ML20211D805
| ML20211D805 | |
| Person / Time | |
|---|---|
| Issue date: | 08/25/1997 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Diaz N, Dicus G, Shirley Ann Jackson, Mcgaffigan E, The Chairman NRC COMMISSION (OCM) |
| References | |
| NUDOCS 9709290243 | |
| Download: ML20211D805 (132) | |
Text
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y po uruq I g i UNITED STATES g j NUCLEAR REGULATORY COMMISSION t WASHINoToN. D.C. N*
\*****/ Auust 25, 1997 MEMORANDUM TO: Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan FROM: L. Joseph Callan Executive Director for Operations f
SUBJECT:
RESPONSE TO STAFF REQUIREMENTS MEMORANDUM (SRM)
DATED JUNE 30,1997 in SRM dated June 30,1997, SECY 97-054 - Final Recommendations on Policy Statement and Implementing Procedures for: " Statement of Principles and Policy for the Agreement State Program" and " Policy Statement on Adequacy and Compatibility of Agreement State Programs," the Commission approved the two Policy Statements and the accompanying implementing procedures, subject to direction provided by the Commission. The purpose of this memorandum is to inform the Commission of the actions the staff has taken to address its comments, items 1, 2,3b, 6, 7,8, and 9 of the SRM, all of which have a SECY suspense date of August 29,1997, are discussed below.
DISCUSSION:
ITEM 1: The Policy Statement on Adequacy eno Compatibility of Agreement State Programs (Policy) and procedures should be revised to identify specifically the regulations in the "NRC" category that the States may adopt for clarity and a separate category created for those regulations that are reserved for the NRC and that States may not adopt and still be found to have compatible regulatory programs. The flow chart in Appendix A to Handbook 5.9 should also be revised to reflect this distinction.
RESPONSE: .The Policy Statement was revised to indicate that there are regulatory areas reserved to the NRC and the States may not adopt regulations or program elements in these regulatory areas. The following section was added:
"E. AREAS OF EXCLUSIVE NRC REGULATORY AUTHORITY These are program elements that address areas that cannot be relinquished to '
Agreement States pursuant to the AEA or provisions of Title 10 of the Code of Federal Reg r:ations. However, an Agreement State may inform its licensees of
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k The Commissioners 2-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 purnoses of notification, and does not exercise any regulatory authority pursuant to them "
Changes also were made to the implementing procedures to indicate that Compatibility Category "NRC" addresses only areas of regulation that cannot be relinquished to Agreement States. Handbook 5.9, page 3, was revised to read:
E &i: :: th: NRC Areas lof Exclusl#NRC.Regulato(Authoritv (f)
These are NRC program elements that address areas ofiegUlstiori that cannot be relinquished to Agreement States pursuant to the AEA or.provisionsfof Title 10'of the Code:of Federal _ Regulations. TheseWogramielements are designated "NRC; and.should not,beladopted.byiAgreement States; in addition, Handbook 5.9, page 14, was revised to eliminate the following text:
Areas Reserved Solely to NRC (F)
Certain regulatory areas cannot be relinquished to the States under 274 b agreements and remain the sole jurisdiction of the Federal Government. NRC rules promulgated to regulate these areas are reserved solely to the NRC. However, States may adopt program elements (including regulations) ;.1, or otherwise address, these areas for the purpose of clarity :,nd ease of communication, States may not adopt regulations, other legally binding requirements or program elements that would cause the State to regulate such activities.
By removal of the wording above, the concept that the Compatibility Category "NRC" contains both program elements reserved to the NRC and those States may adopt for clarity and ease of communication is eliminated. This distinction is explained further on page 6 of Handbook 5.9.
Finally, the key to the compatibility categories and tables of the OSP Internal Procudure 8.7, Revision 1 (B.7): Compatibility Categories and Health Safety Identification for NRC Regulations and Other Program Elements, was revised to delineate program elements reserved to the NRC from those that States may adopt and still be found to be compatible.
Those program elements that were previously identified as Compatibility Category "NRC" and which the States could adopt for clarity, were changed to a designation of Compatibility Category "D," not needed for compatibility. All designations of "NRC" in the tables now indicate program elements which are the sole regulatory jurisdiction of the NRC.
Thus, after the completion of the revisions described above, it was no longer necessary to create a new compatibility category (NRC-X) or to revise the flow chart to clarify regulatory
Y The Commissioners areas reserved to the NRC Copies of the Policy Statement, Management Directive 5.9 and Handbook 5.9 and Internal Procedure B.7 are attached (Attachments 1,2,3, and 4, respectively) in line-in line-out text to show where changes were made in addition, Management Directive and Handbook 5.9 have been sent out for final Office concurrence in accordance with Management Directive 1.1 prior to their issuance in final.
ITEM 2: Revise the flow chart in Appendix A to Handbook 5.9 to clarify that regulations required for health and safety may also be included in compatibility categories A, B, and C as we;l. The staff should also add the following sentence to the second paragraph of the
" Background" section of the Policy Statement: "Many program elements for compatibility also impact public health and safety; therefore, they may also be considered program elements for adequacy."
RESPONSE: The flow chart was revised to include a footnote for Compatibility Categories A, B, and C. The footnote states:
"Many program elements for compatibility also impact public health and safety; therefore, they may also be considered program elements for adequacy."
In the Policy Statement, the above language was added to the " Background," section.
ITEM 3,b.: Review regulation and other program element tables to identify inconsistencies, errors, or omissions, and to verify the appropriateness of ti.e compatibility assignments.
RESPONSE: The staff performed a review of the Tables in B 7. The staff also updated the tables to reflect all final rules adopted by the Commission since May 16,1996 through August 8,1997 that are applicable to the regulation of Agreement materials. Tables which show the proposed revisions and updates to reflect final rules are contained in the attached Charts, Attachment 5. The revisions and updates will be shared with the Agreement States for review and comment before being incorporated into B.7 as final changes.
ITEM 6: Defer findings on Agreement State quality management (QM) rules until NRC issues a revised Part 35 rule ar directed in the SRM on DSI-7 and an effective date for Agreement State implementatiol has been set. Such a date could be earlier than the normal 3-year interval for Agrerment State implementation of an NRC rule.
RESPONSE: The staff informed the Agreement States of the continued deferment of the compatibility findings for the CM rule by All Agreement State letter SP 97-057, dated August 6,1997, from Paul H. Lohaus, Deputy Director. Office of State Programs, Attachment 6.
ITEM 7: Modify the definition of " basic radiation protection standards" contained in the
" Policy Statement on Adequacy and Compatibility of Agreement State Programs" to reflect recent Commission decisions on the imposition of constraints, such as the " constraint" rule on air emissions and the license termination rule.
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The Commissioners RESPONSE: As directed by the Commission, the staff modified the definition of " basic radiation protection," as follows, with the added text highlighted:
For purposes of this Policy Statement, this category includes "batic radiation protection standards" meaning dose limits, concentration and release limits related to rad!ation protection in 10 CFR Part 20 that are generally applicable, and the dose limits in 10 CFR 61.41.8 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
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c' onstraints or otlier limits below the level ass'ociated with " adequate protection" that take into account permissible; balancing considerations such as economic cost and other factors; 2 The Commission willimplement this category consistent with its earlier decision in the LLW area to allow Agreement States flexibility to establish pre-closure operational release limit objectives, ALARA goals or design objectives at such levels as the State may deem necessary or appropriate, as long as the level of protection of public health and safety is at least equivalent to that afforded by Commission requirements.
ITEM 8: Modify Management Directive 5.9 to reflect the Commission's direction in the SRM on DSI 22 to develop an implementation plan that would reassign responsibility for preparation and coordination of rulemaking from the Office of Nuclear Regulatory Research to the Program Offices. Suggested editorial changes to accomplish this objective were provided.
RESPONSE: Management Directive 5.9 was revised as directed by the Commission.
ITEM 9: Eliminate references in the text to voluntary reporting and make it clear that reporting of materials events is mandatory.
RESPONSE: The Program Element table of OSP Internal Procedure B.7 (Revision 1),
indicates that event reporting to NRC by an Agreement State is a compatibility category C program element. The table was revised to state that event reporting it. mandatory as directed by the Commission and failure to provide reports may serve as a sole basis for a finding of not compatible (Attachment 7).
In addition, to the actions discussed above, the staff revised the draft Federal Reaister (FR) notice: " Statement of Principles and Policy for the Agreement State Program; Policy Statement On Adequacy and Compatibility of Agreement State Programs," in accordance
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l The Comm'issioners ~ i l with the'SRM. The FR notice along with the Co'ngressional letters to be distrit uted when the FR notice is signed; have been provided to the Office of Administration, Division of
- - Administrative Services. The Office of Administration will coordinate the signing of the i notice with SECY and the signing of the Congressional letters with the Office of Congressional Affairs. A copy of the FR notice is attached,- Attachment 8.
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RESPONSE TO STAFF REQUIREMENTS MEMORANDUM (SRM) DATED JUNE 30,1997 ATTACHMENTS ATTACHMENT 1: Final Policy Statement on Adequacy and Compatibility of Agreement State Programs ATTACHMENT 2: Management Directive 5.9 Adequacy and Compatibility of Agreement State Programs ATTACHMENT 3: Handbook 5.9 Adequacy and Compatibility of Agreement State Programs ATTACHMENT 4: Internal Procedure 0.7 (Revision 1): Compatibility Categories and Health and Safety identification for NRC Regulations and Other Program Elements (Note: Rule and Program Element tables are not t
includeo in Attachment 4)
ATTACHMENT 5: Chart 1 Proposed Revisions to the Internal Procedure 8.7 Rule Tables Chart 2 Compatibility Categories of Final Rules Adopted Since May 10,1996 through August 8,1997 ATTACHMENT 6: All Agreement State Letter SP 97-057, Dated August 6,1997 SECY 97 054 and Staff Requirements Memorandum ATTACHMENT 7: Progiam Elements Table from OSP Internal Procedure B.7 (Revision 1)
ATTACHMENT 8: Federal Realster Notico Statement of Principles and Policy for the Agreement State Program; Policy Statement on Adequacy and Compatibility of Agreement State Programs
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V Final Polley Statement on Adequacy and Compatibility of Agreement State Programs
Deleted text is indicated by drikeout.
Added text is indicated by redline.
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 Comrnission's policy for determining the adequacy and compatibility of Agreement State programs established pursuant to Section 274. This Policy Statement clarifies the meaning and use of the terms " adequate to protect public health and safety" and " compatible with the Commission's regulatory program" as applied to the Agreement State program. The Policy Statement also describes the general l
framework that will be used to identify those program elements' that Agreement State programs should implement to be adequate to protect public health and safety and to be compatible with the Commission's regulatory program. Finally, the Policy Statement reflects principles discussed in the Commission's Statement of Principles and Policy for the I 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 Stato program. This Policy Statement does not itself
, impose legally binding requirements on the Agreement States. In addition, nothing in this j Policy Statement expands the legal authority of Agreement States beyond that already granted to them by Section 274 of the Atomic Energy Act and other relevant legal authority, implementation procedures adopted pursuant to this Policy Statement shall be consistent with the legal authorities of the Commission and the Agreement States.
BACKGROUND The terms " adequate" and " compatible" represent fundamental concepts in the Agreement State program authorized in 1959 by Section 274 of the Atomic Energy Act of 1954, as amended (AEA). Subsection 274d, states that the Commission shall enter into an Agreement under subsection b., discontinuing NRC's regulatory authority over certain materials in a State, provided that the State's program is adequate to protect public health and safety and compatible, in all other respects, with the Commission's regulatory program. Subsection 274g. authorizes and directs the Commission to cooperate with States in the formulation of standards to assure that State and Commission standards will be coordinated and compatible. Subsection 274j.(1) requires the Commission to review periodically the For the purposes of this Policy Statement, " program element" means any component or function of a radiation control regulatory program, including regulations and/or other legally binding requirements imposed on regulated persons, that contributes to implementation of that program.
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Agreements and actions taken by States under the Agreements to ensure compliance with provisions of Section 274. In other words, the Commission must review the actions taken by States under the Agreements to ensure that the programs continue to be adequate to protect public health and safety and compatible with the Commission's program, Section 274 of the AEA requires that Agreement State programs be both " adequate to protect the public health and safety" and " compatible with the Commission's program." These separate findings are based on consideration of two different objectives. First, an Agreement State program should provide for an acceptable level of protection of public health and safety in an Agreement State (the " adequacy" component). Second, the Agreement State should ensure that its program serves an overall nationwide interest in radiation protection (the
" compatibility" component). As discussed in more detail below, an " adequate" program should consist of those program elements necessary to maintain an acceptable level of protection of public health and safety within an Agreement State. A " compatible" program should consist of those program elements necessary to 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, l whereas program elements for compatibility focus on the impacts of an Agreement State's regulation of agreement material on a nationwide basis or its potential effects on other jurisdictions. Many program elements for compatibility also impact public health and safety; therefore, they may _also be considered program elements for adequacy, in identifying those program elements for adequate and compatible programs, or any changes thereto, the Commission will seek the advice of the Agreement States and will consider such advice in its final decision.
ADEQUACY An Agreement State's radiation control program is adequate to protect public health and safety if administration of the program provides reasonable assurance of protection of public health and safety in regulating the use of source, byproduct, and small quantities of special nuclear material (hereinafter termed " agreement material") as identified by Section 274b. of the AEA. The level of protection afforded by the program elements of NRC's materials regulatory program is presumed to be that which is adequate to provide a reasonable assurance of protection of public health and safety. The overalllevel of protection of public health and safety provided by a State program should be equivalent to, or greater than, the level provided by the NRC program. To provide reasonable assurance of protection of public health and safety, an Agreement State program should contain five essential program elements, identified below, that the Commission will use to define the scope of its review of the program. The Commission also will consider, when appropriate, other program elements of an Agreement State which appear to affect the program's ability to provide reasonable assurance of public health and safety protection. Such consideration will occur only if concems arise.
A. LEGISLATION AND LEGAL AUTHORITY State statutes should:
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- authorize the State to establish a program for the regulation of agreement material and provide authenty for the assumption of regulatory responsibility under an Ar reement with the Commission; authoitze 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 Tallings 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 l agreement materialin the State. Specifically, Agreement States should adopt a limited number of legally binding requirements based on those of NRC because of their pasticular health and safety significance. In adopting such requirements, Agreement States should adopt the essential objectives of those of the Commission.
B. LICENSING The State should conduct appropriate evaluations of proposed uses of agreement material, before issuing a license, to assure that the proposed licensee's operations can be conducted safely. Licenses should provide for reasonable assurance of public health and safety protection in relation to the licensed activities.
C. INSPECTION AND ENFORCEMENT The State should periodically conduct inspections of licensed activities involving agreement material to provide reasonable assurance of safe licensee operations and to determine compliance with its regulatory requirements. When determined to be necessary by the State, the State should take timely enforcement action against licensees through legal sanctions '
authorized by State statutes and regulations.
D. -PERSONNEL The State should be staffed with a sufficient number of qualified personnel to implement its regulatory program for the control of agreement material.
