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NRC expands definition of byproduct material

Radiology Administrator's Compliance and Reimbursement Insider, January 1, 2009

An expanded definition of radiological byproduct from the Nuclear Regulatory Commission (NRC) may change licensing arrangements for hospitals in some states. The new rules took effect November 30, 2007, but the NRC rolled out phase two of the changes September 30, 2008. (Visit www.nrc.gov/reading-rm/doc-collections/news/2008/ 08-179.html to read the release.) This makes the start of the new year an appropriate time to ensure that your radio-logy department has all the necessary compliance pieces in place.

Hospitals may need to amend their NRC licenses to include the material covered under the expanded definition. Radiology administrators should coordinate with their facility safety officer and team to double check that the radiation safety officer, nuclear pharmacists, and nuclear physicians are aware of the changes. 

Seek out your radiation safety officer

The definition outlines radioactive byproduct material, but the revisions won’t substantially change how a hospital conducts its nuclear medicine program, says Duane White, a health physicist at the NRC.

“The day-to-day operation is going to stay the same,” White says.

Under NRC regulations, healthcare facilities need licenses to use certain radioactive substances, called byproduct material, for medical therapy or diagnosis.

Hospitals must meet a variety of requirements to be licensed, including designation of a radiation safety officer.

The changes may require action from licensees in the 16 so-called nonagreement states, says David McIntyre, a spokesperson for the NRC.

There are 35 agreement states in the country, which regulate byproduct material under agreements with the NRC. The NRC regulates this material in nonagreement states.

The expanded definition of byproduct material now includes any:

• Discrete source of radium-226 that is produced for commercial, medical, or research activity. Radium- 226 is an abundant form of radium, which is a radioactive element generally used in industrial products.
• Radioactive material produced by a particle accelerator for commercial, medical, or research activity. This provision affects hospitals.
• Discrete source of naturally occurring material that the NRC believes could pose a threat similar to radium-226. This provision won’t affect hospitals.

Particle accelerators produce radioactive material for medical treatment, and the energy beams from some accelerators also have medical uses. Hospitals use both applications. Some hospitals operate accelerators that produce PET radionuclides, which fall under the new definition, White says.

The NRC will not regulate the incidental radioactive material produced by accelerators (e.g., linear accelerators) that facilities operate to produce particle beams only and not radioactive material.

Determine your license status

Agreement states already recognize the new definition of byproduct material, so the NRC’s amendments simply become part of the agreements with these states, McIntyre says. For nonagreement states, the new rules have more implications due to possible license amendments, White says. Material produced by accelerators fell to state oversight, rather than the NRC as was previously the case.

Hospitals in nonagreement states used to deal with state and NRC requirements, but the expanded definition now puts the material solely under NRC oversight.

Licensees in other states under NRC jurisdiction will need to meet the requirements according to the schedule set out by the agency, which is available at http://nrc-stp.ornl.gov/narmtoolbox.html.

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