ML22105A569

Nrc/Agreement State Working Group Charter: Rulemaking Plan for Exempt Quantities in Section 30.71, Schedule B

ML22105A569
Person / Time
Issue date:	05/25/2022
From:	Theresa Clark, Tara Inverso NRC/NMSS/DMSST, NRC/NMSS/DREFS
To:
Taylor T
References
NRC-2021-0077
Download: ML22105A569 (5)

Text

WORKING GROUP CHARTER Rulemaking on Exempt Quantities in Section 30.71, Schedule B PURPOSE: The purpose of this working group (WG) is to develop a rulemaking plan to request Commission approval to initiate a rulemaking to revise Section 30.71, Schedule B, of Title 10 of the Code of Federal Regulations (10 CFR), to include additional radionuclides that are currently not listed in the table. This table is used along with 10 CFR 30.18, Exempt Quantities, in determining the need for a specific license. The staff also plans to revise certain sections in 10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, related to exemptions to make clear when a license is required.

DISCUSSION: The regulation in 10 CFR 30.18(a) exempts persons from the requirements for a license for byproduct material if the quantity does not exceed the applicable quantity listed in Schedule B. On August 8, 2005, the President signed into law the Energy Policy Act. This law expanded the definition of byproduct material, which added additional byproduct material to the U.S. Nuclear Regulatory Commissions (NRC) jurisdiction. Schedule B does not include all of the radionuclides that are now within the NRCs jurisdiction. Many people use these radionuclides in research and as check sources. Because the radionuclides are not listed in Schedule B, a person must obtain a license for possession and use. The addition of radionuclides, including alpha emitters, for use by the medical, industrial, commercial, and academic communities will reduce regulatory burden for end users of these products which would be used under 10 CFR 30.18 Exempt quantities. Schedule B would be updated using the quantities that are in Appendix C, Quantities of Licensed Material Requiring Labeling, to 10 CFR Part 20, Standards for Protection Against Radiation.

MEMBERSHIP: This WG is sponsored by the Office of Nuclear Material Safety and Safeguards (NMSS), Division of Rulemaking, Environmental, and Financial Support (REFS) and Division of Materials Safety, Security, State and Tribal Programs (MSST). The rulemaking organization, REFS, will be the rulemaking lead organization, and MSST will be the principal technical lead organization. The management sponsors for this activity are Jill Shepherd, Branch Chief, NMSS/REFS/Materials Rulemaking and Project Management Branch (MRPB); Maria Arribas-Colon, Branch Chief, NMSS/MSST/Materials Safety and Tribal Liaison Branch (MSTB); and Christian Einberg, Branch Chief, NMSS/MSST/Medical Safety and Events Assessment Branch (MSEB). The WG will consist of NRC staff members and a representative from the Organization of Agreement States (OAS). The membership of the WG is provided in the table below. The WG may seek additional expertise as needed.

Name Organization Role Shirley Xu NMSS/MSST/MSTB/SSDT Technical Lead Torre Taylor NMSS/REFS/MRPB Rulemaking Project Manager Helen Chang NMSS/REFS/RASB Regulations Specialist Alexa Sieracki NMSS/REFS/RASB Cost Analyst Daniel Dimarco NMSS/MSST/MSEB Working group member Jeffery Lynch NMSS/MSST/SALB Working group member Betsy Ullrich RI/DRSS/CIRDA Working group member Brenda Miles OCIO Paperwork reduction act support Brian Harris OGC/LRAA/RASFP Attorney Frank Peffer OAS Working group member 1

Working Group Charter Rulemaking Plan - Exempt Quantities A Steering Committee will be convened if the WG needs management support to resolve issues that are more than minor. The Steering Committee Chairperson is the Director or Deputy Director of REFS, and the members include:

1. Chair, Director of REFS

2. Deputy Director of MSST

3. Director of Region I Division of Radiological Safety and Safeguards

3. OGC Assistant General Counsel for Rulemaking, Agreement States, and Fee Policy

4. OAS Director of Rulemaking or their designee OBJECTIVES:

1. Develop a rulemaking plan to request Commission approval to initiate a rulemaking to revise 10 CFR 30.71, to include additional radionuclides that are currently not listed in the table, and revise certain sections in 10 CFR Part 30 related to exemptions, to make clear when a license is required. In developing the rulemaking plan, the WG will ensure that all options for accomplishing the objectives of the rulemaking have been appropriately considered. The WG will also evaluate the need for a regulatory basis before developing a proposed rule.

2. Develop proposed and final rule packages for Commission review and approval with consideration of associated public comments.

SCHEDULE: The estimated high-level schedule below covers development of the rulemaking plan document as well as the proposed and final rules. If staff determines that a regulatory basis is needed, the schedule will shift by about 1 year. The schedule is preliminary and may change. Detailed schedule information will be provided to WG members.

WG kick-off meeting March 21, 2022 Develop rulemaking plan document April-July 2022 Management and Agreement State review October 2022-March 2023 Rulemaking plan due to Commission April 2023 Proposed rule due to Commission 12 months after approval of initiation of rulemaking by Commission Final rule due to Commission 14 months after end of public comment period LEVEL OF EFFORT: The level of effort for each WG member is estimated to be approximately 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br /> and is listed below. The level of effort is subject to change.

