Training and Experience (T&E) Evaluation
On August 17, 2017, the U.S. Nuclear Regulatory Commission (NRC) issued a Staff Requirements Memorandum (SRM) SRM-M170817 approving the final rule revising 10 CFR Part 35 and directing staff to evaluate: (1) Whether it makes sense to establish tailored training and experience (T&E) requirements for different categories of radiopharmaceuticals; (2) How those categories should be determined (such as by risks posed by groups of radionuclides or by delivery method); (3) What the appropriate T&E requirements would be for each category; and (4) Whether those requirements should be based on hours of T&E or focused more on competency. In response to the SRM, the NRC staff documented its initial results, status, and next steps related to this evaluation in SECY-18-0084, "Staff Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals in Response to SRM-M170817." In SECY-18-0084, the staff concluded that additional outreach with the medical community is needed. For more information, please see the following topics on this page:
In SECY-18-0084, the NRC staff concluded that it may be feasible to establish tailored T&E requirements for different categories of radiopharmaceuticals under 10 CFR Part 35, Subpart E, and to create a means of authorizing the administration of certain categories of radiopharmaceuticals (i.e., a limited authorized user [AU] status). In addition, the staff concluded that there are viable options for creating a competency-based approach to demonstrate acceptable T&E for limited AUs. The staff plans to conduct more extensive outreach with the medical community focused on assessing options related to tailoring the T&E requirements to establish a limited AU status, the specific T&E requirements that should apply, and determining how the T&E requirements should be met (e.g., hours of training, demonstration of competency, or some combination of the two). As part of that outreach, the staff will consider whether a competency-based approach makes sense for demonstrating the requisite knowledge level with respect to the T&E requirements for all the medical uses authorized under 10 CFR 35.300.
In addition to the planned outreach, the staff plans to conduct some additional activities. They include:
- Evaluating patient access and whether or not there is a shortage of AUs;
- Reviewing medical and radiation safety events for potential trends related to T&E;
- Reviewing international standards for radiopharmaceutical T&E requirements; and
- Coordination with the Advisory Committee on the Medical Uses of Isotopes.
Once the work described above is completed and input from planned outreach is evaluated, the NRC staff will determine a path forward. The staff will develop recommendations related to tailored T&E requirements for different categories of radiopharmaceuticals or describe its rational to maintain the current regulations. The staff's recommendation will be documented in a paper that will be provided to the Commission.
Page Last Reviewed/Updated Thursday, April 09, 2020