* subsequent amendments thereto; or for licenses authorizing the possession radiation protection an~ other national other regulations which are required to* , and use of radioactive materials; and program needs is obt$ied. . be essentially identical for compatibility (c) Taking enforcement actions.- * *

• C FI I

Federal Register /. VoJ. 59, No. 139 / Thursday. July 21,* 1994 / Notices

7. Statutes 2. Uniform Manifest 1. avoids a significant burden on State statutes and/or duly State regulatory programs shall interstate commen:e; promulgated regulations shall be 2. ensures clear communication on establish a manifest system in established to authorize the State to fundamental radiation protection accordance with 10 CFR Part 20.

carry out the requirements under terminology:

3. Transportation Regulations

• 3. ensures the establishment of the Section 274b of the Atomic Energy Act, as amended and any other statutes as dose limits and radiation-protection*

State regulations regarding related release limits in 10 CFR Part 20 appropriate, such as Public Law 95-604, transportation of radioactive materials Uranium MiU Tailings Radiation

• and 10 CFR Part 61 applicable to all must be identical or essentially verbatim licensees; or any subsequent Control Act (UMTRCA). with those in 10 CFR Part 71. amendments thereto;

a. Laboratory Support 4.EventReporting 4. assists the Commission in The State. shall have available evaluating the effectiveness of the The State regulatory program shall overall national program for radiation calibrated *field and laboratory require licensee reporting in a manner instrumentation sufficient to protection.

• so that information on identical type . If none of the above criteria is met, the independently determine the licensee's events is consistent with the reporting control of materials, to validate the State would have the flexibility to established by the NRC. This design its own program including licensee's measurements, and to information shall be provided to the respond to events involving radioactive NRC.

• incorporating more stringent 3 material. requirements provided that: .

5. Reciprocity a. the requirements for adequacy are

9. Licensing still met; and

• The State regulatory program s~all b. the more stringent requirements do he State regulatory program review have reciprocal recognition of out-of-cense applications for the purpose not preclude or effectively. preclude a State licensees and Federal licensees practice within the national interest

• valuating the applicant's through a process which authorizes the qualifications, facilities, equipment, without an adequate public health and safe cqpduct of similar operations safety or envirqnmen.t al basis.

procedures and use of materials shall within the Agreement State.

provide reasonable assurance that the E. Implementation public health and safety are being 6. \9cords and !teports Notwithstanding the provisions protected. An adequate lice_nsing The State regulatory program shall ab-ave, the Agreement States shall program includes: p~paration and use require that holders and users of exercise their regulatory authority in a of licensing guides and policy radioactive materials (a) maintain responsible manner and shall nqt adopt memoranda to assµre technical quality records covering personnel radiatiop-- more stringent regulations or in the licensing program and review of exposures, radiation surveys and requirements as a means to bar or licensing actions by senior staff or disposal of materials, (b) keep records of preclude a practice.without an adequate supervisors. In addition, procedures the receipt and transfer of the material, safety or environmental basis, or bar a involving the licensing of products (c) maintain reports of significant practice needed in the national interest.

containing radioactive material require a high degree of uniformity with those of the NRC. The review staff incidents involving radioactive intended for interstate commerce should materials.

7. Radiation Protection Terminology In order to permit the NRC to provide early coordination and oversight of any proposed more stringent regulations or requirements, NRC will request technical expertise should be similar to The State regulatory program shall Agreement States t? identify any sue~

NRC staff qualifications. adopt fundamental radiation protection regulations or reqwrements and provide

- - Investigation (Response to Events) terminology in a manner essentially opportunity for NRC review before identical to NRC definition of these publication as a draft rule for comment The State regulatory program shall terms to ensure clear communication or before the institution of the provide for timely and effective about radiation protection. Some investigation of incidents, reportable requirement as a legally binding examples of these terms are "byproduct measure.

events, allegations and any potential material;" "total effective dose wrongdoing. equivalent;" "sievert;" "gray;" and F. Examples 4 for the Compatibility "becquerel." Criteria'

11. Budget The State radiation control program 8. Radiation Protection Standards 1. Avoids a Significant Burden on (RCP) shall have.adequate budgetary Interstate Commerce The State regulatory program shall support to implement an effective adopt dose limits and radiation- -The adoption of transportation program. The total RCP budget must protection related release limits in 10 requirements for all Agreement States provide adequate funds for salaries, CFR Part 20, and 10 CFR Part 61 should be essentially identical to training, travel costs associated with the applicable to all licensees, or. any assure that the flow of radioactive compliance program, laboratory and subsequent amendments thereto. materials in or through another survey instrumentation and other equipment, contract services, and other D. Compatibility Criteria 3 Local governmental entities are not usually administrative costs. authorized by the NRC_under Section Z74 to The following criteria shall be applied regulate radiological safety. Thus, with limited C. Elements of a Compatible Program to program elements and regulations to exception. the authority to set more stri~~ent determine whether they must be requirements would not extend to localities unless

1. Radiation Labels, Signs, and Symbols adopted by Agreement States in a approved by the Commission through a Section 27 -4 Agreement.

States must have radiation labels, manner essentially identical to that of

• The examples are not part of the Policy signs and symbols identical to that of the NRC for the purposes of Statement and are neither exhaustive nor the national standard. compatibility: controlling.

37274 Federal Register / Vol. 59, No. 139 / Thursday, Ju!Y 21, 1994 / Notices jurisdiction is not impeded. For and 10 CFR Part 61 applicable to all requirements in 10 CFR 34 do not meet example, if States were allowed to licensees, or any subsequent any of the four compatible criteria.)

change 10 CTR 71.47, "External amendments thereto, then a State IV. Pap.erwork Reduction Act Radiation Standards for all Packages" should generally have the flexibility to Statement then it would be very difficult to tailor its program. More stringent transport radioactive material requirements, other than the above This draft statement of policy does packages. mentioned dose limits and radiation- not contain a new or amended protection release limits could be information collection requirement

2. Ensures Clear Communication on subject to the Paperwork Reduction Act Fundamental Radiation Protection applicable to all classes of licensees in a State. For example, an Agreement of 1980 (434 U.S.C. 3501 et seq.).

Terminology Existing requirements were approved by State's record.keeping provisions for all

-The definition of the terms "sievert" licel)ses could be more stringent than the Office of Management and Budget, and "gray" (or "rem," "rad") v,rould NRC's. Other examples of State actions approval number 3150--0029.

need to be adopted essentially . . . which impose stricter requirements than Dated at Rockville, Maryland, this 15th day identically by all Agreement States. NRC regulations, and which would be of July, 1994.

3. Ensures the Establishment of Dose "adequate" under the draft policy For the Nude~ Regulatory Commission.

Limits and Radiation-Protection Related statement, are-- John C. Hoyle, Release Limits in 10 CFR Pait 20 and 10 1. State of Florida-20.304 Actin& Secretary of the Commission.

CFR Part 61 Applicable to all Licensees,. (FR Doc. 94-17n8 Filed 7-20-94; 8:45 cm) or Any Subsequent Amendments Between 1957 and 1981, several State BILLING CODE 7$90-01...P Thereto representatives expressed concern to the

-The basic dose limits and radiation- Commission over the risk from burials protection related release limits for all of radioactive waste allowed by 10 CFR [DocketNos.50-424-0LA-3;50-425-0LA-j classes of licensees set forth in 20.304, that was in effect at that time.

This regulation, "Standards for 3; Re: License Amendment {Transfer to Southern Nuclea~ ASLBP No.96-671 Subpart C, "Occupational Dose 0LA-3) t Limits," and Subpart D, "Radiation Protection Against Radiation; Buri;il of Dose Limits for Individual Members Small Quantities of Radionuclides" Georgia Power Company, et al. (Vogtle of the Public," of 10 CFR Part 20 provided that licensees.c;puld bury I

Electric Generating Plant, Units 1 and would need to be adopted essentially small quantities of radionuclides 2); Notice (Prehearlng Conference) identical by all Agreement States without prior NRC approval. The State

• along with any other subsequent of Florida submitted a request to the Atomic Safety and Licensing Board; Before amendments to 10 CFR Part 20 that NRC to be more stringent by precluding Administrative Judges: Peter B. Bloch, Chair, may set forth dose limits. 10 CFR Part this practice within the State because of Dr. James H. Can,enter, Thomas D. Murphy.

61.41, "Protection of general its high ground water level. The State's Pursuant to 10 CFR 2.752, we v.*iH population from releases of exemption request was reviewed and* hold a public prehearing conference radioactivity" and 10 CFR Part 61.43, approved by the NRC. from 10 am witil about noon on July 29 "Protection of individuals during 2. Shallow Land Burial at the Hearing Room, Two White Flint operations" would also need to be North, 11545 Rockville Pike, Rockville, adopted essentially identically by all Several States ~rohibit the practice of Maryland. The purpose of the Agreement States. shallow land bunal of low-level waste. conference will be to discuss contested These more s~ngent regulations would .a motions, if any, and for case

4. Assists the Commission in Evaluating be allowed under the draft policy management.

the Effectiveness of the Overall Natiodal statement even though a practice is Program for Radiation Protection For the Atomic Safety and Licensing prohibited. There is no overriding Board.

-The adoption of 10 CFR 35.33, national interest in allowing shallow "Notifications, reports, and records of Peter B. Bloch, land burial oflow-level waste. A misadministrations" would be different !8Sult would likely be obtained Chair.

adopted by the Agreement States in a if disposal of low-level waste altogether IFR Doc. 94-17729 l:iled 7-20-94; 8:45 a.":l]

manner essentially identical to that of was prohibited, unless the State was BILLING CODE 7590-01-M the NRC. able to convince NRC of special public G. Examples s of More Stringent health and safety or environmental basis [Docket No. 03M2278; license No. 24-Requirements

• for this action. 00513-32 EA 94-113}

I As noted above, if the State program 3. Texas Industrial Radiography The Curators of the University of t

• is equivalent to, or more stringent than, Certification*

Missouri-Columbia, Columbia, 1,, NRC's program to assure the protection* Texas bas established a prog!'am for Missouri; Confirmatory Order I

of the public health and safety, and it r' I incorporates all the elements of the NRC program identified by the Commission the certification of industrial radiography that is more rigorous than Modifying License (Effective Immediately)

Commission requirements. This as necessary to achieve the national program requires persons to perform I interest in radiation protection, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of on-the-job training, . The Curators of the University of including ~e requirement to a.stablish complete 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom Misso.uri-Columbia (Licensee) is the re~lations which are uniform with the instruction and successfully complete bolder ofNRC License No. 24-00513-32 dos~ limits. and radiation-protection i.ssued by the Nuclear Regulatory .

related release limits in 10 CFR Part 20 an examination before receiving authorization to conduct radiographic Commission (NRC or Commission)

'The examples are*nol pert of lbe Policy services with radioactive materials. pursuant to 10 CFR Parts 30 and 35. The Statement and are neilher exhausti\'e nor (This example is based on the license authorizes the Licensee to controlling. assumption that the training conduct research and development,

(j)

OF Fl Ct 01 ..;E(:r,t::-;:,,RY DOC KCL T1 ,.., ' ' c' '! e r H. A. Caves 'r./... Eugene-Crump *L Chairman Executi~ ij;/i:atp[ , ,General Counsel October 19, 1994 Secretary U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Atten: Docketing and Services Branch RE: Adequacy and Compatibility for NRCs and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy.

Dear Sir /Madam:

Enclosed are my comments as Executive Director of the Central Interstate Low-Level Radioactive Waste Commission regarding your request for comments addressing "agreement states" adequacy and compatibility issues.

These comments are not responses by the individual member states of the Commission and do not reflect state policy. Thank you for the opportunity to provide comments for your record.

Question 1:

The Federal Law and supportive federal regulations pertaining to the disposal of low-level radioactive waste provide safe and scientific levels of protection and reduction/ minimization of potential harm . These limits or standards provide the foundation for the national protection of the environment and the people who live near or work at the respective disposal facility.

"Agreement States" agreed to follow the federal law and regulations adopted by the respective federal agency having regulatory authority of low-level radioactive waste. There can and will be circumstances where it is beneficial to the "agreement state" to consider more stringent requirements for localized health and safety considerations that are unique or desirable to their particular situation. In the joint federal/ state regulatory process, (Agreement State status) deviations by "agreement states" from the federal guide lines/requirements should be accomplished only after the respective federal agency determines that the degree of deviation (stringentness) is not in fact a iFEB 2 4 1995 233 South 13th Street

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Comments to NRC October 19, 1994 Page2 vehicle or policy to effectively ban or prohibit the action or activity under the label of being more stringent.

Just as agreement states are required to achieve certain levels of compatibility consistent with federal regulations, the appropriate federal regulatory body should review, critique and approve the deviations from compatibility (in both the spirit and letter of the law) by the agreement state before they are adopted and implemented. Consistent with the Utah example, no rule that the agreement state adopts for the purpose of the state assuming responsibilities from the United States Nuclear Regulatory Commission with respect to regulation of sources of ionizing radiation may be more stringent than the corresponding federal regulations which address the same circumstances. In adopting those rules, the state may incorporate corresponding federal regulations by reference. The state may adopt rules more stringent than corresponding federal regulations only if it makes a written finding after public comment and hearing and based on evidence in the record that corresponding federal regulations are not adequate to protect public health and the environment of the state. Those findings shall be accompanied by an opinion referring to and evaluating the public health and environmental information and studies contained in the record which form the basis for the state's conclusion.

The respective federal agency should be required to "sign off" on all deviations from compatibility so as to permit necessary deviations, while maintaining the overall national goal of health and safety protection for essentially the same source term material.

Great care should be exercised by the NRC in permitting "agreement states" the ability to establish stricter dose limits for particular classes of licensees.

Examples should be given by the respective "agreement state" for the need to establish stricter dose limits for particular classes of licenses in order to insure or maintain reasonable state regulatory oversight. Localized tailored dose limits with reasonable and necessary distinctions from the federal limits would enhance state authority to immediately and locally respond to health and safety demands for isolation and segregation of radioactive emissions.

Again, this "stricter" dose limits for state licensees should not be contrary to the federal policy and not prohibitive or exclusionary in operation to the regulated activity and licensee.

Question No. 2. Yes, the four criteria in the proposed policy statement for determining whether Commission regulation or other program element should be adopted in a manner essentially identical by the agreement states is sufficient to insure compliance with the national interest of radiation isolation and protection. With that being said, the NRC must work harder in

Comments to NRC October 19, 1994 Page3 ensuring that those proposed policy statements do, in fact, become operative in spirit and in implementation by the respective agreement states in order to achieve the national goal of health and safety protection for low-level radioactive waste disposal. This would allow agreement states the necessary leeway and flexibility to meet the goals, standards, and requirements with local regulatory attention to enforcement.

I would not offer examples other than to say that the discussion and analysis provided thus far in the proposed criteria appear to be reasoned, cogent and well thought out.

Question 3: I would prefer to let the respective "agreement states" illustrate their examples of "stricter requirements" and their rationale and jurisdiction for the need and necessity for "stricter requirements". I would also hope that the respective agreement states in their justification for the need for "stricter requirements" identify the objective to be achieved through the application of stricter measures. This would permit the NRC the flexibility to observe, review, evaluate and approve the stricter requirement for particularized and localized needs.

Question 4: As always, the national policy and the state policy should be the elimination or minimization of harm to the environment or the people who could realistically or potentially be subjected to radiation releases. There is no exception as is the case with "non-agreement states" from federal law and regulations thereby requiring that those states radiation activity be governed by and regulated by the national law and appropriate regulation. Those states that have "agreed" to regulate in place of the NRC (with "NRC regulations" in state law) should be held to a strict scrutiny standard as to the reason and rationale for their deviation from national law and regulations. Since "Agreement states" have agreed to follow federal law and regulation pursuant to their acceptance of "agreement state" status, the federal government should be in the same position of "agreeing" to or accepting necessary and desirable state deviation from health and safety standards rationally developed and nationally implemented.

If the respective agreement states make a good case for their deviation (level of strictness) that does not negatively impact national policy, irrationally or unreasonably prohibit or preclude a particular practice or activity, they should expect concurrence from the NRC and permission to deviate. If the goal of the agreement state is to be a willing partner in the regulated activity that they have chosen to administer, they should do so in good faith and be prepared to justify by request their rationale for this deviation and after review and approval from the NRC carry out their activity.

Comments to NRC October 19, 1994 Page4 The standard of review by the NRC should be: a) does this deviation enhance health and safety consideration; b) does this deviation assist the "agreement state" in their responsibility to minimize harm; and c) does this deviation operate to prohibit or impede licensee from their ability to get a license or operate the disposal facility with that license?

Question 5: Other necessary dose or regulated release limits are covered by criterion 1 under the compatibility criteria in that compatibility is required because of interstate commerce, or, in the case of wastes, multi-state compacts.

Dose limits contained in 10 CFR Part 61 should be included under criteria 3, in that 10 CFR Part 61.43 refers directly to 10 CFR Part 20, and these are the standards that NRC has established to ensure public health and safety and protection of the environment.

The performance objectives of 10 CFR Part 61.41 are hypothetical "worst case scenarios", with limits on exposure to the public required to be both conservative and bounding. Furthermore, the regulation also requires "reasonable effort" to keep actual releases as low as it is reasonably achievable, within the guidelines of staying under the dose limits. This requirement should be adequate to satisfy stringency concerns, yet still give some flexibility to administration of the regulations on a more local basis.

Question 6: The NRC should not be unnecessarily rigid and inflexible in implementing national low-level radioactive waste policy and their regulations for health and safety protection. The various nuances and rationale suggested by agreement states for deviations from compatibility should be reviewed in good faith by the NRC. The NRC should enhance communication and oversight with the agreement states through meaningful compliance checks and audits as both the NRC and the agreement states seek to provide environmental protection and health and safety standards for the populous and affected workers. However, such deviation should receive the explicit review and approval (on a case by case basis) of the NRC to ensure observance and compatibility with foundational or fundamental standards of health and safety protection. If in the determination of the NRC that such deviation does not enhance or maintain health and safety considerations or to the contrary, impede disposal progress or effectively inhibit or prevent safe and proper disposal, then such deviation should not be approved or allowed to occur.

The success of the "agreement state" program is the joint federal and state enforcement and protection of the public health and safety. The "agreement" by the respective states is to work with the federal government to achieve low-level radioactive waste reduction and safe disposal. Case by case analysis should not be viewed by the states as unwarranted or an unreasonable federal

Comments to NRC October 19, 1994 Pages intrusion into state activities, but rather an acceptance and coordination of joint responsibilities to achieve meaningful and rational levels of public safety.

