International Isotopes’ failure to adequately address the 2018 breach of a radioactive source at its Idaho headquarters contributed to a similar, larger event months later in Seattle, according to the Nuclear Regulatory Commission.
Following a routine inspection earlier this year, the agency on Monday cited the Idaho Falls-based nuclear medicine company with apparent individual violations of both federal regulations and its NRC license in connection with the May 2019 release of cesium-137 that forced the closure and ongoing remediation of a research facility for the University of Washington’s Harborview Medical Center.
In the two years leading up to the incident, International Isotopes failed to set administrative procedures ensure it could establish safety evaluations mandated under NRC regulations, the report says. The company also failed to secure NRC approval for a procedure used in removal of the radioactive sealed source in Seattle, which was not authorized under its license, the regulator said in an inspection report.
“The NRC inspectors determined that one root cause of the Seattle contamination event was the licensee’s failure to implement corrective actions identified through the corrective action program for a contamination event that occurred at its facility five months prior to the Seattle contamination event,” the report says. “The NRC inspectors determined the second root cause involved the licensee’s radiation safety committee makeup and implementation.”
The agency is considering escalated enforcement for the identified breaches, Mary Muessle, director of the NRC Division of Nuclear Materials Safety, wrote in a June 22 letter to International Isotopes President and CEO Steve Laflin. She did not say what measures the agency might take if the violations are confirmed, and an NRC spokesman said Thursday additional information was not immediately available.
Laflin did not respond to multiple queries through the week.
From the date it received the letter, International Isotopes has 10 days to request a pre-decisional enforcement conference to discuss its perspective on the matter with NRC officials or mediation in an effort to resolve the dispute.
International Isotopes in April said it no longer is taking contracts for the field radiological source recovery work under which it breached a sealed source on May 2, 2019, during a job for the private firm that manages the Department of Energy’s Los Alamos National Laboratory in New Mexico. By that point, DOE had already suspended or canceled all such contracts with the company.
Recovery of sealed sources contained in devices used in hospitals and other settings had been one of International Isotopes’ bread-and-butter missions, helping to ensure radioactive materials do not fall into the wrong hands for potential acts of terrorism. Its main customers have been the Department of Energy and the United Nations’ nuclear agency.
On Dec. 26, 2018, International Isotopes workers unintentionally cut into a sealed source from JL Shepherd & Associates while trying to remove it from the source holder within a hot cell at the company’s main facility in Idaho Falls, the inspection report says. A power failure at that point allowed a cobalt-60 contamination escape into the air. The same sealed source model was involved in the subsequent accident in Seattle.
The following February, management issued a new work instruction laying out the procedure for safe extraction of a source from the holder if cutting or other destructive means become necessary. The instruction was to be applied both to International Isotopes’ fixed hot cell in Idaho Falls and its mobile hot cell for off-site operations. It specifically directed sufficient negative ventilation to curb the spread of radioactive contamination following a source breach.
The mobile hot cell used during the Seattle job had been employed on 16 distinct instances over six years to remove 1,180 sealed sources from devices, the NRC noted in its inspection report. The May 2019 assignment from Los Alamos lab prime Triad National Security involved removal of a JL Shepherd Mark 1 blood irradiator containing 2,900 curies of cesium-137. The work was conducted under the Off Site Source Recovery Program for the National Nuclear Security Administration (NNSA), which manages nuclear security and nonproliferation operations at Los Alamos and other sites for the Energy Department.
International Isotopes personnel were to remove the source from its holder with a high-speed cutoff saw within the mobile hot cell. Removal was determined to be necessary as the full source holder could not fit into one transport cask, while external radiation dose rates were too high for another, the NRC said. During the operation, workers unintentionally made several cuts into the sealed source itself.
“Since this work was performed within the mobile hot cell, it would be assumed that a radioactive release would have been contained; however, this mobile hot cell was not designed to contain unsealed radioactive material, so the contamination subsequently spread outside of the mobile hot cell and into the room in which the work was ongoing, contaminated the workers within the room, and eventually spread throughout the University’s Harborview Medical Center,” the inspection report says.
Adherence to the work instruction, including the direction of ventilation, could have reduced the contamination spread, inspectors found. Thrirteen people were reported at the time to have been contaminated
The federal agency had not authorized removal of the sealed source from the holder during a field job involving the mobile hot cell.
Another contributor was the overlap between members of International Isotopes’ Radiation Safety Committee and the personnel who run the company, and establish, approve, and are trained on its procedures and processes, the agency said. That tight relationship prevented “an “independent and objective review” of procedures to ensure sufficient radiation safety oversight.
Three NRC inspectors, all health physicists, conducted the on-site inspection at Idaho Falls from Feb. 25-28 of this year. Their visit included evaluations of procedures and records, observing operations, radiation measurements, and meetings with employees. The agency discussed its findings with Laflin by telephone on June 3.
A joint investigative team for the NNSA and Triad National Security said in a report made public in May that the Energy Department, Triad, and International Isotopes all shoulder some responsibility for the Seattle incident.
International Isotopes assisted in the initial cleanup at the building, which is now being managed by Atlanta-based Perma-Fix Environmental Services. Decontamination and remediation are expected to continue for much of 2020, including removing cesium from walls, floors, elevator shafts, and other sections of the building. That would be followed through the first six months of 2021 by reconstruction, including replacing ducts and dry wall extracted during decontamination, along with some equipment.
The NNSA is paying for the work, which is estimated to cost at least $60 million, an NNSA spokesperson said Thursday. “We cannot speculate or comment on what, if any, legal liability stems from the incident,” the spokesperson said by email. International Isotopes has said it should be indemnified under the federal Price-Anderson Act for damages sustained under its NNSA contracts.