E. RESPONSE TO EVENTS AND ALLEGATIONS The State should respond to and conduct timely inspections or investigations of incidents, reported events, and allegations invo'ving agreement material within the State's jurisdiction to provide reasonable assurance of protection of public health and safety.
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O COMPATIBIUTY An Agreement State radiation control program is compatible with the Commission's regulatory program when its program does not create conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. For purposes of compatibility, the State should address categories A, B, and C identified below:
A. BASIC RADIATION PROTECTION STANDARDS For purposes of this Policy Statement, this category includes " basic radiation protection standards" meaning dose limits, concentration and release limits related to radiation protection in 10 CFR Part 20 that are generally applicable, and the dose lin,its in 10 CFR 61.41'. Also included in this category are a limited number of definitions, signs, labels and scientific terms that are necessary for a common understanding of radiation protection principles among licensees, regulatory agencies, and members of the public. Such State standards should be essentially identical to those of the Commission, unless Federal statutes provide the State authority to adopt different standards. Basic radiation protection standards do not include ' constraints or other limits below the level associated with
- adequate protection" that take into account permissible balancing considerations.such as economic cost and other factors; B. PROGRAM ELEMENTS WITH SIGNIFICANT TRANSBOUNDARY IMPLICATIONS i
The Commission willlimit this category to a small number of program elements (e.g.,
' transportation regulations and sealed source and device registration certificates) that have significant and direct transboundary implications. Agreement State program elements should be essentially identical to those of the Commission.
C. OTHER COMMISSION PROGRAM ELEMENTS These are other Commission program elements (e.g., reciprocity procedures) that are important for an Agreement State to have in order to avoid conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. Such Agreement State program elements should embody the essential objective of the corresponding Commission program elements.
8 The Commission will implement this category consistent with its earlier decision in the LLW area to allow Agreement States flexibility to establish pre-closure operational release limit objectives, ALARA goals or design objectives at such levels as the State may deem necessary or appropriate, as long as the level of protection of public health and safety is at least equivalent to that afforded by Commission requirements.
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, l D. PROGRAM ELEMENTS NOT REQUIRED FOR COMPATIBILITY The 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 junsdiction that are not addressed by NRC.
All program elements of an Agreement State relating to agreement material should:
- be compatible with those of the Commission (i.e., should not create conflicts, duplications, gaps, or othar conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis);
- not preclude, or effectively preclude, a practice'in the nationalinterest without an adequate public health and safety or environmental basis related to radiation protection; or e
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 I,RC provisions through a mechanism that is appropriate under the State's administrative procedure laws as long as the State adopts theJe provisions solely for the purposes'of notification, and does not exercise any regulatory authority pursuant to them.
SUMMARY
AND CONCLUSIONS To foster and enhance a coherent and consistent nationwide program for the regulation of agreement material, the Commission encourages Agreement States to adopt and implement program elements that are patterned after those adopted and implemented by the Commission. However, the fact that an Agreement State's program is compatible with that of the Commission does not affect that State's obligation to maintain an adequate program as described in this Policy Statement.
By adopting the criteria for adequacy and compatibility as discussed in this Policy Statiment the Commission will provide Agreement States a broad range of flexibility in the administration of individual programs. In doing so, the Commission allows Agreement 3tates
- " Practice" means a use. procedure, or activity associated with the application, possession, use, storage, or disposal of agreement material. The term " practice"is used in a broad and encompassing manner in this Policy Statement. The term encompasses both general activities involving use of radioactive materials such as industrial and medical uses and specific activities within a practice such as industrial radiography and brachytherapy.
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1 to fashion their programs to as to reflect s,pecific State needs and preferences, recognizing the fact that Agreement States have responsibilities for radiation sources in addition to agreement material.
The Commission will minimize the number of NRC regulatory requirements that the Agreement States will be requested to adopt in an identical manner to maintain compatibility.
At the same time, requirements in these compatibility categories will allow the Commission to ensure that an orderly pattern for the regulation of agreement material exists nationwide, !
The Commission believes that this approach achieves a proper balance between the need for Agreement State flexibility and the need for coordinated and compatible regulation of agreement material across the country.
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I ATTACHMENT 2
, Management Directive 5.9 - Adequacy and Compatibility of
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Directive 5.9 Contents Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Objectives ........................................1 Organizational Responsibilities and Delegations of Authority . . . . . . . . 2 Executive Director for Operations (EDO) ................2 Director, Office of State Programs (OSP) ................2 Office of the General Counsel (OGC) . . . . . . . . . . . . . . . . . . . 3 Director, Office of Nuclear Regulatory Research (RES) ....... 3 Director, Office of Nuclear Material Safety and Safeguards (NMSS) . . . . . . . . . . . . . . . . . . . . . . . . . 4 Director, Office for Analysis and Evaluation of Operational Data (AEOD) . . . . . . . . . . . . . . . . . . . . . . 4 Regional Administrators ...........................4 A pplica bility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Ilandbook ........................................5 Re fe re n c es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Adequacy and Compatibility of Agreement State Programs Directive 5.9 Policy (5.9 01) -
It is the polley of the U.S. Nuclear Regulatory Commission to evaluate Agreement State programs established pursuant to Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, for adequacy to protect puhlle health and safety and compatibility with NRC's regulatory program.
Objectives (5.9 02)
- To establish the process NRC staff will follow to determine when a proposed or final Conunission regulation or program element should be adopted as a legally binding requirement by an Agreement State and whether adoption is required for the purpose of compatlhility or health and safety as set out in the Polley Statement on Adequacy and Compatibility of Agreement State Programs. (1)
- To identify Conunission regulations and program elements that must he implemented as legally binding requirements by an Agreement State to maintain a program that is adequate to protect pubile health and safety and compatible with NRC's regulatory program. (2)
- To descrlhe how NRC staff should apply provisions of the Polley Statement to current and future Agreement State regulations and program elements. (3)
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l Volume 5, Governmental Relations and Public Affaire Adequacy and Compatibility of Agreement State Programs Directive 5.9 Organizational Responsibilities and Delegation of Autliority (5.9 03)
Executive Director for Operations (EDo)
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Oversees the program to evaluate adequacy and compatibility of Agreement State programs.
Director, Office of State Programs (OSP)
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- Reviews the adequacy and compatibility of Agreement State programs through the Integrated Materials Performance Evaluation Program (Management Directive 5.6) (a)
- Reviews, evaluates, and determines, in coordination with other NRC offices, those NRC program elements that an Agreement State should adopt for compatibility or adequacy. (b)
- Assists in the review, evaluation, and determination of those NRC regulations that an Agreement State should adapt as legally hinding requirements for the purpose of compatibility or he. Ith and safety. (c)
- Coordinates the review of Agreement State regulations and program elements with other NRC offices. (d)
Approved: (Date) 3
Volume 5, Governmental Relations and Public Affairs Adequacy c.nd Compatibility of Agreement State Programs Directis'e 5.9 Office of (lie General Counsel (OGC)
(033)
!
- Assists in the review, evaluation, and determination of those NRC program elements and regulations that an Agreement State should adopt for the purpose of compatibility or health and safety. (a) e Advises staff on findings regarding the adequacy and compatibility of Agreement State regulations and program elements (b)
Director, Office of Nuclear Material Safety au(1 Safeguartis (NMSS)
(Oh.
- Reviews, evaluates, and determines, in coordination with other NRC offices, those NRC regulations that an Agreement State should adopt as legally binding requirements for the purpose of compatibility or health and safety. (a)
- Assists in the review, evaluation, and determination of those NRC program elements that an Agreement State should adopt for the purpose of compatlhility or health and safety. (b)
Director, Office of Nuclear Regulatory Research (RES)
(035)
- Reviewsr evaluate &randsleterinines r in-coordination-with-otint-NRG officesrthose-NRC-regulations-that-en-Agreementi-Stat (9,lunild stlopt-as legally 41ewling-requireinents-for-tlie-purpose-of-coenpatibility-or-lusiltlHiinl safetyr(a)
- Assists in the review, evaluation, and determination of those NRC progrr.m elements and regulations th;.t'an Agreement State should adopt for the purpose of compatibility or health and safety. (b)
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Volume 5, Governmental Relations and Public Affairs Adequacy and Compatibility of Agreement State Programs Directive 5.9 Director, Office for Analysis and Evaluation of Operational Data (AEOD)
(036)
Assists in the review, evaluation, and determination cf those NRC program elements and regulations that an Agreement State should adopt fvr the purpose of compatibility or health and safety.
Regional Adminit,trators (037)
Assists in the review, evaluation, and determination of those NRC program elements and regulations that an Agreement State should adopt for the purpose of compatlhility or health and safety.
Applicability (5.9 04)
The policy and guidance in this directive and handbook apply to all NRC employees who are responsible for and participate in the review and evaluation of Agreement State regulatory programs or are involved in development and promulgation of NRC regulations or program elements for hyproduct, source, and special nuclear materials.
Handbook (5.9 05) llandbook 5.9 describes the criteria and the process that will be used to determine the compatibility and health and safety components of NRC regtlations and program elements (nat an Agreement State should adopt for an adequate and compatible program.
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Volume 5, Governmental Relations and Public Affairs Adequacy and Compatibility of Agreement State Programs i Directive 5.9 References (5.906)
Rtle 10 of the Code of Federal Regulations Managernent Directive 5.6, " Integrated Materials Perfortnance Evaluation Prograin (IMPEP)."
" Final Polley Staternent on Adequacy and Compatibility of Agreement State Progrants," dated [ Insert effective date].
" Final ' Statement of Prinelples and Polley for the Agreement State Program" dated (Insert effective date].
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Handbook 5.9 - Adequacy and Compatibility of Agreement State Programs i
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o Volume 5, Governmental Relations and Public Affairs Adequacy and Compatibility of Agreement State Programs IIandbook 5.9 Parts I - VI
! Contents j Part I Introduction . . . . . . . . . . ...................1 O ve rv i ew . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Policy Statement on Adequacy and Compatibility of Agreement State Programs . . . . . . . . . . . . . . . . . . . . . . . . 1 Part II Categorization Criteria . . . . . . . . . . . . . . . . . . . . . 4 C ri t e ria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Part III Categorization Process for NRC Program Elements 8 Part IV Applicability to NRC Program Elements . . . . . . . . 9 Current NRC Regulations and Other Program Elements ..........9 Future NRC Regulations and Other Program Elements . . . . . . . . . . . 9 Part V Applicability to Agreement State Program Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 j Current Agreement State Program Elements . . . . . . . . . . . . . . . . . 10 Future Agreement State Program Elements . . . . . . . . . . . . . . . . . . 11 Evaluation of Applications for Agreement State Status . . . . . . . . . . . 11 Part VI Additional Implementing Issues . . . . . . . . . . . . . . 12 i
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Use of Management Directive 5.9 and llandbook 5.9 . . . . . . . . . . . . 12 Essentia10bjectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Essenilully Identical I anguage . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Legally Binding Requirements ..........................13 Time Frames for Adoption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Pa rt VII G lo s sa ry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 APPENDIX Appendix A Flow Chart .......................16 11
Part I Introduction j Overview (A) l The Policy Statement on Adequacy and Compatibility of Agreement State Programs (Policy l Statement) sets fonh the approach that the Commission will use to detennine those program elements that should be adopted by an Agreement State to maintain an adequate and compatible program. This handbook describes the specific criteria and process that will be
! used to identify the compatibility categories of those NRC program elements that should be adopted and implemented by an Agreement State for purposes of compatibility, as well as for identifying those program elements that have a particular health and safety significance. It i
further describes how NRC staff is to apply the provisions of the Policy Statement to current and future Agreement State program element: for purposes of compatibility, llowever, the overall determination of adequacy and compatibility for an Agreement State is made pursuant to Management Directive 5.6, The Integrated Materials Performance Evaluation Program i (IMPEP).
Policy Staternent on Adequacy and Cornpatibility of Agreernent State Programs (B)
An Agreement State radiation control program is compatible with the Commission's regulatory program when the State program does not create conflicts, duplications, gaps, or other conditions that jeopardize an orderly pattern in the regulation of agreement material (source, byproduct, and small quantitles of special nuclear material as identified by Section 274b. of the AEA) on a nationwide basis. As a general matter, compatibility focuses primarily on the potential effects of State action or inaction either on the regulation of agreement material on a nationwide basis or on other jurisdictions. The concept of compatibility does notr-hewever, directly address matters of health and safety within a particular Agreement State; such matters are addressed directly under adequacy. Iloweveli many ' program elements for compatibility also impact public health andfsafety; therefore; they also'may,be_ considered program elements for adequacy. Further, basic radiation protection standards an:1 program elements with transboundary implications, although important for health and safety within the State, should be uniform nationwide for compatibility purposes. (1)
An Agreement State radiation contral pragram is adequate to protect public health and safety if administration of the program provides reasonable assurance of protection of public health and safety in regulating the use of agreement material. The level of protection afforded by the program elements of NRC's materials regulatory program is presumed to be that which is adequate to provide a reasonable assurance of proteuton of public health and safety, A subset of one of the five elements identified to help provide such reasonable assurance is
(
Approved (Date) 1
legally binding requirements addressing protection of public health and safety within the State. (2)
Based on the Policy Statement, :lRC program elements (including regulations) can be placed into four compatibility categories. In addition, NRC program elements can also be identified as having particular huith and sa.' ty significance or as being reserved solely to the NRC.
These are summarized below. (3)
Compatibility Category A (a)
NRC program elements in Category A are those that are basic radiation protection standards and scientific tenns and definitions that are necessary to understand these rad.lation protection concepts. The ! nguag: ef =h program elements adopted by an Agreement State should be essentially identical to that those of NRC to provide uniformity in the regulation of agreement material on a nationwide basis.
Compatibility Category H (b)
NRC program elements in Category B are those that apply to activities that have direct and significant transboundary implications. An Agreement State should adopt program elements essentially identical to those of NRC.
Compatibility Category C (c)
NRC program elements in Category C are those that do not meet the criteria of Category A or B, but the essential objectives of which an Agreement State should adopt to avoid conflict, duplication, gaps, or other conditions that would jeopardize an order.y pattern in the regulation of agreement material on a nationwide basis. An Agreement State should adopt the essential objectives of the NRC program elements.
Compatibility Category D (d)
NRC program elements in Category D are those that do not meet th: ectnpatibilityeiteria set-forth in the Pelicy Stat =n:imyjf the criteria lof Category / afb, or C, abovej ard, thus, do not need to be adopted by Agreement States for purposes of compatibility.
Health and Safety (e)
These are NRC program elements that are not required for compatibility by the cri: ria of thePolicy S: :::nen: (i.e., Category D), but that have been identified as having a particular health and safety role (i.e., adequacy) in the regulation of agreement material within the State. Although not required for compadbility, the State should adopt program elements in this category based on those of NRC that embody the essential objectives of the NRC Approved (Date) 2
program elements because of particular health and safety coMStations.
