United States Nuclear Regulatory Commission - Protecting People and the Environment

Training and Experience (T&E) Evaluation

Related Information

The public comment period closed January 29, 2019. Visit Regulations.gov to see comments the NRC received. The NRC will hold a public teleconference on T&E with the Advisory Committee on the Medical Uses of Isotopes on February 26, 2019. See Public Involvement for details.

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

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.

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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.

Public Meeting Date and Time Participation Information Related Documents
November 14, 2018
1:00 p.m. – 3:00 p.m. EST
Webinar Meeting Summary
Meeting Transcript
Public Meeting Notice
November 14 Slide Presentation

December 11, 2018
1:00 p.m. – 4:00 p.m. EST
Webinar and In-Person Meeting Meeting Summary
Meeting Transcript
December 11 Slide Presentation
Public Meeting Notice
January 10, 2019
1:00 p.m. – 4:00 p.m. EST
Webinar and In-Person Meeting Meeting Summary
Meeting Transcript
January 10 Slide Presentation
Public Meeting Notice
January 22, 2019
10:00 a.m. – 12:00 p.m. EST
Webinar Meeting Summary
Meeting Transcript
January 22 Slide Presentation
Public Meeting Notice

February 26, 2019
10:00 a.m. – 12:00 p.m. EST

ACMUI Public Teleconference on the T&E Subcommittee Report Training and Experience (T&E) for All Modalities
Subcommittee - Final Report

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.

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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.

Key Milestones Date Related Documents
Staff Requirements Memorandum (SRM) SRM-M170817 published August 17, 2017 SRM-M170817
Information paper SECY-18-0084 published August 28, 2018 SECY-18-0084
Attend the American Society for Radiation Oncology (ASTRO) 2018 Annual Meeting October 21 – 24, 2018 Meeting Poster

Meeting Handout
Federal Register notice published and three-month comment period begins October 29, 2018 83 FR 54380
Webinar November 14, 2018 Meeting Summary
Webinar and Public Meeting in the Commission Hearing Room at NRC Headquarters December 11, 2018 Meeting Summary
Webinar and Public Meeting in the Three White Flint Building at NRC Headquarters January 10, 2019 Meeting Summary
Attend the Society for Nuclear Medicine and Molecular Imaging (SNMMI) 2019 Mid-Winter Meeting January 17 – 19, 2019 Meeting Poster
Meeting Handout
Webinar January 22, 2019 Meeting Summary
Federal Register notice comment period closes January 29, 2019 83 FR 54380
Docket NRC-2018-0230
Public Teleconference on the ACMUI T&E Subcommittee Report February 26, 2019  
Commission paper publicly released Fall 2019  

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Page Last Reviewed/Updated Thursday, March 07, 2019