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.

Public Involvement

On October 29, 2018, the NRC published a notice in the Federal Register (83 FR 54380) requesting comments on its evaluation of the T&E requirements for all the medical uses authorized under 10 CFR 35.300, "Use of unsealed byproduct material for which a written directive is required." The Federal Register notice is available on the Federal Register Web site.

Publication of the Federal Register notice opened a three-month public comment period that closed on Tuesday, January 29, 2019. Comments submitted to the NRC during the comment period can be viewed on Regulations.gov, the Federal rulemaking Web site.

The NRC is held four public meetings during the comment period. Details for all four public meetings, including meeting summaries, transcripts, and slides, are included in the table below.

The following links to non-NRC servers and websites are provided solely as a reference for the convenience of users. NRC cannot guarantee the authenticity of documents or the validity of information obtained at these non-NRC websites. See our Site Disclaimer for more information.

In addition to obtaining feedback in the form of public comments, the NRC staff will also work with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) in an open and transparent manner.  The ACMUI meeting minutes, as well as information on how to participate in these meetings, are maintained on the NRC public website to ensure availability to the medical community and to the public.  The Training and Experience Subcommittee—a subcommittee of the ACMUI specifically formed to address issues on these topics—maintains their public documents under the heading, ACMUI Subcommittee Reports.

Schedule

The following table summarizes key milestones in the schedule for the NRC staff's evaluation of training and experience, with links to the related documents.

The following links to non-NRC servers and websites are provided solely as a reference for the convenience of users. NRC cannot guarantee the authenticity of documents or the validity of information obtained at these non-NRC websites. See our Site Disclaimer for more information.