E ii; i: 2: NRC Areas of Exclusive NRC Regulatory Authority (f)
These are NRC 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. These progras[ elements;are' designated "NRC" and abould not be' adopted,by Agg.wa Statesi Approved (Date) 3 i
<4 Part II f'
Categorization Criteria q
Criteria (A)
Compatibility Category A' (1)
To be included in Category A, an NRC program element is to be generally applicable and is to be a dose limit or a related concentration or release limit or a scientific term, definition, sign, or label that is necessary to understand basic radiation protection principles (basic l
radiation protection standard). Basl{ radiation protection standards'do not include constraints L or other liihits belovi the level associated with ' adequate protection'Lthat take'into, account permissible balancing considerations such as economic cost and other factors; (a)
Examples include, but are not necessarily limited to: (b)
I e public dose limits (e.g.,10 CFR 20.1301) plus any regulation that relates directly to these dose limits (i) e concentration and release limits (ii) e occupa;ional dose limits (e.g.,10 CFR 20.1201) plus any regulation that directiv relates to these dose limits (iii) e dose linnts in 10 CFR 61.41 (iv) e radiation symbol (v) e caution signs and labels (vi) e scienti 4 terms (e.g., conventional and Syst6me Internationale units, d,fus;% of types of radioactive material) (vii) e denin as nelded for common understanding (e.g., restricted area, year,
[ stochastic) (viii)
- Compatibility Category B' (2)
To be included in Category B, an NRC program element is to be one that applies to activities that have direct and Lgnificant effects in multiple jurisdictions. (a)
Examples include, but are not necessarily limited to: (b)
' C:=;::!!!!!:y ::::g=!:: A, B ==! C :!:: !=:!=d: :: qui := : ,:: :' :: ::: !:=pe.":-:for prc':::!:= cf biany prograni blemeidsfol compatibility also impait public health and safety) therefore they and-may also be consideredprogram elementsfor adequacy.
Approved (Date) 4
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- transportation requirements (e.g., low level mdioactive vaste manifests, packaging requirements) (i) e requirements for approval of products that are vistributed nationwide (e.g.,
sealed sources and devices) (ii) e definitions of products (e.g., sources and devices) that licensees routinely transport in multiple jurisdictions (iii) e content and format of sealed source and device registration certificates. (iv)
Compatibility Category C' (3)
To be included in Category C, an NRC program element is to be one, the essential objective (s) of which an Agreement State should adopt to avoid conflicts, duplications, or gaps in the regulation of agreement material on a nationwide basis and that, if not adopted, would result in an undesirable consequence. Definitions of " conflict," " duplication," and
" gap" are included in Part VII (Glossary). (a)
Examples of undesirable consequences include, but are not necessarily limited to: (b) e _ exposure to an individual in a different jurisdiction in excess of the basic radiation protection standards estnblished for compatibility in Category A, above; (i) e undue burden on interstate commerce (e.g., additional recordkeeping or training requirements); (ii) e preclusion of an effective review or evaluation by the Commission of the NRC and Agreement State programs for agreement material with respect to protection of public health and safety; (iii) e preclusion of a practice in the national interest; (iv) e absence or impairment of effective communication; (v) e lack of minimum level of safety for agreement material - containing products distributed nationwide: (vi) e disruption of the regulation of agreement material on a nationwide basis (vil)
Examples of program elements in this category include, but are not necessarily limited to: (d) e reports of lost or stolen agreement material or misadministrations (i) e radiation surveys for industrial radiographers and well-loggers (ii) e documents and records required at temporary job sites. (iii)
Compatibility Category D (4)
NRC program elements that do not meet any of the criteria of Category A, B, or C, above, are Category D and are not required for compatibility purposes. (a)
Approved (Date) 5 i
Health and Safety (5)
An NRC program element that is not required for compatibility and could result directly (i.e.,2 or fewer failures )2in an exposure to an individual in excess of the basic radiation protection standards in Category A if its essential objectives were not adopted by an Agreement State is identified as having particular health and safety significance. (a)
Examples of such program elements include, but are not necessarily limited to: (b) e requirement for irradiator interlocks (i) e safety checks for medical teletherapy facilities (11) e package opening procedures. (iii)
Exclusive NRC RegulatorffAuthofityl(6)
The liRC pioj![ranilelements"in'thistateg6ry'arefth6se that'rstats direstlff to; areas of regulation reserved to the NRC byfthe AEA'or the provisions of Title _10_of the Code of Fed:ral RegulationsG(a)
Example.s include;but'areTnot;necessarily limited ltoi;(b)
- l Tissuance"of licenses for production and' utilization facilities (i)
- L ? regulation of activities in' federal ' offshore l waters (ii) et Lissuance of licenses for distribution to exempt personsC(lii)
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Alth6ughisniAgreementState'may?not ad6pt program' elements l reserved lto NRClit maylwish lo infonn its licensecs of certain NRC. requirements;via a ' mechanism that' is consistent with ths particular State's~ administrative procedure laws, as'long as the' State adopts these provisions solely for the purposeslof notification.,;and'does not exercise any regulatory authority; pursuant to themh (c)
Eiample{inbidde[but are;nai[necessarilyjidilted to:L(d)
[?lsjAgreembnt" State licessee submission f6 ths~Comniission'of nuclear material transfer rep 6sts pursuant to 10 CFR 150.16 (i)
- ~MAgreement State licensee compliance with US/IAEA safeguards agreement pursur$nt to 10 CFR 150.17a and,10 CFR Part 75L(.11)l 2
The concept embodied by "2 or fewer failures" is that if the essential objectives of the program element were not adopted and implemented, then an event could occur that would not have taken place were the essential objectives adopted. This alone, or in conjunction with at most one other event, could result in exposure of an individual in excess of limits set by basic radiation protection standards.
Approved (Date) 6
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, ,*ITS~fAgr,eem. en. t' State licenses submission ^t.o:t.he Co.mmiss. ion ^of tr. itism te~ ' " .its
- pursuan.t'.to,,'.10 C.FR 150,19,,((iii) l 4
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r Part III Categorization Process for NRC Program Elements
, The protocol to be used to assign a compatibility category to NRC program elements or to identify a program element as having particular health and safety significance is diagramed in the now chart in Appendix A. The basis of the flow chart is a series of questions that are listed below. Each program element is tested by asking the series of questions below in the order given. The answers to these questions determine the compatibility category for each NRC program element or identify it as having particular health and safety signincance. (A)
Question (1) Do the essential objectives of the program element address a regulatory area reserved solely to the authority of the NRC? If the response to the question is "yes", the compatibility category is "NRC." If the response to the question is "no," then proceed to Question (2). (1)
Question (2) Do the essential objectives of the program element address or define a basic radiation protection standard as defined by the Policy Statement or is it a definition, term, sign, or symbol needed for a common understanding of radiation protection principles? If the response to this question is "yes", the
- compatibility category is "A." If the response to the question is "no", then proceed to Question (3). (2)
Question (3) Do the essential objectives of the program element address or define an issue
, that has a significant, direct transboundary implication? If the response to this
^
question is "yes", the compatibili:y category is "B." If the response to the question is "no", then proceed to Question (4). (3)
Question (4) Would the absence of the essential objectives of the program element from an
- Agreement State program create a conflict or gap? If the response to this i
question is "yes", the compatibility category is "C". If the response to the 2
question is "no", then the compatibility category is "D" and proceed to Question (5) to determine whether the program elem:nt should be identified as having particular health and safety significance. (4)
Question (5) Would the absence of the essential objectives of the program element from an agreement state program create a situation that could directly result in exposure to an individual in excess of the basic rafiation protection stan aards found in co npatibility category A? If the response to this question is "yes",
the program element is not required for purposes of compatibility, but is identified as having pa::icular health and safety significance. (5)
A pproved (Date) 8
Part IV Applicability to NRC Program Elements Current NRC Program Elements (A)
The compatibility category and identification of particular health and safety significance for current Commission program elements that are applicable to the regulation of agreement materials are found in OSP Internal Procedure B.7 (Revision 1), " Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements."
B.7 will be updated periodically as final rules are published.
Future NRC Regulations and Other Program Elements (B) ,
The compatibility category or identification of particular health and safety significance of a proposed mie is to be suggested at the time the miemaking plan is formulated and is to be coordinated with the Agreement States according to Management Directive 6.3, "The Rulemaking Process." Staff is to use Management Directive 5.9 to determine the
' compatibility category or to identify particular health and safety significance for each draft rulemaking plan. OSP Internal Procedure B.7 (Revision 1) will be revised to incorporate the results of these determinations after the final mle or program element is adopted.
Approved (Date) 9
PART V Applicability to Agreement State Program Elements Current Agreement State Program Elements (A)
Regulations (1)
NRC regulations that had not been required for compatibility according to OSP Internal Procedure B.7, " Criteria for Compatibility Determinations," but, pursuant to the new Policy Statement, are included in compatibility categories A, B, or C or are identified as having health and safety significance should be adopted by the States with an effective date within three years of the effective date of the Policy Statement and implementing procedures. (a)
NRC regulations that had been required for compatibility according to OSP Internal Procedure B.7, but will not be required under the Policy Statement do not require any action by the States. (b)
In addition to the foregoing, if an Agreement State's regulations had been evaluated using OSP Internal Procedure B.7 and NRC's program review procedures prior to the effective date of the Policy Statement and found: (c) e to be compatible, then no further action is required by the State except in'the special circumstance where^the~compatibil_i.ty catsgory now re' quires the State to be~ essentially identical _(eig. a change from Division 2 to Category B) and the: State regulation ~is not so deemed then the State should conform the .
regulEtion as expeditiously as possible, but n'ot later than three years after the Policy's effective date; (i) e to be not compatible, then the regulation deemed not compatible should be changed to conform to the Policy as expeditiously as possible, but not later than three years after the Policy's effective date; (ii) e not to htve adopted a regulation previonsi relsired l foicompatibilityLarid still required'by in compatibility category A, B or C or identified as having health
.and safety significance, then the regulation should be adopted as expeditiously as possible, but not later than three years after the Policy's effective date or other date set by the Commission. (iii)
~ Program Elements (2)
Program elements other than regulations had not been identified previously for purposes of compatibility or for having health and safety significance. Such program elements now identified under the new Policy Statement should be adopted and implemented by the States within six months of the effective date of the Policy Statement and implementing procedures.
Approved (Date) 10
If, d'ue to other factors, an Agreement State cannot adopt and implement such a program
- element within the: six month time frame, then the State and the Commission will agree upon a mutually acceptable timetable for adoption and implementation.
Future Agreement State Program Elements (B)
General (1)
Any changes to Agreement State program elements after the effective date of the Policy Statement should conform to the Policy Statement and implementing procedures set out in this handbook.
Future Regulations (2)
Proposed and final Agreement State regulations for agreement materials that will be
, submitted to the NRC will be reviewed in accordance with guidance provided in OSP Internal Procedures, D.7, " Reviewing State Regulations" and B.7 (Revision 1),
, " Compatibility Categories and IIealth and Safety Identification for NRC Regulations and Other Program Elements." Results of the evaluation will be transmitted to the State in accordance with OSP internal procedures. Note: The overall determination of the adequacy and compatibility of individual Agreement State programs will be made in accordance with Management Directive 5.6, Integrated Materials Performance Evaluation Program (IMPEP)."
Future New or Changed Program Elements (3)
~
NRC staff will review the adoption and implementation of any new or revised (non-regulation) program element by an Agreement State in accordance with the Integrated Materials Performance Evaluation Program review procedures set out in Management Directive 5.6 at the time of the next regularly scheduled review.
Evaluation of Applications for Agreement State Status (C)
NRC staff will apply the compatibility and health and safety categorization criteria and process in this handbook when reviewing the regulations and program elements contained in applications for Agreement State status submitted after the effective date of the Policy Statement.
Approved (Date) 11
PART VI Additional Implementing Issues Use of Management Directive 5.9 and Handbook 5.9 (A)
For IMPEP reviews of States in accordance with Management Directive 5.6, review teams ,
will use Management Directive 5.9 to assess the status of the State's program elements with respect to those that should be adopted for compatibility or for health and safety reasons.
Specific Agreement State regulations will be assessed as they are submitted by the State and a summary report will be provided to the IMPEP review team at the time of the State's next program review. Ilowever, the overall determination of adequacy and compatibility of individual Agreement State programs will be made in accordance with Management Directive 5.6, " Integrated Materials Performance Evaluation Program."
Essential Objectives (B)
The essential objective of each NRC program element in compatibility component C or identified as having particular health and safety significance should be adopted by the Agreement State. The term " essential objective" is defined in Part VII (Glossary). (1)
For those NRC program elements in compatibility category C, adoption of the essential objective (s) by an Agreement State means that the State is compatible with respect to that program element. (2)
For those NRC program elements identified as having particular health and safety significance, adoption of the essential objective (s) by an Agreement State means that the State is providing a level of protection equivalent to NRC with respect to that program element. A State has the latitude to adopt essential objectives that are more stringent. (3)
Essentially Identical Language (C)
Program elements in compatibility categories A and B should be adopted by Agreement States in identieel-er sh6uld bs essentially identical language 10;those of NRC. The term
" essentially identical" is defined in Part VII (Glossary). If language is used the requir.ement id6piid by an Agreement State that differs in any significant respect from that used-in of the.
NRC regula:icas, the State should. justify $c equivalency of de language explain ho(the Fequireminisare(esssnii.silf[identidal. An example of such language a substitution that would not be considered significant would be use of the term " deterministic" in place of the term "non-stochastic." In this case, the former term is one commonly accepted in the international radiation protection community. Similarly, the use of Systame Internationale (SI) units rather than conventional units is hvould be deemed essentially identical. Further, Approved (Date) 12
the adoption by States of more recent technical information (e.g., with respect to reference man) is would be viewed as being essentially identical. Finally, changes to reflect increased scope of State authority (e.g , use of the term " radioactive material" in place of the term
" byproduct material") er wording needed to conform to State administrative procedures (e.g.,
ose of State agency name in place of " Commission") would not be considered significantly different.
Legally Binding Requirements (D)
Where appropriate, Agreement States should adopt program elements in compatibility categories A, B and C or those identified as having particular health and safety significance and applicable to all licensees in the form of a mle or other generic legally binding requirement in a manner consistent with the State's administrative laws. The use of generic requirements will help to avoid inconsistency and confusion that may result from the imposition of individual requirements on a case-by-case basis. (1)
Further, requirements applicable to more than a few licensees also should be adopted in the form of a generic requirement. However, since the appropriate approach to such issues will depend on the types and numbers of licensees involved, the State's approach will be reviewed on a case-by-case basis. (2)
The mechanism used by the State should be legally binding on the licensee (s) and enforceable as law. Examples of such legally binding requirements may include license conditions (including licensee commitments referenced in " tie-down" conditions), orders or other mechanisms determined by the State to be legally binding and enforceable. The State has the responsibility of demonstrating that requirements adopted other than by regulation are legally binding. (3)
Time Frames for Adoption (E)
Commission regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety should be adopted in a time frame such that the effective date of the State requirement is not later than three years after the effective date of NRC's final rule. Certain circumstances (e.g., adoption of a basic radiation protection standard or other rule that will have significant impact on the regulation of agreement material on a nationwide basis, such as the low-level radioactive waste manifest) may warrant that the effective dates for both NRC licensees and Agreement State licensees be the same. In some cases, and with sufficient justification, health and safety considerations may warrant adoption by the States in less than the recommended three year (or six month) time frame. (1)
Program elements, other than regulations or equivalent legally binding requirements, that have been designated as necessary for maintenance of an adequate and compatible program should be adopted and implemented by the Agreement States within six months of such Approved (Date) 13
designation by NRC. If, due to other factors, an Agreement State cannot adopt and implement such a program element within the six month time frame, then the State and the Commission will agree upon a mutually acceptable timetable for adoption and implementation. (2) i _ _ _ - n _. . a c _ i i . . u sin 1, .
