NRC Advisory Committee on Medical Uses of Isotopes Spring Meeting Summary

May 25, 2017

The Nuclear Regulatory Commission (NRC) held the spring meeting of its Advisory Committee on Medical Uses of Isotopes (ACMUI) on April 26 and 27, 2017. The ACMUI typically meets for public meetings during the spring and fall of each year and holds public teleconferences as needed. The ACMUI discussed several topics of importance to SNMMI, including an update on CFR 10 Part 35, the Patient Release Project, and training and experience (T&E) requirements. 

Training and Experience Requirements

As previously reported, an ACMUI subcommittee was formed to address training and experience requirements. The subcommittee was charged with two items. 

1. to begin a thorough review of T&E requirements in CFR sub parts D (35.190, 35.290) and E (35.390, 35.392, 35.394, 35.396), and
2. to make recommendations for/against changes in these T&E requirements for presentation at the Spring 2017 ACMUI meeting.  

The standing subcommittee provided an update on their progress. Dr. Christopher Palestro reported that in order to conduct reviews in a systemic and consistent fashion, the subcommittee developed a review template. The subcommittee suggested that the current requirements for training and experience be classified as appropriate, inappropriate, or perhaps, obsolete. The subcommittee continues to grapple with the complex issue of competence and is exploring certification processes and granted status through the NRC. The subcommittee conducted an initial review of 10 CFR 35.190 and plans to move through the rest of sub parts. 

Patient Release Project

The NRC is currently in Part 2 of the patient release project. As previously reported, the patient release project aim is for the NRC staff to verify assumptions made concerning patient release guidance. Part 2 of the project includes an evaluation of whether significant regulatory changes to the patient release program are warranted and exploring with the public, licensees, and state partners whether the agency should change 10 CFR Part 35.75 for specific reasons. 

Currently, the NRC is requesting comments from the general public on its patient release programs. 

NRC is seeking feedback in six areas listed below. The comment period closes on June 27, 2017. 

1. Development of an Activity-Based Patient Release Threshold
2. Clarification of the Time Covered by the Current Dose Limit in 10 CFR 35.75(a) for Releasing Individuals
3. Appropriateness of Applying the Same Limit on Dose From Patient Exposure to All Members of the General Public
4. Requirements for Releasing Individuals Who Are Likely To Expose Young Children and Pregnant Women
5. Requirement for Timely Discussion With the Patient About Patient Isolation to Provide Time for Licensee and Patient Planning
6. Requirement To Ensure Patients Are Given Instructions Prior to the Procedure

SNMMI is reviewing the Federal Register Notice and will submit comments to regulations.gov by the close of the comment period.

Part 35 Update

NRC staff provided an update on CFR 10 Part 35, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments. The proposed rule was published July 21, 2014, and the NRC received 69 comment letters, including the society's. The ACMUI provided NRC staff with its recommendations on the Final Rule in January 2016 and discussed its recommendations. NRC reported that the rule was provided to the Commission on June 17, 2016 and is still under review. Once the Commission reviews the rule, it will then need to be packaged and sent to OMB for review and approval. Once approved the Final Rule will become effective 180 days from the date of publication. The agreement states will have 3 years from the effective date to adopt the final rule. 

The notice of the next public ACMUI meeting will be published in a Federal Register Notice, but will likely take place in September or October 2017.  

ACMUI Session at SNMMI Annual Meeting

ACMUI members Chris Palestro, MD, and Darlene Metter, MD, will be presenting an ancillary session on Tuesday June 13, from 10:00 to 11:30 am, "What is the Advisory Committee on the Medical Use of Isotopes and What is Its Purpose?" The session will take place in room 203 of the Colorado Convention Center. All SNMMI members are encouraged to attend and learn more about the ACMUI.