Re: Generally Licensed Po-210 Static Eliminators- Responses

[Wes Van Pelt <VanPeltW@idt.net>]

Hi Radsafers,

A while ago I posted the following question. I am reporting here on the
several responses I received.

the Original Question:

I have a question about how you manage Po-210 static eliminator devices
which are received under a general license (see 10 CFR 31.3).  

These include devices which have a small brush and a Po-210 source used
to clean lab balances and eliminate static electricity in balances and
elsewhere. They can contain up to 500 microcuries each.

And they can be purchased from scientific catalogs and other catalogs
without any regard to radiation safety. Clearly, they can be purchased
by "anybody".

The general license (i.e., 10 CFR 31.3 itself) is quite clear that these
devices must comply with 10 CFR parts 19 and 20, as well as portions of
part 30. (Anybody disagree?)  This would include compliance with such
issues as inventory, signs, labels, contamination surveys (maybe),
transfer, disposal, employee training, etc.

My question is: if you are the RSO of an institution, do you track these
items, do you conduct routine inventory inspections, conduct employee
training, control purchase, control transfer, control disposal, control
DOT shipment, etc.??? 


the Responses I received:

#1
0CFR32 Specific License to Manufacture or Transfer Certain Items
Containing RAM...never gets back to 31.3.  However, 31.2 says "unless
indicated otherwise in the language of the general license."  31.3 (the
general license) continues that the general license is issued in
accordance with the specific license issued by the commission.

If I remeber, I obtained a copy of the specific license from one
manufacturer and their requirements to maintain these sources.  The
manufacturer recommended returning the source, but the words weren't
that strong.

I would call one of the manufacturer.  There is an RSO somewhere if they
are making them.  They have been responsive in faxing their license
noting commitments for tracking or disposal to the NRC.  They also can
fax you the info they send the customers...ie the general license
requirements noted in their specific license.

#2
It is hard to get a handle on Po-210 devices, although the exempt
quantity
is 0.1 mCi. Generally, they are distributed as static eliminators, not
"radioactive sources"  so the users don't even know they are purchasing
radioactive materials. (The same as smoke detectors) Training on our
side
won't work. The vendor doesn't inquire whether or not we have a license,
and
the user doesn't know enough to ask. We only see these sources when they
decay away and don't work, then someone thinks to look at the small
label
and notices the radiation symbol. This just happened last month. Even
though
they've decayed to nothing, we still have to put them in the rad trash
because our license only allows decay with half-lives less than 100
days.

In answer to your question, we WOULD purchase, inventory, wipe test and
dispose the sources if the distributors were more stringent in observing
the
regulations about exempt quantities. 

#3
We here at the University of xxxxxx have a broad scope
license issued to us by the State for the use of radioactive material. 
One
of the conditions of that license is that we are to track ALL sources of
radioactive material that pass through our hands.  By signing this
license
we agreed to give up our right to treat generally licensed material as
can
an ordinary citizen (e.g., by ignoring it for the most part).  The
reason
for this license condition is to insure that the total amount of
radioactive
material at our location remains at a safe amount.
     In reality there is no way we can do this.  People can go to the
local
hardware store and purchase smoke detectors, static brushes, and all
manner
of radioactive devices without going through us.  We have no way of
knowing
they exist.  We have, then, ignored this condition of our license.  If
the
State were to discover this during an inspection they could cite us. 
They
have not done so, therefore we will continue to operate as usual until
they
do.

#4
My regulators require me to handle the Po-210 static eliminators as I
would any
radioactive material in my posession.  Even with assay dates going back
to 1989,  I have
to dispose of them as low level rad waste.

#5
I was supervising construction of new shielded rooms of a 1000+ bed
hospital.  The construction people gave me about 10 smoke detectors
which
had 1 microcurie of radium each.  They told me they had taken at least
100
of the smoke detectors to the dump.  I called the head of the state to
find
out if anything should be done and he said consumer items are not
regulated
by the state (so that would follow with the NRC since the states have to
be
as least as strict as the NRC).  The answer to your question is consumer
items do not fall under regulatory requirements.  The best thing to do
is to
collect some to use in your education and training to show people that
common consumer items contain radioactive materials and this will help
you
to help them put radiation into perspective.