Question 7: According to the NRC document "Appendix A. Categorization of NRC Rules by Compatibility Type", Division I compatibility requires language to be identical. Included in Division I are definitions listed in 10 CFR Part 61.2. Definition differences are apparent with Nebraska regulations, both in the Department of Health Title 180 (Control of Radiation), Chapter 12 regulations relating to disposal; and the Department of Environmental Quality Title 194 (disposal of low-level radioactive waste) regulations.

A major difference in the definitions between 10 CFR Part 61.2 and Nebraska's Title 180 Chapter 12 is the use of "management" in ten of the state definitions in the place of "disposal" which is used in the corresponding federal definitions. Other Title 180, Chapter 12, definitions which vary from NRC include "monitoring", "near-surface disposal facility" and "surveillance".

Several definitional differences exist between Nebraska's Title 194, Chapter 1 and 10 CFR Part 61.2. An example is "disposal". In this case the state regulation is much more stringent (restrictive), in that it includes a zero-release objective. NRC noted this incompatibility during their review of proposed amendments and suggested that the more restrictive phrase be removed; however, the Department of Environmental Quality chose to leave the incompatibility in the State's definition.

Question 8: Yes, but only if there is a particular reason to deviate from the current standards and such deviation would enhance health and safety protection while at the same time not unreasonably restricting or prohibiting the national policy of the states and compacts working together to safely and economically dispose of low-level radioactive waste.

s~

A. EugenV~ e ~

Executive~ : r r cc: Commissioners

'94 OCT 24 P4 :17 STATE OF TENNESSEE DEPARTMENT OF ENVIRONMENT AND CONSERVATION DIVISION OF RADIOLOGICAL HEALTH QFf IL f '] * -~ '.* ~ T f AR v 3RD FLOOR. L & C ANNEX DOCK!::. Tl :i ~ ,. _K f ;C 401 CHURCH STREET B ~.L' ,,t NASHVILLE, TN 37243-1532 October 17 1994 U.S. Nuclear Regulatory Commission ATTN: Docketing & Services Branch

- Washington, D.C. 20555 RE: SP-94-107, Federal RegisterNol. 59, No. 139/July 21 , 1994/Notices Gentlemen:

This letter is in response to the July 21 , 1994 Federal Register Notice on "Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy." I want to pass along to you some of the specific observations and comments made by some of my staff, as well as give you my perspective on this proposal.

1. The term "national radiation protection program" is used numerous times. We cannot pass up this opportunity to remind NRC again that there are more aspects to radiation protection than AEA materials.

2. At numerous places in this notice is found the wording "considered necessary by the Commission", without any significant discussion of the need for state involvement, input, or concurrence in the decision. It is time for the NRC to take seriously its commitment as party to a Section 274 Agreement to "cooperate" and "coordinate" in the "formulation of standards and regulatory programs of the State and the Commission", rather than attempting to dictate the terms. The opinion of some Agreement States is that the Commission considers Agreement States as if they are "licensees" and that representatives of Agreement States are representatives of the Commission through the recently discovered "overall national program" concept. We would remind the Commission that we are equal parties to the Agreement and are not bound by any interpretation of the NRC or its representatives that is contrary to or supersedes state law.

3. Page 37271 , II. C. indicates that the Management Review Board (MRB) would be taking over the OSP's role regarding existing Agreement States, and having the final say before FEB 2 4 1995 Acknowledged by card .................................~

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U.S. Nuclear Regulatory Commission Page Two October 17, 1994 the Commission on determinations of both adequacy and compatibility issues. The role and practices of the MRB are not yet established. Compatibility indicators are not yet developed. What reasonable assurances have the Agreement States that this change would represent an improvement in NRC's ability to work with the Agreement States to insure an adequate and compatible national AEA radioactive material control program?

4. . Despite rhetoric about the necessity of "program elements" being compatible, every requirement listed under Item III. C. 1-8, "Elements of a Compatible Program" appears to be addressable by essentially identical wording of regulations, i.e., compatibility in the historical sense.

5. It is not clear whether the numerous references to "dose limits and radiation protection related release limits in 10 CFR 20 and 10 CFR 61" would prohibit our more restrictive sewer release limits. Not even the definition of "radiation protection standards" clarifies whether the sewer release limits would be considered "Division 1 equivalent".

6. Page 37272, III. B. 5. indicates that Agreement State staff shall meet the same qualification criteria as ("no less stringent than") NRC staff. III.B.3 . and III.B.9. state it differently, saying "expertise should be similar". Please clarify the nature and intent of the distinction.

7. We would hope that, in accordance with Page 37271, II.A., the reference on Page 37273, III. B. I 0, regarding the investigation of reportable events, would not require that the State adopt program elements which mimic those in place in the NRC. For example, we see no benefit in going through extensive and unnecessary dosimetry calculations (like Region II does) for each and every misadministration notification.

As I have stated numerous times, I wholeheartedly believe that compatibility is absolutely necessary between states, as well as, between each state and the NRC. I do not agree that the NRC is necessarily the standard bearer. While that may have been true in the early days of this program, it is not true today. I envision a management group consisting of state and NRC representatives that determines which items require compatibility, at what level, and when it must be achieved.

Regarding the increased attention that is being directed to the materials program and Agreement States, I believe this is a result of the years of inattention the Commission/Staff lavished on the materials program. I remember when the NRC was derisively labeled the "Nuclear Reactor Commission" because of its total disregard for materials issues. Obviously, the Agreement State issues were a small and even more ignored segment. That has changed and we (NRC and the

U.S. Nuclear Regulatory Commission Page Three October 17, 1994 states) must change also. The additional resources being allocated for Agreement States' interaction (note the choice of "interaction" here) should be carefully allocated to provide support/oversight in order to build on the success of the past and not destroy the mutually supportive relationships that remain. This is a very important issue. The recent discovery of Agreement States by the Commission does not have to be a negative issue. We can build on the past, but it does require trust, responsible interaction and risk-taking by all parties.

Tennessee is committed to providing real protection to its public and the environment. We desperately want to work with a national radiation regulatory agency to accomplish this effectively and efficiently. We do not want to get bogged down in a sham paperwork exercise such as that foisted on the public by other federal agencies.

Sincerely,

~//~

Michael H. Mobley, Director Division of Radiological Health MHM:sk cc: Paul H. Lohaus, Deputy Director, OSP Agreement States sp 107/MHM94#3

- OCKET NUMBER PROPOSED RULE p M15. G _ -

(5'1 FR 31261) DOCKETED US RC [7590-01-P]

• 94 OCT 19 P2 :14 NUCLEAR REGULATORY COMMISSION OFFICE OF SECRf"TARY OOCKE Tlt'G & SHJICf Agreement State Regulatory Programs Adequacy to Pro i *' blic Health and Safety and Compatibility with the NRC Regulatory Program Draft Statement of Policy: Extension of Comment Period.

AGENCY: Nuclear Regulatory Commission.

- ACTION: Draft Statement of Policy: Extension of Comment Period.

SUMMARY

On July 21, 1994, (59 FR 37269), the Nucl ear Regulatory Commission published for public comment a draft general statement of policy regarding the review of Agreement State radiation control programs. The comment period for this draft policy statement was originally to have expired on October 19, 1994. The NRC plans to nold a public meeting on the draft policy statement on November 15, 1994, which will also be announced in a Federal Register notice.

In order to assure that the public meeting on the draft policy statement i:

held during the comment period and in order to assure that an adequate opportunity is provided for the public to comment on this important issue, the NRC has decided to extend the comment period. The extended comment period now expires on December 19, 1994.

DATES : The comment period has been extended and now expires December 19, 1994. Comments received after this date will be considered if it is practical to do so butt ~~ Commission is able to assure consideration only for comments received before this date.

ADDRESSES: Send written comments to Secretary, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Services Branch.

Deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm on Federal workdays.

FOR FURTHER INFORMATION CONTACT: Cardelia Maupin, State Agreements Program, Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 504-2312.

Dated at Rockville, Maryland this ;/f!:- day of c:1'c-3/4, , 1994 .

For the Nuclear Regulatory Commission ct1ng Sec etary of the Commission 2

- OCKET NUMBER R .

PROPOSED RULE p /1 J Gt (5q FR 312 61) DOCKETED US RC [7590-01-P]

NUCLEAR REGULATORY COMMISSION

• 94 OCT 19 P 2 :14 Workshop to Discuss the Draft Pol icy Statement for A<OFEfe nf ;S f , -~g , atory

'O OC KETl.,G ~ c-[i~ qrr_

Programs Adequacy to Protect Public Health and Safety and C m t fbility with the NRC Regulatory Program.

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of Meeting.

SUMMARY

The Nuclear Regulatory Commission {NRC) staff plans to convene a public workshop with representatives of Agreement States, non-Agreement States, the regulated community, public groups and the general public to discuss the draft policy statement for Agreement State adequacy to protect public hea 1th and safety and comp at i bil i ty of Agreement State regulatory programs with that of the NRC. The purpose of the workshop is to seek comments and recommendations from the full spectrum of interested parties on the various issues pertaining to the draft policy statement.

DATE: The workshop will be held on November 15, 1994. The time is 8:30 a.m.

to 5:00 p.m.

ADDRESSES: The meeting is to be held at the Nuclear Regulatory Commission's Auditorium, Two White Flint, 11545 Rockville Pike, Rockville, Maryland 20814, Telephone {301) 504-3340.

FOR FURTHER INFORMATION CONTACT: Cardelia Maupin, Office of State Programs, Mail Stop 3D23, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone (301) 504-2325.

SUPPLEMENTAL INFORMATION: On July 21, 1994, (59 FR 37269), the Nuclear Regulatory Commission published for public comment a draft general statement of policy regarding the review of Agreement State radiation control programs.

The comment period for this draft policy statement expires on December 19, 1994. A copy of the draft policy statement, which will be the subject of the November 15, 1994 workshop can be obtained at the NRC Public Document Room, 2120 L Street NW. (Lower Level) Washington, DC 20555. Howc; er, a copy can also be obtained by contacting: Cardelia Maupin, Office of State Programs, U. S. Nuclear Regulatory Commission, Washington, DC. 20555, Telephone (301) 504-2312.

Conduct of the Meeting The workshop will be condurted in a manner that will expedite the ~rderly conduct of business. A transcript of the workshop will be available for inspection, and copying for a fee, at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC 20555 on or about December 15, 1994.

The following procedures apply to public attendance at the workshop:

2

I. Questions or statements from attendees will be entertained as time permits.

2. Seating for the public will be on a first-come, first-served basis.

Dated at Rockville, Maryland this 6 tJ day of October, 1994.

For the Nuclear Regulatory Commission.

l clr,4 ex !k I

1

( / *".J Richard Bang art, Di rector//

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11__.t Offi e of State Programs.

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CABINET FOR HUMAN RESOURCES COMMONWEAL TH OF KENTUCKY FRANKFORT 40621-0001 DOCKc.1 1'UMBER PB 1u- L's* G -

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PROPOSED RULE DEPARTMENT FOR HEALTH SERVICES (SC/FR. 312.6 '1) *94 OCT 19 P3 :19 October 18, 1994 0F FiC1 C;- SG~R:~ y_:, Y DDC KE1 11,:: :' : - ,. ,,,.

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Secretary of the Commi ss ion U.S. Nuclear Regulatory Commi ss ion Washington, D.C. 20555 ATTENTION: DOCKETING AND SERVICES BRANCH RE: ADEQUACY AND COMPATIBILITY FOR NRC AND AGREEMENT STATE RADIATION CONTROL PROGRAMS NECESSARY TO PROTECT PUBLIC HEALTH AND SAFETY; DRAFT STATEMENT OF POLICY {FED. REG, VOL. 59, No. 139 THURSDAY JULY 21, 1994, PAGES 37269-37274 )

The U.S. Nuclear Regulatory Commission (NRC) has reque s ted comments on a number of issues related to the adequacy and compatibil ity for NRC and "Agreement State" programs. Health and safety will not be protected by policy statements, rather public health and safety will be enhanced through a cooperative approach by the NRC with the States as mandated by Section 274(g) of the Atomic Energy Act. Furthermore , is the NRC taking these actions as a " knee jerk" reaction to congressional hearings which questioned NRC oversight of "Agreement State" programs?

The following are comment s related to questions regarding the adequacy and compatibility approach which NRC wishes to implement.

Agreement States should be allowed to implement more stringent requirements and dose limits for their licensees when public health and safety is the central issue. If "Agreement State" actions do not interfere with reciprocity, cross state or regional boundaries, the setting of more stringent requirements and dose limits should not be a compatibility or adequacy is sue .

Since NRC has relinquished its authority in "Agreement States" for most radiation related issues, the states must be ultimately responsible for their citizens' health and safety.

o For example, release s to sanitary sewers of radionuclides should not be a strict compatibility requirement but should be evaluated based not only on the release limits, but also on the methods of treatment of the waste water and the fate of sludge, etc. This is a case where health and safety may better be served by standards which address local issues rather than the national interest.

o Another issue is standards for disposal of low-level radioactive waste . The Low-Level Radioactive Waste Policy Act of 1980 and the Low-level Radioactive Waste Policy Amendments Act of 19 85 established the States as the Ak FEB 2 4 1995 "An Equal Opportunity Employer M/F/H" c nowledged by card '""'"'"""'."'""'w

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Secretary of the Commission, U.S. Nuclear Regulatory Commission PAGE TWO OCTOBER 18, 1994 responsible parties for ensuring disposal capacity is available for low-level radioactive waste generated within their borders. Since Compacts and hence member States will dictate the eventual fate of the waste streams, the setting of standards must fall to the states and Regional Compacts and not the NRC.

The four (4) Compatibility Criteria appear to be reasonable except for the setting of certain standards and the promulgation of regulations which may impact only a few members of the regulated c ommunity. Compatibility Criteria must be applied only to those program elements or regulations which may interfere with reciprocity and cross state or regional boundaries. The setting of more stringent requirements and dose limits should not always be a compatibility or adequacy issue.

o If an NRC regulation only impacts a few licensees of the total regulated community in a state, the "Agreement State" should have the flexibility to determine whether the issue is best handled via an administrative regulation or through a license condition. Clearly, in some instances significant amounts of time and monies will be realized by not having to promulgate unnecessary NRC regulations.

0 Low level radioactive waste issues should not be a compatibility criteria since it is the regional compacts which have the authority to address this issue and not NRC.

If the federal government feels the need to set standards, they should take responsibility for the waste.

States should be allowed to preclude an action only if it can be determined to be detrimental to health and safety and the environment. Precluding a practice could have a significant impact on the issue of reciprocity and the national interest; therefore, states must document that such actions are not arbitrary or the result of local or political influences.

The above comments touch on the eight (8) questions posed by the NRC in regard to the issues of adequacy and compatibility.

Secretary of the Commission, U.S. Nuclear Regulatory Commission PAGE THREE OCTOBER 18, 1994 Specific Comments:

B. Elements of an Adequate Program Administrative Procedures - Addresses the issues of public participation where appropriate. Public participation is not necessary in enforcement actions. A Radiation Control Program must have the necessary statutory authority for enforcement and be allowed to utilize professional judgement in determining the issues that will impact health and safety.

C. Elements of A Compatible Program Reciprocity - States must be allowed to deny reciprocity to licens ees a s nec e s s ary. For e xample, more control is essential in dealing with medical licensees who administer radioactive material to humans as compared to well logging activities.

Therefore, states must be allowed to deny reciprocity based on the practice.

A gener a l comment is made as follows.

Many problems and controversies occur between the U.S.

Nuclear Regulatory Commission and "Agreement States" due to policies and regulations being promulgated by those having no direct contact with the regulated community and thus lacking an understanding of these issues. Many actions taken by the U.S.

Nuclear Regulatory Commission appears to lack an understanding of the issues and additional responsibilities faced by the "Agreement States" and the regulated community. Examples of these include:

o Numerous responses to incidents involving Atomic Energy Act material and naturally occurring radioactive material.

o A single agency performing inspections/licensing activities as well as promulgating administrative regulations.

o On-the-job training of junior staff, etc.

o Addressing U.S. Department of Energy facilities.

No single U.S. Nuclear Regulatory Commission Office performs all these duties which may contribute to a lack of understanding of

Secretary of the Commission, U.S. Nuclear Regulatory Commission PAGE FOUR OCTOBER 18, 1994 the demands and time frame problems experienced by "Agreement States". If the U.S. Nuclear Regulatory Commission utilizes a Management Review Board (MRB) for oversight of the Agreement State program, the members of the MRB must be comprised of individuals knowledgeable with "Agreement State" programs.

In summary, Kentucky as the first "Agreement State" does not disagree with the majority of the adequacy and compatibility issues as long as these issues do not interfere with 'States' rights which was the initial reason for the Agreement State program. States must be provided with the flexibility to protect the health and safety of their citizens which has traditionally been a state responsibility. Executive Order 12912 of October 26, 1987 in part states "With respect to national policies administered by the States, the national government should grant the States maximum administrative discretion possible. Intrusive Federal oversight .... is neither necessary nor desirable."

Furthermore, Executive Order 12912 also states "When undertaking to formulate .... policies ... agencies shall ... encourage States to develop their own policies ... refrain from establishing uniform, national standards ... and when national standards are required, consult with .... States in developing those standards." The tenants of Executive Order 12912 were manifested as early as 1959 when Congress indicated in Section 274(g) of the Atomic Energy Act that NRC must cooperate with the States. Finally, the NRC must realize the Agreement State Program will flourish only if both parties have input into the mechanisms and requirements needed to determine adequacy and compatibility issues which will establish protocols for protection of health and safety.

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Radiation Control Branch Manager c: Vicki Jeffs, Supervisor Radioactive Materials Section

DOCKET NUMBER PR 1.

PROPOSED RULE /' tJ G* @

(S Cf FR 372b1) OOCKET EO USl!RC Diana SalisbULY, SecLetaLy PORTSMOUTH/PIKETON RESIDENTS FOR ENVIRONMENTAL HEALTH &94 OCT 26 P2 :45 SAFETY 7019 Ashrldge Arnhelm Road Sardinia, Ohio 45171 October 18, 1994 United States Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing & SeLvice BLanch FAX: 301-504-1672 Re: Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs, Draft Statement of Polley, Federal Register Notice, Volume 59, No. 139, July 21, 1994

Dear Commissioner Chllk:

I am submitting these comments on the proposed rulemaklng by NRC on behalf of P.R.E.S.S., a citizen group focused upon issues that directly affect the Portsmouth, Ohio and Paducah, Ky. Uranium Enrichment Plants.

