ML23235A165
| ML23235A165 | |
| Person / Time | |
|---|---|
| Issue date: | 07/20/2023 |
| From: | Allen B NRC/RES/DSA/RSAB |
| To: | |
| Allen B | |
| Shared Package | |
| ML23235A164 | List: |
| References | |
| 20230784 | |
| Download: ML23235A165 (9) | |
Text
U.S. Nuclear Regulatory Commission Public Meeting Summary
Title:
Information Meeting with Q&A Session on the Proposed Revision to Regulatory Guide (RG) 8.39, Release of Patients Administered Radioactive Material
Meeting Identifier: 20230784
Date of Meeting: July 20, 2023
Location: Webinar
Type of Meeting: Information meeting with a question-and-answer session
Purpose of Meeting: To provide information to facilitate stakeholder feedback on the draft regulatory guide (DG), DG-8061, Release of Patients Administered Radioactive Material, included in the Federal Register notice (88 FR 24495).
General Details: The NRC staff published the official public meeting notice on July 6, 2023, providing the agenda and webinar log-in instructions for attendees (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23201A106). The meeting was conducted remotely via webinar and began at 12 :00 p.m. Eastern Time (ET). Sophie Holiday, the meeting facilitator, started the meeting by welcoming all attendees and discussing the meeting logistics and goals for the meeting. Dr. Celimar Valentin-Rodriguez from the Office of Nuclear Material Safety and Safeguards (NMSS) provided opening remarks, welcomed all attendees, and provided the purpose and agenda for the meeting. Dr. Katherine Tapp from NMSS presented an overview of DG-8061 from a patient perspective, including the purpose of the guidance, and proposed changes made since the last revision such as the new baseline equations and modifying factors. Dr. Tapp also discussed how the proposed DG -8061 provides ways physicians could use information provided by patients to demonstrate patients could be released under current regulations in Title 10 of the Code of Federal Regulations (10 CFR) 35.75, Release of individuals containing unsealed byproduct material or implants containing byproduct material. Dr. David Hamby, contractor for the Office of Nuclear Regulatory Research (RES) provided a technical overview of the modifying factors and example calculations using the new proposed methodology. After each presentation, the NRC staff provided an opportunity for members of the public to ask questions and provide feedback. Dr.
Tapp presented on how to prepare and submit comments and the next steps for the rulemaking.
Ms. Holiday then presented on the contact information and resources for this rulemaking and how to provide meeting feedback. Dr. Valentin-Rodriguez provided closing remarks and then Ms. Holiday adjourned the meeting. The staffs slide presentation is available in ADAMS at Accession No. ML23198A203. The meeting had over 250 participants from the NRC, medical community, patient advocates, Agreement States, and the public. A list of NRC and external meeting participants is enclosed. The meeting concluded at 3:15 p.m. ET. The staff has summarized the questions and feedback received and a transcript of the meeting is available in ADAMS at Accession No. ML23226A087.
Summary of Questions and Feedback:
Overview of Proposed Changes in Revision 2 of Regulatory Guide 8.39
One commenter inquired about why DG-8061 did not include references to two regulatory information summaries issued in 2008 and 2011.
One commenter asked why the National Council on Radiation Protection and Measurements (NCRP) Report No. 155 biokinetic models were not used to formulate baseline values in this RG.
One commenter asked whether the NRC anticipated a trend towards less outpatient releases if the conservative values published in DG -8061 are used.
One commenter asked about DG-8061 potential implementationtimeline for agreement states.
Overview of the Modifying Factors and Examples of Calculations
One commenter asked whether biokinetic modifying factor accounts for attenuation of larger patients. Another commenter asked if DG -8061 addressed service worker that may be exposed to a patient or multiply patients. Another commenter inquired about other acceptable biokinetic models that could be used to meeting the regulations.
Three commenter s asked whether the NRC is confident that revision 2 of RG 8.39 would reflect the real-world situation at a hospital or clinical. Another commenter stated their concerns about the voluntary nature of regulatory guide.