1. During the development of the rulemaking plan, the level of effort will be approximately 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> per week for 16 weeks, which includes 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of preparation time. Working group meetings will be scheduled each week for 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />. (32 hours3.703704e-4 days <br />0.00889 hours <br />5.291005e-5 weeks <br />1.2176e-5 months <br /> total)

2. During the rulemaking plan and concurrence period, the level of effort will be approximately 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> to address comments from NRC management and the Agreement States at the five stages of review. The WG will meet after each review with 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> each to review and revise the rulemaking plan based on comments and 1-hour WG writing sessions. (15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> total) 2

Working Group Charter Rulemaking Plan - Exempt Quantities

3. Briefings with the steering committee will be held as needed during the development of the rulemaking plan. (2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> total)

Management briefings will be held as needed during the development of the rulemaking plan and proposed and final rules. Members of the WG will support these briefings as needed. All WG meetings and briefings will be hybrid, with teleconference or Microsoft Teams available.

Maximum use will be made of available electronic communication to facilitate interaction within the WG. Examples of these include Microsoft Teams meetings, conference calls, e-mails, and other options. There is no travel anticipated with this rulemaking activity.

WORKING GROUP MEMBERS ROLES AND RESPONSIBILITIES This WG operates as an NRC/Agreement State WG with the roles and responsibilities described in Section IV of SA-801A, Agreement State Participation in Rulemaking Working Groups, (ADAMS Accession Number ML18263A239). SA-801A details the procedure for NRC and Agreement State interactions during the entire rulemaking process and complements other NRC directives and guidance for rulemaking activities.

Responsibilities of the WG members depend on their areas of programmatic responsibility and expertise. The following points reflect the duties and responsibilities of the WG members. The responsibilities of the Agreement State representative(s) to the WG are specified in Section IV.I of SA-801A and includes keeping the OAS Board (i.e., Director of Rulemaking) informed of the status of the project. In general, WG members should:

1. Work with the rulemaking project manager or technical lead to assess the tasks needed to: prepare the rulemaking product package and any related guidance; review and comment on drafts; address comments; assist in estimating any information collection burden; assist in the development of cost estimates; assist in preparing briefing materials; and facilitate concurrence on the package.

2. Keep their branch, division, and office managers apprised of the status of the rulemaking action; obtain comments and input on policy decisions from their branch and division managers; and notify their BCs of potential problems or policy issues.

3. Ensure that their managements opinion is understood and shared with the WG.

4. Review draft schedules and provide input reflecting their managements views.

Coordinate with the RM project manager (PM) to ensure a feasible and mutually acceptable schedule of deliverables.

5. Attend WG meetings and come prepared to participate.

6. Provide timely input.

7. Inform the RM PM and guidance PM, as appropriate, of conflicting priorities, previously unanticipated problems, and other potential sources of delay.

3

Working Group Charter Rulemaking Plan - Exempt Quantities

8. Review contractor reports (where REFS has lead contractor responsibility) or monitor contractor efforts (where WG members division or office has lead contractor responsibility).

9. Prepare associated licensing, inspection, and enforcement guidance, as appropriate (if the same WG is used for the guidance). The technical lead division is responsible for preparing guidance documents and coordinating with affected organizations. The technical lead should develop milestones for the guidance that ensure that the draft or final guidance will be available for office-level review and concurrence at the same time as the proposed or final rule package enters office-level review and concurrence. (Often the members of the WG for the rule will participate on the WG for the guidance.)

10. Keep their management on the steering committee informed.

11. Facilitate the rulemaking concurrence process by keeping their management informed of significant issues of concern and helping to develop an appropriate resolution of those issues. Clear and frequent WG member communication with their management during document development is essential to minimize the number of new issues identified during the concurrence process.

12. Support briefings, committee meetings, and public meetings, as necessary.

13. Prepare and present material related to the guidance or other areas for which they may have a lead at public meetings.

14. Follow SA-801A and the WG Charter.

Digitally signed by Tara Inverso Tara Inverso Date: 2022.05.25 11:37:14

-04'00' Tara Inverso, Deputy Director, NRC/NMSS/REFS Date Digitally signed by Theresa V.

Clark Date: 2022.05.25 13:53:24 -04'00' Theresa Clark, Deputy Director, NRC/NMSS/MSST Date 05/25/22 Auggie Ong, Chair, Organization of Agreement States Date 4

SUBJECT:

WORKING GROUP CHARTER FOR RULEMAKING PLAN - RULEMAKING ON EXEMPT QUANTITIES IN SECTION 30.71, SCHEDULE B DATED: MAY 25, 2022 ADAMS Accession Number: ML22105A569 OFFICE NMSS/REFS/ NMSS/REFS/ NMSS/MSST/ NMSS/MSST/ NMSS/REFS/ NMSS/MSST/

MRPB MRPB MSTB MSTB:BC MRPB:BC SALB:BC NAME TTaylor PCline-Thomas SXu MAribas JShepherd BAnderson DATE 04/19/22 04/18/22 04/19/22 04/19/22 4/25/22 04/19/22 OFFICE NMSS/MSST:DD NMSS/REFS:DD NAME TClark TInverso DATE 5/11/22 5/11/22 5