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15 March 2010

Answer to Question #6112 Submitted to "Ask the Experts"

Category: Policy, Guidelines, and Regulations — Guidance Documents

The following question was answered by an expert in the appropriate field:

Is there a summary of the changes for 10 CFR Part 35? If so, where can one get it?

I don't believe there is a "summary document outlining the changes in Part 35" that is currently on the Nuclear Regulatory Commission (NRC) Web site. The type and number of changes for the revised Part 35 were voluminous, modifying almost every paragraph of the previous version.

There is a medical "toolkit" on the NRC public Web site that has it all and is quite comprehensive. The Web site toolkit has the 2002 final rule publication and the latest update on specialty board recognition and a redline/strike version of the training requirements. You should also look at NUREG-1556 series, especially Vol. 9, Rev. 1, which was revised for the updated Part 35.

A broad overview of Part 35 changes published in 2002 includes:

NRC regulations structure became more risk-informed and more performance-based
Regulations focused on the radiation aspects of medical procedures that pose the highest risk
Reduction of prescriptiveness of requirements in low-risk activities
Allowed the licensee flexibility in deciding how to implement a radiation protection program
Allowed use of nationally recognized standards and protocols
Updated the requirements for existing treatment modalities
Deleted the "Quality Management Program"
Redefined "misadministration" to "medical incident" that is dose based

Cynthia Jones, PhD

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