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Approved (Date) 14
g.
L Part VII
[ Glossary L . Definitions (A)
Cort /llet means the essential objectives of regulations or program elemmts are different and an undesirable consequence is likely to result in another jurisdiction e in the regulation of agreement material on a nationwide basis. (1) !
- Duplication means identical regulations or program elements apply to the same material at I' the same time. Note: this definition applies primarily to review of Agreement State
! regulations. (2) r Essential objective of a regulation or program element means the action that is to be 1 achieved,-modified or prevented by implementing and following the regulation or program i
element. In some instances, the essential objective may be a numerical value (e.g., -
. - restriction of exposures to a maximum value) or it may be a more general goal (e.g., access
) control to a restricted area). (3)
!: Essentially identical means the interpretation of the text must be the same regardless of the j version (NRC or Agreement State) that is read. (4) b Gap means the essential objectives of NRC regulations or program elements are absent from
, the Agreement State program and an undesirable consequence is likely to result in another
!. jurisdiction or in the regulation of agreement materials on a nationwide basis, (5)
Practice means a use, procedure, or activity associated with the application, possession, use, I storage, or disposal of agreement material. The term ' practice" is used in a broad and
- encompassing manner in the Policy Statement on Adequacy and Compatibility of Agreement l' -State Programs. 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 i industrial radiography and brachytherapy. (6)
- Program element means any component or function of a radiation control regulatory program, including regulations and/or other legally binding requirements imposed on regulated persons, that contributes to implementation of that program. (7)
! Transboundary means across jurisdictional boundaries within the United States. It does not
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l mean between the United States and other nations. (8) t 4
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I l Approved (Date) 15 1
APPENDIX A Flow Chart Approved (Date) 16
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, Flow Chart Prc,m ed Regulation Exclusive r ; N Yes Category:NRC Element No Basic RadiatKm Prdoction Standard, Yes Category: A, or a Related Defir9 tion Terr.
Sign or ,
Labe d
No Direct Transboundary Yes Category.B8 trnpilcations?
No Conflict o 9 ' ed Category: C8 3$,"d s no Yes adopt?
No E
Health and Category: D Dj Safety Criteria Met? )
Yes Ident as HS 3 Compatability categories A,B, and C also include requirements that are important for protection of public health and safety and may also be considered elements for adequacy.
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ATTACHMENT 4 Internal Procedure B.7 (Revision 1): Compatibility Categories and Health and Safety identification for NRC Regulations and Other Program Elements 9
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OFFICE OF STATE PROGRAMS Pre and Post Agreement Activities B.7 (Revision 1): Compatibility Categories and Health and Safety identification for NRC Regulations and Other Program Elements 1 Introduction 1.1 Purpose This procedure provides guidance to NRC staff, Agreement States, and States seeking an Agreement on the compatibility categories assigned to NRC regulations and program elements and the identification of those regulations or program elements that have particular health and safety significance.
1.2 Background
1.2.1 The Policy Statement on Adequacy and Compatibility of Agreement State Programs sets forth the approach that the Commission will use to identify those program elements (including regulations) that Agreement State programs should implement to be adequate to -
protect public health and safety and to be compatible with the Commission's regulatory program.
1.2.2 Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs," describes the criteria and process NRC staff follow to determine which NRC regulations and program elements should be adopted by an Agreement State for purposes of compatibility as well as purposes of health and safety. In accordance with Management Directive 5.9, each regulation and program element first is analyzed and categorized for purposes of compatibility and then identified if it has particular health and safety significance.
1.2.3 OSP Internal Procedure B.7 (Revision 1) has been developed and is maintained by the Office of State Programs to document, for use by NRC and State staff, the compatibility category for each NRC rule and program element and the identification of health and safety significance, as determined in accordance with Management Directive 5.9. In addition, Management Directive 5.9 provides that OSP Internal Procedure B.7 (Revision 1) should be updated at the time a new rule or program element is adopted.
2 Compatibility Categories & Health and Safety Identification The tables in Section 3, below, contain a section-by-section analysis of regulations in Title 10 of the Code of Federal Regulations (10 CFR) and program elements that are applicable to the regulation of agreement materials. The analysis is based on the categorization criteria and process set out in Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs."
b_-_--____.___._____________________________ _ __
The Parts of 10 CFR for which tables are provided all have been analyzed section by section; those Parts that do not heve a corresponding table have been determined to address areas in which Agreement States either do not have regulatory authority or that are applicable specifically to NRC's regulatory program and need not be addressed by an Agreement State.
For the purpose of con)pleteness. those Parts that totally address areas of exclusive NRC authority are listed in Tabb i. Those Parts that generally are applicable specifically to NRC's regulatory progrant '.ut are not areas of exclusive NRC authority, are listed in Table 2, Any future changes to these determinations will be reflected in revisions to Tables 1 and 2 and to the individual section by section analysis tables in Section 3.
Table 1 Specific Parts of Title 10 of the Code of Federal Regulations That Address Areas of Exclusive NRC Authority Parts 10,11, 25, 26, 50, 51, 52, 53, 54, 55, 60, 62, 72, 738, 74, 758, 76, 81, 95,100,110,140, and 160.
3 Table 2 Specific Pac of Title 10 of the Code of Federal Regulations That Address Areas That Ge ,erally Are Applicable Only to NRC's Regulatory Program Paris 0,1, 2, 4, 7, 8, 9,12,13,14,15,16, 21,170, 3 and 171.
' . 9 Section 73.67 (Physical Protection of Special Nuclear Material of Moderate and Low Strategic Significance) of 10 CFR Part 73 is applicable to certain Agreement State licensees pursuant to 10_CFR l150.14?
Agreement States, therefore, may wish to infonn their licensees of the provisions of this part through a mechanism that is appropriate under the State's administrative procedure laws, but does not confer regulatory authority on _the St_ ate in this area of exclusive' NRC jurisdic' tion.
W Part 75 (Safeguards on Nuclear MaterialFiniplementation of US/IAEA Agreement) may be applicable to
'c ertain Agreement State licensees as delineated in Section 75.2 - Scope. ~ Agreement States, therefore, may wish to infonn their. licensees of the provisions of this part through a' mechanism that is nppropriate under the State's
~a dministrative procedure laws, but does not confer regulatory authority on the State'in this area of exclusive NRC jurisdiction; 3 The provisions in Pan 21 derive from statutory authority in the Energy Reorganization Act, not the AEA, that does not apply to Agreement States. Therefore, this Pan cannot be addressed under either compatibility or adequacy. While it may be argued that there are heahh and safety reasons to require States to adopt the provisions of Pan 21, States may not have the statutory authority to do so.
e 3 Regulation and Other Program Element Tables In using the following tables, staff should be aware of the following points:
e The following sections are found in multiple Parts: Purpose, Scope, l Interpretations, Communications, OMB Approval, Violations, Criminal Penalties and Inspections. They are all essentially identical from Pan to Part.
These requirements are not required for either compatibility or health and safety reasons. The State may elect to adopt similar sections based on its requirements.
e A number of terms are defined in more than one Part in 10 CFR. For purposes of consistency, the tables show the compatibility category for the definliion in the most appropriate Part and refer to that Part at all other occurrences of the term with the compatibility category shown in brackets.
See, for example, the definition of " restricted area" in the table for Part 19, Section 19.3.
e Unless otherwise indicated in the tables, the compatibility category or identification of health and safety significance applies to the entire section of the Pan. See, for example, the table for Part 20, Section 20.2003, where individual paragraphs are assigned different components.
Key to categories: A= Basic radiation protection standard or related definitions, signs, labels or terms necessary for a common understanding of radiation protection principlesy that-dx The State program' element should adept w!:h be (essentially) identical lang=ge io"thafof,NRC.
B= Program element with significant direct transboundary
^
implicationsy that-the The State program cisnient should adop: with be essentially identical language to thatlof NRC.
C= Program element, the essential objectives of which 4
should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are addressed need not be :he =mc = NRC provided the ==ntial-objec:ive are me: maf[lic~diffe' rent
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thah*tliat ised b);NRC.
D= Not required for purposes of compatibility.
NRC = Not required for purposes of compatibilityt-4he reguhtcrj ar= i; re=rved to NRC. "cwever, a State may adop: :hc= provisions for purpc=s of chri:y and
. 1 o i ec:n: anica:!ca, ::; !cag ::; de S:::: doc: no: :dop:
regu! :ic:: c: pregr= ::::::::: $2: "/ce!d :=.: 1:
State-tc : ge!::: in $= = ::. These ar(NRC pr6 grani-e16menislthaf sddrGs kreasf or regulation' that cannot be r61[ngtv.shed to" Agreement States pursuant to the%EA oi-
~
provisions of Title 10.of the Code of Federal-R,lements;egulatio_ns.1The e
State,should not ad Il&S = Program elements identified by II&S in the Comment column are not requhed for purposes of compatibility; 4
however, they do have particular health and safety sigallicance. The State should adopt the essential
, ebjectives of such program elements in order to maintain i an adequate program.
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ATTACHMENT 5 .
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! CHART 1 - Proposed Revisions to the i
Internal Procedure B.7 Rule Tables i
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PROPOSED REVISIONS TO TIIE INTERNAL PROCEDURE B.7 RULE TABLES Regulation Section Title Original Revised Comments Rationale i Section Compatibility Compatibility Category Category
- l 19.3 Definition of None [D] Add comment: "Ihis definition was omitted i l " Licensee" This definition also aprs in 10 C.'".. f20.1003. fmm the original B.7 (rev.
I For purposes of compatibility, the language of the . 1) rule charts.
Part 20 definition should be used where it is assigned to Compatibility Category D.
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l 20.1003 Definition of A C Add comment: For various reasons, a
! " Declared Pregnant 7he essential objective of this definition is the woman may not wish to Woman" D - for the voluntary, written notification by a woman to her divulge the estimated date l
estimated date employer that she is pregnant.' of conception to her of conception employer. However, using only good health physics practice, and without the date of conception, the dose to the embryo / fetus can be effectively managed.
.i Definition of A D This definition does not .
" Exposure" provide any information ,
that is essential to understanding basic radiation protection principles beyond the plain dictionary meaning. ,
20.1003 Definition of A D This definition does not i
" External exposure" provide any information that is essential to understanding basic-radiation protection principles beyond the plain dictionary meaning.
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Regulation Section Title Original Revised Casaments Rationale Section Compatibility Compatibuity Category Category ;
Appendix A Protection Factors C B De'ete existing comment.
for Respirators Add new comment:
Assigned protection factors provide acceptable icvels of protection to be afforded by respirators. ,
Consistency is required in protection factors that are established as acceptable in NRC and Agreement State regul.itions to reduce impacts on licensees who may oper&*e in multiplejurisdictions.
30.4 Definition of NRC [D] Add comment: Changed from NRC to D to
" Production This definition also appears in 10 CFR 150.3(h). avoid confusion over which Facility
- For purposes of compatibility, the language.of the provisions related to .
Part 150 definition should be used where it is exclusive NRCjurisdiction assigned to Compatibility Category D.- could be adopted by States.
Definition of NRC [DJ Add comment: Changed from NRC to D to
" Utilization Facility
- This definition also appears in 10 CFR 150.3(1). For avoid confusion over which purposes of compatibility, the language of the Part provisions related to q 150 definition should be used where it is assigned to exclusive NRCjurisdiction Compatibility Category D. could be adopted by States.
30.10 Deliberate D C Changed to be consistent misconduct with 40.10 30.34(h) Terms and D D Add comment: Notification of bankruptcy Conditions of H&S - paragraph (h) only will alert agency to the Licenses possibility of abandonment oflicensed facilities at which there is potential for exposure in excess of Part 20 iimits.
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Regulation Section Title Original Revised Cosaments Rationale Section Coenpatibility Compati*oility Category' Category ,
30.41(a)(6) Transfer of. C NRC Paragraph (a)(6) authorizes byproduct material transfer by export, a function reserved to NRC.
31.9 General license to D C Changed to be consistent own byproduct with 40.21 and 70.20.
material 32.12 Records and material C C Add comment: Comment added to be transfer reports 'Ihe time required for record retention may vary in consistent with 30.51.
accordance with the type of activity being licensed. ,
32.24 Same: Table of B B Revise comment to read.
Organ Doses See 10 CFR $32.51. Column IV of tThis table i should be adopted in essentially identical language !
since Q32.51 should be so adopted. ~Ihe table may I be incorporated with the Agreement State's requirements which are equivalent to f32.51, as appropriate, rather than referenced separately.
I 32.210 Registration of B B - for States Changed to clarify that ,
Product Information that perform States that do not have an SSD SSD evaluation program do evaluations not need to adopt this i section for purposes of :
D - for States compatibility. l that do not
- perform SSD ;
evaluations I
F Regulation . W. Title Original Revised Connnents Rationale Section Compatibility Compatibility Category Category 35.20 ALARA program [D] [D] Revise comment to read: No change in compatioility He provision for ALARA requirements appears in category; eliminates 10 CFR $20.1101(b) and is generally applicable to possible confusion about all licensees. Thb prevbka Section 20.1101(b) is designation of Part 35 not required for purposes of compatibility, but does section.
have is designated as having health and saf ty (II&S) significance.
35.51 Calibration and [D] [D] Revise comment to read: No change in compatibility check of survey He provision for ALARA requirements appears in category; eliminates instruments 10 CFR $20.1501(b) and is generally applicable to possible confusion about all licensees. Thb picvisba Section 20.1501(b) is designation of Part 35 not required for purposes of compatibility, bu' does section.
have is designated as having health and safety (II&S) significance.
35.220 Possession of survey [D] [D] Revise comment to read: No change in compatibility instrurnents ne provision for ALARA requirements appears in category; eliminates 10 CFR f20.1501(b) and is generally applicable to possible confusion about all licerrees. Thb provisba Section 20.1501(b) is designation of Part 35 not required for purposes of compatibility, but does section.
have is designated as having health and safety (II&S) significance.
36.21 Perfcnnance criteria B B Delete comment. No change in compatibility for sealed sources category. De comment to adopt the essential
. objectives is not necessary since the provision is a E and must be essentially identical.
