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.