10 CFR Part 35 — Medical Use of Byproduct Material

Background

SNMMI works with Nuclear Regulatory Commission (NRC) to mitigate any regulatory changes that affect nuclear medicine.  10 CFR Part 35 contains the requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. 

Current Status

On August 8, 2013, the NRC released the Proposed Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63). The proposed rule addresses three ongoing rulemaking projects and several other related topics.

  1. First, this rule proposes amendments to the reporting and notification requirements for a medical event (ME) for permanent implant brachytherapy.

  2. Second, the rule proposes changes: (1) to the training and experience (T&E) requirements for authorized users (AUs), medical physicists, Radiation Safety Officers (RSOs), and nuclear pharmacists; (2) to the requirements for measuring molybdenum contamination and reporting of failed technetium and rubidium generators, and (3) to allow Associate Radiation Safety Officers (ARSOs) to be named on a medical license.

  3. Third, the rule proposes changes to address a request filed in a petition for rulemaking to exempt certain board-certified individuals from certain T&E requirements (i.e., “grandfather” these individuals) so that they may be identified on a license or permit for materials and uses that they performed on or before October 24, 2005, the expiration date of the former Subpart J of Part 35 which contained the prior T&E requirements.


SNMMI will be presenting before the NRC in the coming weeks regarding the Proposed Rule.  Additionall, we will continue to monitor this process and comment on any changes that affect nuclear medicine.