The American College of Radiology (ACR) submitted comments to the U.S. Nuclear Regulatory Commission (NRC) March 9 addressing the agency’s ongoing evaluation into whether to expand source tracking, license verification and physical security requirements to include Category 3 quantities of certain isotopes of security interest. The expansion under consideration would likely cover Iridium-192 sources used in high-dose rate (HDR) brachytherapy.
The ACR expressed concern about the burden, cost and indeterminate value of adding Category 3 Ir-192 HDR sources to the sealed source tracking initiative, with transfers of those sources from licensees back to manufacturers also requiring license verification. The expansion under NRC consideration would increase the volume of sources and licenses covered by these programs exponentially, which could overwhelm agency resources and further increase medical use license fees.
The ACR also emphasized serious concerns about the patient privacy implications and significant burden for health care facilities of expanding NRC’s rigorous 10 CFR Part 37 requirements to include Category 3 quantities of Ir-192 HDR brachytherapy sources. The ACR warned that certain Part 37 requirements could threaten patient privacy, which — combined with the high costs of implementation by licensees — could deter health care facilities from offering these invaluable patient care services.
The ACR recommended that the future NRC decision on expansion should be risk-informed and should consider the public health benefit of patient access to HDR brachytherapy services, the unique nature of the clinical environment (including patient privacy rights), and the various difficulties experienced by licensees with Category 1 and 2 sources already covered under the current requirements.