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NRC Advisory Committee on Medical Uses of Isotopes Meeting Summary

March 31, 2016

The Nuclear Regulatory Commission (NRC) held their Spring meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on March 17-18, 2016. The ACMUI typically meets for public meetings during the Spring and Fall of each year and holds public teleconferences as needed. On Thursday, March 17 the ACMUI met with the NRC Commissioners and discussed several topics of importance to SNMMI, including, training and experience (T&E) requirements for alpha, beta, and gamma emmiters, I-131 patient release instructions, and Decommissioning Funding Plan (DFP) requirements. 

The ACMUI recently met via public teleconference on March 10, 2016, to present their recommendations to NRC staff related to training and experience requirements for alpha, beta, and gamma emmiters. The ACMUI proposed two recommendations during this call, which they reiterated to the NRC Commissioners. The Commissioners appreciated the ACMUI's thorough review of this issue and will report a decision on whether or not there will be a delay in Part 35 or PRN (as needed) rulemaking will be initiated to address T&E requirements. 

Recommendations:

  1. ACMUI recommends against the reduction in the number of hours of T&E required because it is not possible to conclude that the current T&E requirements are the only, or even the principal, cause of the decreased use of radiopharmaceuticals like Zevalin® and Bexxar®, and because of the potential issues raised by the proposed changes in T&E.
  2. ACMUI recommends that the ACMUI establish a standing subcommittee with the specific charge of periodically reviewing the T&E requirements currently in effect and making recommendations for changes as warranted.

SNMMI made public comments against lowering the training and experience requirements and requested a meeting with the Commissioners to discuss the problems with reducing the training hours from 700 to 80. SNMMI believes it is essential that the NRC Commissioners understand the full range of activities performed by multiple personnel in the delivery of radioactive therapeutics. Alpha emitters are a separate class of therapeutic radionuclides from beta-emitters, like I-131, due to the potential for extreme toxicity from internal contamination and difficulty of detecting alpha-particle contamination for those with little training. 

Regarding the topic of I-131 patient release instructions and website, the ACMUI stressed to the Commissioners the importance of not interfering in the practice of medicine and/or confusing patients with inconsistent information posted on the NRC website. The ACMUI was appreciative of information provided by medical societies and believes education is critical in reducing the inconsistency of information shared with patients. As previously reported, SNMMI submitted public comments to NRC on this issue. 

Concerning the Decommissioning Funding Plan (DFP) for Ge-68/Ga-68, the ACMUI presented to NRC Commissioners on the burdens of a DFP. The NRC Commissioners plan to review the topic and the draft report developed by the ACMUI. NRC staff have been working on language for a temporary exemption of a DFP while the rulemaking process begins to appropriately regulate Ge-68/Ga-68.

The notice of the next public ACMUI meeting will be published in a Federal Register Notice, but will likely take place in September or October 2016.