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RE: Regulatory Authority of Accelerator Products on Indian Reserv atio ns
To clarify my statement, "Currently, *the accelerators and cyclotrons* would
not come under regulatory agency." I did not mean Indian (Native American)
reservations do not come under any regulatory agency. I am not sure what
standards the FDA has on PET radionuclides for human use, but they do not
regulate the production machines. That is usually done by the states.
-- John
-----Original Message-----
From: Jacobus, John (OD/ORS)
Sent: Tuesday, February 05, 2002 1:41 PM
To: RadSafe
Subject: RE: Regulatory Authority of Accelerator Products on Indian
Reserv atio ns
Tom,
Currently, they would come under regulatory agency. Indian (Native
American) reservations are essentially sovereign territories. The Food and
Drug Administration has nothing to do with accelerator or
cyclotron-produced material, whether or not it is produced on a reservation
or a state of the Union. Of course, state regulatory agencies do not have
control over reservations, either.
-- John
John Jacobus, MS
Certified Health Physicist
3050 Traymore Lane
Bowie, MD 20715-2024
E-mail: jenday1@email.msn.com (H)
-----Original Message-----
From: Huston, Thomas E [mailto:HustonThomasE@UAMS.EDU]
Sent: Tuesday, February 05, 2002 11:39 AM
To: radsafe@list.vanderbilt.edu
Subject: Regulatory Authority of Accelerator Products on Indian
Reservatio ns
This is somewhat of an obscure question...but someone asked me and I do not
know the answer.
Anyway, here's the question:
What regulatory agency is responsible for licensing possession and use of
accelerator-generated radionuclides on U.S. Indian Reservations (e.g.,
cyclotron-generated PET radiopharmaceuticals)?
I asked the NRC (via their website/Public Affairs) and was simply and
literally told "The Food and Drug Administration" (with no other details).
I am not satisified with this answer. I realize that this is partially true
in the sense that the FDA regulates pharmaceuticals....but who regulates
their use with respect to radiation exposure on Indian Reservations.
. . .
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