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

[Mark Smith <marksmith28211@YAHOO.COM>]

I haven't really pursued the regulation on

Reservations, since our PET cyclotrons are typically

located in industrial parks, but off the top of my

head, I can add a few items to the discussion (no

guarantees that any of this is exactly correct):



The sovereign authority of the Reservation would mean

that the state does not have immediate jurisdiction -

the Indian nation would.  However, since few of the

Nations are set up for such a regulatory program,

there are some legal provisions for the Indian nation

and the state to enter into an agreement so the state

program can cover such operations.  I do not know of

that happening (actually, I do not know of a PET

facility on a Reservation, but there may be).  



The NRC is out of it - material is not source,

byproduct or special nuclear - unless the pharmacy is

also compounding radioiodine or other byproduct

radiopharmaceuticals, in which case there would be an

NRC license where they would look at the personnel

doses from cyclotron-produced material (they do this

currently with our facilities).  However, the F-18

would not be licensed by the NRC.



OSHA would have regulations dealing with radiation

exposure to workers, but they do not license nor

regulate the uses of radioactive material.  Emissions

would fall under the radiation regulatory authority

(either Indian nation or OSHA...although their

regulations really don't address nonworker exposures),

not the EPA.



Typical PET pharmacy is not regulated by the FDA.  As

Dave Derenzo mentioned, the FDA regulates the

"manufacture" of pharmaceuticals, but pharmacy

operations are not manufacturing...it's considering

compounding and does not fall under FDA.  However,

there is some discussion about the actual production

of F-18 labelled FDG being "manufacturing" and the

dose drawing portion of the operation being the

compounding.  This is a current, undecided topic, but

FDA may get into the PET pharmacies at some point.



I lost the original posting (too quick on the

"delete"), but if the person who had the question

would like to contact me privately, I can see if we

can look into the issue more thoroughly.  (e.g., is

this for production of FDG on a Reservation or only

for performing the scan...there is probably a

difference in the degree of regulatory concern).



Mark A. Smith, CHP

marksmith28211@yahoo.com





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