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Regulation Section Title Original Revised Comments Rationale Section Compatibility Compatibility Category Category 39.61 Training C B His was changed to be consistent with 34.43 - ,
Radiographer training since ,
the transboundary impacts i are similar, although well , j loggers are not certified.
40.4 Definition of D [D] Add comment: Changed to point to Part 20
" License" This definition also appears in 10 CFR f20.1003.; definition to be consistent For purposes of compatibility, the language of the with other cases where a Part 20 definition should be used where it is assigned definition cccurs in more i to Compatibility Category D. than one part.
t 40.4 Definition of D [D] Add comment: Changed to point to Part 20
" United States' His definition also appears in 10 CFR {30.4. For definition to be consistent i purposes of compatibility, the language of the Part with other cases where a 30 definition should be used where it is assigned to definition occurs in more Compatibility Category D. than one part.
40.4 Definition of D [D] Add comment: Changed to point to Part '20
" Transient This definition also appears in 10 CFR $70.4. For definition to be consistent ;
shipment" purposes of compatibility, the language of the Part with other cases where a t 70 definition should be used where it is assigned to definition occurs in more Compatibility Category D. than one part. ,
40.4 Definitin of D [D] Add comment: Changed to point to Part 20
" Uranium This definition also appears in 10 CFR {l50.3(m). definition to be consistent ;
enrichment facility" For purposes of compatibility, the language of the with other cases wlere a Part 150 definition should be used where it is definition occurs in more assigned to Compatibility. Category D. than one part. ;
40.12(b) Carriers B NRC Paragraph 40.12(b) addresses import / export of j material.
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i Regulation Section Title Original Revised Comments Rationale !
Section Compatibility Compatibility Category Category l'
4114(c) Specific exemptions NRC D Add comment: Changed to be consistent ;
and (d) Paragraph (b) is reserved. with 30.11,61.6 and 70.14.
40.20(a) Types eilicense D C Add comment: Changed to be consistent State may adopt a single provision that incorporates with 30.31.
those of this paragraph and those of 30.31 and 70.18 40.24 [ Reserved] Inadvertently omitted. ,
40.31(i) Application for D (II&S) D Delete comment. This paragraph was specific license misdesignated; changed to be consistent with 30.32(h).
40.31(j) Application for D D Add comment: Changed to be consistent - l specific license II&S - paragraph (j) only. with 30.32(i). l 40.32 General D - paragraphs D - paragraphs No change to compatibility requirements for (a) through (g) (a),(b),(c) categories; language was !
issuance of a specific except and (f) changed to eliminate license possible confusion. !
NRC- NRC-paragraphs (d), paragraphs (d), l (e) and (g) (e) and (g) !
40.41(b) Terms and D C Changed to be consistent !
conditions oflicenses with 30.34(b). i t
40.41(f) Terms and D D Add comment: Notification of bankruptcy ;
conditions oflicenses II&S - paragraph (f) only will alert agency to the i possibility of abandonment }
oflicensed facilities at ;
which there is potential for ,
exposure in excess of Part j 20 limits. j r
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l Regulation.' Section Title Original , Revised Comments Ratios
- Section Compatibility . Compatibility Category Category 40.51 Transfer of source or B C - paragraphs Changed to be consistent byproduct material (a),(bXI) with 30.41.
through (bX5),
(bX7),(c) and (d)
NRC- I paragraph (bX6)
! 61.9b Deliberate D C Changed to be consistent misconduct with 40.10.
61.24(a) Conditions of D C Changed to be consistent i licenses with 30.34(b).
61.24(h)(1) Conditions of D NRC Changed because it deals licenses with common defense and I security.
61.24(k)(1) Conditions of D D Add comment: Petification of bankruptcy.
licenses (bankruptcy H&S - paragraph (kXI) only 411 alert agency to the notification) possibility of abandonment of licensed facilities at .
which there is potential for -
exposure in excess of Part 20 limits.
i 61.42 Protection of D D Add comment:
individuals from H&S inadvertent intrusion
Regulation Section Title Original Revised Comments Rationale Section Compatibility Compatibility Category Category 61.43 Protection of D D Add comment: .
individuals during II&S operations Add comment:
Covered by provisions in Part 20 70.1 Purpose D NRC Paragraphs (c) and (d)
(c) and (d) address spent fuel and high level waste and physical security and accountability of materials, areas reserved to NRC.
70.4 Definition of NRC D Add comment: Changed from NRC to D to "Special nuclear This definition may be adopted by an Agreement avoid confusion over which material oflow State for purposes of clarity and communication. provisions related to strategic exclusive NRCjurisdiction significance" could be adopted by States.
70.4 Definition of NRC D Add comment: Changed from NRC to D to "Special nuclear This definition may be adopted by an Agreement avoid confusion over which material of moderate State for purposes of clarity and communication. provisions related to strategic exclusive NRCjurisdiction significance" could be adopted by States.
70.4 Definition of NRC D Add comment: Changed from NRC to D to
" Strategic special This definition may be adopted by an Agreement avoid confusion over which nuclear material" State for purposes of clarity and communication. provisions related to exclusive NRCjurisdiction could be adopted by States.
_g_
Regulation Section Title Original Revised Cesaments Rasiemale Section CWy C ,~Q Category Category 70.4 Definition of NRC D Addcormncic: Changed from NRC to D to
" Transient This definition may be adopted by .at Agicue; avoid confusion over which shipment- State for purposes of clarny and communicatsost. provisens related to exclusive NRCjurisdiction couM be adopted by States.
70.4 Definition of NRC [D1 Add comment: Changed from NRC to D to
" United States' This defuntion also appears in 10 CFR 530.4. For avoid confusion over v.hich y-rm> of compatibility, the language of the Part provisions related to 30 defuntxm should be used where it is @ to exclusive NRCjurisdcuon Compatibility Category D. couM be adepted by States.
70.4 Definition of NRC [D] Add comment: Changed from NRC to D to
" Uranium This der.rution also ap in 10 CFR 51503(m). avoid confusion over which enrichment facility ~ For purposes of compatibility, the language of the provtsions related to Part 150 defunnon should be used where it is exclusive NRCjurisdiction assigned to Compatibihty Category D. could be adopted by States.
70.10 Deliberate D C Changed to be consistent misconduct with 40.10.
70.18 Types oflicense D C Add comment: Changed to be consistent State may adopt a single provision that. " mpmh with 3031.
those of this p r.ep.ph and those of 3031 and 40.20(a).
70.21(a) Filing C D Changed to be consistent with 3032(a) and 4031(a).
70.21(b) Filing C D Changed to be consistent nh 3032(d) and 4031(d).
70.21(d) Filing C D Changed to be consistent with 4031(c).
Regedation Sedies Title Original Revised C- Rasionale Section C- , ^ T:y Canspatibility Category Cateltery 70.21(0 Filing NRC D Changed to be consistent with 3032(0 and 4031(0 NEPA emis s-.w.tal evaluation requirements are not exclusive NRC jurisdiction.
70.23(aX2), Requiremenr s for the D D Add comment: Changed to be consistent (3) and (4) approval of H&S - paragraph (aX2), (3) and (4) only with 3033 and 4032.
applications NRC- Paragraph (b) was missing.
Paragraph (b) 7032(a)(1), Terms and NRC Not applicable Add comment: Paragraphs that are (0 and (h) conditions oflicenses ParagrapbGaXI), (0 and (h) are reserved. " reserved ~ do not have a compatibility category designated.
7032(aX3) Terms and D C Changed to be consistent conditions oflicenses with 3034(b).
7032(aX9) Terms and D D Add comment: Notincation of bankruptcy conditions oflicenses H&S - psi. gig. (aX9) only will alert agency to the (bankruptcy p:xsibii tty of abandonment notification) oflicemed facilities at which there is potential for exposure in excess of Part 20 limits.
7032(bX2). Terms and NRC D Do not address areas of (4) and (5) conditions cflicenses exclusive NRCjurisdiction.
7032(i) Terms and NRC D To be consistent with conditions oflicenses 3034(0; not an area of exclusive NRC authonty.
Regulaties Section Title Original Revised Ceauments Rationale Section C: , ^' 2 s C_ , ^7 T^y Casegory Category 70.42 Transfer of SNM B C Changed to be consistent with 30.41.
NRC-paragraph (bX6) 70.51 Material balance. NRC C - paragraphs This requirement differs inven:ory, and (a) and (b) from the equivalent Part 30 records requirements requirement in that a NRC-- physical inventory of SNM paragraphs (c). is included. This should (d) and (e) apply to Aym.wiState licensees so that a gap is not created in the nationwide regulation of this class of materials.
Inspections NRC D Changed to be consistent 70.55(a)
- with 30.52 and (b) 70.56 Tests NRC D Changed to be consistent with 30.53 71.4 Definition of Close NRC D Add comment: Changed from NRC to D to reficction by water' 7his definition may be adopted by an Agim.s4 avoid confusion over which State for ymW of clarity and communication. provtsions related to exclusive NRCjurtsdiction could be adopted by States..
71.4 Definition of NRC D Add comment: Changed from NRC to D tc
' Optimum This defimtion may be adopted by an Asicu. aa avoid confusion over which interspersed State for purposes of clarity and communication. provisions related to hydrogenous exclusive NRCjuttsdiction moderation' could be adopted by States.
. s Regulation Section Title Original Revised Commments Rasionale section C- , - _ r:, C_ , - r:,
Category Category 71.20 General license: D D Add comment: No change of w..Aity Fissile material. Tables I and 11 list quantities of U-235 that are category; explanatory limited moderator greater than States have the avilan ny to regulate. comment added.
per package The
- ables should be modified to exclude these quantities or other indication made tI.at the State cannot regulate such <;-irk 71.38 Renewal of a None NRC This section was certificate of inadvertently omitted from compliance or the original tables.
quality assurance program approval 71.83 Assumptions as to NRC B This appears to have been unknown prop rties an error in the SOC assigmng this to Disision 4 that was carried mer as NRC. The remaining
] paragraphs of this section i are all designated B.
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150.3(h) Definition of NRC D Addcomment: Changed from NRC to D to l ;
- Production facili7 This definition may be adopted by an As. avoid confusion over which State for puq% of clarity and communicanon. provisions related to l exclusive NRCp2risdicuon j could be adopted by States.
150.3(I) Definition of NRC D Add comment: Changed from NRC to D to
" Utilization facility' This defiaiten may be adopted by an Ashm.sg avoid confusion over which j State for purposes of clanty and communicanon. prmisions related to i exclusive NRCjur:sdiction could be adopted by States.
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! Regulatica Secties TMe Original Revised C- Rasiemmie Section rW CW
- Cseeswr Cateswr i .
, 150.3(m) Definition of NRC D Add comment: Changed from h1C to D m
" Uranium This definition may be adopted by an A riw avoid confusion over which unil-ocis- Stase for purposes of clarity and ca====ir*= provisions related to exclusive NRCimodin=i could be adopted by States.
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e ATTACHMENT 5 CHART 2 Compatibility Categories of Final Rules Adopted Since May 16,1996 Through August 8,1997
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COMPATIBILITY CATEGORIES OF FINAL RULES ADOITED SINCE MAY 16,1996 (Designated pursuant to the Policy Statement on Adequacy and Compatibility approved June 30,1997)
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS SECTION COMPATIBILITY CATEGORY (as designated in the final rule)
Termination or Transfer ofIAensed Activkies: Recordkeeping R; J _A (61 FR 24669; May 16,1996)
Effective June 17,1996 20.2108(b) Records of Waste 3 D Disposal 30.35(g) Financial assurance and 2 D Rerise comment to read recordkeeping for H&S - paragraphs (a) (b), and (d) and (g) only decommissioning Add comment:
The H&S designation for paragraph (g) is warranted because of the requirement for transfer of certain records (e.g. spills or spread of contamination) important for deconumssioning to a subsequent licensee at the same facility.
Expiration and 3 D Revise comment to read; 30.36(k)(4) termination oflicenses H&S - Paragraphs (c). (d). (e). (g). (h). (j). and (k)'I). (2) and (3) and decommissioning of only.
sites and separate buildings or outdoor areas 30.51(d) Records 3 D
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS SECTION COMPATIBILITY CATEGORY (as designated in the final nde) 30.51(e) Records 2 D II&S Add co mnent:
The H&S designation for pr.p@ (e) is warranted by the requirement for transfer of certain records (e.g. spills or spread of contammation) i..,wi.d for Jew. .issionmg to a hre licensee at the same facility.
30.51(O Records 3 D 40.36(0 l'inancial assurance and 2 D II&S recordkeeping for decommissioning Reine comment to read:
II&S - paragraphs (a), (b), and (d) and (0 only Addcomment:
The H&S designation for p.i.si.pt (0 is warranted by the requirement for transfer of certain records (e.g. spills or spread of contamination) hgetan for Co m..issionmg to a subsequent licensee at the same facility.
40.42(k)(4) Expiration and 3 D Revise comment to read termination oflicenses II&S - Paragraphs (c). (d), (c), (g), (h), (j), and (k)(I), (2) and (3) and decommissioning of only. .
sites and separate buildings or outdoor areas 40.61(d) Records 3 D r____ __, ____ __ -- _a
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, REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS SECTION COMPATIBILITY CATEGORY ;
l (as designaded in i the final rule) i
/.0 61(c)
. Records 2 D Add comment H&S- paragraph (c) only i i
Add comment: '
The H&S designation for p .p.y;. (e) is warransed by the i requirement for transfer of certain records (e.g. spills or spread of .
j contamination) important for decommissioneg to a subsequent !
j licensee at the same facility.
40.61(f) Records 3 D 61.30(a)(3) Transfer oflicense 3 D t 61.31(c)(3) Termination oflicense 2 D Add comment: l H&S p.i.p.ph (c)(3) only l Add comment:
! The H&S designation for p.s.5 ii .ph (c)(3) is warranted by the ,
requirement for transfer of certain records (e.g. spills or spread of contamination) iuv=I.ut for decommissioning to a subsequent j !
t licensee at the same facility.
- 70.25(g) Financial assurance and 3 D !
recordkeeping for i decommissiomng ;
i 70.38(k)(4) Expiration and 3 D :
4 termination oflicenses i and decommissioning of !
sites and separate !
,- buildings or outdoor [
f
- areas [
i I
s l
t f
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMDIS SECTION COMPATIBILITY CATEGORY (as Qred in the fmal rule) 70.51(bX6) Material balance. 3 D inventory, and records requirements 70.51(bX7) Material balance. 2 D Add comment:
inventory, and reccrds II&S - par.pgA (b)(7) only requirements Add comment:
The H&S ArJy im for paragraph (b)(7) is warranted by the requirement for transfer of certain records (e.g. spills or spread of contamination) inet.nt for &wo.udwioning to a subsequent licensee at the same facility.
, Resolution of Dual Regulation of Airborne Emments of Radioactive Materiah; Clean Air Act (61 FR 65119; Decesaber it,1996) j ENective January 9,1997 20.1003 Definitions i
Constraint 2 C 4 20.1101(d) Radiation Protection 2 C - Paragraph (d) Add comment:
Programs The remainder of Section 20.1101 remains D and is identified as H&S.
