In a final safety evaluation report, the U.S. Nuclear Regulatory Commission (NRC) has given SHINE Technologies a nod of approval for the company’s medical isotope production facility, The Chrysalis, to receive its operating license, meeting a milestone not seen in over 35 years.

Once operational, the company will produce medical isotopes at The Chrysalis, including molybdenum-99, which is used in over 40 million medical procedures annually to diagnose heart disease, cancer and other conditions.

In its report, the NRC says that SHINE has met all technical requirements to obtain an operating license, which it filed for in 2019.
“By reaching this milestone not seen with the NRC in more than 35 years, we’ve managed to accomplish what no startup has done before, and are that much closer to reaching our goal of using fusion to make lifesaving medicine,” said Greg Piefer, founder and CEO of SHINE, in a statement.

The report includes a review of all safety aspects for The Chrysalis’ design and operation.

SHINE responded to more than 300 formal requests for additional information and took part in regulatory audits on more than two dozen topics. The process’ technical review took place over 11 days in 2022, with NRC’s Advisory Committee on Reactor Safeguards choosing to recommend that the Commission issue an operating license.

The NRC also recommended the operational license be granted in its Final Environmental Impact Statement Supplement, which covers matters that differ from, or that reflect significant new information relative to, that considered in the Final Environmental Impact Statement that was prepared when SHINE was issued a construction permit.

SHINE filed its construction permit application in 2013, receiving it in 2016.

SHINE will continue to install production equipment in The Chrysalis and keep the NRC updated on construction progress. Only when operational readiness inspections are complete, will the NRC decide on issuing the license.

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