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:

• Activities
• Public Involvement
• Schedule

Activities

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:

1. Evaluating patient access and whether or not there is a shortage of AUs;
2. Reviewing medical and radiation safety events for potential trends related to T&E;
3. Reviewing international standards for radiopharmaceutical T&E requirements; and
4. 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.