Department of Energy September 2, 2014 – Federal Register Recent Federal Regulation Documents

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 April 9, 2014, to provide the public with notice and seek public comment on the Department's intent to withdraw from the production and distribution of Ge-68 used in the manufacture of calibration sources, while maintaining its current position in the production and distribution of Ge-68 for Ge-68/Ga-68 generators. Three comments in response to this Notice of Intent were received and assessed by the Department to conclude the evaluation process with this Record of Decision. The Department's decision is to: (1) Withdraw from sales of Ge-68 for the purpose of fabricating calibration sources, while maintaining production capability in the event circumstances change; (2) maintain its current position in the production and distribution of Ge-68 for use in the manufacture of Ge- 68/Ga-68 generators; and (3) require the Department's Ge-68 customers to sign an end-use statement that the Ge-68 will be used only in the fabrication of Ge-68/Ga-68 generators.