[ RadSafe ] FDA approval of bioassay methods

[Chris Alston]

Thanks for your opinion, Ed.  I can still see an open question, or
two, here, but I think that I shall allow folks to develop their own
questions.

FYI, for those who are not in-the-know, Ed was for many years the RSO
at the CDRH.  So, if anyone has an authoritative take on the subject,
I should think that it is he.

Cheers
cja


---------- Forwarded message ----------
From: Edward Tupin <Tupin.Edward at epamail.epa.gov>
Date: Mon, Feb 27, 2012 at 1:35 PM
Subject: [ RadSafe ] FDA approval of bioassay methods
To: radsafe at health.phys.iit.edu



Another interpretation is that routine bioassay measurements are made
to:

1. Verify adequacy of engineering and work practice controls.

2. Show compliance with regulatory requirements.

When the detected intake is large enough that some action, such
administration of decorporation (chelating) agents is considered,
bioassay would then move into the realm of a diagnostic medical
procedure.


Ed
Edward A. Tupin, MS, CHP
Health Physicist
Radiation Protection Division
Office of Radiation and Indoor Air
USEPA
Office: 202-343-9383
Cell: 202-253-8206

Location: 1310 L St., NW 5th floor
Washington, DC
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