ML18123A329

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Response Letter to Dr. Gerald Tobias in Regards to Medical Policy Statement (65 Federal Register Notice 47654, August 2000)
ML18123A329
Person / Time
Issue date: 05/15/2018
From: Douglas Bollock
NRC/NMSS/DMSST/MSEB
To: Tobias G
- No Known Affiliation
Bollock D
References
Download: ML18123A329 (3)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 15, 2018 Dr. Gerald Tobias 9933 East Jenan Drive Scottsdale, AZ 85260

Dear Dr. Tobias:

I am writing in response to your letters to the U.S. Nuclear Regulatory Commission (NRC)

Chairman, Kristine Svinicki. The NRC has a published medical policy statement (65 Federal Register Notice 47654, August 2000) which provides the NRCs general intentions in regulating the medical use of byproduct material. This medical policy states: 1) The NRC will continue to regulate the uses of radionuclides in medicine, as necessary, to provide for the radiation safety of workers and the general public. 2) The NRC will not intrude into medical judgments affecting patients, except as necessary, to provide for the radiation safety of workers and the general public. 3) The NRC will, when justified by the risk to patients, regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordance with the physicians directions. 4) The NRC, in developing a specific regulatory approach, will consider industry and professional standards that define acceptable approaches of achieving radiation safety. As physicians communications with patients are medical judgements which affect patients, it is NRCs policy not to dictate or intrude in them.

However, as it is NRC policy to regulate the radiation safety of patients primarily to assure the use of radionuclides is in accordance with the physicians directions, the NRC requires physicians to have training in radiation safety aspects prior to being able to administer byproduct material to humans. Specifically, Title 10 of the Code of Federal Regulations Part 35.290 requires all physicians who administer for imaging and localization procedures, such as a nuclear stress test, to complete a minimum of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies. This training must include training in radiation biology and experience in calculating, measuring, and safely preparing patient or human research subject dosages.

You may find information on radiation doses from diagnostic procedures from a number of professional societies and organizations, such as the Health Physics Society, American College of Radiology, and the National Council on Radiation Protection and Measurements, among many other sources.

G. Tobias If you have any further questions or concerns, please feel free to contact me by e-mail at Douglas.Bollock@nrc.gov, or by phone at (301) 415-6609.

Sincerely,

/RA/

Douglas Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Security

G. Tobias

SUBJECT:

RESPONSE LETTER TO DR. GERALS TOBIAS.

DATED: ______________________.

ML18123A329 OFC NMSS/MSST NAME DBollock DATE 5/15/18 OFFICIAL RECORD COPY