November 14, 2017
SNMMI has submitted comments to the Nuclear Regulatory Commission (NRC) on its open petition for rulemaking, asking that its regulations be revised to include radionuclides and their corresponding activities to the list of "Quantities of Licensed Material Requiring Labeling." The NRC also received a petition for rulemaking from Matthew McKinley on behalf of the Organization of Agreement States (OAS) dated April 14, 2017, making the same request. The petition was docketed by the NRC on June 21, 2017, and assigned Docket No. PRM–30–66. The NRC is examining the issues raised in PRM–30–66 to determine whether they should be considered in rulemaking.
The society's comments addressed four questions raised by NRC.
Question 1. What products or technologies, other than the germanium-68 generators cited in the petition, are being or could be negatively affected because the radioactive materials required for these products or technologies are not currently on the table in appendix B of 10 CFR part 30?
Question 2. Please provide specific examples of how the current NRC regulatory framework for decommissioning financial assurance has put an undue hardship on potential license applicants. Explain how this hardship has discouraged the development of beneficial new products, or otherwise imposed unnecessarily burdensome requirements on licensees or members of the public (e.g., users of medical diagnostic or therapeutic technologies) that depend on naturally-occurring or accelerator-produced radioactive materials (NARM).
Question 3. Given NRC’s current regulatory authority over the radiological safety and security of NARM, what factors should the NRC take into account in establishing possession limits for any of these materials that should be listed in appendix B of 10 CFR part 30?
Question 4. Does this petition raise other issues not addressed by the questions above about labeling or decommissioning financial assurance for radioactive materials? Must these issues be addressed by a rulemaking, or are there other regulatory solutions that NRC should consider?
SNMMI agrees with the Organization of Agreement States petition for rulemaking. This petition is well supported by the findings of the Advisory Committee on the Medical Use of Isotopes (ACMUI) Germanium-68 (Ge-68) Decommissioning Funding Plan (DFP) Final Report of August 12, 2015 (ACMUI Ge-68 report).