Two commenters asked if the theoretical model used in DG -8061 was compared to published literatures. Another commenter inquired whether the draft regulatory guide went through any sort of peer review process.
One commenter asked about the logic the NRC used to add Yttrium-90 threshold values to DG -
8061 since the radionuclide was removed from earlier version of the RG.
One commenter asked whether the NRC considered providing release guidance for patients that are undergoing dialysis. Another commenter asked how the ACMUI recommendations on revision 1 of the RG 8.39 were used to modify revision 2 of DG -8061.
One commenter asked why the NRCP Report No. 155 approach was not adopted into the revision 2 of DG -8061.
One commenter asked why Fludeoxyglucose (FDG) was listed as the only Flourine-18 diagnostic imaging agent in the breastfeeding interruption tables. Another commenter asked if DG-8061 could be used for animals, such as cat and dogs.
Next Steps: The NRC staff will consider the comments received as it finalizes DG-8061. Once the NRC staff has incorporated the feedback received, they will transmit the draft final regulatory guide to the Advisory Committee for the Uses of Medical Isotopes (ACMUI) for review and comment.
SUBJECT:
SUMMARY
OF JULY 20, 2023, PUBLIC MEETING ON THE Revision to REGULATORY GUIDE 8.39, RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIAL
DISTRIBUTION:
PUBLIC KTapp, NMSS CValentin-Rodriguez, NMSS BAllen,RES JTomon, RES CEinberg, NMSS
ADAMS Accession Nos.: Meeting Summary ML23226A087; Slide Presentation ML23198A203; Meeting Notice ML23201A106; Meeting Transcript ML23226A087
- via email RES/DSA/RPB/ NMSS/MSST/MSEB/ RES/DSA/RPB/ NMSS/MSST/MSEB/
OFFICE PM PM BC BC NAME BAllen KTapp JTomon CEinberg DATE 08/18/2023 08/21/2023 8/22/2023 8/22/2023 OFFICIAL RECORD COPY ENCLOSURE
MEETING ATTENDEES
Public Meeting on the Proposed Revision to Regulatory Guide 8.39, Release of Patients Administered Radioactive Material
July 20, 2023 Webinar 12:00 - 3:00 PM (Eastern Time)
U.S. Nuclear Regulatory Commission Tapp, Katherine Valentin-Rodriguez, Celimar Allen, Brian Harvey, Edward Holiday, Sophie Shaw, Daniel Ayoade, Maryann Flora, Rigel Brenneman, Ken Williams, Kevin Spence, Sarah Evans, Carly Tomon, John Armstead, Lillian Dimarco, Daniel Dimmick, Lisa Einberg, Christian Cook, Jackie Karagiannis, Harriet
Public Name Affiliation (If provided)
Lieto, Ralph Michalski, Jeff Miller, John J.
Barrickman, Deborah M.
Buckalew, Judi Mason, Jeffrey S Spilker, Mary Ann Siegel, Barry Yonemitsu, Ron Bravenec III, Joseph S
Enclosure Public Name Affiliation (If provided)
Rodgers, Jessica Cohn, Gregg Andersen, Eric Freeland, Jon L.
Rook, Alan Ogretici, Akin Thomas, Jerry Kovats, Catalina E..
Senglaub, Todd Drelich, Mike Dickson, Allan W Tawatao, James Von Ahn,Karl Stephens, Mike N Isaac Gonzalez Speers,Robert Amurao, Max Hall, Ike Bailey, Derek Dufford, Chris Johnson, Jennifer E.
