Industry FAQs
What is an Agreement State?
Under section 274 of the Atomic Energy Act, any state may voluntarily enter into an agreement with the NRC to assume regulatory authority over the use of most forms of radioactive materials within their state. Such states are referred to as “Agreement States.” As of September 30, 2009 there are 37 Agreement States.
How is the use of radioactive materials regulated in the United States?
The primary national authority regulating the use of radioactive materials is the U.S. Nuclear Regulatory Commission (NRC).
In addition to Agreement States, other agencies include the Department of Transportation (DOT) which regulates the shipment of radioactive materials, the Food and Drug Administration (FDA) which regulates the use of medical devices using radioactive sources in cooperation with the NRC, the Environmental Protection Agency (EPA) which among many responsibilities issues standards for disposal of radioactive waste, the Occupational Safety and Health Administration(OSHA), which regulates radiation exposure to workers, the Department of Energy (DOE), which regulates the use of radioactive materials at nuclear weapons and federal research facilities, the Federal Emergency Management Agency (FEMA) which organizes the nation抯 response to radiological disasters, the Department of Homeland Security (DHS) which secures the nation抯 borders, and the Department of Defense (DOD) which uses radioactive materials both independently and through licenses issued to them by the NRC.
What is the difference between byproduct material and NARM?
Byproduct material is produced within a nuclear reactor. NARM stands for Naturally occurring and Accelerator Produced Radioactive Material, and is either naturally occurring or produced in an accelerator. The Atomic Energy Act only governed the use of byproduct material, thus the use of NARM is the regulatory jurisdiction of individual states. The Energy Policy Act of 2005 includes provisions for regulating the use of certain NARM materials.
What are the different levels of regulatory approval of devices containing radioactive sources?
Specifically Licensed: The user must possess written authorization in the form of a license to possess and use the device. This authorization includes limitations on the use of the device and requirements for user training in radiation safety. An example of this type of device is a moisture/density gauge used in road construction.
Generally Licensed: The user does not require written authorization in the form of a license to obtain the device, but must adhere to certain regulations regarding periodically testing devices for proper disposal of the device at the end of its service life, and maintaining records. Note that the NRC and Agreement States now requires certain generally licensed devices to be registered upon receipt. An example of this type of device is a static elimination device used in the manufacturing industry.
Exempt: There are no regulatory requirements for the end user. An example of this type of device is a smoke detector.
What do the letters and numbers of a device registration approval mean?
The format for device registration certificates is XX-0000-X-000-X. The first two letters indicate the authority which approved the device; NR= NRC or the two letter abbreviation for each state. The next 4 digits (3 for older vendor) is the vendor code, a unique number assigned to the device distributor. The next letter is either “S” for source or “D” for device,the next digit is a unique number assigned to this particular device, and the final letter refers to the requirements for the end user “S” = specifically licensed, “G”= generally licensed, “E”= exempt, and “B” is both specifically licensed or generally licensed.
Do foreign governments have a category for generally licensed devices?
No. Almost all nations either classify devices as either specifically licensed or exempt.