Record of Decision To Withdraw From Production and Distribution of the Radioisotope Germanium-68 Used for Calibration Sources

Resumo

The Department of Energy (Department or DOE) Isotope Program, within the Office of Science, currently produces and distributes the radioisotope germanium-68 (Ge-68). There are two primary uses of the Ge-68: In the manufacture of calibration sources for Positron Emission Tomography (PET) scanners used for diagnostic medical imaging; and in the manufacture of germanium-68/gallium-68 (Ge-68/Ga-68) generators, which provide Ga-68 as a positron source in radiopharmaceuticals used in PET imaging. The Department published a Notice of Inquiry and Request for comment in the Federal Register, on March 8, 2013, concerning its consideration of withdrawal from commercial production of Ge-68. The Department received numerous comments in response to this Notice of Inquiry, evaluated substantial information provided by one private domestic company seeking the Department's withdrawal, and assessed other available information. The Department determined that Ge-68 is reasonably available from the commercial sector for use in the manufacture of calibration sources but not for use in Ge-68/Ga-68 generators. The Department published a Notice of Intent and Request for comment in the Federal Register, on