Background:

The Department of Energy by Congressional directive ls in the process of transferring authority for oversight to the Nuclear Regulatory Commission ln November 1994. Ohio ls the 11 host 11 state for Midwest Compacts low level waste disposal facility for the slx states of this compact plus Kentucky and Illinois by reciprocal agreement with Central Midwest Compact. By Consent Decree, the DOE has been mandated to clean up "mixed wastes" from its for'tY year' old facility in Piketon, Ohio. The Ohio EPA ls in the process of permitting on site storage of this "mixed waste "

in two existing buildings on site at the Portsmouth Plant.

At public hearing by the Ohio EPA Hazardous Waste Facility Board on Tuesday, October 4, 1994, a representative of the DOE indicated that the permits under consideration by the Ohio EPA could, in fact, result in the Portsmouth site becoming a federal level radioactive waste storage facility fr'om lts former military productions and/or the site of an existing r'adloactlve storage facility for Midwest Compact ~s facility. (Please see enclosure# 1.)

As directly affected parties of the region of Souther'n Ohio likely to live with the consequences and health impacts of this and other proposed rules of the NRC, we offer the following comments and raise the following concerns:

1. The authority of state and local level governments SHOULD NOT BE DENIED AUTHORITY TO PROTECT THE HEALTH AND SAFETY OF THEIR CITIZENS (emphasis added) by the NRC.

FEB 2 4 1995 Acknowledged by card .........................""

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Diana Salisbur-y page 2, 10/18/94 Author-ity to wr-ite mor-e pr-otective standar-ds must be r-etained by states and local gover-nments.

The standar-ds set by U.S. EPA ar-e cur-r-ently mor-e str-lngent than those of the NRC. U.S. EPA mandates clean up at mor-e than 5/r-em standar-d. NRC has set the allowable dose TO THE PUBLIC AT THE FENCE OF BOTH THE PADUCAH AND PORTSMOUTH FACILITIES AT 25/REM <emphasis added) in 10 CFR 76.

Various agency standards, including U.S. EPA and NRC, are 11 best guesses 11 of actual long term health risk. NRC standar-ds allow more risk/more exposure. Any disagr-eement ln level of safety should be on the slde of the more pr-otective standar-d.

2. NRC ls presently developing lts Enhanced Rulemaking on Residual Radloactlvlty <ERORR) Decommissioning Standards.

The level of contamination determined "safe" or "background" will allow sites to be released fr-om regulatory control and release responsible par-ties from liability for- adverse health and environmental impacts to communities surrounding decommissioned sites.

3. 11 Safe 11 or "background" levels of exposure are arbitrary in other- NRC monitored sites in Ohio. The NRC ' s own test results reported 17/r-em doses in residences where contaminated slag had been used in construction from the for-mer Cyprus-Foote Miner-al site in Cambridge, Ohio. Those levels of radioactive contamination were reported at public hearing to concerned citizens as 11 nor-mal background for- the area." In actual fact, a radius of 20 to 30 miles has been CONTAMINATED (emphasis added).

4. "Criteria for- Compatibility" requires Agreement States to accept NRC standards in four- categories:

1. Dose limits and release limits in 10 CRF 20. This compatibility requirement sets contamination standards by NRC standards.

2. States have been promised author-ity over the Inter-state Commerce Clause of the Constitution as an incentive to join compacts. With this r-ulemaking, NRC ls setting the standards for the states by requiring that state regulations conform to NRC regulations. "Compatible" standards are NRC standards.

3. Radiation protection terminology should be compatible between agencies, however the agency that defines terminology has the potential to determine not only the language, but the content and concept of the rules. States

Diana Salisbury page 3, 10/18/94 and local governments should have input in areas of disputed or new terminology.

For instance, the NRC defines "incompatibility" in subpart D, Termination of Agreements, as "the significance of performance indicator ' incompatibility ' in an individual State will be Judged on the basis of impact on the national program." The NRC allows states to set standards that do not apply to the four- compatibility requirements and "do not preclude or effectively preclude a pr-actlce within the national interest without an adequate public health and safety or environmental basls. 11 The NRC has defined "compatibility" as NRC authority.

"Adequate" ls defined as whatever NRC determines to be acceptable. The NRC has author-ity to use wide discretion in pr-actices it determines to be "ln the national interest."

The Nuclear Regulatory Commission should not be the authority to determine the "national interest," particularly in the issue of nuclear power, the lndustr-y It has a vested interest in regulating.

4. States are to be compatible assistants In evaluating the effectiveness of the over-all national r-adiation pr-otectlon progr-am. States and local entitles should not be precluded from mor-e str-ingent and innovative testing than NRC standar-ds for r-adiation protection. In effect. the NRC need not r-ecognlze testing or other- agency (state or- local level) findings if NRC standards ar-e less protective.

SUBPART E: SPECIFIC QUESTIONS FOR PUBLIC COMMENT

1. States should be per-mitted to establish mor-e str-lngent requirements for- licensees than those of the NRC. States should have this author-ity as a states ' r-ights issue. Also, states should have author-ity to determine the type of facilities, ther-efore licensees within their respective states. States should have author-ity to appr-ove or- deny specific technologies and processes, ESPECIALLY TECHNOLOGIES WHICH ARE EXPERIMENTAL OR UNPROVEN ON A PRACTICAL PRODUCTION BASIS (emphasis added) even though those technologies, IF SUCCESSFULLY PROVEN (emphasis added) would be in the national inter-est. States should have the author-ity to pr-ovide protection to the citizens residing within their r-espectlve boundar-les as a fir-st concern.

States should always have the author-lty to set str-lcter dose limits for par-ticular classes of licensees as a means to pr-otect the health and safety of the public and workers, as well as the environment. Radioactive disposal facilities,

Diana Salisbury page 4, 10/18/94 for example, should be subJect to the most s tringe nt monitoring and design to prevent leakage.

2. National interest in radiation protection should be defined as low ln risk to the public health and s afety and minimal risk of long term contamination to t he en vironment.

The NRC standards of protection for the Port smout /Paducah facilities do not provide the same level of prote ction as those applied to the general population of th e na tion. This practice, in effect, creates a sacrifice zon e jus if led as allowing greater risk for the greater societa l good. The dose allowed to the general population ls se t at 5/rem.

The general public at the Portsmouth facilit y is, by present NRC standards, allowed exposure of 25/rem dose: five times greater than national standard of protection .

3. States should have authority to prohibit inci neration and flushing radioactive contaminated materi al through sewerage systems as means of acceptable "was te vo lume reduction" by generators. The experience of stat e and local government has been exposure of the public t o heal th risk, environmental contamination, and considerabl e cos t to governmental agencies/taxpayers expense for clean up of such practices. The specific case of the Southerl y Sewer Treatment Plant in Cleveland, Ohio contamina ted by Medical Systems, Inc. provides example of both cost, risk to the public, and lack of liability on the part of the generator/

polluter.

Radioactive contamination of water, especial ly dri nking water supplies, should be stringently regula ted a nd monitored. States and local governments should have the responsibility, not merely the right, to tes t dr inking water supplies as a matter of protecting the publi c heal th and safety.

4. States should not be limited in setting stringent levels of protection to citizens or the environment or i n precluding a practice determined to be low probab ility ln risk, but high in impact, high in risk, not c ost e ffective In comparison to other alternatives, experimental or unproven to be feasible on a practical basis .

6. Low level waste disposal should be left t o st ates, especially considering the present compact sy stem. The host state should have authority to set more stri ngent standards.

The compact states have removed the waste from th eir backyards to the backyard of the host state and i ts citizens. The state willing to site such a f acili ty should have the right to protect its environment an d its citizens.

Diana Salisbury page 5, 10/18/94

8. States must have the authority to set more str-ingent standar-ds for- r-adlation pr-otectlon r-elease l imi ts. The NRC or any other- agency can rewrite standards gradually allowing higher and higher- r-elease limits to su it site conditions.

SUB PART G: EXAMPLES OF MORE STRINGENT REQU IREMENTS

1. States that do not use nuclear power-, such as Montana, should have the right to refuse to site low lev el/high level disposal facilities. States that chose to expl ore alt e rnatives for electrical power- with less risk, long ter-m environmental contamination, and less r-lsk t o t he public should hav e author-lty to refuse to site a r-adioactive dump.

2. State boundar-les wer-e not cr-eated with a tte ntion to flood plains, earthquake fault zones, or vol can ic activity.

States should not be subjected to siting facilities REGARDLESS OF GEOLOGICAL CONDITIONS (emphasis added>.

SUB PART E: IMPLEMENTATION

1. A gover-nment that claims to practice r-epre sen tatlve democr-acy and uphold the r-lghts of its citizens cannot use "national interest" as a Justification for a prac tice that exposes some of the population to high level r isk for- the greater societal benefit. National Envlr-onmen ta l Polley Act of 1969 clearly states that "all citizens have the right to live in a clean healthful environment."

In actual practice, regions and populations of th is country have been sacrificed and exposed to high level ri sk and adverse health impacts "in the national inter-est. 11 The NRC ls well awar-e of the r-egion selected f or ur-anium enr-ichment for nuclear- military pr-oductlon. The Appalachian region of this nation has borne a dispr-opor-tlonate share of the bur-den of national security in the Por-tsmouth facility, its sister- facility in Paducah, Ky. and Oakr-ldge, Tennessee.

These facilities ar-e located in mlnor-lty commu niti es.

Facilities in the western r-eglon ar-e too fr-equ entl y sited near- or on Native Amer-lean populations. Curr-e nt s olutions to disposal of spent fuel rods from power- plan ts a r-e sited on Native American lands, as in the case of Pr airi e Island, Minnesota.

Diana Salisbury page 6, 10/18/94 The Nuclear Regulatory Commission should no t be i n a position to determine the future of nuclear power in this country because of the agency ' s vested inter est i n the continued existence of the industry it regu lates. States must have authority to determine energy and land use policies without the vested interests of ge nerators receiving primary consideration ln those dec ision s.

Finally, and most importantly, the NRC shou ld not preclude state and local governments from setting mor e stri ngent standards because to do so precludes the practice of representative democracy. The officials of state and local government are elected by the people, and th ereby , must remain accountable, in some degree of practl callt y, to the governed. The NRC ls not elected or account able t o the people and should not assume a role, that ln prac tice, places sole authority ln an agency completel y r emoved from the people. An agency should not be granted auth ority in theory or practice that allows lt to determi ne 11 t he national Interest" and balance that interest against the health and safety of a specific population of this nat ions c it i zens.

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Diana Salisbury (513) 446-2763 cc: Vina K. Coll e y, Pr eside nt P.R.E.S.S.

3706 McDermott Pond Creek McDermott, Ohio 45652 enclosures

.Plant: Most 9gree on waste storagE Most agre~ continued from A 1 "The facility would not be However, earlier, Diana Sal-on permit a~le to store waste in a com-pliant manner," said Melda Rafferty, a waste program manager for the Department of Energy. "It could not create isbury, secretary of PRESS said she was concerned th~

permit could lead to a dump for all DOE sites at the local plant.

Reasons vary for wanting mo~e waste. It would have to go mto closure."

"Could this be the beginning of ~ ,?OE storage facility in

_Most of the waste cannot be OhlO? she asked during a continued storage at plant disposed off site, since the h_azardou~ chemical disposal public question period.

"Yes," answered Rafferty ,

~ites wont accept waste which who added that there is a By SUSAN SCHWARTZ Security, said she supported is also radioactive, and nu-Times Staff Writ~r the permit because the com- limit on the volume allowed in clear waste sites won't accept muruty ha~ no other choice waste contaminated with haz-Envir~nmentalists, workers "I think it's a sin they have the two buildings. She added and residents agreed that the ardous chemicals. that_ she doesn't know of any to blackmail the commwi' .* Abo':1t 80 percent of t he u~anium enrichment plant in ~nd workers between thefr off-site waste being accepted Piketo~ should get permission waste is generated by cleanup Jobs .an~ having to store waste ac~i vi ties from past plant oper- at the local facility. although to continue storing mixed haz- ?n site, she said, before ask- ations. Lh c a,; h c ,:; i, :* i

• I .1 1, ~ *., ,d: ~

ardo_us and radioactive waste The remaining 20 per-i~g plant officials for alterna- c~nt comes from present ura- burned at an incinerator in on site. tives to becoming an approved Oak Ridge, Tenn., are being

. Their reasons, however, var- nium enrichment operations waste storage site. by the new U.S. Enrichment brought back to Piketon for ied. Th~ comments were made storage.

"Denial of the permit would Corporation, plant officials The public has until 4:30 dur~ng a four-hour public have said in the past.

take effect immediately " said heanng by the Ohio Hazard-Blaine Beekman of th~ Pike ous Waste Facility Board over Under a two year agree- p.m. Nov. 18 to submit further County Chamber of Com- ment, the DOE is responsible comments on the permit tu th<:

t~e Portsmouth Gaseous Diffu- for USEC's mixed waste, said merce. There would be mass s 1on Plant's application to board.

lay offs." Gary Conner, waste manage-

• Last year. wh(*n thL* Attor-

~tore mixed waste on site. If it John Knauff, president of ment manager for Martin Ih.'.}' s:mu-r,1, L.., ... 1*~ ... h..*r !..:Id n is approved by the board, the Marietta Energy Systems, the the Oil, Chemical and Atomic permit would be valid for five pubhc meeting for comments W~rkers Union at the plant, , DOE contractor running the about the consent decree mon*

years. cleanup. DOE is also perma-said he believed continued At t~e moment, the plant is than 500 residents att~nded, storage would be safe. operatmg under a consent de- nently responsible for any most of whom spoke in fa\*or "We're the ones who handled waste or contamination from of the decree.

cree from the state of Ohio past operations.

the waste when it was gener-

~ted and stored," he said. "We Without the decree, approxi:

mately 17,000 containers of Tanks of depleted uranium I irnv',\' it can be stor(.'d proper- waste currently stored in the presently stored on-site would ly." X-326 and X-7725 buildings ' not be affect~d by the permit, Vina Colley, president of would be illegal. Conner s~1~. The permit Portsmouth/Piketon Residents would also bm1t the amount of for Environmental Safety and Please see PLANT/A10 waste allowed to be stored in the two buildings and forbid the plant to take any waste from other DOE sites, he said.

PORTSMOUTH

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2-A NEWS DEMOCRAT, THURSDAY, OCTOBER 13, 1994 Voinovich s peaks out about low-level radioactive waste.

To the Editor: as evidenced by our efforts to gional disposal facility under taming recommendations on approach to low-level waste I would llke to take this op- reduce the importation of solid their 1987 designation as host a wide variety of issues related disposal ts to construct a safe.

portunity to address some of and hazardous waste. We state. it ls conceivable that the to faclllty development. and the permanent. centralized facU-the allegations that have re- believe that the compact sys- Midwest Compact states would establtshment of a reasonable tty capable of Isolating the cently been made with regard tem provides an equitable ap- be among those with the ex- capacity limit for the Ohio fa- material for the required pe-to the issue oflow-level radio- proach to low-level ra<µoactlvc pectation of access to disposal cUity-- have been successfully rlod of time. To deny the need active waste. waste disposal and that mem- capactly in the near future. undertaken durl~ the past foreffectivemanagementofan bership 1n the Midwest Inter- three years. The next step is existing waste stream. to ad-First. management of low- state Low-Level Radioactive thorough consideration of a vocate delay in the develop-As Governor, its my duty to level ra~ilctlve waste ls a re- Waste Compact ts in the best legislative proposal that ls the ment of a facility at a time deal responsibly with the issue sponsibi that was gtven to interest of Ohio. product of these efforts. when generators have no dis-

• of low-level radioactive waste the state in 1980. through disposal andtodlschargeour We have tn Ohio more than posal .option. and to promote federal 1 islatlon supported In 1984. Governor Ccles~e . obfigatlon to the Midwest ruty-fivegencratorsoflow-level misunderstanding among by the , Uonal Governors' signed legislation. passed by ; Compact. Since July 1991. radioactive waste. There are members of the public about Assocatioil and the National overwhelming margins 1n the i When Michigan's membership an additional 100 generators this critical issue ts trrespon-Conference of State Legisla- General Assembly. that au-

• was revoked. I have been located throughout Midwest slble behavior on t~e part of tures. The primary concern thorized Ohio to become a

• working closely with the lead- Compact region. These faclll- those profess to be concerned was equity -- that a few states member of the Midwest Com- . ershlp in the General Asscm- ties provide a wtde range of wllh environmental protection would no longer.be required to pacL In 1987. Ohio accepted . bly to develop a program that goods and services to our ciU- in Ohio.

take the rest of the nation's designation as the first alter- zens. including electrical gen- Development of a regional will accomplish those tasks. A low-level waste. Their go_als nate host state for the regional eration: medical research. di- low-level radioactive waste number of slgniflcant events--

were to establish a system faclltty. Those actions com- agnosis. ana treatment: and disposal facillly ls one of the the negotiation of Compact where the responsibility was mitted Ohio to the course that consumer products. They most Important ancj challeng-amendments that provide Im-distributed more evenly we follow today. It ts truly make use of industrial and 1ng public policy issues on portant assurances to Ohio as throughout the counb'y and. unfortunate that Michigan commertcal applications of Ohio's environmental agenda.

host state. the appointment of at the same time. to allow the failed to fulfill its obligation to a Blue Ribbon panel of experts radioactive matertals in a vari- As such. we must resolve to states some flexibility tn the the mtdwest Compact and that .to consider appropriate siting ety of manufacturing pro- approach the issue responsi-way they handled the obliga- the Compact Commission was_ criteria, the completion of a cesses. They are not. however, bly and to move forward ex-tion. The principle of equity 1n forced to revoke their mem- located or designed for long- pedittously.

series of public hearings term, on~site waste manage- George V. Voinovtch waste management ts funda- bership. Had Michigan pro- throughout the state. the is-mental to thtsAdmtnlstratlon. ceeded to develop the first re- . suance of two reports con- ment. Governor The environmentally sound

DOCKET NUMBE~ .

PROPOSED RULE p f1 s 9 1 =

(sci FR 3 126c,) /rJ DOCKETED l1/

USHRC STATE OF WASHINGTON

• 94 OCT 17 P4 :17 DEPARTMENT OF HEALTH

. . D1v1s10N oF RADIAnoN PRon~T10N . FICE /"I f ~:.:cRETAR1 Airdustr,a/ Center, Bldg. 5

• P.O. Box 47827

• 0/ymp,a, Washmgton 98504*7W6' c Kf 'i"IH~ &_ ~~~-r;* lCt

.

