ML24318C389
| ML24318C389 | |
| Person / Time | |
|---|---|
| Issue date: | 11/14/2024 |
| From: | Dafna Silberfeld NRC/NMSS/DMSST |
| To: | Davies S Teen Cancer America |
| Shared Package | |
| ML24291A159 | List: |
| References | |
| LTR-24-0227 | |
| Download: ML24318C389 (1) | |
Text
November 14, 2024 Simon Davies Teen Cancer America 11845 Olympic Blvd. #775W Los Angeles, CA 90064 simon@teencanceramerica.org
Dear Mr. Davies:
I am writing in response to your letter dated October 16,2024. I can assure you that the NRC staff is committed to keeping the Commission fully and currently informed about any matter that may affect its evaluation and decision of a policy matter.
On August 13, 2024, the NRC staff submitted the draft proposed extravasations rulemaking package to the Commission; which can be found at SECY-24-0067, Proposed Rule: Reporting Nuclear Medicine Injection Extravasations as Medical Events. The SECY paper provides recommendations to the Commission on the next step of the rulemaking process that began when the Commission, in SRM-SECY-22-0043, approved rulemaking to amend the NRCs regulations to include certain nuclear medicine injection extravasations as reportable medical events. The package also includes the Draft Regulatory Guide DG-8062, which is currently with the Commission for review.
During the development of the proposed rule and associated guidance the NRC staff received input from a variety of stakeholders, including patient advocacy groups and members of the public. Moreover, the rulemaking docket continues to be updated with stakeholder correspondence available at https://www.regulations.gov/docket/NRC-2022-0218, and this letter will be added accordingly. The Commission may use this stakeholder information, in conjunction with the NRC staffs recommendations, in making its determination on the NRCs path forward for the extravasations rulemaking.
In response to the Office of the Inspector Generals (OIG) report dated March 26, 2024, NRC staff is undertaking several efforts to ensure we uphold the public trust. An updated internal procedure regarding the administration of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) was issued in August. This procedure strengthened conflict of interest screenings and ensured that procedures were consistent with updated Federal Advisory Committee Act requirements. The NRC is also working to update the ACMUI members guide and bylaws to further prioritize potential and apparent conflicts of interest, and to provide enhanced ethics training. Finally, the NRC has reviewed our hiring practices to include questions during interviews regarding ethics and conflict of interest policies. Questions about any other allegations can be submitted to the OIG.
Your letter also reflects a concern that the NRC is not treating extravasations as a serious radiation protection issue and that the NRC should take more immediate action outside the
S. Davies 2
rulemaking process. However, the staff did not find extravasations that rose to the level of immediate safety concern requiring immediate action outside of the rulemaking process.
As such, the agency is proceeding with rulemaking to address the potential risks of extravasations with these radiopharmaceuticals as directed by SRM-SECY-22-0043.
If you have any questions or need additional information, please contact me at Dafna.Silberfled@nrc.gov.
Sincerely, Signed by Silberfeld, Dafna on 11/14/24 Dafna Silberfeld, Deputy Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards
ML24318C389; Ltr ML24318C389 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST NAME DDimarco KTapp CEinberg DSilberfeld DATE Nov 13, 2024 Nov 13, 2024 Nov 13, 2024 Nov 14, 2024