20.2203(a)(2Xvi) Report of exceeding of 2 C constraint dose 20.2203(bX-)(iv) Corrective steps 2 C 20.2203(bX2) Report contents 2 C
- Recognition of Asia..a..
- State Licenses in Areas Under Exclusive Federal Jurisdiction Wehim an Agreemsent State (62 FR 1662; January 13,1977)
ENective February 27,1997
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMESTS SECTION COMPATIBILITY CATEGORY (as designated in the final rule) 150.20(a) & (b) Reciprocal recogmten 1 C Add comment:
of AS licenses The Agretsnent State shouki adopt these requirements so that the State i%vc.lly recognizes licenses issued by other Asiae States and NRC within itsjuredction. including provisions for notifying the regulatory agency when work is to be pfm..J ander reciprocity. Any fee provisions are Compatibility Category D.
150.20(c) Filing Form 241 I NRC Criteria for the Release of Individuals Adesimissemi Radienctive Material M2 FR 4I29; January 29,19F7)
Effective May 29,19F7 20.1002 Scope 3 D 20.1003 Definitions Occupational dose 1 A Public dose 1 A 20.1301(a) Dose limits for I A individual members of the public 20.1903 Exceptions to posting Not designated in D requirements final rule 35.8 Information collection Not designated in D requirements: OMB final rule .
.gmval
__ _ _ _ _ _ _ _ _ _ _______J
. - . ~. _ - . .- - - . - - . . - . - - - _ ~ - . . _ - - .-. _-.--. .----. .
f REGULATION SEC110N TITLE B.7 DEVISION COMPAT!BILITY COMMENTS l SECTION COMPATIBILITY CATEGORY }
(as Q ^ 2 in ;
the fient rule) [
T l 35.75 Release ofindividuals 2 - Paragraphs (a) C - F ,rA p yl (a) 4 containing and (b) ;
radiopharm wicalsor D - Paragraphs (b). : !
i puiiwca implants 3 - Paragraphs (c) (c) 2nd (d) !
and (d) [
35.315 Safety precautions Not applicable Not applicable Paragraph (a)(6) is remped and resen ed. ;
35.415(a)(1) Safety precautions Not applicable Not applicable Paragraph (a)(7)is removed.
i -
Fheile Material r ~, -- , and E_--
^~ _ - (62 FR 5997; February 10,1977)
['
Effective February IS,1997 71.18 GL: Fissile inaterial. Not ocsignatal in D l ,
- linuted quantity per fmal ru!c j package 71.22 GL- Fissile material. Not designated in D f limited quantity, final rule 4
controlled shipment [
71.53 Fissile material Not designated in NRC [
exemptions fmal rule l l i USEC Priv=nraden Act: Certirscution and IW of Uraniums Ear &4===t FM (62 FR 6663; February 12,1997) l
[. Effective April 14,1997 40.4 Definitions i 4 !
i Corporation Not designated in D Add comment: l i fmal rule This defuntion is not reqmred for compatibility since it dermes an entity, the regulation of winch is is.ml to NRCJ A State may
- adopt a de'imtaon for purposes of clarwy or commumcation. j i i
- 40.38 Incligibility of certain Not designated in NRC j
- applicants fmal rule !
4 I
]
I
o, REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS ,
SECTION COMPATIBILITY CATEGORY (as M- :ed in the real rule) 70.l(e) Purpose Not designated in NRC Add comment final rule Although
- Purpose" sechons generally are categorized "D."
paraggd (e) pertams to issuance oflicenses for an actrvity resend solely to NRC.
70.4 Definitions Corporation Not designated in [D] Add comment:
final rule This definition also appears in 10 CFR 40.4. For twW cf compatibility, :he language of the Part 40 dernuten should be used where it is assigned to ConipatilnTay Category D.
70.40 Incligibility of certain Not designated in NRC applicants final rule Licenses for Industrial R ":,,..,A.y and Radiation Safety - R; , _'_ - - - Tor Industrial R: N_ ,,. / j Cr. ^~ ___ (62 FR 28947; May 28,1997)
EfTective June 27,1997 30.4 Definitic ns Radiographer Not applicable Not applicable Definid-m removedfrom this Parr.
Radiographer's assistant Not applicable Not applicable Dc]Inition removedfrom this Part.
Radiography Not applicable Not applicable Definidon removedfrom this Parr.
3
4.1 Purpose and Scope
3 D 34.3 Definitions ALARA 1 [A] Add comment:
This defmition also appears in 10 CFR f20.1003. For purposes of compatibility, the Iqwc of the Part 20 definition should be used where it is assigned to Compatibility Category A.
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS SECTION COMPATIBILITY CATEGORY (as designated in
'he real rule)
Annual refresher safety 2 C training Associated equipment 2 B Becquerel 1 [A] Add comment:
"Ihis definition also appears in 10 CFR 20.1005. For purposes of cu Aity, the language of the Part 20 defunhon should be used where it is assigned to Compatibility Category A.
Certifying entity 2 B Collimator 2 B Control (drive) cable 2 B Control drive 2 B mechanism Control tube 2 B Excesure head - 2 B Field station 2 D Gray 1 [A] Add comment: .
This defimtion also appears in 10 CFR 20.1004 For purposes of compatibility, the language of the Part 20 dermition should be used where it is assigned to Compatibility Category A.
Guide tube (projection 2 B sheath) llands-on experience 2 C Independent certifying 2 B organization
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS SECTION COMPATIBILITY CATEGORY (as designated in the final rule) ;
t Industrial radiography 2 B (radiography) t lay-barge radiography 2 B l t
Offshore platfor a 4 B Add commart:
radiography State should adopt i definition of " platform radiop.phy' if such activity is antian kot in waters other than " offshore waters" that are
.: the exclusivejurisdicion of NRC.
1 Pernanent radiographic 2 D j isllation t
Practical examination 2 C -
) Radiation safety officer 2 D for industrial l radiography Radiographer 2 C Radiographer 2 B i
- certification ;
j Radiographer's assistant 2 B Add comment:
A State does M have to adopt this defm' ition unless it authortzes radivp.pheri s istants.
l 1 Radiographic exposure 2 B l device l l
r i i l i
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENIS SECTION COMPATIBILITY CATEGORY (as designaded in the runal rule)
Radiographic operations 2 C S-tube 2 B Scaled source I [A] Addcomment:
This dermition also appears in 10 CFR 30.4. For purposes of wArmy, the language of the Part 30 dernutson should be used where it is assigned to Compatibility Category A.
Shielded position 2 D Sievert 1 [A] Add u,rmwar:
'Ihis definition also appears in 10 CFR 20.1004. For pwi- of wuAity, the language of the Part 20 dernution should be used where it is assigned to Compatibility Category A.
Source assembly 2 B Source changer 2 B Storage area 2 D Storage container 2 B Temporaryjobsite 2 B Underwater 2 B radiography 34.5 Interpretations 3 D 34.8 Information collection 4 D requirements: OMB approval Subpart B Specific Licensing Provisions
_ . . - - _ _ ~ . . - - . _ _ . _ . _
1 i REGULATI9N SECTION TITLE B.7 L1 VISION COMPATIBILITY COMMENTS I
SECTION COMPATIBILITY CATEGORY ;
(as "- 4 ^ 2 in ;
, the final rule) !
34.11- Appimatxm for a 3 D l i specific Irense '
t
, 34.13 Specific license for 2 C j i irmiumM radiography .
l
- Suk"-t C Equipment ,
!1 34.20 Performance 2 B ,
4 requirements of !
- industnal radiography [
equipment }
4
, 34.21 Limits on external 2 B !r l radiation levels from l
{ storage containers and l 3
source ciwogers -
34.23 Locking of radiographic 2 B i exposure devices, i storage containers and source changers
- 34.25 Radiation survey 2 C l
- instruments -
1 t I
l 34.27 Leak testing and 2 C replacement of scaled sources 4
, 34.29 Quarterly m ' ventory 2 C i i l I f >
1
- - II - I
- - ~ - ... - , , - , ,
REGULATION SECTIONTITLE B.7 DIVISION COMPATIBILITY C090ENTS SECTION COMPATIBILITY CATEGORY (as designated in time final mie) 3431 Inspection and 2 C maintenance of radiographic exposure devices . . . . . .
3433 Permanent radiographic - 2 D H&S installations 3435 Labeling. storage, and 2 B h mieindon Subpart D Radiation Safety Requirements 34.41 Conducting simi-h;.1 2 B Addcomment:
radiography operations An Ap-~.I State need not adopt paragraph (c) unless k authorizes D - Paragraph (c) these activities. If paragraph (c) is adopeed, the requirements should be essentially idenocal to those of NRC.
34.42 Radiation safety officer 2 D Addcomment:
for industrial H&S for the first sentence only of this section.
rad;gi.py 34.43 Training 2 B Add commentr:
Because of certdication requsrements, there should be unifornuty D - Paragraphs required by the tini ?-y unphcations ofis.buc.i recognition (a)(2) and (c) of certifications. If a State wishes to clearly specify the member of bours of formal el=== room trainsg as speedied in the SSRs, this would be considered compatible.
34.45 Operating and 2 C - Paragraph (a) escrgm y procedures D- Paragraphs (aX9) and (b)
L REGULATION SECTION TITLE ' B.7 DIVISION COMPATIBILITY COMMENTS '
SECTION COMPATIBILITY CATEGORY i
, (as designated in
- the final nele) !
i 34.46 Supervision of 2 B l radiographer's l
+
assistants i
! 34.47 Personnel monitoring 2 C l i
l 34.49 Radiation surveys 2 C - Paragraphs (a) ;
through (c) j D- Paragraph (d) f 34.51 Surveillance . 2 C ;
34.53 Posting 2 C l Subpart E Recordkeeping Requirements t 34.61 Records of the specific 2 D !
license for industrial {
radiography j
- 34.63 Records of receipt and 2 C [
transfer of: aled !
sources i
i 34.65 Records of r.diation 2 C survey instruments l 34.67 Records ofleak testing 2 C ;
4 34.69 Records of quarterly 2. C I inventory [
34.71 Utilization logs 2 B
- I I
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T N
E M
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T I Y L
I R BO I
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- 7. M "s h BO C (a t 2 2 2 2 2 2 2 2 2 3 d d E n e n ns aer s
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ri u ev i
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i h
i .
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ct r r cd t t s s lon e na e Rard Ryo s ci m Rce e o A C6 Rm Rs&u r F
o a N o
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ON I
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t r
a 1 t
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GE S 3
7 5
7 9
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8 3
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8 7
8 9
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4 4 4 4 4 4 4 u 4 u 4 u 3 3 3 3 3 3 3 S 3 S 3 S
i i
} REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS !
SECTION COMPATIBILI1T CATEGORY {
(as 2- 4 ^ _l in [
the final rule) !
- 34.121 Violations 3 D 34.123 Criminal penahies 3 D Appendix A Radiographer 2 B Add comment
- I certification An Agreement State need not adopt Appendix A unless it *' - , so be a certifymg entay or wants to identify independent certsfying i organizations or both. In the first case, Sections II and III of j Appendix A shooki be adopted; in the latter cases, Sections I. II and l III should be adopted. !
l 71.101 Quality assurance Not designated in D !
l
, requirements final rule I
150.20(b) Recognition of Not designated in C Add comment:
agicci..ci; state licenses final rule The Asicui m; State should adopt these requirements so that the i State io.pucally recognizes licenses issued by other Agicou.; }
l States and NRC wahin itsjurisdiction, including provisions for notifying the ic h y agency when worlt is to be performed under
- reciprocty. Any fee provisions are Compatibility Category D. ;
- t WM Crieeria for IJcense Terh ( 62 FR 39857; July 21,1977)
Effective August 29,1977
]
- 20.1003 Definitions 1 Background radiation 2 A !
l i
! Critical group 2 B I, I i
1 l e i'
i
, ~ , -
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILilY COMMENTS SECI1ON COMPATIBILITY CATEGORY (as ?- 4 '-l in the final rule)
Decommission 2 LC} Add comment:
This definition also appears in 10 CFR 30.4. Ihr purposes of compatibility, the language of the Past 30 defmition should be used where it is assigned to Compatibility Category C.
Distinguishabic from 2 B background Residual radioactivity 2 B 20.1009 Information coliccrion 2 D requirements: OMB approval Subpart E Radiological Criteria for Decommissioning 20.1401 General provisions and 2 C scope 20.1402 Radiological criteria for 2 C '
unrestricted use 20.1403 Criteria for license 2 C termination under restricted conditions y 20.1404 Alternate criteria for l2 C license term'mation 20.1405 Public notification and 2 C public participation 20.1406 Minimization of 1 C contamination l
_ .. .= _ _ _ _____ _ . _ . . _ _ ___ . _ _ _..___._ _ . __ ._ _ ._
1 REGUIATION SECTION TITLE B.7 DIVISION COMPATIBILITY COTNTS SECTION COMPATIBILITY CATEGORY
~
] (as designated in the renal rule) 20.2402(b) Criminal penahics 2 D 30.4 Definitions
. Decommission 2 C
- 30.35(f)(5) Financial assurance and 2 D l recordkeeping for
! decommissioning 30.35(gX3Xiv! 2 D 30.36(jX2) Expiration and 2 D Add comment:
I termination oflicenses H&S
- and decommissioning of sites and separate buildings or outdoor areas 30.36(kX3XI) & 2 D Add comment
- (ii) H&S i
i 40.4 Definitions Decommission 2 [C] Add comment:
This definition also appears in 10 CFR 30.4. For purposes of
- compatibility, the language of the Part 30 dermition should be used where it is assigned to Compatibility Category C.
i i
40.36(eX5) Financial assurance and 2 D ,
recordkeeping for decommissioning
- 40.36(f)(3Xiv) 2 D
~, .
REGULATION SECTION TITLE B.7 DIVISION COMPATIBILITY COMMENTS SECTION COMPATIBILITY CATEGORY (as A '. ^12 in the final rule) 40.42(jX2) Expiration and 2 D Addcomment:
termination oflicenses H&S and decommissioning of sites and separate buildings or outdoor areas 40.42(kX3) 2 D Addcomment:
H&S 70.4 Definitions Decommission 2. [C] Addcomment:
This defuntion also appears in 10 CFR 30.4. For purposes of compatibil' ay, the language _ of the Part 30 defimtion should be used where it is assigned to Compatibility Category C.
70.25(fX5) Financial assurance and 2 D record keeping for decommissioning 70.25(gX3Xiv) 2 D 70.38(jX2) Expiration and 2 D Add corvnent:
termination oflicenses H&S and decommissioning of sites and separate buildings or outdoor areas 70.38(kX3) 2 D Addcomment:
H&S
.7 s
F ATTACHMENT 6 All Agreement State Letter SP-97-057, Dated August 6,1997 SECY-97-054 and Staff Requirements Memorandum h
1 p UNITED STATES g ) ,] NUCLEAR RE ULATGRY CIMMISSION WASHINGTON. o.c. soNH001
% , y , , *" August 6, 1997 ALL AGREEMENT STATES OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP 97-057 )
Your attention is invited to the snelosed correspondence which contains:
INCIDENT AND EVENT INFORMATION.........
