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. The current regulations require parties to file a notice when the target US business is classified by one of 27 North American Industry Classification System (NAICS) Codes. The proposed regulations would rely on the US export control regulations and regimes – and not on NAICS codes – to determine when parties must notify CFIUS. In short, although the proposed changes represent an expansion of the potential industries affected by the mandatory declaration requirements through the elimination of the 27 NAICS codes, they narrow the focus for the nuclear industry to those foreign persons (and the countries where they are located) that are subject to export licensing requirements.

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.”

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. During the inspection, NRC identified three apparent violations in the following areas:

  1. Monitoring occupational exposure of workers from various sources of radiation
  2. Developing and implementing a robust radiation protection program
  3. Reporting an occupational exposure in excess of the annual limits in 10 CFR 20.1201

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 first IN alerts medical-use licensees to four strontium (Sr)-82/rubidium (Rb)-82 generator elution events that resulted in patients receiving concentrations of Sr-82 and Sr-85 in excess of regulatory requirements. The IN describes four separate events in which approximately 90 patients were administered Rb-82 chloride for cardiac imaging that contained Sr-82 and Sr-85 concentrations in excess of the regulatory limits identified in 10 CFR § 35.204. In evaluating these events, the NRC found that:

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. The comments will support a certification that the secretary of Energy must submit in early 2020 pursuant to the American Medical Isotopes Production Act of 2012, Pub. L. 112-239, 126 Stat. 2211 (the Act). The content of this certification will determine whether the US Nuclear Regulatory Commission (NRC) will have authority to issue HEU export licenses for Mo-99 production in foreign research and test reactors.

According to the notice in the November 27 Federal Register, “Historically, the United States has not had the capability to produce Mo-99 domestically and, until 2018, imported 100 percent of its supply from international producers, some of which was produced using targets fabricated with proliferation sensitive HEU.” Congress passed the Act as part of a decades-long effort to ensure domestic availability of Mo‑99, which is used in medical diagnostic and therapeutic procedures. According to the notice, approximately 80% of all of these procedures depend on the use of technetium-99, a decay product of Mo-99. Importantly, Section 3174 of the Act amended the Atomic Energy Act to prohibit the NRC from issuing licenses to export HEU from the United States for purposes of medical isotope production, effective seven years from the date of enactment of the Act. The Act became law on January 2, 2013, and thus the ban on NRC export licenses is scheduled to go into effect in early 2020, unless it is extended through a certification from the Energy secretary.

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. Such reports allow the NRC to identify the causes of the events so as to prevent their recurrence and to notify other licensees so they can take action to prevent such events at their facilities. The NRC Staff and the Advisory Committee on the Medical Uses of Isotopes (ACMUI) perform annual reviews of medical event reports to identify trends, patterns, generic issues, and generic concerns, and to recognize any shortcomings related to specific equipment or procedures.

The US Nuclear Regulatory Commission’s (NRC’s) revised regulations regarding the medical use of byproduct material became effective on January 14, 2019—six months after being published in final form, and nearly a decade after the proposed rulemaking. See Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments, 83 Fed. Reg. 33,046 (July 16, 2018). The revised regulations amend 10 CFR Parts 30, 32, and 35. The NRC also issued guidance to provide additional detail regarding the substance of the revised regulations and to assist licensees with compliance. See Guidance for the Final Rule, Medical Use of Byproduct Material—Medical Events, Definitions, Training and Experience, and Clarifying Amendments, 83 Fed. Reg. 33,759 (July 16, 2018). Among other things, the amendments change the requirements associated with

The New York Times recently published an important article discussing the tightening supply and uncertain future of MO-99, a short-lived medical isotope widely used for medical diagnostics in the United States and worldwide. Currently, there are only six suppliers of MO-99 in the world, all of them government-owned nuclear research reactors located outside of the United States. As noted in the article, one US company—SHINE Medical Technologies—has plans to build a domestic supply chain in Wisconsin to ensure a reliable supply, shielded from potential interruptions that could readily impact a foreign-only supply chain. They have already received Nuclear Regulatory Commission (NRC) approval in the form of a Construction Permit issued in 2016 to begin work on the facility. There was no material opposition to the NRC permit for SHINE, perhaps in recognition of the importance of nuclear medicine in our day-to-day health and well-being. A few other companies are also seeking to build MO-99 domestic production facilities. While nothing is ever easy in the nuclear world and we cannot predict who will get to the finish line first, it seems that the successful addition of a domestic supply of MO-99 is an important first step towards “health independence.” And much like the current focus on US energy independence, it seems equally worthy of national attention.

Read the article here.