U.S. effort to make molybdenum-99 awaits funding commitment from DOE

The U.S. Department of Energy is moving forward with plans to use a nuclear reactor in Albuquerque to produce molybdenum-99, the raw material for several radioisotopes used in nuclear medicine. The agency's effort, however, has not moved as quickly as it could, due to a lack of funding for the project.

The DOE's initiative to create a U.S. supply of molybdenum has gained a higher profile after last month's one-week strike at the Chalk River Laboratories reactor in Canada, which produces most of the world's supply of molybdenum (see story, page 1). Chalk River sells its molybdenum to Nordion International of Kanata, Ontario, which distributes it to radiopharmaceutical companies for inclusion in technetium-99m generator kits. Technetium-99m is used in some 36,000 nuclear medicine procedures in the U.S. every day.

Despite the need for another molybdenum supplier, the DOE's effort has proceeded in fits and starts (SCAN 9/25/96). The agency is trying to bring the Annular Core Research Reactor (ACRR) at Sandia National Laboratories online to produce the radioisotope, but the project is taking longer than expected, primarily due to funding shortages. Officials at Sandia say they could supply most or all of the molybdenum required by the U.S. by the end of this year if they received adequate funding.

In addition, the project has suffered some technical setbacks. In December, an operator's inattention at the ACRR facility allowed the reactor to rise to its automatic safety shut-off point, according to the DOE. In addition, the operator did not immediately report the incident, as required. Although the incident did not pose a safety threat, reactor management were concerned that plant operating procedures and reporting requirements were violated, and instituted an administrative stand-down at ACRR and three other facilities in the reactor's compound area. ACRR operations did not resume until May 13, after the completion of an investigation that resulted in corrective actions, according to the DOE.

The stand-down did not delay the molybdenum project, however, because before it can produce radioisotopes in the quantities required by the medical community, the DOE must also upgrade Sandia's hot-cell facilities. The hot cells separate radioisotopes produced through fission by the irradiation of enriched uranium targets in the ACRR. Because of funding woes, the program was not scheduled to have the hot-cell work completed until long after the ACRR was supposed to be online.

Funds for the molybdenum project must be diverted from other DOE programs, which requires congressional approval, according to Richard Coats, isotope production manager at Sandia National Laboratories. Hopefully, the Chalk River strike will help focus the attention of Congress and the DOE on the molybdenum crisis, and commit to funding the project.

"The strike did two things: It demonstrated the fallibility of a single source, and it demonstrated that the rest of the world cannot help us out (with molybdenum supplies)," Coats said. "Although it had been claimed that Nordion had enough backup capacity to fill the U.S. need, that didn't happen."

As the program awaits additional funding, the DOE is moving forward with efforts to ensure that the ACRR's molybdenum output meets the Food and Drug Administration's good manufacturing practices (GMP) guidelines, as well as the quality standards of pharmaceutical companies. Sandia has begun some of the initial validation tests and has prepared its drug master file (DMF), but has not yet submitted it to the FDA. Sandia has sent some of its molybdenum to Nordion and radiopharmaceutical firm Mallinckrodt of St. Louis. Nordion said that Sandia's molybdenum was of higher quality than that produced by Chalk River, according to Coats.

"All the technology is in place, and we've demonstrated the ability to produce excellent material," Coats said. "How we are staffed to provide material is a function of what the DOE instructs us to do. If they put more money into it, we will get it done faster."