Blum,Stefanie Bruner, Angela P Chek, Roman Anger, Bob Dundulis, Bill Franklin, Elizabeth Thorvaldson, Tim Sit, Roger Studer, Kaci Williamson, Matthew Gu, Tianliang Sheetz, Michael A Hewadikaram, Kamani Hampton, Stanley D Day, Alexis Hamrick, Barbara Tomlinson,Cindy Ramirez,Sandra M Phillip Peterson Peros, Richard
Enclosure Public Name Affiliation (If provided)
Harvey Wolkov Fairchild, Greg Kircher,Philip Norton, Gregory Ma, Collin Le, Dao Eiden, Thomas White, William Kimes, Roxanna Golan, Amir Iman, Jeremy Dawry, Frank P.
Wayson, Michael B Otten, Jonathan J.
Whitelock, Lisa Deibert, Karen M.
Lee, Korressa Neil Petry Bailey Burks Chu Wang Andreani Mouzourou Kudchadker,Rajat J Kelley,Brian M Benke, Roland Colby, Brent Guastella, Michael Wiggins, John Byrnes, Heather Cromie, Meghan Sitek, Mark A.
Derby, Ann Marie Williams, Kendall A Hall, Matt Denman, Morgan Garelick, Ira Crawford, Willie M.
Naylor, Robert Greger, Robert Krebs, Jordan Turner, Adam Yokell, Daniel L.
Enclosure Public Name Affiliation (If provided)
Larinde, Olusegun Akano Peters, Michael Harkness, Kathleen Plathe, Michael D.
Nation, Christopher D.
Aman, Stacie Munisamy, Sivakumar Still, Cami Nair, Satish Jones, Rosaliz Galbraith, Wendy K.
Aumen, Laura Frye, Ross J.
Patel, Neena Fuller, Scott Yoder, Bryan C Wride, Rick Garcia, Jose Bosley, William LTC Rostel, Emily C Mamoun, Eslam Kamal Gift, Matt Mannella, Kelly Schmidt, Lorie Crane, Peter Gabriel, Sandy Tubbs, Brenda Coffman, Daisy Lorenzen, William Recca, Kimyli Bierman, David Giardina, Joseph Fischer, Karl Martin-Macintosh,Erica Newman,Donna Serfass, Jacob Z.
Helstern, Christopher M Collier, Jason Terrenoire, Wendy W Hammersborg, Kaylie Peralta, Byron Eduardo
Enclosure Public Name Affiliation (If provided)
Sanchez, Tim Johnson, Bella Elizabeth Farukhi, Irfan M.
Blacker, James Harisis, Becki Plott, Carmine M Lewis-Kraitsik, Jay Flanigan, Karen Mekuria, Ephrime Boyd, Katherine McIlvain, Josh Knox, Laura M.
Galbraith, Wendy Lyons, Erik Ouhib, Zoubir House, Jennifer R.
Lake, Ian P.
Gersman, Jennifer Ruck II, William R.
Goetz,Danielle M Bergvall, Ethan S LTC Lakey, Beth Swanson, Jasen L MAJ Dehdashti, Farrokh USARMY MEDCOM NRMC (USA)
Vognetz, Jason Luechtefeld, David USARMY DHA MADIGAN AMC (USA)
Grigsby, Perry Woods, Brandi Kelley, Brian M Ma, Collin Zoberi, Jacqueline Beckham,Thomas H Bhakta,Viharkumar S Kunder, Kevin Burton, Olwen F.
Berry, Kendall E Gutierrez-Garcia,Nina Boote, Evan J.
Redman, Harrison Neti, Prasad Merchantz, Heather
Enclosure Public Name Affiliation (If provided)
Higgins,Kevin Boyd, Katherine R Thompson, Diana Wilson, Jamie Stanford University Amurao, Max Lysik, Andrew E.
Pasell, Sally M.
Samii, Jason M.
Ford, Monica Hjelm, Danielle Matos, Lynes Sarfaraz, Esfandiar Welling, Michael Green, Joseph Nichols, Rachel Hintenlang, Kathleen Huston, Thomas E.
Note: The attendance list is based on the Microsoft Teams attendance report and transcript. This list does not include individuals who called in and individuals who did not provide their last name when signing into the meeting.
Enclosure