• PR'\ 11.-1*

October 14, 1994

• Secretary Attention: Docketing and Services Branch

u. s. Nuclear Regulatory Commission Washington, DC 20555 To the Commission:

This is in regard to 59 FR 37269, the Commission's draft statement of policy on adequacy and compatibility for NRC and Agreement State Radiation Control Programs. The state of Washington opposes the draft policy statement as currently proposed. While there are many good elements to the draft policy statement, it is seriously flawed in its treatment of the States and in its development of the term "compatibility" to mean essentially "identical to NRC".

The terms "adequate" and "compatible" were not defined in section 274 of the Atomic Energy Act most likely because the intended meaning of these terms was well understood at the time. That is to say, they should have their dictionary meaning. According to Webster's New World Dictionary. "adequate" means "equal to a requirement or occasion; sufficient; suitable". The draft policy statement refers to "adequate" as an "acceptable level" which comports well with the dictionary definition. On the other hand, "compatible" is defined as "capable of living together harmoniously or getting along well together; in agreement". Given the history of conflicting regulations which prompted section 274 it is clear that "compatible" probably carried with it the connotation of "does not conflict". In any event, the implication that "compatible" requires program elements to be "essentially identical" was not, we believe, intended and is not warranted.

The other major flaw in the policy statement is treating the Agreement States as an interested party or constituent rather than as a co-regulator. Section 274g is especially clear in directing the Commission "to cooperate with the States in the formulation of standards *** to assure that State and Commission programs .** will be coordinated and compatible". It does not say "impose your will upon" or "consult, if you feel like it" or "follow the Administrative Procedures rules for notifying the State, the public, etc."; it clearly says "cooperate with". This recognizes there are two different sovereign governments involved here, both ifEB 2 4 1995 Acknowledged by card ..................... 1"'et..,

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regulating the same area, that should work as "partners"; not one dictating to the other. The draft policy statement inappropriately requires the Agreement States to become clones, or maybe even slaves, of NRC.

The draft policy statement should be referred to the Organization of Agreement States for a re-write. There should be no hurry to cast in concrete a "new" policy that potentially drives further a wedge in the relationship between NRC and the Agreement States!

The current "policy" may also be flawed but please don't make matters worse by running rough-shod over Agreement state concerns.

The background statement to the draft policy notes that "The guiding concept over the years since the beginning of the Agreement State program in the area of compatibility has been to encourage uniformity to the maximum extent practicable while allowing flexibility, where possible, to accommodate local regulatory concerns." This may have been a reasonable beginning but as the background statement also notes: there has been a slow evolution over the life of the Agreement State Program which has brought us to where "compatibility means identical". As with any evolutionary process each step seemed logical at the time, and it has take n time to r e cogni z e that where we are now is NOT WHERE WE WANT TO BE.

Unfortunately, the Federal Register notice and the draft policy statement serve mostly to justify the concept that "compatibility means identical" rather than "cooperate with the States" in determining how standards will be coordinated and not conflict as they did at one time prior to the adoption of section 274.

The Commission's policy should focus on determining "adequacy", and should include a mechanism for government to government cooperation which will assure that State governments' voices are effectively heard by the Commission. As "partners" our comments should be given GREATER weight than those of NRC licensees, environmental groups, or the public in general. Certainly, as "partners" we should have an equal say along with the Commission in determining which specific program elements, procedures and regulations constitute "adequacy". Achieving consensus should be the operative phrase.

Thank you for the opportunity to comment. Selected additional specific comments are attached.

Enclosure cc: Richard L. Bangart, OSP Agreement states

59 FR 37269 DRAFT STATEMENT OF POLICY II. E. Specific Questions:

1. Agreement States should be permitted to establish more stringent requirements for their licensees under all circumstances.

This includes the ability to establish stricter dose limits for particular classes of licensees. An adequate program is one that reaches a sufficient level of protection for the public. stricter standards are "permitted II as long as the regulation does not conflict with NRC's "minimum" standard. Being more stringent does not automatically conflict.

2. The fourth criterion -- Assisting the Commission in evaluating the effectiveness of the overall national program for radiation protection -- is a nice goal but it should not be a mandatory factor in determining whether an Agreement State is "adequate" to protect the public. As with many features of this draft policy, the concept is worthy but the method of attaining your goal is not. The Agreement States are more than willing to help NRC, to p rovid e information, t o cooperate, but NOT "at gunpoint".

4. It is inappropriate to place any limits on the power of the State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice. The State is a Sovereign entity. We promulgate rules following administrative procedures that provide for citizen as well as industry input.

Rules that preclude any particular practice will have been reviewed and deemed in the best interest of all the citizens of the State.

5. Criterion 3 of the compatibility criteria should be viewed as a "minimum" dose limit. The basic "units" should be the same but the numerical value could be more stringent. If one State wanted to implement o. 04 sv instead of o. 05 Sv TEDE as the occupational limit that should be acceptable as meeting the minimum standard and certainly capable of protecting the public health.

While we view it as highly unlikely for states to make these kinds of changes, it should not be NRC's role to punish the state by terminating its agreement for providing a greater level of public health protection than established by the NRC's minimum standards.

8. States should be allowed to establish more stringent standards for radiation-protection related release limits. While we doubt that very many states would do so, it is the principle involved here. What we do to protect our citizens is our business, not NRC's once an adequate minimum program has been established. The main concern should be whether the public is exposed to greater risk than allowed under NRC rule PERIOD.

2.

III. A. 3. Compatibility should be aimed at ensuring that interstate commerce is not impeded (conflicting regulations), and that effective communication in the radiation protection field is maintained (definitions do not conflict). Minimum dose limits and related release limits should b e viewed under "adequa cy" as should information needed for the study of STATE trends. Information for a study of national trends should be a goal not a criteria.

III. B. 2. States have been in the radiation regulatory business for many years. We have considerable expertise and insight into local conditions. We should have a say in designating the requirements necessary for an "adequate" program. The point is:

States are not unreasonable; we are willing to discuss and learn by the experience of others.

III. c. 2. A uniform manifest is a desirable goal and one that we certainly support. However, the compact host states should be able to require necessary information in whatever format we choose. As long as we agree, fine; but we should not be forced by an outsider!

III. c. 4. Event reporting consistent with NRC to provide that overall national perspective is a desirable goal. It should not be a mandatory criteria. Failing to report data to NRC does not compromise health and safety.

III. D. 4. Assisting the Commission in evaluating the overall national program is a worthy goal but not at the expense of state resources. This should not be a mandatory criteria. Also, the term "national interest" is used without specifying what it means or providing clear examples.

NC SYSTEMS, INC. DOCKETED SERVICES FOR NUCLEAR IMAGING USHRC DOCKET NUMBER PR M . *94 OCT 17 P3 :36 PROPOSED RULE '5 G -

Secretary, (sq FP- 311.1,1)

U. S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Services Branch RE: Draft Statement of Policy: Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety 59FR37269 10 October, 1994

Dear Sir:

Per the above referenced notice in the Federal Register, we at the Institute for Nuclear Medical Education (INME), the American Association for Nuclear Cardiology (AANC), and NC Systems, Inc. wish to comment on the Draft Summary of Policy regarding compatibility of Agreement States Programs with NRC Regulatory Programs.

The Institute for Nuclear Medical Education, Inc., the American Association for Nuclear Cardiology, and NC Systems, Inc. have considerable experience in interacting with both Agreement States and the NRC. In particular the Institute for Nuclear Medical Education, Inc. serves to educate physicians to qualify for licensure to utilize radioactive materials in their practices under 10 CFR 35.910(b); 10 CFR 35.920(b), 10 CFR 35.930(b), 10 CFR 932, 10 CFR.934, 10 CFR 35.940(b), 10 CFR 35.941, 10 CFR 35.950(b), 10 CFR 35.960(b), and concomitant Agreement State regulations. The American Association for Nuclear Cardiology is a professional organization representing over 400 physicians and others who perform Nuclear Cardiology studies in medical facilities licensed in both NRC regions and in Agreement States. NC Systems, Inc.,

functions as a consulting agency to physicians to aid them in gaining licensure, establishing facilities, and operating in compliance with appropriate regulations. The experiences gained within these venues have given us broad spectrum experiences with regulations as they differ and concur between federal and state venues Because our experiences are limited to the licensing and use of radioactive materials for human use Imaging and Localization studies within medical practices, we will limit our comments to those areas.

In March of 1992 we responded to the NRC's request for input into the formation of the above referenced Adequacy and Compatibility Policy by submitting comments and opinions to be considered in the development of this policy. A copy of the comments submitted at that time is attached to this letter. Our summary po itions remain unchanged:

• The medical use of radioactive material should be controlled by a standardized set of identical regulations and interpretations, whether administered by a single agency, the NRC or a combination of NRC and Agreement State agencies.

1fEB 2 4 1995 Acknowledged by card .." ......"'""""'"'"",a, 5171 ELDORADO SPRINGS DRIVE BoULDER. C OLORADO 80303 TOLL FREE : 1-800-548-4024 FAX: 1-303-499-3999 TELEPHONE: 1-303-499-4099

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• In medical facilities control of exposure to ionizing radiation from whatever source(s) to workers and the general public should be governed by a single set of identical regulations and administered by a single agency, the NRC or a combination of NRC and closely supervised Agreement State agencie s .

With this po ition as platform, we submit the following comments to the specific questions issued .

Responses to Specific Questions for Public Comment

1. I Jnder what circumstances should Agreement States be permitted to establish more stringent requirements for their licensees, than those established by the commission? Should this include the ability to establish stricter dose limits for particular classes of licensees?

Requirements for medical licensees should be completely standardized between the NRC and Agreement States. T he mobile workforce of occupationally exposed medical personnel should not be burdened with differi ng regulations in eras ing regulatory boundaries.

Radiosensitivity and radioresistance are common properties of the human phenotype. Because all radiation workers are humans, standards for radiation safety must also be common. It is inappropriate to allow workers to receive varying amounts of exposure to ionizing radiation merely because they are employed by a varying type of faci lity. A safe level of exposure as determined by current knowledge should be establis hed for all workers.

2. Are the four criteria in the proposed policy statement for determining whether a Commission regulation or other program element should be adopted in a manner essentially identical by the Agreement States sufficient to ensure protection of the national interest in radiation protection? W hat examples could be used to illustrate how each criterion would be applied?

The four Compatibility Criteria as given are not sufficient to ensure compatibility.

Even the examples within the draft document exhi bit incompatibility. Item #1 describes a criterion to avoid a significant burden on interstate commerce. Yet, Topic G gives the example of State actions which would be found "adequate" as the more stringent requirement by the state of Texas for training and experience requirements for Industrial Radiography Certification. This more stringent requirement by the State of Texas places a significant burden on inter tate commerce to the Industrial Radiographer licensed in Oklahoma under NRC regulations, and who is prohibited by this requirement from cro sing state lines to work in Te as. Also, Item #5 of the Draft Regulatory Guide requires Agreement States to have reciprocal recognition of out-of-state licensees. This example of allowing an Agreement State to set its own criteria for training and experience directly contradicts not only the requirement to support interstate commerce but also contradicts the requirement to have reciprocal recognition of out-of-state and NRC licensees.

NUCLEAR CARDIOLOGY SYSTEMS. INC 51 71 ELDORADO SPRINGS DRIVE BOULDER . COLORADO 80303 TOLL FREE: 1-800-548-4024 FAX: 1-303-499-3999 TELEPHONE l -303-499-4099

These contradictions have direct and severe implications on the issuing of licenses for medical use of radioactive materials. Each medical use licensee is required to name an Authorized User physician to supervise the administration of radioactive material to patients. Like Industrial Radiographers physicians are required to submit ev idence of required training and experience to be granted Authorized User status on a radioactive materials license. Should Agreement States be allowed to set varying training and experience requirements for Authorized User Physician training, the practice of medicine would be severely impacted. Political pressure to restrict physician access to the medical licensing process might succeed in vulnerable States. Physicians who qualify for Authorized User status in one state might not be allowed reciprocal privileges in another state due to differing training requirements, thus impacting the interstate commerce of their services and restraining their opportunity to practice their trade. Patients in those States would have their access to certain medical procedures restricted. This would also block the free market competition of medical services and thus raise the cost of medical care in those areas.

To promote interstate commerce and to ensure reciprocity of licensure, medical licensee requirements and requirement interpretations should be absolutely standardized.

3. What are some examples of State action to establish stricter requirements than those established by the Commission, or establish requirements where the NRC has not?

The following examples are limited to medical use licensees:

• The NRC allows physician preceptorship training to occur in any facility licensed for medical use.

-Florida, New York, California, Texas Colorado and other States onl accept physician training given in a medical institution.

• The NRC requires at lease one qualified Authorized User Physician to be named for each license issued for a medical use facility.

-Florida requires the Authorized User Physician to be within one hour of the facility.

-Colorado requires the Authorized User Physician to be available within one hour by telephone.

-New York requires the Authorized User Physician or Visiting Authorized User Physician to be on site whenever the facility is in operation.

• The NRC and most Agreement States will recognize the credentials of an experienced Authorized User Physician from another regulatory venue and will grant reciprocity of licensure.

-Georgia and Colorado will not grant reciprocity but require complete re-documentation of training and experience.

• The NRC will grant Authorized User Physician status to a physician based upon training and experience requirements of 10CFR35.

-Texas, California, New York and others have repeatedly attempted to require more stringent and extensive training.

NUCLEAR CARDIOLOGY SYSTEMS. INC 51 71 ELDORADO SPRINGS D RIVE BOULDER . COLORADO 80303 TOLL FREE 1-800-548-4024 FAX: 1-303-499-3999 TELEPHONE: l-303-499-4099

4. What limits, if any, should be place on the power of a State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice?

For medical use licensees, federal and State regulations and interpretations should be identical.

5. Are there any other dose of radiation-protection related release limits in the Commission's regulations which should be included under the Criterion number 3 of the compatibility criteria? Should dose limits contained in 10 CFR Part 61 be included in this Criterion?

For medical use licensees, federal and State regulations and interpretations should be identical.

6. Should the draft adequacy and compatibility policy statement be applicable to low-level waste disposal instead of continuing to questions of compatibility on a case-by-case basis?

For medical use licensees, federal and State regulations and interpretations should be identical.

7. Are there currently areas or situations in Agreement State regulations or Agreement State requirements that would not meet the proposed policy statement?

Please see previously stated examples.

8. Should States be pennitted to establish more stringent standards for radiation protection related release limits?

For medical use licensees, federal and State regulations and interpretations should be identical.

Addendum The Specific Questions for Public Comment issued by the NRC primarily address the issue of more stringent requirements implemented by Agreement States for their licensees. While we agree that this is an important issue, our experience indicates that an issue of equally serious consequence to public health and safety is that of less stringent requirements and non enforcements by Agreement States. The attached letter as submitted in March of 1992 contains multiple examples of Agreement State requirements which are less stringent than NRC requirements. These less stringent requirements potentially impact public health and safety by failing to provide minimum standards for control of exposure to ionizing radiation. In addition, the regulation of radiation safety from exposure to non byproduct materials and x-rays is often not effectively enforced by States. Our experience includes anecdotal data of phy icians placed in medical environments of ionizing radiation hazards without having received prior instruction in radiation principles and radiation safety; of physicians not being issued radiation monitoring badges during training because N UCLEAR C ARDIOLOGY SYSTEMS. INC . 51 71 ELDORADO SPRINGS D RIVE BOULDER. COLORADO 80303 TOLL FREE: 1-800-548-4024 FAX: 1-303-499-3999 TELEPHONE 1-303-499-4099

the frequency of overexposures of physicians-in-training created too much paperwork; of physicians who have developed radiation-induced cataracts from excessive exposure to non by-product ionizing radiation; and of one physician who died of work related radiation-induced leukemia. While anecdotal data do not constitute scientific evidence, this type of information should be important in promoting the establishment of a common regulatory agency for enforcement control of exposure to ionizing radiation from whatever source(s) to workers and the general public.

As evidenced by examples in this document the Office of State Programs has not effectively controlled the Agreement State Program to achieve the goal of protecting the public health and safety. The establishment of a Management Review Board (MRB) will only add an additional layer of expensive bureaucracy to the regulatory process. We feel that the Office of State Programs should be delegated and held accountable for stronger regulatory control over the Agreement States. Thi , coupled with a single set identical regulations for the medical use of ionizing radiation administered by a single agency, the NRC or a combination of NRC and tightly supervised Agreement State agencies, will serve to control the hazard to both workers and to the public Summary

• Current regulations and interpretations of regulations by the NRC and Agreement States are heterogeneous,

• Medical radiation workers are transitory,

• Incompatibility of NRC and Agreement State regulations exists both as more stringent requirements and as less stringent and non-enforced requirements,

• The NRC's Office of State Programs has been ineffective in enforcing compatibility of Agreement State regulations and interpretations of regulations.

Conclusions Health care delivery utilizing radioactive materials is a standard medical practice which results in occupational exposure of workers to radiation. Medical practices across the country are operated by personnel who are mobile both within and among facilities. To possess the radioactive materials necessary, practices must hold a license for the possession and use of the radioactivity. Licenses are issued and regulated by a heterogeneous morass of regulations written and interpreted by many regulatory agencies. Even identical regulations are interpreted differently by different regulatory agencies. Transitory employees who have successfully operated in one venue may be in non-compliance in another even though their policies and procedures of operation are identical. Substandard agencies may under regulate facilities and leave patients and employees vulnerable to radiation accidents. Politically motivated agencies may use their regulatory power to manipulate the standards of operation or even block entry to the field . In summary, the heterogeneity of regulations and their interpretation in what is basically a homogeneous area of use, is an inefficient mis-use of regulatory resources.

We recommend, based upon the above evidence, that a more efficient and appropriate regulatory system would consist of a single set of regulations and interpretations for the medical use of radioactive materials. If administered by a single agency or by the NRC in direct control of Agreement States, transitory workers would not need to be re-trained when they cross regulatory lines. Changes in regulations to meet new needs could be implemented smoothly on a single time line through a common public NUCLEAR CARDIOLOGY SYSTEMS. INC 5171 ELDORADO SPRINGS D RIVE BoULDER . COLORADO 80303 TOLL FREE: l -800-548-4024 FAX: l-303-499-3999 TELEPHONE. l -303-499-4099

hearing process. Regulators and enforcement inspectors would operate under a single set of guidelines and interpretations. Training and education standards for workers would be uniform, thus increasing the quality of the services rendered under the licenses. Under a single agency, regulating the use of radioactive materials, both from reactor by-products and from cyclotron production, radiation exposure records could be standardized and more easily enfolded into a common data base which includes radiation exposure from other sources. The cost of the regulatory process would decrease as research and development costs, public hearing costs, printing and distribution costs, regulation and inspection costs, and other standard costs now developed and administered by multiple agencies would be centralized and lowered on a per license basis due to the economies of scale. This in turn would be reflected in both the agencies budget and the budget of the medical institutions involved.

