Research and Test Reactor Licensing Branch
It’s a little known fact: One of the most useful radioisotopes in medicine comes mainly from highly enriched uranium (HEU), the very stuff that can be turned into a nuclear weapon. We’re talking about technicium-99m, or Tc-99m—which has been called the world’s most important medical isotope. It’s used to diagnose a variety of illnesses in millions of procedures each year in the United States alone.
Tc-99m is created from another radioisotope, molybdenum-99, which traditionally has been produced abroad from HEU sources. A supply shortage that delayed patient treatments several years ago, coupled with the desire to reduce proliferation risks, prompted the world community to find better ways of securing the future supply of this isotope.
In 2012, Congress passed the American Medical Isotope Production Act to support private efforts to develop medical radioisotope production facilities using other methods and begin phasing out the export of HEU for medical isotope production. The National Nuclear Security Administration, through its Global Threat Reduction Initiative, has been promoting domestic Mo-99 production using different technologies through formal cooperative agreements with four commercial partners.
These partners and several other companies have said they are interested in producing Mo-99 in the U.S. They have proposed using several different technologies, ranging from non-power reactors to accelerator-driven, sub critical solution tanks. To support the transition to new technologies, the NRC is preparing to receive and review applications for construction permits and operating licenses for new facilities. In fact, we are now reviewing the first medical radioisotope production facility construction permit application, received earlier this year.
But not all Mo-99 production facilities will need an NRC license. While reactors fall strictly under NRC regulation, accelerator technologies that do not use enriched uranium or plutonium would be regulated by the states.
Companies, facilities and technicians involved in producing and administering Tc-99m to patients may also need to be licensed by either the NRC or an Agreement State. (There are 37 Agreement States, which have formal agreements with the NRC allowing them to regulate certain nuclear materials, including medical isotopes).
For more information on the role of the NRC and other agencies in regulating the medical use of nuclear materials, visit the NRC webpage.
Kara Mattioli also contributed to this post.