[ RadSafe ] FDA approval of bioassay methods

Chris Alston achris1999 at gmail.com
Mon Feb 27 18:54:43 CST 2012

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

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.


---------- 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

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

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

Location: 1310 L St., NW 5th floor
Washington, DC
Sent by EPA Wireless E-Mail Services

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