We feel that the NRC proposed Compatibility and Adequacy policy does little to implement these far reaching and innovative suggestions. In its current form the draft document contains direct discrepancies. In addition, this policy does little to promote consistency of operations in medical use facilities under NRC and Agreement State regulations.

Sincerely, C~ #-t~/ 4--.._

Charles H. Rose. MA. MSPH. (D)ABSNM enclosure N UCLEAR CARDIOLOGY SVSl EMS. INC. 5171 ELDORADO SPRINGS D RIVE BOULDER. C OLORADO 80303 Toll FREE: l -800-548-4024 FAX: 1-303-499-3999 TELEPHONE l-303-499-4099

NC SYSTEMS, INC.

SERVICES FOR NUCLEAR IMAGING Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Services Branch 10 March 1992 RE: 56FR66457

Dear Sir:

Per the above referenced notice in the Federal Register, we at the Institute for Nuclear Medical Education (INME), the American Association for Nuclear Cardiology (AANC) and N.C. Systems, Inc. wish to comment on the compatibility of Agreement States Programs with NRC Regulatory Programs.

The Institute for Nuclear Medical Education, the American Association for Nuclear Cardiology, and Inc.N.C. Systems, Inc. have considerable experience in interacting with both Agreement States and the NRC. In particular the Institute for Nuclear Medical Education, Inc. serves to educate physicians to qualify for licensure to utilize radioactive materials in their practices under 10 CFR 35.910(b); 10 CFR 35.920(b), 10 CFR 35.930(b), 10 CFR 932, 10CFR.934, 10 CFR 35.940(b), 10 CFR 35.941, 10 CFR

35. 950(b), 10 CFR 35. 960(b), and concomitant Agreement State regulations. N.C.

Systems, Inc., functions as a consulting agency to physicians to aid them in gaining licensure, establishing facilities, and operating in compliance with appropriate regulations.

The experiences gained within these two venues have given us broad spectrum experiences with regulations as they differ and concur between federal and state venues Because our experiences are limited to the licensing and use of radioactive materials for human use Imaging and Localization studies within medical practices, we will limit our comments to those areas.

Significant Differences Among Agreement States and with NRC Our experiences in interfacing with various NRC regions and with multiple Agreement States demonstrate that Agreement States' regulations are a diverse patchwork.

Even though each individual Agreement State is mandated to have regulations "substantially in agreement" with the federal rules, the regulations and their interpretations vary as widely as the states themselves. Variations from the median range from the ultra liberal to the ultra conservative, and within a single Agreement State it is impossible to predict on a regulation-by-regulation basis whether or not an individual rule will be identical or not to the concomitant NRC rule. Even when the Agreement State statute is identical to the NRC regulation, often the state will interpret the regulation in a vastly different manner than the NRC or different than other States with identical statutes. In our experiences we have garnered many examples of these non-agreements. For ease of readibility references are not given here, but are available from our facility.

fhysician Training Required to Ap_JllY- for License:

• NRC requires 500 total hours of physician supervised preceptorship to include concurrent technical and clinical experiences and 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom instruction to qualify for a license to perform Imaging and Localization Studies (10 CFR 35. 920(b).

5171 ELDORADO SPRINGS DRIVE BOULDER. COLORADO 80303 TOLL FREE* 1-800-548-4024 FAX: 1-303-499-3999 TELEPHONE 1-303-499-4099

• Texas only requires 250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br /> of clinical experience.

• Louisiana required only 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> of classroom instruction until 1990.

• Florida, New York, California, Colorado and other states will not accept physician preceptorship performed other than in an institution.

R.e.ciprocity of Licensure

• NRC and most Agreement States will recognize the credentials of an experienced Authorized User and will grant reciprocity of licensure qualification.

• Georgia will not grant reciprocity to licensee of NRC or other agreement states either as an Authorized User or as a Visiting Authorized User.

The Physician Authorized User

• NRC requires at least one qualified Authorized User to be named for each license to be responsible for the operation of the facility.

• Florida requires Authorized User to be within 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of facility.

• Colorado requires the physician Authorized User to be available within 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> by telephone.

• New York requires an Authorized User or Visiting Authorized User to be on site whenever the facility is in operation.

Possession and Use of a Dose Calibrator

• NRC requires each facility to possess a dose calibrator and use it to measure patient doses.

• Texas does not require a medical facility to possess a dose calibrator Tests for Removable Contamination

• NRC requires facilities to test for removable contamination at the end of each week with a system sensitive enough to detect 2000 dpm. This sensitivity level for evaluation is only attainable with Nal well/scaler detection system.

• New Yark accepts a Nal well/scaler or a Victoreen brand wipe counter for removable contamination counting.

• Florida allows removable contamination tests to be evaluated with a survey meter and a pancake probe.

• New Jersey accepts removable contamination test evaluations with either a Nal well/scaler system or with counting on the face of a gamma camera.

fhY-sicians Right to Interpret Studies

• NRC does not require physicians to hold a radioactive materials license to read images.

• New York, Wyoming and others require a physician to hold a radioactive materials license to read films.

N UCLEAR C ARDIOLOGY SYSTEMS, INC . 5171 ELDORADO SPRINGS D RIVE BOULDER . C OLORADO 80303 TOLL FREE : l -800-548-4024 FAX: l-303-499-3999 TELEPHONE l-303-499-4099

Time Line for Implementing_R_egulatory.: Chang..e.s

• Changes are made to federal regulations by the NRC.

• Agreement State concomitant regulations are phased in over a time line.

• A confusing millieu of regulations which do not agree results.

Implications of Differences Between Agreement States and NRC Common Princi~

• Like all United States' workers , the medical radiation worker, Authorized Users ,

Radiation Safety Officers , and Technologists , are a mobile work force. Often these workers change geographical working area.

• Radiation workers in health care also change from one technical modality to another , e.g.

dignostic x-ray to nuclear imaging to cath lab , acquiring radiation exposure in each location which may or may not be accounted for appropriately.

• The effects of radiation exposure on human beings is common, whether that human is a resident of an Agreement State or of an NRC district.

• The effects of radiation exposure on human beings is common, whether the source of that radiation exposure is from a reactor by-product, cyclotron produced radioactive materials, or artificially produced X-rays.

• ALARA practices and principles are standard for medical facilities of similar type.

• 10 CFR 19 , 10 CFR 20 , and 10 CFR 35 (Subparts A , B, and K) provide regulations which ensure standards of operation for the medical facility.

• 10 CFR 35 (Subparts C through J) categorizes certain regulations which need to be more or less stringent for differing types of medical environments.

• Distribution of radioactive materials across state lines is uniformly regulated by Title 49 under the Department of Transportation.

Summary

• For medical facilities standards of operation for use of radioactive material do not differ substantially by geographical area.

• For medical facilities , standards of operation do differ by types of studies.

• Medical Authorized Users , Radiation Safety Officers, and Technologists are transitory workers.

• Current regulations and interpretations of regulations by the NRC and Agreement States are heterogeneous.

• Current NRC regulations account for both the similarities and differences in types of medical use licenses.

N UCLEAR C ARDIOLOGY SYSTEMS. INC. 5171 ELDORADO SPRINGS D RIVE BoULDER. C OLORADO 80303 TOLL FREE . 1-800-548-4024 FAX: 1-303-499-3999 TELEPHONE 1-303-499-4099

Co n clusions Health care delivery utilizing radioactive materials is a standard medical practice which results in occupational exposure of workers to radiation. Practices across the country are operated by personnel who are mobile both within and among facilities. To possess the radioactive materials necessary, practices must hold a license for the possession and use of the radioactivity. Licenses are issued and regulated by a heterogeneous millieu of regulations written and interpreted by many ragulatory agencies. Even identical regulations are interpreted differently by different regulatory agencies. Transitory employees who have successfully operated in one venue may be in non-compliance in another even though their policies and procedures of operation are identical. Substandard agencies may underregulate facilities and leave patients and employees vulnerable to radiation accidents. Politically motivated agencies may use their regulatory power to manipulate the stndards of operation or even block entry to the field. In sumary, the heterogeniety of regulations and their interpretation in what is basically a homogenious area of use , is an inefficient mis-use of regulatory resources.

We recommend , based upon the above evidence , that a more efficient and appropriate regulatory system would consist of a single set of regulations for the medical use of radioactive materials. If administered by a single agency, transitory workers would not need to be re-trained when they cross regulatory lines. Changes in regulations to meet new needs could be implemented smoothly on a single time line thourgh a common public hearing process. Regulators and enforcment inspectors would operate under a single set of guidelines and interpretations. Training and education standards for workers would be uniform , thus increasing the quality of the services rendered under the licenses. Under a single agency , regulating the use of radioactive materials , both from reactor by-products and from cyclotron production, radiation exposure records could be standardized and more easily enfolded into a common data base which includes radiation exposure from other sources. The cost of the regulatory process would decrease as research and development costs, public hearing costs , printing and distribution costs, regulation and inspection costs, and other standard costs now developed and administered by multiple agencies would be centralized and lowered on a per license basis due to the economies of scale. This in tum would be reflected in both the agencies' budget and the budgets of the medical institutions involved.

We urge the NRC to implement these far reaching and innovative suggestions. We feel that public welfare will be served on multiple fronts with such a plan.

Sincerely, Signed N UCLEAR C ARDIOLOGY SYSTEMS, INC . 517 l ELDORADO SPRINGS D RIVE BOULDER . COLORADO 80303 Toll FREE : 1-800-548-4024 FAX: l-303-499-3999 TELEPHONE l -303-499-4099

UUliKI: I NUMt)t:n PR ,

PROPOSED RULE M 1.5 0 (5Cf FR 31Z6'1J ENVIRONMENTAL COALITION ON NUCLEAR POWER *- Director: Judith H. Johnsrud, Ph.D.

433 Orlando Avenue, State College, PA 16803 DOC KETED Telephone/FAX: 814-237-3900 USNRC August 31, 1994 (j)

Secretary of the Commission '94 OCT 17 P4i:iE1 59 FR 40058 U.S. Nuclear Regulatory Commission Draft Policy Statement on Washington, D. C. 20555 E OF SV 'RETA y Agreement State Program:

ATTN: Docketing and Service Br f}fl i CE Tlr 'G &csri*:,,.,. . [ Compatibi 1i ty Requirements

Dear Madame or Sir:

8R .~rEi '

These comments are submitted on behalf of the Pennsylvania-based Environ-mental Coalition on Nuclear Power CECNP>, a not-for-profit public-interest organization. ECNP is represented on the Pennsylvania State Low-Level Radio-active Waste Advisory Committee, but does not speak for the committee or the Commonwealth. Nonetheless, we have a stakeholder's interest in Agreement State Compatibility Requirements. The commenter, representing then the National Energy Committee of the Sierra Club, was an invited panelist in the NRC Staff's July 1993 workshop on this issue; and we have also recently attended as observers the NRC 1994 workshop for State Radiation Control Program Directors.

We urge the Commission to give serious heed to our recommendations.

This issue has profound Constitutional significance for the relationships of the States and Federal government with respect to health, safety and environ-mental protection of the citizens of the nation and the states. We contend that the Federal government, in the forms of the Nuclear Regulatory Commission, Environmental Protection Agency, and Departments of Energy and Defense (NRC, EPA, DOE, DOD>, has failed, in these fifty years of the atomic age, to provide first and foremost for the protection of the American people and the environ-ment on which they depend. This failure lies in the Federal agencies having fostered the growth and continuation of nuclear energy technologies without adequately regulating themselves, one another, or their licensees, vendors, and contractors.

Resultant from these failures of their statutory missions to protect our citizens are thousands of sites contaminated with radioactive and other toxic materials and wastes rendering them a danger to present and future populations.

They are both a s'hort- and long-term burden upon States and Municipal !ties to oversee and pay for monitoring, restrictions, decontamination, revenue losses, and future damages. ln repeated instances, the states have been placed in the position of clean-up or continuous monitoring of Federally-regulated sites, as weli as sites that have been placed under the authority of Agreement States (AS>. These, in turn, are frustrated in their regulatory control by NRC's preemption and compatibility requirements, or by failure of DOD and DOE to abide by State environmental and health and safety regulations. Indeed, the responsibility for "disposal" of radioactive wastes, which are generated primarily by facilities that are licensed and regulated by the NRC, was unceremoniously and deceptively dumped onto the States under the guise of mis-leadingly named "low-level" nuclear wastes that, in turn, were misrepresented to the Congress in 1980 as coming mainly from medical sources.

The States differ markedly in the number, distribution, activities, and geographic conditions of nuclear industries within their jurisdiction. Some Agreement State Program Managers are now requesting more authority, in order to FEB 2 4 1995 Acknowledged by card ........................,.,,.....,.

U.S. NUCU.:,.i.ri Rc*GULA W RY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics fostmark Date / 0 / I Lf Iq L/

Clpies Received /

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Page two (Comments on 59 FR 40058: Agreement State Program Policy Statement>

set radiation protection standards and regulations that are more, but not less, restrictive than those of the Federal agencies. The Federal agencies, in turn, should be setting baseline national standards and regulations with which all must comply as the minimum requirements. NRC should grant States' requests for more State authority and control but appears unwilling to do so.

At 40059, the Commission asks for comment on its proposed categories of findings of adequacy tor AS programs, on its process tor suspension or termina-tion of an AS program, and on use of 10 CFR Part 2, Subpart L for informal hearings on suspension or termination decisions rather than those detailed in sections V and VI of this FR notice. We commend the Commission for seeking public input at this early stage of policy modification but ask that the public suggestions and recommendations actually be incorporated, rather than ignored, in the final policy statement.

In its review of legislative intent in the Atomic Energy Act of 1954, as amended (Section II, at 40059), the staff fails to even mention the role, four decades ago, of the military in the development of nuclear weapons to meet 1950's Cold War demands for national security. The retention of Federal preemptive authority over radiological safety and radiation protection standards was, at least in part, in accordance with the maintenance of federal control of the military nuclear programs and the relationship of the commercial reactor programs to them. Only secondarily, we would claim, were the concerns for "uniformity" among the states, discussed at Section 111.2 to 111.4. Both have been outgrown over the years. If states are to be entrusted to administer radiation control programs, they should also be empowered to determine what levels of added safety and standards are appropriate to the needs of the people within each state, above and beyond the baselines set by the Federal agencies.

Similarly, the NRC's rightful concerns about the quality of state programs, discussed at Section 111.1, can be met within a regulatory framework that permits the states to exceed the NRC's minimum requirements for an Agree-ment State program. We're all in favor of excellence, of minimization of complacency, and effectiveness in NRC's exercise of its oversight of Agreement States. However, the public, and the State Program Directors, may differ with respect to the adequacy of NRC or EPA standards for radiation protection.

So long as a state is able to satisfy the NRC's reporting requirements that it has indeed met radiation program quality requirements, there should be no barrier, no impediment raised by the NRC to an State's going beyond to provide an even higher level of radiation protection and safety for its citizens. For example, although the Federal agencies must comply with the National Environmental Policy Act, there is no Federal Constitutional provision that addresses environmental protection, or health and safety -- beyond, perhaps, Articles IX and X of the Bill of Rights. But the Constitution of the Commonwealth does contain a provision that sets forth our responsibility to leave to our descendants a clean, livable environment. Therefore, our State regulators, in order to be in compliance with the State Constitution, may find it necessary to require degrees of safety and stringency of standards that go beyond those of NRC or other Federal agencies.

The staff says as much at Section 111.2: "The basic elements *** include ability to ensure adequate protection of the public health and safety, ***

sufficient flexibility to accommodate local needs and conditions **** " Since

some State Program Directors are asking for this authority to exceed NRC's requirements <as was emphatically voiced at the NRC's July 1994 annual workshop with the State Program Hanagers, the Commission should give it to them.

There would be little disagreement with the need for commonality of definitions and measurements. But, rather than attempting to bind the states to its often inadequate or antiquated standards and regulations, the Federal agencies should be leading the way in encouraging excellence, in rewarding states' concern to maximize the protection of their citizens. If a state concludes, from its own observations, inspections, or reading of the records that a power reactor is not performing satisfactorily to assure protection for that state's people, it should have the authority to step in to correct the failings. In the case at low-level radioactive waste management in Pennsyl-vania, for example, this principle is recognized: a Host Hunicipality's own inspector is authorized to close the regional LLRW disposal facility if it is not in conformity with regulations, and certain authorities are granted to the local govern ent to assure safety. Less regulation, lower standards? No. But higher and better ones, yes, by all means.

Obviously, if a State Radiation Control Program is derelict in its duties or failing to meet NRC requirements, or worse, the Agreement State status should be reviewed, suspended, and/or revoked, depending on the severity, duration, and deleterious consequences of the failures. We can support the Commission's proposals to do so, and a process that assures ample opportunity for public participation.

I would add, however, that the street runs in both directions, and if the states find that the NRC is failing in its statutory obligations, or is intrepreting its authority in ways that a state has reason to believe may prove detrimental to the health and safety of its citizens or to the quality of its environment, then the NRC's regulatory authority should also be reviewed, suspended, or revoked. We would caution, moreover, that, for either a State Radiation Control Program or NRC regulation, the consequences of any serious failure of regulation that results in releases of radioactive materials or wastes into the biosystem are intolerably high. "Harginally acceptable" is, in the instance of any production or uses of nuclear energy or management of its wastes, unacceptable.

Sincerely, 1~ ,(/.;tffi,v~

Judith H. Johnsrud, Ph.D.

Director

EO NEVADA NUCLEAR WASTE TASK FORCE, PORATED@)

Alamo Plaza 4550 W. Oakey Blvd.

DOCKET NUMBER po M *94 OCT l 2 A.} :35 Suite 111 P OPO ED AULE...:...::.::.R_.:;....--""'E,,-,G_

Las Vegas, NV 89102' 709-6§!8 IMS ,,;:ulP-11.:10 (S'f Fl< 311...6'1) OfflC-  ::.ECR_E TAR .

1 FAX 702-iJ!lil @ilH _,~,-11.zr DOC ETIN St~ C 800-227-9809 BRANC October 4, 1994 US Nuclear Regulatory Commission Washington DC 20555 Attention: Docketing & Service Branch Re: Comments to NRC draft policy statement on Agreement State Adequacy & Compatibility 59FR139:37269-74 7/21/94 Several individuals and organizations have expressed serious concerns to this office regarding the implications of this draft policy.

