Radiation Safety Office

AUTHORIZED USER INFORMATION

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) .

REGULATORY AUTHORITY

Sources in Pennsylvania are licensed by both the US Nuclear Regulatory Commission (NRC) and PA Dept of Environmental Protection (DEP).

The DEP regulations are found in Title 25 Chapter 217 of the Pennsylvania Code. Currently these regulations only apply to naturally occurring and accelerator produced material (NORM ), such as Ra-226 and I-129.

The NRC regulations are found in Title 10 Part 31 of the Federal Code of Regulations. These regulations apply to by-product material such as Cs-137, Ba-133, Eu-152, and Ni-63.

By 10CFR31.5(a) a general license is issued to the research, educational or medical institution to acquire, receive, possess , use, or transfer radioactive material in certain named devices.

RESPONSIBILITIES OF THE MANUFACTURER

The manufacturer must submit quarterly to the NRC a report containing the identity of the recipients of devices. This report must include the name, title and phone number of an individual who has knowledge of and authority to take required actions to ensure compliance with the regulations.

For our institutions, the designated individual should be: Michael Sheetz, Radiation Safety Officer, 412-624-2728.

It is the manufacturer’s responsibility to provide you with certain information, including:

Copies of the pertinent regulations including responsibilities.

A list of services that can only be performed by a specific licensee.

Information on disposal options and estimates of cost [Note: current disposal cost for a Ni-63 EC source are about $250, for a LSC source $750]

A notice that penalties can be imposed for failure to comply with regulations.

This information is typically included with the documentation package included with the device.

RESPONSIBILITIES OF THE INVESTIGATOR

When purchasing a device containing a generally licensed source, provide the name of the designated individual to the seller.

Inform the Radiation Safety Office when a device containing a generally licensed source is received.

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 it’s 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 for a three year period. Action must be taken to replace the source if the leakage exceeds a specified activity.

For devices in storage, a physical inventory must be confirmed every three months and documented.

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

There are specific regulations which apply to transfer of ownership.

A. Transfers within the institution

Transfers between departments or between P.I.’s in the department require only that the Radiation Safety Office be notified.

B. Transfers to another institution

If the principal investigator relocates the device to another institution, then by regulation (10CFR31.5(c)(8)), there are two requirements:

1. The recipient (institution) must hold a specific license (NRC or state) to possess the device.

2. The NRC must be notified within 30 days after the transfer of the manufacturer’s name and model number of the device, the name and address of the recipient with a contact name.

Donations of used equipment to outside individuals, schools, institutions, and companies must be made under this regulation.

C. Return of the device to the manufacturer as a trade-in or in exchange for a replacement

The requirements under B above apply.

D. DISPOSAL OF EQUIPMENT

POLICY STATEMENT:

In order to comply with the transfer of possession regulations stated above, it is the policy of the University 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" 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.

Radiation Safety Office
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Revised May 21, 2003