PROGRAM MANAGEMENT INFORMATION...XX SECY 97 054 AND STAFF REOUIREMENTS MEMORANDUM ON THE POLICY STATEMENTS CONCERNING THE AGREEMENT STATE PROGRAM AND CONTINUED DEFERMENT ON COMPATIBILITY DETERMINATION FOR THE QUALITY MANAGEMENT RULE TRAINING COURSE INFORMATION..............
TECHNICAL INFO RM ATIO N.........................
OT H E R I N F O R M ATIO N.... ....... .. . . . . . . .. .. ... ... .. .
Supplementary information: Enclosed for your information is SECY 97 054, Final Recommendations on Policy Statements arid implementing Procedures For: " Statement of Principles and Policy for the Agreement State Progratn" and " Policy Statement on Adequacy ar.d Compatibility of Agreement State Programs," dated March 3,1997 and the Staff Requirements Memorandum (SRM) approving SECY 97 054 with comments, dated June 30,1997.
in response to item 6 of the SRM, NRC will continue to defer compatibility findings for Agreement States that have not yet adopted a compatible Quality Management rule, until NRC lasues a revised Part 35 rule, compatibility designations for the new rule are established, and an effective date for Agreement State implementation has been set.
, i*
o, o -
'/* . SP.97 057 2- 'AUG*f sg7 The remaining documents and procedures discussed in the SRM will be sent to you at a latter date, if you have any questions regarding this correspondence, please contact me or the individual named below.
POINT OF CONTACT: Cardella H. Maupin TELEPHONE: (301) 415 2312 FAX: (301)415 3502 INTERNET:
KXS@NRC.0%
<) }l0
- s. Q,.
/
3,-
Paul H. Lohaus, D ty9Jirector Office of State Programs
Enclosures:
As stated e
O 4
a ,
f I
i
g:
, - .( -
. . .a.S . d ,
i a
3 k i
ATTACHMENT 7 -
Program Elements Table from OSP Internal Procedure B.7 (Revision 1) f
. _ w e-e-rw ee-n-w n -r 4-- rw w - em s-w ,awr-,+,.m-c r- e e,=.m m e --c er w -es ,---+, w w v r -n w ,ws --- e-v e w=v ve -e-, ww -w-m.w-e,- , , , -
PROG'.2AM ELEMENTS 1 PROGRAM ELEMENT REQUIRED FOR COMMENTS Legislation and Legal Authority Adequacy See discussion in Adequacy Section of Policy Statement Regulations See Classification Tables for 10 CFR .
parts in OSP Internal Procedure B.7 (Rev.1)
Guidance documents and D interpretations Licensing Adequacy See discussion in Adequacy Section of Policy Statement Reciprocal recognition 9f C This program eierient has significant effects on the regulation of agreement material on a licenses national basis. However. States should be provided flexibility for the type of license and ,
time period recognized under reciprocity. Although there are transboundary implications, there is not a necessity for all States to be identical, such as would be required by a ,
- classification of "B."
k Written procedures C
- Maintenance of records, C especially for decommissioning Inspection and licensing files C I
Inspection and Enforcement Adequacy See discussion in Adequacy Section of Policy Statement 6
Written procedures C Radiological laboratory D support Instrumentation D Personnel Adequacy See discussion in Adequacy Section of Policy Statement
+
- PROGRAM ELEMENT REQUIRFD FOR COMMENTS Qualification procedures C There should be minimum education and expenence requirements for all technic 2 personnel in RCPs nationwide. Flexibility is provided to allow for different state administrative requirements.
2.sponse to Events and Adequacy See discussion in Adequacy Section of Policy Statement Allegations Written procedures C Major incident investigation C Need to prevent gaps in reporting .ffectiveness of national program procedures Procedures for investigation C of " wrongdoing
- Scaled source and device program Adequacy Non-common performance indicator Standard review plan C Format and content of B Need to have national consistency so that all RCPs can rely on the specific information registration certificates included in these documents.
Written procedures C Low level waste Adequacy Non-common performance indicator.
Written procedures C Uranium recovery Adequacy Non-comr on performance indicator.
Written procedures C Exchange of information C Necessary for effective regulation of agreement material on a national basis; necessary for effective review of NRC and Agreement State programs for agreement material with respect to protection of public health and safety.
Event reporting to NRC C See previous comment. In addition, Agreement State event reporting to NRC is mandatory as directed by the Commission in a Staff Requirements Memorandum dated June 30,1997.
Failure to comply with this provision can serve as a basis alone for a finding of "not compatible."
Legal assistance D
+
- PROGRAM ELEMENT REQUIRED FOR COMMENTS Technical advisory committees D Technical assistance and support D Prosi iii funding, including D program support services Organization, management & D location of radiation control PW
, .3 ATTACHMENT 8 Federal Register Notice - Statement of Principles and Policy for the-Agreement State Program; Policy Statement on Adequacy and Compatibility of Agreement State Programs
\
[7590 01 P]
NUCLEAR REGULATORY COMMISSION Statement of Principles and Policy for the Agreement State Program; Policy Statement On Adequacy and Compatibility of Agreement State Programs AGENCY: Nuclear Regulatory Commission.
ACTION: Final policy statements.
SUMMARY
- The Nuclear Regulatory Commission (NRC)is publishing two final policy statements: the " Statement of Principles and Policy for the Agreement State Program," and
" Policy Statement on Adequacy and Compatibility of Agreement State Programs."
EFFECTIVE DATE: (Upon publication in 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.
1
= FOR FURTHER INFORMATION CONTACT: Ms. Cardelia Maupin, Sr. Project Manager, Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415 2312.
SUPPLEMENTARY INFORMATION:
- 1. BACKGROUND
! A. Statement of Principles and Policy for the Agreement State Program i
i 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 p'ublic 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 95115) 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 Progra i , . The procedures for suspension, emergency suspension and termination of agreements were finalized on April 25,1996, and the procedure for placing an Agreement State in probationary status was finalized on July 3,1996, i
B. Statement on Adequacy and Compatibility of Agreement State Programs.
I s
On July 21,1994 (59 FR 37269), the Commission published in the Federal I
! Register, for public comment, a draft Policy Statement regarding the adequacy of Agreement State programs to protect public health and safety and compatibility with NRC regulatory programs. The comment period for the draft Policy Statement was scheduled to expire on October 19,1994, but was extended to December 19,1994 (59 FR 52317). In addition, a public workshop was held on November 15,1994 (59 FR 52321) to provide an opportunity for Agreement States and interested members of the public to provide comments on the draft Policy Statement.
3
4
'A final " Policy Statement on Adequacy and Compatibility of Agreement State Program" was prepared based on the public comments and other activities and issues before the Commission. On May 3,'1995, the NRC staff submitted to the Commission the
" Final Policy Statement on Adequacy and Compatibility of Agreement State Programs" (SECY 95-112) that contained the full analysis of comm6nts.
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 allimplementing procedures were completed and approved by the Commission. On August 2,1995 (60 FR 39463), the Commission published in the Federal Register the status of these two policy statements and a notice of their availability.
NRC staff also prepared draft implementing procedures for phased implementation of a new Agreement State program that contained language for a standard agreement (Management Directive 5.8 and its associated handbook). Comments on the draft implementing procedures for phased implementation of new agreements and the standard agreement were requested from the Agreement States on November 15,1996. The complete analysis of these comments is included in " Final Recommendations on Policy Statements and implementing Procedures for: Statement of Principles and Policy for the
-Agreement State Program and Policy Statement on Adequacy and Compatibility of 4
_ . . . -_ _ . . _ _ _ . _ . _ . . _ __ ~ _ _ _ _ = _ ._ _ . _ _ . _ _ _
i 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.
i in October 1995, a Working Group consisting of representatives of Agreement l States and the NRC was formed to develop implementing procedures for the " Policy 1
Statement on Adequacy and Compatibility of Agreement State Programs." The formation j
of this Working Group was announced in the Federal Register on December 1,1995 (60 FR 61716). A notice announcing availability of the initial Working Group report (August 21, 1996) and implementing procedures was published _in the Federal Register on September r
19,1996 (61 FR 49357). Comments also were requested specifically from Agreement
- States and panelists who participated in the November 15,1994, public workshop. The analysis of State and public comments is part of the supplemental report of the Working i
l Group dated January 27,1997, that is available for inspection at the NRC Public j Document Room. A summary of the comments appears with the text of the final policy statement in this notice, ll. STATEMENT OF PRINCIPLES AND POLICY FOR THE AGREEMENT STATE PROGRAM 1
A. Comment Summary I
Comment letters were received from twelve Agreement States on the implementing procedures for phased agreements (Management Directive 5.8). There was strong j
opposition from the Agreement States on the inclusion of mandatory phased agreements i
9 5
.9 for states seeking Agreement State status. Staff a'nalyzed 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 tegnily binding requirements on its licensees through mechanisms other than rules.
The text of the final policy statement follows, B. 'The Commission Policy STATEMENT OF PRINCIPLES AND POLICY FOR THE AGREEMENT STATE PROGRAM
- 1. PURPOSE.
The purpose of this Statement of Principles and Policy for the Agreement State -
Program is to clearly describe the respective roles and responsibilities of the U.S. Nuclear Regulatory Commission (NRC) and States in the administration of programs carried out under Section 274 of the Atomic Energy Act of 1954, as amended. Section 274 provides broad authority for the NRC to establish Federal and State cooperation in the administration of regulatory programs for the protection of public health and safety in the industrial, medical, and research uses of nuclear materials.
6
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 ragulatory program for the use of byproduct, source, and small quantities of special nuclear material; and (2) ensure that post agreement interactions among the NRC and Agreement State radiation control programs are coordinated and compatible and that Agreement State programs continue to provide adequate protection of public health and safety.
This Policy Statement establishes principles, objectives, and goals that the Commission expects will be reflected in the implementing guidance and programs of the
~ NRC and Agreement States to meet their respective program responsibilities and that should be achieved in the administration of these programs.
This Policy Statement is intended solely as guidance for the Commission and the Agreement States in the implementation of the Agreement State program. This Polict Statement does not itself impose legally binding requirements on the Agreement States, in addition, nothing in this Policy Statement expands the leg'ai 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.
4 The Atomic Energy Act of 1954 did not specify a role for the States in regulating j the use of nuclear materials. Many States were concerned as to what their responsibilities j in this area might be and expressed interest in seeing that the boundaries of Federal and 2'
State authority were clearly defined. This need for clarification was particularly important 2
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 i special nuclear material, the responsibility for protecting the public from the radiation hazards of other sources such as x-ray machines and radium had been borne for many
- years by the States.
i Consequently, in 1959 Corgress enacted Section 274 of the Atomic Energy Act to
- establish a statutory framework under which States could assume certain regulatory jurisdiction over byproduct, source,'and special nuclear materialin quantities less than a
[
) critical mass, The primary purpose of the legislation was to authorize the Commission to discontinue its regulatory autnority over the use of these materials and for assumption of l 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 l
1 speelal nuclear material, and the export and import of nuclear materials.
In considering the legislation, Congress recognized that the Federal government 4
would need to assist the States to ensure that they developed the capability to exercise their regulatory authority in a cornpetent and effective manner. Accordingly, the legislation
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1 authorized the Com' mission to provide training and other services to State officials and 1
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 j 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.
i
- 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 j 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 I-necessary to protect public health and safety or that the State has not complied with the
{ provisions of Section 274(j). In these cases, the Commission must offer the State 4
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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,.a 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" reco0nize that strong, vigilant management and a desire to improve a
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 commoa 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 implementerl 'n an open and publicly credible manner aad should be able to withstand scrutiny. Such scrutiny should be welcomed by the regulator. The regulator should be independent and impartialin 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
4 Y.'
should be documented explaining the rationale for such decisions. The public should have an opportunity for early involvement in significant regulatory program decisions. Where
, , several effective alternatives are available, the alternative that best assures safety while i i
considering differing views should be adopted, considering the resources needed to implement that alternative. Regulations should be necessary, and appropriate, to assure 3 safety, and should be clear, coherent, logical, and practical. Regulatory actions should be 1
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, i
i I
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 4
will result in needed improvements. Allinvolved should welcome expressions of concern l that indicate a program may not be operating in accordance with these principles and l revise their program to more completely reflect these principles.
, it is not intended that these principles of good regulation be established as formal criteria against which NRC and Agreement State programs would be assessed. Rather, the 5 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 assesaments of program effectiveness. Application of these principles will ensure that complacency will be minimized, that adequate levels of protection of public health and safety are being provided, and that government employees tasked with the responsibility 11
i 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 formr! c. ogram performance reviews may indicate that the program is not adhering to these principit.s 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 perfo.mance on a consistent and systematic basis, and principles of good regulation in prograia 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 4
4 programs controlling the uses of AEA materials. Accordingly, NRC and Agreement State i
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 salety.
l 4. Comoatible in Areas of National Interest.
NRC and the Agreement States have the responsibility to ensure that consistent and 5
compatible radiation control programs are administered. Such radiation control programs
! should be based on a common regulatory philosophy including the common use of definitions and standards. They should be not only effective and cooperatively implemented by NRC and the Agreement States, but also should provide uniformity and consistency in program areas having national significance.
4 i Such areas include those affecting interstate commerca, movement of goods and prevision 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 I common understanding, the ability to ensure an adequate level of protection of public
~
health and safety that is consistent and stable across the nation, and the ability of NRC 13
and each Agreement State to evaluate the effectiveness of the NRC and Agreement State programs for the regulation of agreement material with respect to protection of public health and safety.
- 5. Flexibility.
With the exception of those compatibility areas where all programs should be essentially identical, to the extent possible, Agreement State radiation control programs for AEA materials should be provided with flexibility in program implementation to accommodate individual State preferences, State legislative direction, and local needs and conditions. However, the exercise of such flexibility should not preclude, or effectively preclude, a practice authorized by the Atomic Energy'Act, and in the national interest.
That is, a State would have the flexibility to design its own program, including incorporating more stringent, or similar, requirements provided that the requirements for adequacy are still met and compatibility is maintained, and the more stringent requirements do not preclude or effectively preclude a practice in the national interest without an adequate public health and safety or environmental basis related to radiation protection.