At a time when states and communities are faced with the siting of new nuclear waste facilities and the cleanup, decontami-nation and decommissioning of old facilities, there is widespread anxiety about protection of public health and safety. Citizens living in communities affected by these activities are apprehensive and doubt the ability and willingness of industry and federal government agencies to provide adequate protection to them and their environment.

Serious understanding gaps exist between regulators facility operators and the affected community, and there is a general lack of public trust and confidence.

The NRC's proposed policy allows limited opportunities to set standards that are stricter than federal regulations. Restricting or preempting local ability to establish standards further erodes confidence and will likely result in polarized opposition to projects and programs. We urge NRC to create a policy statement that acknowledges the need for public and state recognition so as to foster local support. To achieve that, the affected communities must determine what is "adequate," and "compatibility" must not be used as a hammer to beat local entities into conformance with standards that they believe are unsatisfactory.

The involved communities and citizens must be given every opportunity to participate and feel served not victimized by the policy.

FEB 2 4 1995 ckn wle ged y card ......................

s. NUCL[ ,An rr ooc:<tfl\ , ...-c-- . .. *.*1vN 1 ,. ~*,v:

... * . ' t ICE sr:cr C OF!- .,t. 0~ r t ::,i:CRETARY N OF- I ,-It CvMV.!SS:ON

The effective management of nuclear waste is a formidable challenge. Efforts to enact sound programs will only be successful if local communities and states are convinced that they are recognized and respected. Since the citizens are the first to be impacted environmentally, financially and personally, they must be allowed to control the regulations that provide their security both short and long term.

Submitted by, Stx~~

Executive Director f A \1200 l.A.l!1Ju[_ ~ 19th- --

Street, -

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American (202) 429-5120 Pel t!B~)223-4579 The Society College of Nuclear DOCKET NUMBER PROPOSED RULE Pl Ht.JC... _ *94 SEP 30 p 3 :49 of Nuclear Medicine Physicians (S" Of F fl 37 2 , Cf)

OFFICE Of s::-cRf.. TAR OOCK ETlt G & SERVICE September 28, 1994 BRANCH Secretary of the Commission Attn: Docketing and Services Branch U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: Comments on Adequacy and Compatibility for NRC and Agreement State Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy (59 Fed. Reg. 37269): and Comments on Draft NRC Agreement State Policies (59 Fed. Reg. 40058)

Dear Mr. Chilk:

The American College of Nuclear Physicians ("ACNP") and Society of Nuclear Medicine ("SNM")

appreciate this opportunity to comment on the Nuclear Regulatory Commission's ("NRC") proposals to issue a statement of policy on the adequacy and compatibility of Agreement State Programs, 59 Fed. Reg. 37269 (July 21, 1994) and on Agreement State Programs, 59 Fed. Reg. 40058 (August 5, 1994). We at the ACNP and SNM agree that the time has come for the NRC to review and clarify its policies on Agreement State Programs and the criteria for determining their adequacy and compatibility as required by Section 274 of the Atomic Energy Act of 1954, as amended

("Atomic Energy Act"). Our conclusion that clarification of the Agreement State Program is appropriate is based on the ongoing concerns raised by-the NRC's expanding regulation of the use of radioisotopes in Nuclear Medicine and the additional regulatory complications that could result from the subject proposed policy statements. These concerns are described and discussed in the following detail. In addition, they will be considered as part of the pending review of the NRC medical program by the National Academy of Sciences Institute of Medicine ("NAS-IOM"). We hope that their expression will lead to a more complete dialogue that culminates in policy statements that take into account the recommendations of the NAS-IOM, are consistent with the NRC's statutory authority and the existing regulatory requirements on physicians who use radioisotopes in their practice of Nuclear Medicine.

We also hope that such a dialogue will realistically consider the economic realities that limit the ability of the specialized Nuclear Medicine practice to absorb increasing regulatory costs. The time when such costs can be assessed to patients has long since passed. The cost of unnecessary regulation continues to escalate, exacerbated further by reimbursement caps from private payors and federal agencies like the Health Care Financing Administration. Therefore, to the extent that these proposed policy statements could lead Agreement States to increase the regulatory costs of using radioisotopes in medicine, those policy statements would lead to the further erosion of the availability of these modalities of diagnosis and treatment, to the ultimate detriment of the public.

FEB 2 4 19 5 Acknowledged by card ......""""""'"' -

1/4S 1 !UC'_ f;* ,- ;* -:_;: t _;-, 1"(JSY COMMISSION 1.f r *,< -1*~ , ~ *. !:FlVICE SECTION

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ACNP/SNM Agreement State Comments September 28, 1994 Page2 The high potential for such adverse impacts has already been demonstrated by NRC fee increases which have resulted in the diminution of the availability of Nuclear Medicine services. Any policies

_whiclt l)r~_ the potet1tia.l f'o_r ~ditioruµ ~~ ecQnoIDic imp~ Q_Q our~iliti~s t9_ <;leijy~_tp~iy~ .__ .

services should not be considered. In particular, policies which would require the Agreement States to adopt most of the NRC's regulatory requirements, beyond those necessary for demonstrating adequacy and compatibility of the Agreement State program, as limited in accordance with the legislative history of Section 274 and descnbed below, should not be adopted.

In conclusion, because we believe that these policies could have a significant adverse impact on the public health and safety by limiting the availability of Nuclear Medicine, we strongly urge you to carefully review and modify the proposed policies to maximize state flexibility and minimize additional regulatory cost burdens.

Fundamental Concerns; Interference with State Authority The ACNP and SNM have carefully reviewed both proposed policy statements. We find that they express an interpretation of Agreement State Programs that is neither derivable from nor consistent with the NRC's statutory authority under Section 274 of the Atomic Energy Act. Because these concerns are so fundamental, we have focused our comments exclusively on them. This does not mean, however, that we are not also concerned about numerous minor points and administrative details in the proposed policy statements. We have not addressed these minor points because we believe that they will be modified substantially to be conformed to changes in the major policy statements. . . - - - ---*--------- - ---* .- . . -** . - - -

The major items of concern in each policy statement are addressed in order of the publication of those statements. To fully appreciate and understand our concerns, it is first necessary to review the legislative history of Section 274 of the Atomic Energy Act in order to accurately apply Congress1 intent. A review of that legislative history follows. It shows that Congress intended that the Atomic Energy Commission {11 AEC 11 ), the predecessor to the NRC 1s regulatory authority, would encourage the states to become Agreement States in order to regulate radioisotopes under State authority, subject only to findings that the programs are adequate and compatible; where adequate meant no undue risk to public health and safety and compatible meant that bas1c radiation standards, of the kind addressed by the Federal Radiation Council, would be uniform, but that other state radiation standards simply would not conflict with federal standards.

ACNP/SNM Agreement State-Comments September 28, 1994 Page3 To the extent the proposed policy statements assign far more- elaborate .meanings to the terms adequate and compatible, they exceed the NRCs statutory authority under Section 274 of the Atomic

_ -~~gy Aft. As _a pr:ae!i~_ll!8.!t~, ~.Q~ expl!Ilded. defimtio~_11Ie _incp@fil~!lt with CQDgr~sio1u!l .

intent because they discourage states from becoming Agreement States. And with respect to the practice of Nuclear Medicine, these policy statements contradict Congress' intent because they will not increase State regulatory authority but, rather, will subject the existing state regulation of medicine to additional constraints imposed by the NRC. For these reasons, the ACNP and SNM request the NRC to withdraw its proposed policy statements and to revise them to be consistent with the NRC's authority as carefully formulated by Congress in Section 274 of the Atomic Energy Act.

• Analysis of Section 274 and its Leeislative History As the NRC has acknowledged, neither of the key statutory terms "adequate" and "compatible" are defined in the Atomic Energy Act. Under these circumstances, it is well-established that the intent of Congress with respect to these tenns should be derived, to the maximum extent pos&ble, from the legislative history that accompanied the enactment of the legislation that incorporates these tenns.

~ Blum v. Stenso~ 465 U.S. 886, 896 (1984). For Section 274 of the Atomic Energy Act, the most authoritative available legislative history is the Senate Report which was adopted by the Joint Committee on Atomic Energy and accompanied the bill that ultimately was enacted. ~ Garcia v.

United States, 469 U.S. 70, 76 (1984). S. Rep. No. 870, 86th Cong., 1st Sess. (1959), 1959 U.S.

Code Cong. & Admin. News 2872.

Congress Intended to Empower-the-States-- - - - - ------ -

Senate Report No. 870 extensively discussed the terms "adequate" and "compatible" in a manner which clearly stated a Congressional intention to encourage the states to regulate byproduct material free from close federal prescription in all areas except for basic radiation standards. To fully appreciate the Congressional understanding of the terms "adequate" and "compatible," it is useful to review the context in which Congress discussed them. This context is provided by the Congressional statements of the objectives which Congress intended to &ehleve through the adoption of Section 274 of the Atomic Energy Act. The following summary of those statements clearly shows that Congress intended to encourage the states to assume responsibility for the regulation of certain radioactive materials by giving the states jurisdiction over the uses of those materials ..

ACNP/SNM Agreement State Comments September 28, 1994 Page4 States Were To Become the Sole Regulatory Authority The overriding objective of Section 274 was to permit increased State p~cip_ation in tl_1e r~gJJlatiQIJ of radioisotopes. USCCAN at 2875. -This-objective was supported by both the President of the United States and the Joint Committee on Atomic Energy. USCCAN at 2877. As the AEC put it, the object of Section 274 of the Atomic Energy Act was to establish procedures and criteria under which the AEC could "turnover" specifically identified areas of regulatory jurisdiction to the states, as they became ready. USCCAN at 2873. This turnover of regulatory authority would be permitted by Section 274, which authorized the AEC to withdraw its responsioility for regulation. USCCAN at 2874.

To help the States to realize this objective, the Federal Government was directed to increase its programs of assistance to and cooperation with the States to prepare them to receive jurisdiction and regulatory authority over radioisotopes and other activities. USCCAN at 2878. The States were considered capable of either assuming these responsibilities or becoming capable of assuming them because several states had already demonstrated their ability to regulate comparable radiation hazards from other sources, like x-ray machines. USCCAN at 2879. And where the States weren't ready, the AEC was to help them to get ready by exercising newly provided authority to provide training and other services to state officials and employees. USCCAN at 2874.

Federal Regulation Was To Be Minimized Congress explicitly rejected dual or concurrent jurisdiction as had been proposed by the AEC.

USCCAN at 2879 and 2875. Congress clearly..stated--that-after--entering-iRtG an-agreement with the Commission, the state shall have the authority to regulate the covered materials for the protection of the public health and safety from radiation hazards. USCCAN at 2880. States were encouraged by Congress to assume regulatory jurisdiction as a means of enhancing protection of the public health and safety. USCCAN at 2879. Id. Accordingly, Congress directed the AEC to assist the states to prepare themselves to assume independent regulatory jurisdiction. USCCAN at 2879. And as states gained experience through the exercise of this independent regulatory authority, Congress expected that Section 274 would require an amendment to give the states increased responsibilities. USCCAN at 2880.

In summary, then, Congress determined that the AEC should encourage and help the states to assume regulatory jurisdiction over certain radioactive materials because the local regulation -of those radioactive materials would enhance the public health and safety. Independent regulation by the states who had already shown themselves competent to regulate comparable radiation hazards was contemplated by the Congress. Minimal interference by the Federal Government was expected, as clearly indicated by Congress' strong rejection of suggestions of dual, concurrent or overlapping jurisdiction.

- ACNP/SNMAgreement State Comments September 28, 1994 Page 5 Adequate Focuses On Protection of Public Health/Safety In the context of this clear Congressional initiativ:e for _autonomous"state regulation, it_ i~ cl_~ that ilie limitecrrefererices to the terms 11 adequate 11 and 11 comparable 11 reinforce the Congressional intent to provide for independent state regulation. Two of the three references to the term "adequate" as applied to an Agreement State Program are coupled with the need to ensure that the program provides protection against radiation hazards. USCCAN at 2873, 2881. This understanding is also implied in the third reference. USCCAN at 2878. This conclusion is corroborated by the statement that a program is to be terminated only ifit does not protect public health and safety. USCCAN at 2874.

Thus, the term "adequate" as used in Section 274 was intended by Congress to direct the Commission simply to determine that a state's regulatory program would protect the public against radiation hazards. Moreover, by referring approvingly to existing state programs for comparable radiation hazards, Congress implicitly concluded that such programs would be found adequate for the purposes of an agreement under Section 274, provided that the modifications necessary-for accommodating the increased scope of regulated activities were made. Nothing in the legislative history suggests that the term "adequate" was to be freighted by the Commission with any additional limitations that would inhibit Congress' clear intent to encourage states to enter into Agreements under Section 274 of the Atomic Energy Act.

Compatible Focuses On Basic Radiation Standards References to the term "compatible'!.similarly.show-that-it-was-USed-lll-a-limited sense in order to maximize state autonomy and minimize Federal interference. To fully understand these references, it is first necessary to note that Section 274 of the Atomic Energy Act also created the Federal Radiation Council ("FRC"). A brief discussion of the FRC and its role follows.

Role Of the Federal Radiation Council The FRC was initially created by the President through an Executive Order. USCCAN at 2874. The FRC was comprised of Secretaries from agencies which conducted activities that involved radioactive materials. The FRC was directed to consult with experts on radiation matters and advise the President on them. USCCAN at 2873.

Congress reestablished the FRC through Section 274.h of the Atomic Energy Act. USCCAN at 2879. In addition to advising the President on radiation matters, Congress directed the FRC to assist the Federal agencies to obtain uniform "basic radiation standards. 11 USCCAN at 2880, 2882. Those uniform basic radiation standards also were to be encouraged to be included in programs of cooperation with the States. Id.

ACNP/SNM Agreement State Comments September 28, 1994 Page 6 Only Basic Radiation Standards Are To Be Uniform The importance of Congress' creation of the FRC, as *it*-relates to ~~--analysis_ _pf th~ *tenn

. "compatibfo," is that tlie .FRC focuses -on the need to *establish national uniform "basic radiation standards" as distinct from the broader class of radiation standards addressed by compatibility.

National uniformity was limited to basic radiation standards to be set by the agencies in accordance with guidance developed by the FRC and promulgated by the President. USCCAN at 2880. The scope of such basic standards has been established by subsequent practice. It is limited to fundamental radiation protection matters like the maximum yearly radiation exposures permitted to be received by radiation workers and the special precautions for protecting fetuses from exposures to radiation. Basic radiation protection standards do not include the more detailed radiation protection requirements promulgated by the NRC.

More general radiation standards adopted by Agreement States were expected by Congress to be either identical or compatible with those adopted by the Federal Government. USCCAN at 2879.

In light of the above discussion, what this directive means is that to the extent a radiation standard adopted by a state is a basic radiation standard, it is expected to be identical to Federal basic radiation standards, but to the extent that a radiation standard adopted by a state is not a basic radiation standard, it need only be compatJ.ole.

Compatibility Is Narrowly Defined As for the scope of compatioility the ABC, early on, adopted a test of "not in conflict" with the radiation safety standards adopted by the-NRG.- USCCAN-at287S.. ~-test-was-intended to be a modest test, as indicated by the ABC's explicit recognition that the states would use their sovereign police powers to adopt, inspect against, and enforce radiation standards. USCCAN at 2875. When the ABC adopted that test, it also contemplated dual regulation. Congress' rejection of dual regulation was motivated by an intent to avoid the confusion that could result from the concurrent application of regulatory agencies that led to overlapping and inconsistent standards to the hinderance of industry and jeopardy of public safety. Congress' concern would not have arisen unless the ABC's "not in conflict" test did not contemplate uniformity of radiation standards.

Thus, all Federal Government supporters of the Agreement State program contemplated some flexibility in the radiation standards that could be considered compatible for the purposes of Section 274 of the Atomic Energy Act. The extent of that flexibility is as follows. Basic radiation standards should be uniform in the Federal agencies and Agreement States. USCCAN at 2882. State radiation standards for the protection against radiation haz.ards must be compatible and, in most cases, should be identical to federal standards to avoid conflict, duplication, or gaps. USCCAN at 2879, 2882. Where these concerns about radiation standards are met, compatibility is achieved.

ACNP/SNM Agreement State Comments September 28, 1994 Page7 Compatibility does not extend beyond radiation standards. _As long as state radiation standards do not conflict with, duplicate, or leave regulatory gaps as compared with Federal standards, those state

~ _are compatible. ___An ~ensj.on of compatibility to-iP:cJude ~e _!"egu~tory__action_s such_ as_

inspection and enforcement are inconsistent with Congress' clear intent that the NRC was to "turnover' its regulatory authority to the states so as to improve the protection of public health and safety.

Analysis of the Proposed Policy Statements In light of the foregoing legislative history, it is clear that the meanings proposed in the draft policy statements for the terms "adequate" and "compatible" are inconsistent with the NRC's statutory authority. We start by addressing the draft policy statement regarding the review of Agreement State radiation control programs.

Acce_ptability By Comparison With NRC Regulations Is Not Appropriate To Show the Adequacy of a State Program The adequacy of a state's program would be established by a showing that the program provides an "acceptable" level of protection of public health and safety. This showing could be made by a state by demonstrating that the program elements necessary for providing that acceptable level of protection provide a level of protection that is equivalent to or greater than the level of protection provided by the NRC's regulatory program. This definition of adequacy and the comparison method for demonstrating it are both inconsistent-with-Section27A...ofthe-.A.tomic-Energy Act.

The legislative history of Section 274 shows that Congress intended the term adequate to mean protect public health and safety. Protection of the public is descn"bed alternatively, but comparably, as either reasonable assurance of adequate protection or reasonable assurance of no undue risk. ~

50 Fed. Reg. 50764, 50768, c.1 (Dec. 12, 1985) (final rule amending 10 CFR § 50.12(a)) ("The 'no undue risk standard' ... represents the statutory requirements of Section 182 of the Atomic Energy Act for adequate protection of the health and safety of the public"). Acceptability of the level of protection has not been an element of the level of safety that is required beyond its implicit inclusion in the statutory terms as applied elsewhere by the NRC. ~ Union of Concerned Scientists v. United States Nuclear Regulatory Commission, 824 F.2d 108 (D.C. Cir. 1987). Accordingly, acceptability is not a cognizable element of adequacy for the purposes of Section 274 of the Atomic Energy Act.

It should be deleted.

ACNP/SNM Agreement State Comments

.September 28, 1994 Page 8 Adequacy Must Be Defined To Enhance State Empowennent As for comparison with the NRC's regulatory program, not only is that not the statutory test for the adequacy of a state program but it also is inconsistent with Congress' intent to empower the states to regulate radioisotopes under their own, inherent police powers. To the extent that the NRC's program contains elements that are not necessary for the reasonable assurance of adequate protection, any NRC requirement that those program elements be incorporated in Agreement State Programs goes beyond the NRC's authority to find a program adequate for the purposes of Section 274.

