FW: Broad Scope Licenses and Exempt/Gene

["Edgerton, Patricia" <pedgerto@rhb.dhs.cahwnet.gov>]

As a focal point for Radsafe here at the Radiologic Health Branch in 
California, I am forwarding this response to the message listed below. 
  Please respond to Dave Wesley directly with any comments, or if you feel 
they are of interest to all of Radsafe, post them.  Dave has access to read 
Radsafe, but not to respond (I move all of the messages onto our LAN for our 
entire Branch to read.)  Read on....             (from Trisha Edgerton, 
pedgerto@rhb.dhs.cahwnet.gov)
 ----------

In response to Donald P. Mercado's question regarding the request for 
additional information from his Licensing agency with respect to exempt and 
GL sources:

The purpose of the request you received is to ensure that your license is 
inspectable.  If you are mingling exempt/generally licensed and specifically 
licensed materials in such a way that the inspection agency cannot readily 
determine which is the specifically licensed material, then it will all be 
inspected as though it was specifically licensed material, not exempt or GL.

GL and exempt devices and some exempt sources may automatically be 
segregated by the fact of their labeling.  However, if your program uses 
exempt quantities or exempt concentrations (received from a distributor with 
an E-type license), or generally licensed source material, then you must be 
able to identify (at all times) that this material is not a part of your 
specific license.  Your method of identifying the exempt or GL materials 
must become a part of your license commitments so that the issue remains 
clear to both you and the inspectors.  The "comprehensive procedures" you 
were asked to provide, were meant to spell out how you will segregate or 
identify the specifically licensed materials (and any associated 
contamination) from the generally licensed and exempt material.  As such, 
the Radiation Safety Committee will not be required to approve the use of 
exempt or GL material as long as you can maintain segregation.

We recognize and support the use of exempt and generally licensed materials, 
but we can't allow their use to undermine our ability to inspect (and 
enforce the regulations for) the specifically licensed material.

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David Wesley, Chief           
Industrial Licensing/SS&D          916-445-1884
Radiologic Health Branch           916-324-3610 (fax)
Sacramento, California             DWesley@rhb.dhs.cahwnet.gov
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********************************
From: radsafe
To: Multiple recipients of list
Subject: Broad Scope Licenses and Exempt/General
Date: Wednesday, January 29, 1997 9:05AM

Hello all.

I recently received a request for more information from our regulatory
agency regarding our type A broad scope license renewal/amendment. They
make a statement, "Individuals in a broad scope license may not operate
under individual exempt or general license status unless the company
submits comprehensive procedures to be used to segregate uses of
radioactive materials procured under exempt/general status from those
obtained under the broad scope program."

Why is this? Exempt/generally licensed devices are designed
for/distributed to individuals who have no formal training in radiation
safety, and no radiation safety program. Why, as a broad scope licensee,
should we bear the additional administrative burden for something that
is a non-hazard? Do we need to control our H-3 exit signs the same way
we control our 2300 Ci Co-60 irradiator? Are the exempt products,
concentrations, and quantities no longer exempt, and their use has to be
approved by our Radiation Safety Committee?

What are your thoughts on this? How are you handling this? My license
renewal application will have to be drastically changed to account for
exempt/general license devices.

Donald P. Mercado, O/47-20, B/101      PROFS Nickname: DMERCADO
Radiation Safety Officer            Email: Don.Mercado@lmco.com
Lockheed Martin Missiles & Space            Tel. (408) 742-0759
Sunnyvale, Ca 94089                         Fax. (408) 742-0611