ML24261B999
| ML24261B999 | |
| Person / Time | |
|---|---|
| Issue date: | 11/27/2024 |
| From: | Kevin Williams NRC/NMSS/DMSST |
| To: | Lattanze R Lucerno Dynamics |
| References | |
| Download: ML24261B999 (1) | |
Text
November 27, 2024 Ronald K. Lattanze Lucerno Dynamics, LLC 140 Towerview Court Cary, NC 27513 rlattanze@lucernodynamics.com
Dear Mr. Lattanze:
I am writing in response to your letter dated August 27, 2024. I can assure you that the U.S Nuclear Regulatory Commission (NRC) staff is committed to keeping the Commission informed about any matter that may affect its evaluation and decision of a policy matter. It is my understanding that the Commission is aware of your views on extravasations, including your view that NRC staffs paper to the Commission, SECY-22-0043, Petition for Rulemaking and Rulemaking Plan on Reporting Nuclear Medicine Extravasations as Medical Events, contains inaccuracies.
On August 13, 2024, the NRC staff submitted the draft proposed extravasations rulemaking package to the Commission; the package 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. The package accompanying SECY-24-0067 refers to the extravasations rulemaking docket, which includes all stakeholder information provided to the NRC in this matter, including your letters dated August 7, and 27, 2024. 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.
While the staff may withdraw or revise Commission papers if necessary, that practice is separate from the information correction process you mention in your letters. The staff has reviewed the information provided in your August 7 and August 27, 2024, letters and did not identify any new or significantly different information that would change the recommendation or scope of the proposed rule. The information provided in SECY-22-0043, as well as in SECY 0067, is based on peer-reviewed scientific literature as described in the referenced enclosure (Agencywide Documents Access and Management System (ADAMS) Accession Number ML21268A011) as well as input from external stakeholders, including yourself, provided during the NRCs request for public comment (ADAMS Accession No. ML21268A007). Additionally, if the proposed rule is approved by the Commission, there will be opportunity to provide comments on the proposed rule prior to final rule development. In the public comment period, we will get a wide range of perspectives because there are different opinions on the matter.
Your letter also reflects a concern that the NRC is not treating extravasations as a serious radiation protection issue and that the NRC should issue immediate interim guidance. While the agency is aware of increased use of therapeutic radiopharmaceuticals, which have a higher potential to cause radiation injury following an extravasation, the total evidence in front of the
staff, which includes all information provided by you, does not justify the immediate imposition of a reporting requirement for extravasation. 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.
In response to the Office of the Inspector Generals (OIG) report dated March 26, 2024, the 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 2024. 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 eliminating 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.
In accordance with 10 CFR 2.390 Public inspections, exemptions, requests for withholding, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room (ADAMS Accession Number ML24261B999). ADAMS is accessible at https://www.nrc.gov/reading-rm/adams.html. If you have any questions or need additional information, please contact Dafna Silberfeld at Dafna.Silberfled@nrc.gov.
Sincerely,
/RA/
Mirela Gavrilas, PhD Executive Director for Operations