ML20304A406
| ML20304A406 | |
| Person / Time | |
|---|---|
| Issue date: | 10/30/2020 |
| From: | White A NRC/NMSS/DMSST |
| To: | |
| WHITE D/NMSS/MSST | |
| Shared Package | |
| ML20304A405 | List: |
| References | |
| CN279-202 | |
| Download: ML20304A406 (5) | |
Text
CN279-202 ENSURING NATIONAL COMPATIBILITY ACROSS MULTIPLE REGULATORY AUTHORITIES Duncan White and Margaret Cervera United States Nuclear Regulatory Commission What is Compatibility? An Agreement State program whose program elements that do not create conflicts, duplications, gaps or other conditions that jeopardize an orderly pattern in the regulation of agreement material on a national basis. Flexibility is needed since States regulate other sources of radiation and need to fashion their programs to reflect specific State needs and administrative requirements What is a Program Element? Any component or function of a radiation control program, including regulations, procedures, and/or other legally binding requirements, imposed on regulated persons that contributes to implementation of that program.
What is an Agreement State? States can enter into agreements with the NRC where the federal government discontinues and individual states assume regulatory authority over certain radioactive and nuclear materials and their uses within the states border. The National Materials Program (NMP) is comprised of 39 Agreement States that regulate 88% of academic, commercial and industrial radioactive material licensees in the U.S. and the NRC regulates the remaining 12% of licensees in 11 non-Agreement States and territories.
Under the NMP, NRC and Agreement States function as regulatory partners.
International Conference on Radiation Safety: Improving Radiation Protection in Practice (CN279-202) 9-20 November 2020
ADEQUACY AND COMPATIBILITY OF PROGRAM ELEMENTS Adequacy: protection of public health and safety within NRC or Agreement State QUESTION: Can program elements for compatibility impact health and jurisdiction safety?
Compatibility: impacts of an Agreement States regulation of agreement material ANSWER: Yes, they must also be nationwide basis or its potential effects on other jurisdictions. considered program elements for adequacy.
Examples of Program Elements Program Element State Requirement Compatibility/Adequacy Category Legal - Statutory Authority Sections of state law that authorize the program and C Agreement Regulations Safety and security standards in equivalent State A, B, C, D, NRC, H&S provisions Licensing Administrative Procedures Procedures for processing licensing actions D Inspection Procedures Inspection program description, inspection procedures C and guides, inspection frequency Formal Qualification Program for Technical Written plan to qualify inspectors and license reviewers C Staffing Event Reporting to the NRC Equivalent State procedure and regulations B A complete table of all program elements can be found at https://scp.nrc.gov/regtoolbox.html.
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CHARACTERIZATION PROCESS FOR PROPOSED NRC PROGRAM ELEMENTS Description of Adequacy & Compatibility Categories A: Basic radiation protection standards and scientific terms and definitions that are necessary to understand radiation protection concepts.
B: A practice or licensed activity that necessitates identical requirements to ensure an orderly regulatory pattern for the use of agreement material between all NRC and Agreement State jurisdictions C: Agreement State needs to avoid conflicts, duplications, gaps or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis D: Program element that does not meet any of the criteria of Category A, B, C, or have a particular health and safety role and thus not required to be adopted by Agreement States for the purposes of compatibility NRC: Areas of regulation that were not relinquished to Agreement States and therefore cannot be adopted The complete process and examples can be found in Management Directive 5.9 Adequacy and Compatibility of Program Elements for H&S: Not required for compatibility, but that have been identified as Agreement State Programs at having a particular health and safety role (i.e., adequacy) in the https://www.nrc.gov/docs/ML1808/ML18081A070.pdf regulation of agreement material within the State.
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How do Agreement States Influence the Compatibility KEY IMPLEMENTATION CONSIDERATIONS Determination Process?
- Work with NRC to set annual goals and priorities for the NMP Essentially Identical: the interpretation of the text must
- Work with NRC to prioritize what new rules and other program be the same regardless of the version (NRC or Agreement elements are developed or revised State)
- Co-Chair Working Groups that are responsible for developing or
- Compatibility Categories A and B revising any guidance associated with the NMP
- Provided multiple opportunities to comment on proposed version of rules or guidance Essential Objective: the action to be achieved, modified,
- Co-Chair Standing Committee on Compatibility that reviews all or prevented by implementing and following the program elements requiring compatibility regulation or other program element - this can be a
- Input from two national organizations representing States numerical value or general goal interests:
- Compatibility Category C and Health & Safety (H&S)
Organization of Agreement States; and Conference of Radiation Control Program Directors Legally Binding Requirements Participation by Agreement State is codified or included in:
- Enforceable and binding Section 274 of the Atomic Energy Act
- Part of license Agreement State Program Policy Statement Management Directives 5.3, 5.9 and 6.3 https://www.nrc.gov/reading-rm/doc-collections/management-directives/
Timeframes for Adoption Office Procedures: SA-10, SA-202, SA-801, SA-801A
- 3 years unless otherwise directed by NRC Commission https://scp.nrc.gov/procedures.html 4
Challenges Agreement States have to Maintain Compatibility with NRC Regulations
- Frequent amendments to regulations by the NRC that require Agreement State to amend their regulations
- Typically 2 - 5 NRC amendments per year are required for compatibility
- Agreement States seek flexibility in regulations to meet local conditions versus desirability by licensees to have national uniformity
- Compatibility Category B (more uniformity) versus Category C (more flexibility)
- Agreement States have already adopted requirements that NRC adopts at a later time, sometimes years later. Agreement States Successfully Maintain Compatibility
- Meeting the 3 years adoption period required by NRC
- Wide range and complexity of processes and levels of
- Based on program audits conducted every 4 to 5 years, State government involved with the adopt of regulations nearly all Agreement States maintain compatibility with
- Use of legal binding requirements such as license conditions to NRC requirements meet compatibility requirements when regulatory adoption
- In cases where an Agreement State has not updated their process is lengthy regulatory requirements in a timely manner, the impact on
- Depending on regulation, can require the amending of the NMP is minimal large number of licenses by the Agreement State https://scp.nrc.gov/reviews.html 5