ML22229A131
| ML22229A131 | |
| Person / Time | |
|---|---|
| Issue date: | 08/19/2022 |
| From: | Kevin Williams NRC/NMSS/DMSST |
| To: | Ajango M Patients For Safer Nuclear Medicine Coalition, Young Survival Coalition |
| Lopas S | |
| References | |
| Download: ML22229A131 (3) | |
Text
M. Ajango UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Mary Farrell Ajango Young Survival Coalition on behalf of the Patients for Safer Nuclear Medicine Coalition 405 Lexington Avenue, 26 Fl.
New York, NY 10174 Sent via email to majango@youngsurvival.org
Dear Ms. Ajango:
I am responding to your letters dated June 2, 2022, and August 8, 2022 (Agencywide Documents Access Management System Accession Nos. ML22164A919 and ML22222A138),
requesting that the U.S. Nuclear Regulatory Commission (NRC) correct a statement made in a 1980 Federal Register notice (45 FR 31701; May 14, 1980). In this Federal Register notice of the NRCs final rule on misadministrations, now referred to as medical events, the Commission states, [e]xtravasation frequently occurs in otherwise normal intravenous or intraarterial injections. It is virtually impossible to avoid. Therefore, the Commission does not consider extravasation to be a misadministration. You requested, based on recent studies indicating that quality improvement methodologies may reduce the occurrence of extravasation, that the NRC correct the statement that extravasation is virtually impossible to avoid and immediately revise NRC regulations to require medical event reporting of extravasations resulting in a localized dose equivalent exceeding 0.5 sieverts.
As cited in your letter, there is a petition for rulemaking on this subject pending before the Commission (PRM-35-22). The NRC staff has determined that the concerns in your request will be addressed in the petition for rulemaking process, and staff has added your letters to the petition docket (NRC-2020-0141 on www.Regulations.gov). As the NRC explained in the Federal Register notice that published the agencys Information Quality Guidelines, interpretations of data or information publicly disseminated after October 1,2002, are not subject to the NRCs Information Quality Guidelines and information correction process (67 FR 61695; October 1, 2002). Rather than the NRCs information correction process, the more appropriate vehicle to seek revision of NRC regulations is a petition for rulemaking, filed in accordance with 10 CFR § 2.802.
While the Commission is considering this issue, the decision published in the 1980 Federal Register notice remains in effect. The information in your request, information submitted by the petitioner, public comments on the petition, published literature reviewed by NRC staff, and input from the Agreement States and NRCs Advisory Committee on the Medical Uses of Isotopes, will all help inform the Commissions evaluation of the petition for rulemaking. The Commissions decision on the petition will determine whether the NRC will pursue a rulemaking to classify certain extravasations as medical events. If there are further regulatory actions related to extravasation, there will be additional opportunities to inform the staffs implementation of the Commissions petition decision.August 18, 2022 M. Ajango If you have further questions or concerns, please contact me by email at Kevin.Williams@nrc.gov, or by phone at 301-415-3340.
Sincerely, Kevin Williams, Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards Einberg, Christian signing on behalf of Williams, Kevin on 08/18/22
ML22229A131 OFFICE NMSS/MSST NMSS/MSST NMSS/MSST OGC NMSS/MSST NAME SLopas CValentin-Rodriguez CEinberg MLemoncelli KWilliams DATE 07/13/22 07/14/22 07/14/22 8/15/222 08/17/22