The NRC Adopts Many of SNMMI's Recommendations in Final Rule on Medical Use of Byproduct Material

July 25, 2018

The Nuclear Regulatory Commission, on July 16, 2018, released the final rule and guidance on "Medical Use of Byproduct Material— Medical Event Definitions, Training and Experience, and Clarifying Amendments." 

The final rule incorporates many changes recommended by SNMMI.  It amends training and experience requirements in certain sections, provides new details on measuring molybdenum contamination, and amends Part 35 to allow a licensee to appoint a qualified individual to serve as an associate radiation safety officer (ARSO), among other provisions.

The training and experience requirements portion of the rule was amended to remove the requirement to obtain a written attestation for an individual who is certified by a specialty board whose certification process has been recognized by the NRC or an Agreement State. The NRC determined that certification by a specialty board, coupled with meeting the recentness training requirement, is sufficient to demonstrate that an individual has met the T&E requirements and has the requisite current knowledge; in this situation, additional attestation by a preceptor is unnecessary. Individuals who are not board certified will still need to obtain a written attestation; however, the language of the attestation has been modified. Additionally, residency program directors will be allowed to provide these written attestations.

The provision regarding measuring the molybdenum-99 (Mo-99) concentration for elutions of Mo-99/Technetium-99m (Tc-99m) generators has been modified to include a requirement for reporting a notification of a generation eluate exceeding permissible Mo-99m strontium-82 or strontium-85 concentrations. It also adds a new requirement for when to report a failed technetium and rubidium generator. 

Regarding the ARSO provision, NRC states that the change to allow a licensee to appoint a qualified individual with expertise in certain uses of byproduct materials to be named on a license to serve as ARSO will make it easier for an individual to increase the number of individuals available to serve as preceptors for those seeking to become a radiation safety officer or associate radiation safety officer. 

SNMMI commented on each of the aforementioned provisions during the rulemaking process and is supportive of the final amendments issued by NRC.  

The NRC final rule will become effective on January 14, 2019.