RE: Regulatory Authority of Accelerator Products on Indian Reservatio ns

["Jacobus, John (OD/ORS)" <jacobusj@ors.od.nih.gov>]

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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