The US Nuclear Regulatory Commission (NRC) recently issued its Report to Congress on Abnormal Occurrences for fiscal year 2020. The report documents key aspects of those events that the NRC considers “Abnormal Occurrences” (AOs) and allows the regulated community to review the operating experience of reactor, medical, and industrial users of radioactive materials. AOs are unscheduled events that the NRC determines to be significant from the standpoint of public health or safety.
KEY TRENDS IN LAW AND POLICY REGARDING
NUCLEAR ENERGY AND MATERIALS
NUCLEAR ENERGY AND MATERIALS
The NRC held a public meeting on November 17 to review regulatory relief currently available to medical and other materials licensees, and to identify potential additional relief that the Staff is currently considering.
The US Department of the Treasury’s Committee on Foreign Investment in the United States (CFIUS) published proposed rule changes on May 21 addressing when parties must notify the Committee of proposed transactions.
Read our Health Law Scan blog addressing a process identified by the US Nuclear Regulatory Commission’s Office of Nuclear Materials Safety and Safeguards (NMSS) to review medical licensees’ requests for temporary exemptions from certain NRC regulations, as well as guidance on regulations NMSS has evaluated and deemed appropriate for temporary exemptions, due to the COVID-19 pandemic.
The US Nuclear Regulatory Commission (NRC) issued a letter including frequently asked questions (FAQs) on April 7 to all agreement and non-agreement states to address the NRC’s regulation of nuclear materials—and its policies and recent activities related thereto—in light of the coronavirus (COVID-19) pandemic. The NRC posted a copy of the FAQs to its password-protected Materials Security Toolbox and intends to update that site “as additional information becomes available.”
NRC’s Advisory Committee on the Medical Uses of Isotopes Discusses Radiopharmaceuticals, ‘Patient Intervention,’ and Medical Events
The US Nuclear Regulatory Commission’s (NRC’s) Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a meeting on March 30 to discuss a variety of topics of interest, including recent trends in radiopharmaceuticals, the scope of “patient intervention” as occurrences that are not Medical Events. Below are some items of potential interest from these discussions.
The US Nuclear Regulatory Commission (NRC) on March 11 issued a Notice of Violation to Avera St. Luke’s Hospital stemming from findings during an inspection of its Aberdeen, South Dakota facility in July 2019.
The NRC’s Office of Nuclear Reactor Regulation and Office of Nuclear Material Safety and Safety and Safeguards recently issued two Information Notices (INs) in response to medical events arising from the administration of radiopharmaceuticals.
The US Department of Energy (DOE) is requesting comments on whether there is a sufficient supply of molybdenum-99 (Mo 99) to meet medical needs without the export of highly enriched uranium (HEU) from the United States. Comments are due by December 27, 2019.
Licensees are required to report certain medical events that meet the criteria defined in 10 CFR § 35.3045, Report and Notification of a Medical Event.