[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
Re: Broad Scope Licenses and Exempt/Generally Licensed Devices
Before I give you my experiences with this subject, let me say that
you will have a mightly long wait if you expect a General Consul (NRC
or Agreement) to make a comment on regulations. Once that comment is
made, it becomes a legal reference, which is something they don't
want to do. That sort of statement is only brought about in court.
As for general versus exempt sources, I have been RSO on a couple of
Broad Scope Type A licenses and have consulted on several others in
this area. The main hangup with regulators seems to be the transfer
of these sources. Generally licensed sources can be transferred from
facility to facility with no inventory tracking or papework as
required in 10CFR30 through 33. However, Broad Scope Type A licenses
are VERY specific with regards to the locations that sources can be
used and to whom they can be transferred. Also, transferring a
source from a Broad Scope Type A license has a record keeping
requirement associated with it and regulators will give you a violation
if you don't maintain those records. In your case, it is clear that
they want to know which sources are going to be on your license so
they can inspect your records and not confuse the issue with generally
licensed sources.
This also seems to be an interpretation of individual inspectors. In my
most recent inspection, my inspector told me that exempt sources did
not have to be inventoried. However, in a inspection several years ago,
at another facility, I had an inspector tell me that all sources used for
licensed activites had to be inventoried. Very confusing, but it has lead
me to always recommend the conservative approach, inventory all
sources under licensed activities. This may also save you a trip to the
local landfill to recover an exempt source that was tossed in the trash.
In your case, I would suggest that you write in you identify all licensed
activites and make a positive statement that all such sources will be
placed on the inventory, even if they are considered general or exempt
sources for other applications. This has worked for me in the past.
Vince Chase
RSO, Boehringer Ingelheim Pharmaceuticals
This expressed here are solely those of the author and do not express,
represent or state the opinions and/or policies of Boehringer Ingelheim