Identify two major regulatory frameworks governing radiation protection in healthcare in the United States.

• A. NRC 10 CFR Part 20 and NRC 10 CFR Part 35 and equivalent state regulations.
• B. EPA regulations only.
• C. OSHA fire safety standards.
• D. FDA medical device labeling.

Answer: (A)

The question tests knowledge of the primary regulatory frameworks that govern radiation protection in healthcare in the United States. The two main frameworks are the Nuclear Regulatory Commission’s rules in 10 CFR Part 20 and 10 CFR Part 35, with equivalent regulations in states that operate their own programs.

Part 20 establishes general safety standards for protecting people from radiation, covering dose limits, the ALARA principle, monitoring requirements, recordkeeping, and program oversight for all uses of radiation. Part 35 governs the medical use of byproduct material, detailing licensing for medical facilities and practitioners, patient dosing procedures, safety controls, training, and written directives for medical treatments involving radioactive materials. In Agreement States, these NRC standards are implemented at the state level, ensuring consistent protection across jurisdictions.

Other agencies have roles related to safety (EPA in environmental radiation protection, OSHA in worker safety, FDA in device regulation), but they do not provide the overarching regulatory framework for radiation protection in healthcare in the way NRC Parts 20 and 35, along with state equivalents, do.