SNMMI Comments on NRC Part 35 and Part 20 Rules

November 21, 2014

The Society of Nuclear Medicine and Molecular Imaging recently submitted comments on the Nuclear Regulatory Commission (NRC) 10 CFR Part 35 Proposed rule and Part 20 advance notice of proposed rulemaking. SNMMI works with the NRC to mitigate any regulatory changes that may adversely affect nuclear medicine. Part 35 contained updates for the medical use of byproduct material, specifically, medical event definitions, training and experience, and clarifying amendments. Part 20 addressed radiation protection regulations.

The Society’s comments on Part 35 pertained to an update to allow an assistant/associate Radiation Safety Officer (RSO) on a license, a new exception of board certified individuals from training and experience requirements and Molybdenum-99 (Mo-99) breakthrough tests after each elution and required reporting of failed Mo-99 breakthrough tests.

Regarding the RSO update, SNMMI believes the proposed changes would make it easier for an individual to become a Radiation Safety Officer on other medical licenses and would increase the number of individuals who would be available to serve as preceptors for individuals seeking to be appointed as RSOs or ARSOs. As a result, SNMMI supports relaxing the qualifications for the assistant/associate RSOs to allow on-the-job training while serving in the assistant/associate capacity. Additionally, SNMMI recommends that NRC allow authorized users (AU), authorized nuclear pharmacists (ANP), or authorized medical physicists (AMP) to serve as RSOs on individual licenses for private practices (i.e. non-hospital sites).

Additionally, SNMMI endorses retaining the attestation requirement for those individuals pursuing initial board certification and alternate pathways, with attestation provided by preceptors with similar status (AUs, RSOs, AMPs and ANPs) with whom the individual trained. SNMMI believes retaining the preceptor attestation helps ensure accountability and credibility by clearly identifying an authorized user who can attest that the individual has satisfactorily completed the required NRC training.

SNMMI endorses the recommendation to change the requirements for measuring the Molybdenum-99 (Mo-99) concentration for elutions of Mo-99m/technetium (Tc) generators as well as adding reporting requirements for failed Mo-99/Tc-99m and strontium-82 (Sr-82)/rubidium-82 (Rb-82) generators, and recognizes that codifying it into regulation would not impose any additional burden on licensees. The current requirement to measure the Mo-99 concentration after the first elution each day would be changed to require that the Mo-99 concentration be measured in each eluate because of several incidents of excessive breakthrough reported to the NRC. Current standards of practice as well as manufacturers recommendations already include breakthrough testing for every generator elution.

The Society’s comments on Part 20 address several issues in radiation protection including methodology and terminology, occupational dose limit for the lens of the eye, dose limit for embryo/fetus of a declared pregnant occupational worker, individual protection, metrication, and reporting of occupational exposure.

SNMMI’s comments were consistent with previous positions on these issues, with the exception of the occupational dose limit for the lens of the eye and adoption of new methodology and terminology. It is the opinion of this committee that the proposed decrease in occupational dose limit for the lens of the eye should likely be lowered to new standards as proposed by the ICRP publication “ICRP statement on Tissue Reactions in Normal Tissues and Organs – Threshold Doses for Tissue Reactions in a Radiation Protection Context.” New information regarding the threshold for cataracts appears to be lower than previously thought and should be acted upon. Despite cataracts being a surgically correctable disease, unlike most other radiation induced morbidities, it is felt that the efforts to reduce such disease can and should be enacted in its prevention.

Additionally, SNMMI recommends the adoption of the current methodology and terminology associate with effective dose and total effective dose as this is consistent with current publications in this regard even it may involve some level of effort to implement these changes. To date, the NRC has utilized the methodology as described in International Commission on Radiological Protection (ICRP) Report 26 and the definition of effective dose equivalent and total effective dose equivalent (EDE and TEDE) as opposed to effective dose and total effective dose (ED and TED) as described in ICRP Report 103.

If the NRC develops draft supporting guidance for a proposed 10 CFR Part 20 rulemaking, then the public will have an opportunity to provide comment on the draft guidance. If the NRC decides not to pursue a 10 CFR Part 20 rulemaking on this topic, the NRC will publish a document in the Federal Register that will generally address public comments and withdraw the Advanced Noticed of Proposed Rulemaking.

The Society will communicate updates on Part 35 and Part 20 as they occur.