UPDATE: CBNC received a response from the NRC on September 17, 2020. As the response was received after the CBNC Certification initial application period was closed (August 24, 2020), the CBNC was unable to modify the CBNC eligibility requirements for the 2020 CBNC application period. The NRC exemption is only valid through December 31, 2020.
ATTENTION CBNC Preceptors and Applicants:
The CBNC is aware that due to the closures of many commercial radiopharmacies to training visitors based on COVID-19 guidelines, some of today’s fellows may be unable to attend these commercial radiopharmacies in person to fulfill training and education (T&E) requirements for 10 CFR Part 35.290 (c)(1)(ii)(G) which states “Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs”.
The CBNC has sent a letter asking the Nuclear Regulatory Commission (NRC) to consider allowing “virtual” training for 10 CFR Part 35.290 (c)(1)(ii)(G), Training for imaging and localization studies as a potential area for regulatory relief during and after the COVID-19 Public Health Emergency (PHE). The CBNC letter is similar to and supports the request made by The American Society of Nuclear Cardiology, the Society of Nuclear Medicine and Molecular Imaging, the American Society of Radiation Oncology and the American College of Radiology.
As you know, the Nuclear Regulatory Commission (NRC) is an independent agency of the U.S. government that regulates commercial nuclear power plants and other uses of nuclear materials, such as in nuclear medicine, through licensing, inspection and enforcement of its requirements. Their goal is to protect public health and safety related to radioactive materials (nuclear energy).
In order to be recognized by the NRC the CBNC must follow the NRC’s guidelines. Therefore, until such time we receive notification from the NRC that “virtual” training is acceptable to meet the 10 CFR Part 35.290 (c)(1)(ii)(G) standard for Training for imaging and localization studies, our current requirements stand as stated. If the CBNC request is approved by the NRC, the CBNC will modify our policies, procedures and/or forms to allow for acceptance of virtual training to meet the NRC standard. When applying to the NRC using CBNC as a pathway for Authorized User status, you must submit your original CBNC certification certificate. NRC currently does not accept the CBNC recertification certificates.
If and when more information becomes available, we will post it here.