Remember, the NRC was directed by Congress to encourage states to become Agreement States, not to discourage them by requiring them to adopt many unnecessary regulatory requirements.

Concurrent Jurisdiction Has Been Prohibited By Congress More generally, by using its own regulatory program as the yardstick, the NRC is trying to indirectly impose the concurrent jurisdiction which Congress explicitly rejected. Agreement States were to exercise their own authority to devise appropriate regulations subject only to very broad limitations that were necessary protection of the public health and safety. This intended empowerment of the states would be rendered nugatory if the details of their regulatory programs had to ape the details in the NRCs program to pass muster. Accordingly, the NRC should delete this comparison standard that is used consistently throughout the Atomic Energy Act: If an Agreement State Program provides reasonable assurance of adequate protection of the public health and safety, it should be found to be adequate for the purposes of Section 274 of the Atomic Energy Act.

Compatibility As A Matter Of Overall National Interest Is Not Supported By Congress' Clear Directions To the AEC The definition of compaboility deviates even more from Congress' intent than did the definition of adequacy. A finding of compatloility would be based on a demonstration that the Agreement State Program provides for the overall national interest in radiation protection. Nowhere in Section 274 does such a national interest test appear. Extraterritorial effects of states' action were not addressed.

Where national uniformity was necessary, the NRC was to retain jurisdiction.

Compatibility Focuses On Radiation Standards By compatibility, Congress did contemplate the uniformity of basic radiation standards of the kind set by the FRC. Congress also expressed a strong expectation that other state radiation standards would be either uniform or compattole, i&., not contradictory of federal standards. Congress never expressed even a hint that compatioility would require any other elements of a State's program to be essentially identical to the corresponding elements of the NRC's program for any reason. And Congress never expressed any intent to require such identity in order to achieve a larger national interest beyond adequacy protection, such as ensuring that interstate commerce is not impeded.

ACNP/SNM Agreement State Comments September 28, 1994 Page9 Compatibility concerns only radiation safety. It does not .include .any erroneous, ancillary concepts, such as commercial concepts that are beyond the NRC's regulatory jurisdiction. . Accordingly, this co~ ~{~mpatioility_should_ be witl).dra'Yl} ~ unsµP.porte~ ~Y any aufeority_grant~d_to_th~ ~G __ _

by Congress. In its stead, the NRC should adopt the Congressional concept of compatibility that had been explained above.

Interference With State Authority To Determine How Best To Regulate the Practice Of Medicine and Pharmacy In addition to the lack of statutory authority for the proposed definition of compatibility,. it should be emphasized that, as a practical matter, this definition would interfere with the current sta{e regulation of the practice of medicine and pharmacy. To the extent that specific program elements fu. the NRC's regulatory program would be required to be adopted to the states, the authority to regul~te physicians and pharmacists would shift in the state from the purview of the Boards of Medicine tnd Pharmacy to that of the Bureau of Radiation Health. Thus, this impermissively expansive definition of compatioility, when applied in an Agreement State, would override that state's decision_ on how to assign responsibility for regulating the practice of medicine and pharmacy. Such interfereµce with sovereign state power would constitute the very antithesis of state empowerment which the CJ_ongress intended to achieve by enacting Section 274 of the Atomic Energy Act. AccordingJy, the purpose/definition of compatlbility would be especially descriptive of states' regulation of the practice of medicine and pharmacy and, therefore, should be withdrawn.

Comments on Proposed Policy Regarding--Agr-eemoot-St,ate P-romms----** -- -

The proposed Policy Statement on the Agreement State Program also containsseyeral concepts that not only were never contemplated by Congress but also go beyond the NRC's statutory authority.

Most troublesome are: (1) a federal mandate that requires continual Agreement State striving for excellence in some undefined, subjective manner; (2) the limited scope of regulator 'impartiality; (3) NRC responsibility for developing a coherent national radiation control program; and (4) Agreement State responstbility for consistency in program areas having national significance.

Each concept is discussed, in order, below.

Continual Striving For Excellence Has Not Been Supported By Reasoned Decisionmaking Continual Agreement State striving for excellence is neither explicitly nor implicitly contained in Section 274 or any other section of the Atomic Energy Act. The Atomic Energy Act requires only reasonable assurance of adequate protection of the public health and safety: No less and no more.

Although the NRC also is authorized to adopt regulatory requirements that go beyond the basic level of adequate protection, the NRC, and the courts, have recognized that a reasoned analysis that includes a showing that the benefits of additional regulation outweigh the costs, is a prerequisite to adopting more stringent regulations.

ACNP/SNM Agreement State Comments September 28, 1994 Page 10 In the absence of such an analysis, the NRC's adoption of a principle of-continual improvement of Agreement State regulatory programs has no reasoned basis of support. Although ACNP and SNM support this ~:£fort, it is not the role of the NRC to di_ctate. Indeed, no reasoned basis is available _

where the idea of excellence or continual improvement is not defined and is potentially so open-ended as to require the adoption of any improvement, no matter how trivial, despite an incommensurate cost. Experience with the NRC's regulation of nuclear power reactors has shown that the adoption of such an open-ended, undefined principle of excellence leads to uneconomic operation. Having learned its lesson once, the NRC should not repeat that mistake for Agreement State Programs. The principle of excellence should be deleted.

Regulator Impartiality Has Been Stated Unconstitutionally Regulator impartiality is stated in a limited way which, in fact, is contrary to impartiality. Agreement States are admonished by the NRC to be "free from pressure and inappropriate influences from the regulated community." 59 Fed. Reg. at 40060. Moreover, "[t]he public should have an opportunity for early involvement in significant regulatory program decisions." Id. Finally, "[w ]here several effective alternatives are available, the alternative that best assures safety while considering differing views should be adopted, considering the resources needed to implement that alternative." Id. Each of these proposed principles is contrary to established regulatory practice and, thus, seriously flawed.

Regulators, including Agreement State agencies that regulate the use of certain radioactive materials, are governmental agencies. As such, either the Federal or State Constitution guarantees the regulated community the same right to petition the government as is guaranteed to all other members of the public. Therefore, it is unconstitutional for theNRC to..demand--that state.regulatory.agencies be free from pressure by the regulated community. That community, like all others, has the right to use all legally available alternatives to press its case regarding regulation. Accordingly, this principle should be withdrawn and conformed to constitutional requirements.

Early involvement by the public in significant regulatory decisions suggests the creation of an impermissible dichotomy between the public, as limited to the non-regulated community, and the non-public, as limited to the regulated community. Such a dichotomy is unconstitutional and false. The Constitution recognizes only one public. It includes both the regulated and non-regulated communities. Both must be given equal protection under the law. In this case, that means equal opportunity to participate in the regulatory process. That equality should be made clear.

Finally, a requirement to choose the regulatory alternative that best assures safety is not necessary under the Atomic Energy Act. Such a requirement is essentially a restatement of the principle of excellence and is subject to the same analysis. Reasoned decisionmaking supports the choice of the most cost-beneficial requirement that at least satisfies the regulatory floor of adequate protection.

That principle is consistent with the Atomic Energy Act and should be adopted as the only rational, regulatory principle consistent with sound economics as well as public safety.

ACNP/SNM Agreement State Comments September 28, 1994 Page 11 National Unifonnity Is Limited To

.Basic (FRC-Type) Radiation Standards NRC responsibility for developing a coherent national radiation control program is limited to the establishment of uniform basic radiation standards as discussed above. Any additional program elements adopted to meet this goal are contrary to the empowerment of the states and the consequent diversity in radiation control programs envisioned by the Congress when it enacted Section 274.

Therefore, this principle should be restated narrowly in terms of basic radiation standards in order to comport with the scope ofNRC statutory authority.

"Areas Of National Significance" Is Not A Statutorily Cognizable Term Agreement State responsibility to assure a consistent radiation control program in areas having national significance is a concept created out of whole cloth by the NRC. No Agreement State has extraterritorial responsibility nor could any be assigned by Section 274 of the Atomic Energy Act.

If a concern is a national concern, it should be addressed directly by the NRC. Required uniformity of basic radiation standards is the only such concern identified by Congress in enacting Section 274.

That concern is met by requiring all Agreement States to adopt identical basic radiation standards.

It is not met by assigning the states extra-territorial responsibilities that they do not possess.

In addition to these legal limitations on the concept of extraterritoriality, the mischief that could arise from this concept is clearly illustrated by the NRC's principal example of the need for Agreement States to be concerned with extra-territorial matters:-Movement of-goods and.provision of services in interstate commerce. These are economic matters beyond the jurisdiction of the NRC and, therefore, beyond its authority to impose on the Agreement States as a price for entering into agreements with the NRC. For these reasons, this concept should be withdrawn.

Conclusion In conclusion, for the many reasons discussed above, the ACNP and SNM strongly urge the NRC to withdraw the two proposed policy statements and to revise them as suggested above before they are re-published for comment. As currently drafted, these policy statements go far beyond the NRC's statutory authority, especially under Section 274 of the Atomic Energy Act, and, therefore, contradict the intent of Congress in enacting that provision. Only if the policy statements are revised as suggested above will they implement Congress' clear intent to encourage the states to regulate the uses of radioisotopes by empowering the states to exercise their inherent regulatory authority, as each sees fit, consistent with uniform basic radiation standards. Such encouragement has been turned to discouragement by these policy statements. That must be corrected.

ACNP/SNM Agreement State Comments September 28, 1994 Page 12

- The NRC also should delay taking any action until it can talce into consideration the review of the medical program by the National Academy _of Sciences Institute of Medicine (NAS-IOM"). This

_- ~- s!_ucly is e_xarnjoi}!g-the_ ~pprgp_tjJit~n~s of~C :r~gl!latio!l of m~gµ_ijceo~ees aud_epwd hav_e_ ~L __

significant impact on the role ofNRC and medical programs in Agreement States. The draft report is due May, 1995 and the final report is expected January, 1996. We believe that the report will contain essential insights into the necessary effective reform of the present regulation of Nuclear Medicine, Nuclear Pharmacy, and Radiation Oncology_ Thus, it would be premature for the NRC to consider making major policy changes until after the NAS-IOM evaluation is completed, its report and recommendations are received and the NRC has had time to consider and act on them.

Federal Interference Wrth State Regulation of Medicine and Pharmacy Federal interaction in existing state determinations of how best to distribute regulatory authority must also be avoided. These proposed policy statements would transfer regulatory authority from state Boards ofMedicine and Pharmacy to state Bureaus of Radiation Health, contrary to state decisions.

Such federal interference in state prerogatives is clearly unacceptable, if not unconstitutional. It also contradicts Congress' determination that local control enhances public health and safety and was to be realized by the ABC's implementation of Section 274 of the Atomic Energy Act. These policy statements turn that Congressional reliance on the safety advantages oflocal control on their head.

Accordingly, these policy statements should be revised to recognize state decisions and to abide by them to the greatest extent possible.

• w~~- 1Ylc.~ - _since~e~~-r~,b?-,

William H. McCartney, MD. James J. Conway, M.D.

President President American College of Nuclear Physicians The Society of Nuclear Medicine

DOCKET NUMBER PROPOSED RULE Pl. I~~r~ ,. , '.

DOCKETED

( 51 Fl<. 372{, 1) [7 59 ~ .Gp ]

• 94 JUL 15 P4 :1 4 NUCLEAR REGULATORY COMMISSION OFFICE OF SEC .ET:,_ ':J. Y DOCKET! G l ~,C /!C f BRAHC Adequacy and Compatibility for NRC and Agreement state Radiation Control Programs Necessary to Protect Public Health and Safety; Draft Statement of Policy AGENCY: Nuclear Regulatory Commission.

I ACTION: Draft Statement of Policy.

SUMMARY

The Nuclear Regulatory commission is revising its general statement of policy regarding the review of Agreement State radiation control programs. This action is necessary to clarify the meaning and use of the terms "adequate" and "compatible" as applied to an Agreement State radiation control program. This draft policy statement would not be intended to have the force and effect of law or binding effect; it is intended as guidance to the Agreement states, NRC staff, and the public to make clear how the Commission intends to evaluate the adequacy and compatibility of NRC and Agreement State programs.

Comments are solicited on the draft policy statement and specific questions contained in this n-tice.

/ o 1 ,eil9'--J DATES: Comments are due on or before (90 days after publication in the Federal Register).

ADDRESSES: Send writte~ comments to Secretary, u.s. Nuclear Regulatory Commission, Washington, D.C. 20555, Attention:

Docketing and Services Branch. Deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm on Federal workdays.

FOR FURTHER INFORMATION CONTACT: Cardelia Maupin, State Agreements Program, Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone

• I '

(301) 504-2312.

SUPPLEMENTARY INFORMATION:

Table of Contents I. Background Results of Discussions with Various Groups A. states B. Regulated Community

c. Environmental Group II. Discussion A. Adequate B. Compatibility

c. Compatibility and Adequacy Determination of Agreement States D. Termination of Agreements E. Specific Questions for Public Comment III. Policy statement 2

A. Definitions B. Elements of an Adequate Program

c. Elements of a Compatible Program D. Compatibility criteria E. Implementation F. Examples for the ~compati6ili ty crrte:r~ia G. Examples of More Stringent Requirements IV. Paperwork Reduction Act Statement I. Background The terms "compatible" and "adequate" constitute core concepts in the Commission's Agreement state program under Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, in 1959. Subsection 274d. states that the Commission shall enter into an Agreement under subsection b., discontinuing NRC's regulatory authority over certain materials in a state, if the State's program is both adequate to protect public health and safety and compatible with 4I the Commission's regulatory program. Subsection 274g. authorizes and directs the Commission to cooperate with the States in the formulation of standards to assure that State and Commission standards will be coordinated and "compatible." Subsection 274(j) (1) requires the Commission to periodically review the Agreements and actions taken by the States under the Agreements to insure compliance with the provisions of section 274.

Although the terms "compatible" and "adequate" are fundamental requirem;;;ts in the Agreement State pro.gram under- Section 274 of 3

the AEA,. these terms ~re not defined in the Act. Neither has the commission provided a formal definition or formal comprehensive guidance on how the terms should be interpreted in implementing Section 274. The guiding concept over the years since the beginning of the Agreement State program in the area of compatibility has been to encourage uniformity to the maximum extent practicable while allowing flexibility, where possible, to accommodate local regulatory concerns. This concept has been implemented in case-by-case decisions by the Commission and in internal procedures developed by the staff to assign designations of degrees of "compatibility" {i.e. uniformity), from "essentially verbatim" to "no degree of uniformity required," to sections of the Commission's regulations. More recently, the Commission has attempted to involve the States earlier in the process of developing new regulations and determining what level of "compatibility" (i.e. uniformity) will be required of the Agreement States.

The Commission's approach to making compatibility determinations has evolved slowly over the life of the Agreement State program.

At the same time, since 1962, the Agreement State program has expanded and developed significantly both in the number of Agreement States, as well as depth of experience and expertise of state regulators. To clarify the matter of compatibility, the commission has directed the staff to develop a comprehensive interpretation and application of compatibility.

4

on April 2, 1993, the Commission directed the staff to develop a compatibility policy for all program areas other than low level radioactive waste. While developing the policy, the staff participated in discussions with the Agreement States, the non-Agreement States, the regulated community, and the general

- * -public~ A working* group was formed and a* draft issues paper-was-developed. The draft issues paper was discussed with the Agreement States in a public meeting in May 1993 and draft options, SECY-93-290, were discussed in October 1993 at the All Agreement States Meeting. The Agreement and' non-Agreement States, the regulated community and the general public participated in a public workshop on the final issues paper in July 1993.

Results of Discussions with Various Groups A. states The States would like to see a minimum number of requirements for 4I compatibility determinations. From the comments at the July 1993 public workshop and during the October 1993 All Agreement States Meeting in Tempe, Arizona, the following positions, though not a formal consensus, emerged:

The states are in favor of:

1. uniformity of requirements that are necessary to assure interstate commerce, i.e., labels, signs and symbols.

2. uniformity of radiation standards necessary to protect public health and safety. However, States want the 5

flexibility to set stricter dose limits when local

~ conditions warrant them.

3. early and substantive involvement in the deliberations on the development of regulations.

B. Regulated community The regulated community desires strict adherence to uniform national radiation standards so that licensees meet the same standards in all states and will not be subject to different regulations in different States.

c. Environmental Group An environmental advocacy group indicated that Federal and

.state regulations should be the minimum requirements with the proviso that communities may have the flexibility to go beyond those regulations.

In the formulation of this draft policy statement, the staff has carefully considered the views of the Agreement States, the regulated community, the environmental group and other members of

- the public.

II. Qiscus~ion The question posed by the current task to develop a compatibility policy centers on making a determination of what components or elements of a State radiation control program are needed beyond those which establish and maintain an adequate radiation control program. Presently, adequacy of Agreement State programs is only applied to program elements in terms of their direct or indirect

• • bearing on public-health and safety anaciompatibility ls only 6

applied to the degree of conformity between State regulations and NRC's regulations. However, staff believes that some regulations should be a matter of adequacy to protect public health and safety and some program elements should be a matter of compatibility. In order to fully understand this concept, the

- relationship between adequacy and compatibility must be examined.

Section 274 of the Atomic Energy Act requires that Agreement State programs be both "adequate to protect the public health and safety" and "compatible with the Commission's program." Thus, under the proposed compatibility policy, these separate findings must be based on consideration of two different objectives; first, providing for an acceptable level of protection for public health and safety in an Agreement State (the "adequacy" component), and second, providing for the overall national interest ;j..n radiation protection, (the "compatibility" component). An "adequate" program, including regulations or 4I other legally binding measures (e.g., license conditions) and program elements (e.g., organiz.ation and resources) should consist of those attributes considered necessary by the Commission to maintain an acceptable level of protection of the public health and safety within the Agreement State. A "compatible" program, inc:::.::.ding radiation protection standards and other program elements, should consist of those attributes considered necessary by the Commission to meet a larger national o Interest in-radiation protection. The~requirements for adequacy 7

would focus on the protection of public health and safety within a particular State, whereas the requirements for compatibility would focus on the extraterritorial effect of State action or inaction either on other States or on the national program for radiation protection. As a basis for determining what ultimately

--wi-11 -1:>if-requ.1:i:.*ea.-for- compa.t~ibrlity ,--th-e-commissi-on- 1Dust- -f-irst--

identify what is necessary for a state program to be "adequate."

