Overview

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An executive order has initiated a review of regulations governing the medical use of byproduct material under 10 CFR Part 35 which establishes requirements for the medical use of radioactive material and serves as a foundation for many radiation safety requirements applicable to medical use licensees.

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What This Means for Radioactive Material Licensees

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At this time, no changes to existing radioactive material license requirements have occurred. Licensees should continue operating in accordance with their current licenses, applicable regulations, and approved radiation safety programs.

Any future changes to 10 CFR Part 35 would require completion of the applicable regulatory process before becoming effective.

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Agreement State Considerations

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Licensees operating under an Agreement State program should be aware that changes to NRC regulations may result in corresponding evaluations by state regulatory authorities. Agreement States maintain regulations compatible with applicable NRC requirements and will determine whether revisions to state regulations, licensing requirements, or guidance are necessary. The timing and implementation of any future changes may vary depending on actions taken by individual regulatory authorities.

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Potential Areas of Future Review

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At this stage, the outcome of the review is not known. Depending on any future regulatory changes, areas potentially affected could include:

• Medical use requirements under 10 CFR Part 35

• Radiation safety program requirements

• Training and experience requirements

• Authorized user and supervised individual requirements

• Other provisions affecting medical use licensees​​

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York Medical Physics will continue monitoring regulatory developments from the NRC and applicable state regulatory authorities and will provide additional information as changes affecting radioactive material licensees become clearer.

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References

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• Reducing Barriers to Medical Use Licensing