Requirements for Users of Devices Containing Generally Licensed Radioactive Material
Generally licensed material is radioactive material contained in certain devices distributed by licensed facilities to individuals or institutions which do not have to obtain a license in order to possess the material because the regulations provide for it. However, THIS MATERIAL IS NOT UNREGULATED.
There are rules for its use and it may not be transferred or disposed of without regard to its radioactivity.
Typical devices are gas chromatographs with electron capture detectors (Ni-63), liquid scintillation counters with internal sources (Cs-137, Ba-133, Eu-152, Ra-226), and gamma counters with internal sources (I-129).
Sources in Pennsylvania are licensed by the PA Department of Environmental Protection. The Pennsylvania regulations are found in Title 25 Chapter 217 of the Pennsylvania Code. They incorporate by reference the NRC regulations. When an instrument containing a generally licensed source is purchased, a general license to possess, use, etc. is issued to the purchaser. In many cases the principal investigator is recorded as the purchaser, not the University of Pittsburgh.
Responsibilities of the Manufacturer
It is the manufacturer’s responsibility to provide you with this information, though they often do not inform you verbally or at the time of sale. Enclosed with the device documentation are copies of the regulations and responsibilities of the users under the general license.
Responsibilities of the Owner
Devices containing 100 uCi or more of beta-gamma emitting material require testing for leakage every six months. The purpose of this test is to assure that the source has not lost its integrity and is not releasing radioactive material into the workplace. Some manufacturers provide you with instructions for performing this test, some sell kits for performing the leak test and some will analyze the sample for you. Records of leak tests are required to be kept by the owner. Action must be taken to replace the source if the leakage exceeds a specified activity.
At the University of Pittsburgh, the Radiation Safety Office keeps track of all known sources, maintaining an inventory and performing the required leak tests every six months.
Transfer of Ownership
The following regulations apply to transfer of ownership.
- Transfer of ownership may be made to another general licensee only if the device remains in use within a particular location (the institution). Assuming the principal investigator is the licensee, then transfer to another investigator within the University of Pittsburgh system would qualify. By regulation (10CFR31.5(c)(9)(i)), there are two requirements:
- A copy of the pertinent regulations must be transferred with the device.
- Notification must be made to the NRC including the manufacturer’s name and model number of the device, and the name and address of the transferee with a contact name.
- If the principal investigator relocates the device to another institution, then the transfer is not covered under the above provision. By regulation (10CFR31.5(c)(8)), there are two other requirements:
- The recipient (institution or individual) must hold a specific license (NRC or state) to possess the device.
- Notification must be made within 30 days after the transfer to the NRC, including the manufacturer’s name and model number of the device, and the name and address of the recipient with a contact name.
Disposal of Equipment
In order to comply with the transfer of possession regulations stated above, it is the policy of the University of Pittsburgh Radiation Safety Office that generally licensed radioactive sources must be removed prior to disposal of the device. The source must be removed by a qualified vendor (often the manufacturer’s service technician). There is a charge for this unless the unit is accepted as a trade-in. The department or principal investigator is responsible for paying this charge.
The device may not go to surplus property or storage unless there is a clear understanding of the liability associated with the radioactive source transfer regulations.
The Radiation Safety Office must be consulted prior to removal of the device from the institution. The unit will be posted with proper instructions.