A. Adequate

..  ! ~

Under the draft policy, "adequate" would focus on those elements of a State program that are necessary to provide a level of protection of the public health and safety within the state that

• is equivalent to, or greater than, 'Lhat provided by the NRC regulatory program for its licensees. The requirements for "adequate" would not require that NRC regulations or other program elements be incorporated in an essentially identical

~anner. Under the adequate provision, states would also be allowed to establish requirements throu9h measures other than regulations, such as license conditions.

B. compatibility The "compatibility" requirement would focus on those elements of a State program which would be required to be essentially identical with the NRC regulatory framewor~ in order to achieve a larger national interest beyond that required for adequate

.,. protection -of-the public healt!n arid safety wi-thin the st*at~. The 8

draft policy establishes four criteria 1 that the NRC would use to determine which elements of the NRC regulatory program, including specific NRC regulations, that the State would be required to incorporate in an essentially identical manner into its regulatory program. The dose limits and radiation-protection

• • ---rela:tea**relea-ere-1imits **in* -1:o--cFR-Part*--20 and---1-0--eFR Part---61:------

applicable to all licensees, or any subsequent amendments thereto, or other NRC regulations which are required to be essentially identical for compatibility purposes will automatically be required to be identical. ' 2 states will not have the flexibility to deviate from the program elements that the Commission requires for compatibility.

c. Compatibility and Adequacy Determination of Agreement states The staff has developed a management directive for the use of common performance indicators in review of the Agreement States and regional materials program. The development of the common performance indicators for the evaluation of Agreement States and the NRC regional offices will be directly related to adequacy 1The compatibility criteria are specified in Section III.D, below.

2 In issuing this Draft Policy Statement for comment, the Commission is revisiting its earlier decision to review compatibility of Agreement state program~ in the low level radioactive waste area on a case-by-case basis. The Commission based. its earlier decision on a belief that such case-by-case consideration could best address the special circumstances that confront Agreement States in that area. Using the case-by-case apEroach, the Commission has determined that the low level radioacti'.ve waste- regulations. of., Pennsylvania and Illinois are ,

compatible.

9

requirements for Agreement State programs, and consequently, will need to be closely coordinated with the staff efforts to define the elements of an adequate State program. In January 1994, the staff provided to the Commission a paper further describing the use of common performance indicators in NRC region and Agreement state reviews. The staff is currently implementing a pilot program on the common performance indicators program. The current proposed common performance indicators program contemplates using a Management Review Board (MRB) to make the decision on the adequacy of existing Agreement State programs.

The initial adequacy determination of a proposed new Agreement State progr:am. will be made by the Office of State Programs, rather than the MRB, because the adequacy of a proposed new program is not dependent on effectiveness of actual program implementation. The staff plans to follow this same split of responsibilities for the compatibility determination of an Agreement state program, with the MRB making the compatibility determinations for existing Agreement state programs, and the Office qf state Programs making the initial compatibility determinations for proposed new programs. The initial adequacy and compatibility determinations for proposed new Agreement State programs are reviewed and approved by the Commission. Indicators of compatibility will also be developed by the staff.

10

o. Termination of Agreements Termination of an Agreement can occur when an Agreement State program is either inadequate or incompatible. The proposed MRB, reviewing discrete common performance indicators, would judge the overall adequacy of an Agreement state program. Similarly, the MRB would review discrete "compatibility indicators" and determine the overall compatibility of an Agreement State program. For either of the adequacy or compatibility determination, failure to satisfy an individual indicator may not necessarily result in an overall finding of inadequacy or incompatibility. In some situations, individual indicator weakness(es) could result in a "marginal" finding by the MRB calling for Agreement State improvements and the State program may be placed on probation. In extreme cases, indicator(s) failure could lead to inadequate or incompatible findings resulting in the initiation of program suspension or termination.

In terms of the compatibility evaluation, the significance of performance indicator "incompatibility" in an individual State-

~

will be judged on the basis of the impact on the national program.

E. Specific Questions for Public Comment In responding to this notice, the following questions should be specifically addressed along with any additional comments.

11

1. Under what circumstances should Agreement States be permitted to establish more stringent requirements, for their licensees, than those established by the Commission?

Should this also include the ability to establish stricter dose limits for particular classes of licensees?

2. Are the four criteria in the proposed policy *statement for determining whether a Commission regulation or other program.

element should be adopted in a manner essentially identical by the Agreement states sufficient to ensure protection of the national interest in radiation protection? What examples could be used to illustrate how each criterion would be applied?

3. What are some examples of State action to establish stricter requirements than those established by the Commission, or establish requirements where the NRC has not?

4. What limits, if any, should be placed on the power of a State to preclude or, by exceptionally stringent regulations, effectively preclude a particular practice?

' 5. Are there any other dose or radiation-protection related release limits in the Commission's regulations which should be included under the criterion number 3 of the compatibility criteria? Should the dose limits contained in

\

10 CFR Part 61 be included under this criterion?

6. Should the draft adequacy and compatibility policy statement be applicable to the regulation of low-level waste disposal 12

instead of continuing to consider questions of compatibility in this area on a case-by-case basis?

7. Are there currently areas or situations in Agreement State regulations or other Agreement State requirements that would not meet the proposed policy statement?

a. Should states be permitted to establish more stringent standards for radiation-protection related release limits?

III. Policy statement

• The purpose of this Policy Statement is to provide a comprehensive interpretation and application of the terms "adequate" and "compatible" as they apply to the NRC Agreement State regulatory programs.

The terms "compatible" and "adequate" consti~ute core concepts in the Commission's Agreement State program under Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, in 1959. Subsection 274d. states that the Commission shall enter into an Agreement under subsection b., discontinuing NRC's regulatory authority over certain materials in a state, if the State's program is both adequate to protect public health and safety and compatible with the Commission's regulatory program. Subsection 274g. authorizes and directs the commission to cooperate with the states in the formulation of standards to assure that State and Commission standards will be coordinated and "compatible." Subsection 274j(1) requires the Commission to* periodically review the 13

Agreements and actions taken by the states under the Agreements to insure compliance with the provisions of section 274.

A. Definitions For the purpose of evaluating the adequacy of Agreement State regulatory programs to protect public health and*safety, the-*

following terms are defined:

1. Adequate The acceptable level of protection for the public health and safety from the radiation hazards associated with the use of byproduct, source, and special nuclear materials.

2. An Adequate Agreement state Program An effectively implemented regulatory program containing elements considered necessary by the Commission to provide an acceptable level of protection for the public health and safety from the radiation hazards associated with the use of byproduct, source, and special nuclear materials.

3. Compatible The consistency between NRC and Agreement State regulatory programs which is needed for the regulation of byproduct, source and special nuclear material which assures an orderly and effective regulatory pattern in the administration of the national radiation protection program. Compatibility shall be aimed at ensuring that interstate commerce is not impeded, that effective communication in the radiation protection field is

- maintained, that dose limits and radiation-protectfon-related 14,

release limits applicable to all licensees are maintained, and that information needed for the study of trends in radiation protection and other national program needs is obtained.

4. A Compatible Agreement State Program A regulatory program containing elements considered necessary by the Commission to effectively implement the term "compatible" as defined above.

5. Element "Element" or "program element" is used to describe any of the essential components and functions of a radiation protection regulatory program. The term includes any a~pect of a radiation protection regulatory program that is necessary to implement a program that is adequate to protect public health and safety and is compatible with the NRC regulatory program. The term "element" may include organizational structure, staffing level, inspection frequency, regulations, policies and procedures or any other component or function that the Commission considers necessary.

6. Practice The term "practice" describes a use, procedure or activity associated with the application, possession, storage or disposal of byproduct, source and special nuclear materials. The term "practice" is very broad ""-nd encompassing'in nature. For example, the term "practice," as applied in the policy statement, not only applies to very general activities involving radioactive

• -materials* sucn as industrial radiography, row-level waste 15

disposal, nuclear medicine procedures, and well logging, but also includes specific activities conducted within these very broad activities, such as shallow land burial, sanitary sewerage disposal, and incineration of materials.

7. Radiation Protection Standards As used in this Policy Statement, the term "radiation protection standards" means dose limits and radiation-protection related release limits in 10 CFR Part 20 and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto.

B. Elements of an Adequate Program

1. PROTECTION The Agreement state program shall be designed and administered to protect the public health and safety of its citizens against radiation hazards.

2. REGULATIONS Except for dose limits and radiation-protection related release limits in 10 CFR Part 20 and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto, or other regulations which are required to be essentially identical for compatibility purposes, an Agreement state program shall adopt regulations or other legally binding measures, equivalent to, or more stringent than, those designated by the NRC.

16

3. INSPECTION The State regulatory program shall provide for the inspection of the possession and use of radioactive materials by the regulatory authority. The State inspection of licensee facilities, equipment, procedures and use of materials shall provide reasonable assurance that the public health and safety is being protected. ~nspection and testing shall be conducted to assist in determining compliance with regulatory requirements. Frequency of inspection shall be related directly to the hazards associated with amount and kind of material and type of operation licensed. The minimum inspection frequency, including initial inspections, shall be no less than the NRC inspection frequency. An adequate inspection program includes: preparation and use of procedures and policy memoranda to assure technical quality in the inspection program and review of inspection actions by senior staff or supervisors. The inspection staff technical expertise should be similar to NRC staff qualifications.

4. ENFORCEMENT PROGRAM Licensee noncompliance with requirements necessary for the safe possession and use of radioactive materials shall be subject to enforcement t~rough legal sanctions, and the regulatory authority shall be authorized by law with the necessary powers for prompt enforcement.

17

5. STAFFING AND PERSONNEL QUALIFICATIONS The regulatory agency shall be sufficiently staffed with an adequate number of qualified personnel to implement the radiation control program effectively. Agreement State staff shall be qualified using criteria no less stringent than criteria used for NRC staff.

6. ADMINISTRATIVE PROCEDURES State practices for assuring the effective administration of the radiation control program, including provisions for public participation where appropriate, shall be incorporated in procedures for:

(a) Formulation of rules of general applicability; (b) Approving o~ denying applications for licenses authorizing the possession and use of radioactive materials; and (c) Taking enforcement actions.

7. STATUTES State statutes and/or duly promulgated regulations shall be established to authorize the State to carry out the requirements under Section 274b of the Atomic Energy Act, as amended and any other statutes as appropriate, such as Public Law,95-604, Uranium Mill Tailings Radiation control Act (UMTRCA).

18

8. LABORATORY SUPPORT The State shall have available calibrated field and laboratory instrumentation sufficient t~ independently determine the licensee's control of materials, to validate the licensee's measurements, and to respond to events involving radioactive material.

9. LICENSING The State regulatory program review of license applications for the purpose of evaluating the applicant's qualifications, facilities, equipment, procedures and use of materials shall provide reasonable assurance that the public health and safety are being protected. An adequate licensing program includes: preparation and use of licensing guides and policy memoranda to assure technical quality in the licensing program and review of licensing actions by senior staff or supervisors. In addition, procedures involving the licensing of products containing radioactive material intended for interstate commerce should require a high degree of uniformity with those of the NRC. The review staff technical expertise should be similar to NRC staff qualifications.

10. INVESTIGATION (RESPONSE TO EVENTS)

The State regulatory program shall provide for timely and effective investigation of incidents, reportable events, allegations and any potential wrongdoing.

19

11. BUDGET The State radiation control program (RCP) shall have adequate budgetary support to implement an effective program. The total RCP budget must provide adequate funds for salaries, training, travel costs associated with the compliance program, laboratory and survey instrumentation and other equipment, contract services,* and other administrative costs.

c. Elements of a Compatible Program

1. RADIATION LABELS, SIGNS, AND SYMBOLS states must have radiation labels, signs and symbols identical to that of the national standard.

2. UNIFORM MANIFEST state regulatory programs shall establish a manifest system in accordance with 10 CFR Part 20.

3. TRANSPORTATION REGULATIONS State regulations regarding transportation of radioactive materials must be identical or essentially verbatim with those in 10 CFR Part 71.

4* EVENT REPORTING The State regulatory program shall require licensee reporting in a manner so that information on identical type events is consistent with the reporting established by the NRC. This information shall be provided to the NRC.

20

5. RECIPROCITY The state regulatory program shall have reciprocal recognition of out-of-State licensees and Federal licensees through a process which authorizes the safe conduct of similar operations within the Agreement State.

6. RECORDS AND REPORTS The State regulatory program shall require that holders and users of radioactive materials {a) maintain records covering personnel radiation exposures, radiation surveys and disposal of materials, (b) keep records of the receipt and transfer of the material, (c} maintain reports of significant incidents involving radioactive materials.

7. RADIATION PROTECTION TERMINOLOGY The State regulatory program shall adopt fundamental radiation protection terminology in a manner essentially identical to NRC definition of these terms to ensure clear communication about radiation protection. Some examples of these terms are "byproduct material;" "total effective dose equivalent;" "sievert;" "gray;" and "becquerel."

8. RADIATION PROTECTION STANDARDS The State regulatory program shall adopt dose limits and radiation-protection related release limits in 10 CFR Part 20, and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto.

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D. compatibility criteria The following criteria shall be applied to program elements and regulations to determine whether they must be adopted by Agreement States in a manner essentially identical to that of the NRC for the purposes of compatibility:

1. avoids a significant burden on interstate commerce;

2. ensures clear communication on fundamental radiation protection terminology;

3. ensures the establishment of the dose limits and radiation-protection related release limits in 10 CFR Part 20 and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto;

4. assists the Commission in evaluating the effectiveness of the overall national program for radiation protection.

If none of the above criteria is met, the State would have the flexibility to design its own program including incorporating more stringent3 requirements provided that:

a. the requirements for adequacy are still met; and

b. the more stringent requirements do not preclude or effectively preclude a practice within the national interest without an adequate public health and safety or environmental basis.

3 Local governmental entities are not usually authorized by the NRC under Section 274 to regulate radiological safety. Thus, with limited exception, the authority to set more stringent requirements

• - would no-extend-to localities unless-approved by th Commission through a Section 274 Agreement.

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E. Implementation Notwithstanding the provisions above, the Agreement states shall exercise their regulatory authority in a responsible manner and shall not adopt more stringent regulations or requirements as a means to bar or preclude a practice without an adequate safety or environmental basis, or bar a practice needed -in the national-interest. In order to permit the NRC to provide early coordination and oversight of any proposed more stringent regulations or requirements, NRC will request Agreement States to t

identify any such regulations or requirements and provide opportunity for NRC review before publication as a draft rule for comment or before the institution of the requirement as a legally binding measure.

F. Examples 4 for the Co:mPatibility criteria

1. Avoids a significant burden on interstate commerce.

- The adoption of transportation requirements for all Agreement states should be essentially identical to assure that the flow of radioactive materials in or through another jurisdiction is not impeded. For example, if States were allowed to change 10 CFR 71.47, "External Radiation standards for all Packages" then it would be very difficult to transport radioar~tve material packages.

4The examples are not -part of tlie Policy Statement and-are neither exhaustive nor controlling.

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2. Ensures clear communication on fundamental radiation protection terminology.

- The definition of the terms "sievert" and "gray" (or.

"rem," "rad") would need to be adopted essentially identically by all Agreement States.

J. Ensures the establishment of dose limits* arid radiation-protection related release limits in 10 CFR Part 20 and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto.

- The basic dose limits and radiation-protection related release limits for all classes of licensees set forth in Subpart c, "Occupational Dose Limits," and Subpart D, "Radiation Dose Limits for Individual Members of the Public," of 10 CFR Part 20 would need to be adopted essentially identical by all Agreement states along with any other subsequent amendments to 10 CFR Part 20 that may set forth dose limits. 10 CFR Part 61.41, "Protection of general population from releases of radioactivity" and 10 CFR Part 61.43, "Protection of individuals during operations" would also need to be adopted essentially identically by all Agreement States.

4. Assists the Commission in evaluating the effectiveness of the overall national program for radiation protection.

- The adoption of 10 CFR 35.33, "Notifications, reports, and

--- - 0--- .. ,..._. -

records of misadministrations" would be adopted by tne 24

Agreement States in a manner essentially identical to that of the NRC.

G. Examples' of More stringent Requirements As noted above, if the State program is equivalent to, or more stringent than, NRC's program to assure the protection of the*

public health and safety, and it incorporates all the elements of the NRC program identified by the Commission as necessary to achieve the national interest in radiation protection, including the requirement to establish regulations which are uniform with the dose limits and radiation-protection related release limits in 10 CFR Part 20 and 10 CFR Part 61 applicable to all licensees, or any subsequent amendments thereto, then a State should generally have the flexibility to tailor its program. More*

stringent requirements, other than the above mentioned dose limits and radiation-protection release limits could be applicable to all classes of licensees in a State. For example,,

- an Agreement State's record.keeping provisions for all licenses could be more stringent than NRC's. Other examples of State actions which impose stricter requirements than NRC regulations, and which would be "adequate" under the draft policy statement, are

1. STATE OF FLORIDA - 20.304

- (Iii,,,- *

• 5The examples are not part of the Policy Statement and are neither exhaustive nor controlling.

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Between 1957 and 1981, several State representatives expressed concern to the commission over the risk from burials of radioactive waste allowed by 10 CFR 20.304, that was in effect at that time. This regulation, "Standards for Protection Against Radiation; Burial of Small Quantities of Radionuclides" provided that licensees could bury small quantities of radionuclides without prior NRC approval. The state of Florida submitted a request to the NRC to be more stringent by precluding this practice within the state because of its high ground water level. The State's exemption request was reviewed and approved by the NRC.

2. SHALLOW LAND BURIAL Several States prohibit the practice of shallow land burial of low-level waste. These more stringent regulations would be allowed under the draft policy statement even though a practice is prohibited. There is no overriding national interest in allowing shallow land buria.l of low-level waste *

• A different result would likely be obtained if disposal of low-level waste altogether was prohibited, unless the State was able to convince NRC of special public health and safety or environmental basis for this action.

3. TEXAS INDUSTRIAL RADIOGRAPHY CERTIFICATION Texas has established a ~rogram for the certification of industrial radiography that is more rigorous than Commission requirements. This program requires persons to perform 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of on~the-job training, complete 40.hours of classroom 26

instruction and successfully complete an examination before receiving authorization to conduct radiographic services with radioactive materials. (This example is based on the assumption that the training requirements in 10 CFR 34 do not meet any of the four compatible criteria.)

rv. Paperwork Reduction Act statement This draft statement of policy does not contain a new or amended information collection requirement subject to the Paperwork

• Reduction Act of 1980 (434 u.s.c. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, approval number 3150-0029.

Dated at Rockville, Maryland, this/3-1:,_ay of }Lj, 1994.

For the Nuclear Regulatory Commission.

ng ommission.

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