D. NEW AGREEMENTS.
Section 274 of the Atomic Energy Act requires that once a decision to seek Agreement State status is made by the State, the Governor of that State must certify to the NRC that the State desires to assume regulatory responsibility and has a program for the control of radiation hazards adequate to protect public health and safety with respect 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.
i The NRC has published criteria describing the necessary content these documents i 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 assumptkn 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 pr:aposed 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 4
15
V position to provide _immediate assistance to the NRC, the Agreement States are encouraged
! to do so. In addition, NRC and Agreement States will keep'each other informed about relevant aspects of their programs. NRC will provide an opportunity for Agreement States to have early and substantive involvement in rulemaking, policy, and guidance development activities. - Agreement States should provide a similar opportunity to the NRC to make it aware of, and to provide the opportunity to review and comment on, proposed changes in
! regulations and significant changes to Agreement State programs, policies, and regulatory guidance. -
If an Agreement State experiences difficulty in program administration, the Commission would use its best efforts to assist the State in maintaining the effectiveness of its radiation control program. Such assistance could address an immediate difficulty or a chronic difficulty affecting the State's ability to discharge its responsibility to continue to ensure adequate protection of public health and safety.
F. PERFORMANCE EVALUATION.
Under Section 274 of the Atomic Energy Act of 1954, as amended, the Commission retains authority for ensuring that Agreement State programs continue to provide adequate protection of public health and safety. In fulfilling this statutory responsibility, NRC will provide oversight of Agreement State radiation control programs to ensure that they are adequate and compatible prior to entrance into a Section 274(b) agreement and that they continue to be adequate and compatible after an agreement is effective. The Commission, in cooperation with the Agreement States, will establish and 16
. -. . . . - - - . - - . _ - -_ - - - - . - - - .- . - .-. ~ _ .- - - - . - -
1 1
- implement a performance evaluation program to provide NRC and Agreement State management with systematic, integrated, and reliable evaluations of the strengths and i
! weaknesses of their respective radiation control programs and identification of areas needing improvement, i
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- 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 l adequate and compatible., These actions include: (1) periodic assessments of Agreement i State radiation control programs against established review criteria; (2) provision of 1
- 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 3
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 j 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 I evaluation program that will be consistently and fairly applied.
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G. LEVELS OF AGREEMENT STATE PROGRAM REVIEW FINDINGS.
I The following discussion outlines the nature of NRC findings regarding the NRC's
- Agreement State review process.
1 FINDING 1 - ADEQUATE TO PROTECT PUBLIC HEALTH AND SAFETY AND (OR NOT)
COMPATIBLE If the NRC finds that a State program has met all of the Agreement State program 3
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 - ADEOUATE, 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 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 4
in regulation, the program would be found not compatible.
FINDING 3 - lNADEQUATE 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 cri*eria, 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.
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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 Stato management, in the event that the NRC finds that a State program is adequate and compatible, no further action would be required, except a response by the State to any suggestions or recommendations, in the case where minor deficiencies are noted or areas for improvement are identified, the State would be requested to describe their proposed corrective action, if the corrective action appears appropriate, no further NRC action is required if additional clarification of the corrective actions is needed, additional correspondence may be necessary.
FOLLOW-UP REVIEWS In the event that deficiencies are noted during the program review, NRC may increase the frequency of contacts with the State to keep abreast of developments and conduct onsite ?ollow-up reviews to assure that progress is being made on correcting program deficiencies, if, during follow-up reviews, it is shown that the State has taken corrective actions, a letter finding the State adequate and compatible would be provided.
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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 Jeficiencies may be serious enough to require immediate heightened oversight; (2)in other cases, Agreement State program deficiencies previously identified may have been uncorrected for a significant period of time; and (3)if the NRC determines that a State program has been late in adopting required compatibility program elements and significant disruption in the collective nationwide efforts to regulate AEA materials has occurred. If the NRC was not confident that the State would address the program deficiencies in an expeditious and effective manner, the Commission would place the State program on probation.
As a result of placing a State program on probation, the NRC would communicate its findings to a higher level of State management. Notice of such probationary status would normally be addressed to the Governor of the State. Notice would also be published in the Federal Register. A copy of the letter to the Governor would be placed in the Public Document Room and a press release would be issued.
Once a State program is placed on probation, the NRC would heighten its oversight of the program. This would include obtaining commitments from the State in the form of a management plan to describe actions to be taken by the State to address the program deficiencies, including specific goals and milestones. The NRC would increase observation of State orogram activities under the agreement to assure adequate protection of public 21
~ . _ _ . . . _ _ _ . . _ _ . _ _ . _ _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ _ __.___._.__-_m . _ .
j health and safety. -If requested an'd 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 4
circumstances. At the end of that time, if the State has not addressed the deficiencies, the NRC would institute suspension or termination proceedings.
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l' SUSPENSION 4
l 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 j to protect public health and safety, or if the program has not complied with one or more of
. the requirements of Section 274 of the Act, the Commission would suspend all or part of its agreement with the State. In cases where a State has failed to respond in an acceptable manner during the probationary period, suspension would be considered. if the l
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 4
22 i
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 cM safety, and the State has failed to take necessary action within a reasonable time.
TERMINATION Section 274j of the Atomic Energy Act gives the Commission authority to terminate its agreement with a State if such termination is required to protect public health and safety, or if the State program has not complied with one or more of the requirements of Section 274 of the Act (e.g., is found to be not compatible with the Commission's program). When the Commission finds such significant program deficiencies, the Commission would institute proceedings to terminate its agreement with the State.
In cases where a State has failed to respond in an acceptable manner during the probationary period and there is no prospect for improvement, termination will be considered. Before reaching a final decision on termination, the Commission will notify the State and provide the State an opportunity for a hearing on the proposed termination.
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9-Also, notice of the proposed termination will be published in the Federal Register There may be cases where termination will be considered even though the State program has not been placed on probation,
- l. PROGRAM FUNDING.
Currently, Section 274 does not al!ow 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 NAC 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.
4 J. REGULATORY DEVELOPMENT, NRC and Agreement States will cooperate in the development of new regulations and policy. Agreement States will have early and substantive involvement in the development of new regulations affecting protection of public health and safety and of new policy affecting administration of the Agreement State program. Likewise, the NRC expects to have the States provide it with early and substantive involvement in the development of new Suggested State Regulations. NRC and Agreement States will keep each other informed about their individual regulatory requirements (e.g., regulations or 24
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l license conditions; and the effectiveness of those regulatory requirements so that each has tN opportunity to make use of proveri regulatory approaches to further the effective and
, efficient use of resources.
K. PROGRAM EVOLUTION.
The NRC Agreement State program is dynamic and the NRC and Agreement States will continue to jointly assess the NRC and Agreement State programs for the regulation of AEA materials to identify specific changes that should be considered based on experience or to further improve overall performance and effectiveness. The changes considered may include possible legislative changes. The program should also include the formal sharing of
, in stion and views such as briefings of the Commission by the Agreement States.
Ill. POLICY STATEMENT ON ADEQUACY AND COMPATIBILITY OF AGREEMENT STATE PROGRAMS A. Comment Summary Ten comment letters veere 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 ot .34reement 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
O cooperative nature of the NRC Agreement State relationship; (2) to conform it to the position that Agreement States have flexibility with respect to the legally binding mechanism by which regulatory requirements needed for adequacy or compatibility are adopted; and (3) to simplify the language describing compatibility categories. Changes also were made in response to the June 30,1997 Staff Requirements Memorardi .n. These changes (1) reflect that program elements for compatibility also impact public Malth and sfety 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 implernenting procedures were changed to reflect the final Policy Statement.
One Agreement State specifically commented that it did not believe that Section 274 of the AEA required compatibility of programs or program elements after an agreement is effective except for requirements pertaining to the Uranium Mill Tallings Radiation Control Act in section 274(o). This position also was reflected in the recommended changes to the Policy Statement submitted by the Organization of Agreement States.
The Commission does not agree with this interpretation of the AEA. Both Sections 274d.(2) and 274g Indicate that the Commission must find a State program to be compatible with that of NRC in order to enter into a Section 274b. agreement with the State it is the Commission's view that, pursuant to Section 274, an Agreement State's program should be compatible with NRC's program for the duration of the Agreement for the following reasons:
Subsection 274g. authorizes and directs the Commission to cooperate with the 26
States in the formulation of radiation protection standards '1o ass'Jre 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 mer: of the requirements" of the Section 274. The Cornmission 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 agreeruent 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 req'Jirement and no changes were made to the Policy Statement in response to this comment.
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The ioxt of the final pclicy statement follows. !
B. The Commission Policy ,
j l
POLICY STATEMENT ON ADEQUACY AND COMPATIBILITY OF
! AGREEMENT STATE PROGRAMS i
PURPOS3 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 f
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 progiams to ensure compliance with provisions of Section 274. This Policy Statement presents the Nuclear Regulatory Commission's policy for determining the adequacy and compatibility of Agreement State programs established pursuant to Section 274. This Policy Statement clarifies the meaning and use of the terms
" adequate to protect public health and safety" and " compatible with the Commission's regulatory program" as applied to the Agreement State program. The Policy Statement also ,
2 describes the general framework that will be used to identify those program elements' that
.'For the purposes of this Policy Statement, " program element" means any component
-or function of a radiation control regulatory program, including regulations and/or other legally binding requirements imposed on regulated persons, that contributes to 28 i
, . . - - . ,.,-.,y._ . . , _ - - . _ _ , , . _ , , _ . , - . . , , . . , ~ , . . . . _ . . ,. _ . . . _ . _ . _ , - - , . , , , , , . , , _ , , . , . . , , . . _ . , , _ , . . , _ _ , , , . . _ _ _ , , _ _ . _ . .
Agreement State programs should implement to be adequate to protect public health and safety and to be compatible with the Commission's regulatory program. Finally, the Policy Statement reflects principles discussed in the Commission's Statement of Principles and Policy for the Agreement State Program which should be considered in conjunction with this Policy Statement.
This Policy Statement is solely guidance for the Commission and the Agreement States in the implementation of the Agreement State program. This Policy Statement does not itself impose legally binding requirements on the Agreement States, in addition, nothing in this Policy Statement expands the legal authority of Agreement States beyond that already granted to them by Section 274 of the Atomic Energy Act and other relevant lega'. 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 195g 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 implementation of that program, 29
Q fcirmulation of standards to assure that State and Commission standards will be coordinated and compatible. Subsection 274).(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 othe. words, the Commission must review the actions taken by States under the Agreements to ensure that the programs continue to be adequate to protect public health and safety and compatible with the Commission's program.
Section 274 of the AEA requires that Agreement State programs be both " adequate to protect the public health and safety" and " compatible with the Commission's program."
These separate findings are based on consideration of two different objectives. First, an Agreement State program should provide for an acceptable level of protection of public health and safety in an Agreement State (the " adequacy" component). Second, the Agreement State should ensure that its program serves an overall nationwide interest in radiation protection (the " compatibility" component). As discussed in more detail below, an " adequate" a
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; therefoie, they may Mso be considered program elements for adequacy.
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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 quantitles 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 pubile health and safety. The overall level of protection of public health and safety provided by a State program should be equivalent to, or greater than, the level provided by the NRC program. To provide reasonable assurance of protection of public health and safety, an Agreement State program should contain five essential program elements, identified below, that the Commission will use to define the scope of its review of the program. The Commission also will consider, when appropriate, other program elements of an Agreement State which appear to affect the program's ability to provide reasonable assurance of public health and safety protectioni. Such consideration will occur only if concerns arise.
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1 A. LEGISLATION AND LEGAL AUTHORITY
)
State statutes sh'ould:
Authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under an Agreement with the Commission; Authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of protection of public health and safety; Authorize the State to license, inspect, and enforce legally binding requirements such as regulations and licenses; and Be otherwise consistent with Federal statutes, as appropriate, such as 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 cf agreement material in the State. Specifically, Agreement States should adopt a limited number of legally binding requirements based on those of NRC because of their particular health and safety significance in adopting such requirements, Agreement States should adopt the essential objectives of those of the Commission.
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B. LICENSING The State should conduct appropriate evaluations of proposed uses of agreement material, before issuing a license, to assure that the proposed licensee's operations can be conducted safely. Licenses should provide for reasonable assurance of public health and l safety protection in relation to the licensed activities.
C. INSPECTION AND ENFORC,EMENT The State should periodically conduct inspections of licensed activities involving
- agreement material to provide reasonable assurance of safe licensee operations and to determine compliance with its regulatory requirements. When determined to be necessary by the State, the State should take timely enforcement action against licensees through legal sanctions authorized by State statutes and regulations.
D. PERSONNEL The State should be staffed with a sufficient number of qualified personnel to implement its regulatory program for the control of agreement material.
E. RESPONSE TO EVENTS AND ALLEGATIONS The State should respond to and conduct timely inspections or investigations of incidents, reported events, and allegations involving agreement material within the State's 33
i jurisdiction to provide reasonable assurance of protection of public health and safety, COMPATIBILITY An Agreement State radiation control program is compatible with the Commission's regulatory program when its program does not create conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. For purposes of compatibility, the State should address categories A, B, and C identified below:
A, BASIC RADIATION PROTECTION STANDARDS For purposes of this Policy Statement, this category includes " basic radiation protection standards" meaning dose limits, concentration and release limits related to radiation protection in 10 CFR Part 20 that are generally applicable, and the dose limits in 10 8
CFR 61 A1. Also included in this category are a limited number of definitions, signs, labels and scientific terms that are necessary for a common understanding of radiation protection principles among licensees, regulatory agencies, and members of the public. Such State standards should be essentially identical to those of the Commission, unless Federal statutes provide the State authority to adopt different standards Basic radiation protection standards do not include constraints or other limits below the level associated with " adequate
' The Commission will implement this category consistent with its earlier decision in the LLW area to allow Agreement States flexibility to establish pre-closure operational release limit objectives, ALARA goals or design objectives at such levels as the State may deem necessary or appropriate, as long as the level of protection of public health and safety is 6t least equivalent to that afforded by Commission requirements.
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protection" that take into account permissible balancing considerations such as economic cost and other factors.
B. PROGRAM ELEMENTS WITH SIGNIFICANT TRANSBOUNDARY IMPLICATIONS The Commission willlimit this category to a small number of program elements (e.g.,
transportation regulations and sealed source and device registration certificates) that have significant transboundary implications. Agreement State program elements should be
) essentially identical to those of the Commission, j
i C, OTHER COMMISSION PROGRAM ELEMENTS 1
These are other Commission program elements (e.g., reciprocity procedures) that are important for an Agreement State to have in order to avoid conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. Such Agreement State program elements should embody the essential objective of the corresponding Commission program elements.
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.
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l 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'in the nationalinterest 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, l E. AREAS OF EXCLUSIVE NRC REGULATORY AU' r'~.RITY 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
' " Practice" means a use, procedure, or activity associated with the application, possession, use, storage, or disposal of agreement material. The term "p'octice" 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 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 pattem for the regulation of agreement material exists nationwide.
The Commission believes that this approach achieves a proper balance between the need for Agreement State flexibility and the need for coordinated and compatible regulation of 37
t agreement material across the country, PAPERWORK REDUCTION ACT STATEMENT These final policy statements do not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.),
Existing requirements were approved by the Office of Management and Budget, approval
. number 3150 0183, PUBLIC PROTECTION NOTIFICATION The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
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=.
1
.l' l SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACT l
l l
l In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.
Dated at Rockville, Maryland, this day of .1997 For the Nuclear Regulatory Commission.
John C. Hoyle Secretary of the Commission 39