NRC Advisory Committee on Medical Uses of Isotopes Spring Meeting Summary

April 5, 2019

The Nuclear Regulatory Commission (NRC) held their spring meeting of its Advisory Committee on Medical Uses of Isotopes (ACMUI) on April 3-4. The ACMUI discussed several issues of importance to SNMMI including Part 35, training and experience requirements, and Germanium-68/Gallium-68 Generator Licensing Guidance.

Part 35

NRC Team Leader, Lisa Dimmick, provided a brief update on the status of 10 CFR Part 35, which became effective January 14th, 2019. As previously reported, NRC adopted many of SNMMI's recommendations. 

Major changes:

• Permanent implant brachytherapy medical event reporting & notification
• Name Associate Radiation Safety Officers on a medical license
• Training & Experience (T&E) generic changes for all individuals
• Molybdenum (Mo) breakthrough measurement frequency and reporting of failed generators

NRC plans to hold a few public webinars to educate stakeholders on the new changes.

NRC Chairman Kristine L. Svinicki receives special recognition for being the longest serving Commissioner at the 2019 Spring ACMUI meeting.

Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance

ACMUI member Megan Shober provided a brief update on the current and proposed revised Ge-68/Ga-68 generator licensing guidance. As currently written, the 2017 guidance expressly names Eckert and Ziegler brand of generator, includes a specific breakthrough limit, describes the steps to take if a generator has not been eluted within 48 hours, requires notification to the NRC Operations Center if an eluate exceeds breakthrough levels, and requires wipe tests each day of use. 

The NRC is in the process of revising the current guidance. The proposed revisions include, brand neutral, removing reconditioning requirements for generators not eluted within 48 hours, and revised breakthrough reporting requirements ("multiple" failures). 

NRC intends to release the revised guidance in the coming months. 

Training and Experience Requirements 

On April 4th, ACMUI member Darlene Metter, MD, provided an update to the NRC Commissioners on training and experience (T&E) requirements for all modalities. As previously reported, an ACMUI subcommittee was formed to thoroughly review T&E requirements in CFR sub parts D (35.190, 35.290) and E (35.390, 35.392, 35.394, 35.396), and to make recommendations for/against changes in these T&E requirements.

During the spring 2018 ACMUI meeting, the subcommittee noted two concerns. 

1. The approval of Lu-177 DOTATATE for treatment of somatostatin receptor-positive GEP-NETs, including foregut, midgut, and hindgut. The ACMUI believed these broad indications to treat the second most common gastrointestinal tumor could result in potentially high demand for Lu-177 DOTATATE.
2. The waning number of nuclear medicine physicians in the U.S. As a result, the subcommittee recommended an alternate Authorized User (AU) pathway be considered. In order to explore a limited AU pathway the ACMUI subcommittee reported there were a few specific tasks that need to be accomplished. 

The subcommittee spent a year gathering information and reported on the results of their research.

Regarding the potential AU shortage, the ACMUI subcommittee noted two pathways under 10 CFR 35.390:

Pathway 1: Board Certification (American Boards of Nuclear Medicine, Radiology, and Osteopathic Radiology)

• Nuclear Medicine (NM)
• Radiation Oncology (RO)

Pathway 2: Alternate Pathway

• 700 hours of T&E includes 200 lab hours in basic radionuclide handling techniques in the medical uses of unsealed byproduct material requiring a written directive
• Diagnostic Radiology, redesigned* (rDR) 
• Nuclear Radiology 

*16 months NM in a 48 month Diagnostic Radiology program

The ACMUI identified individuals for 2018-2019. 

• 2018-19 AU 35.390 pipeline: 921 (graduate totals include Pathway 1 and 2)
• 2019 Graduates: 269 (graduate totals include Pathway 1 and 2)
• 2018 ABNM: 3,591 practicing AU

The ACMUI Subcommittee also reviewed the Limited-Scope Authorized User pathway. Dr. Metter stated that radionuclide therapy is the highest risk and highest impact of all nuclear medicine procedures. The subcommittee believes that all individuals must have basic level of training and experience necessary to protect public health and safety and the equivalent level of procedural competency. The appropriate training would include basic knowledge topics in 35.390 and due to the complexity of these topics, any category would include nearly all of 35.390. As such, the subcommittee recommended against a limited scope-AU pathway. 

In sum, the final ACMUI recommendations include:

• The ACMUI strongly supports the current AU pathways for 35.390, which protect the public's health and safety
• There is no objective data to support an AU shortage
• The ACMUI does not recommend a limited-scope AU pathway for unsealed byproduct material for which a written directive is required
• The ACMUI unanimously agrees that if the NRC pursues a limited-scope AU pathway, the AU candidate must attest to the acquisition of 35.390 topics and skills by successfully completing a formal competency assessment with continued formal periodic competency reassessment to maintain his/her limited-scope AU status. 

SNMMI agrees with the ACMUI on the importance of patient and public safety, but also believes ensuring access to quality care is essential. SNMMI has provided feedback to NRC and the ACMUI on this topic. Most recently SNMMI submitted comments to NRC in January 2019.

The next ACMUI public meeting will take place in the fall of 2019, likely September or October.