RE: Regulatory Authority of Accelerator Products on Indian Reserv atio ns

[Dave Derenzo <dave@UIC.EDU>]

Great original question that most of us have never thought much 

about.  Here is my guess on this subject.  The FDA regulates manufacture of 

radiopharmaceuticals, probably everywhere in the US.  They are concerned 

with radiopharmaceutical purity, sterility, apyrogenicity, radiochemical 

impurities, etc because the material is injected into patients.  They 

definitely regulate PET material everywhere else.  OSHA might cover 

occupational radiation exposure issues where NRC and states don't 

regulate.  EPA might also have some regulatory authority over emissions, 

radiation levels outside of buildings, etc.  If I'm wrong, I'm sure someone 

will say so!



Dave Derenzo

University of Illinois at Chicago



At 12:40 PM 2/5/02, you wrote:

>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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