#6
   While I'm not suggesting that anyone do the following (in fact I just
included some old static eliminators in "my" last Rad-Wst shipment), but
- if, by some chance, one HAD an OLD Po-210 source that was essentially
99.999% Pb-206...just "laying around"... Couldn't you just spray-paint
the radiation symbol into oblivion and throw the d..n thing away?  All
you have is a shiny thing that's got a radiation symbol on it.  I have
T-shirts (with radiation symbols on them) and there's probably more
radioactivity in the phosphate detergent I wash them in than are in 10
y/o static eliminators.  Aren't we over-regulating" something simple
again?  After all, they ARE Generally Licensed sources.  Weren't they
put in that classification for a REASON?  What about the lantern mantles
I use for "show and tell".  Can't I throw them in the trash when I'm
through with them?  What about the lantern itself (its probably slightly
contaminated)???

#7
Nice common sense answer!!! We continue to rail against the LNT, 
     over-regulation, etc... and then we turn around and want to train 
     people and dispose of something that the regulatory agencies have 
     determined doesn't need this type of controls. Why??? If it's 
     generally licensed and it's legal to dispose of as plain old trash, 
     why not do that?

#8
Just putting in my $0.02 regarding your question on radsafe.  At (xxx a
Big government site), when we
were aware of Po-210 static eliminators, we would keep track of their
whereabouts.  When necessary to dispose of them, it was done through our
Radioactive Waste Service, i.e. to a properly licensed disposal site. 
However,
due to the generally licensed nature of the devices, they were not
necessarily
received through our centralized receiving and inventory system.

In fact, most of the time these were supplied by LSC manufacturers to
eliminate
static effects on LSC done with plastic and/or nylon vials.

As far as we know, we no longer have any of these in house.  In my
opinion, the
NRC needs to seriously consider revising their regulations to CLEARLY
indicate
what their expectations are for each TYPE of generally licensed item. 
Although
there are very specific labelling, etc. requirements for generally
licensed
devices within 32.51, those pertain ONLY to generally licensed items
under 31.5;
Po-210 static eliminators are generally licensed under 31.3.  I can find
no
additional regulatory specifics about 31.3 items in the regs.

What does compliance with 19, 20 & 21 mean, for example?  No one will
get 100
mrem/annum from these devices, so training is not required under part
19.  Part
20 compliance to me means they need to be labelled when they exceed 0.1
microcurie and will need to be "secured" per 20.1801 & 1802 (?!).  The
big
question comes under the requirements in part 20 for waste disposal. 
How is Joe
Citizen who gets one of these for his home darkroom supposed to dispose
of it
when no longer useful.  In order to be compliant with part 20, it should
be done
through "an authorized recipient."  Who is that and how is Joe Citizen
supposed
to know that?

Finally, isn't Po-210 natural radioactive material?  It's the decay
product of
Bi-210 in the Uranium series.  Why is it even addressed in NRC
regulatory space?

#9

We try to get them into our specific license if we know about them.  The
reasoning for this is that the state regs require much of the 10CFR20
requirements and it is the easiest way for us to comply with it.  In
addition, in (xxx agreement) state, some generally-licensed equipment
purchases are
reported to the Dept of Health, at which point, the DOH require that the
recipient add the device (such as gas chromatographs) to their specific
license or if they don't have a license, apply for one.  It is a very
confusing kind of thing and very difficult to comply with.  My general
impression from the regulator I discussed this with is that they do
understand that the RSO cannot possibly know every time someone
purchases
generally-licensed materials.  As yet, we just include them on our
specific
license as we become aware of them.  Hope this helps.

#10
        It turns out that the NRC has "generally licensed" a lot of
things, Po-210 static eliminator devices included. 
        As I understand the present system, under 10 CFR 30, a
manufacturer, who desires to make and market something containing
non-exempt quantities of NRC-licensable radioactive material, must apply
for a specific NRC license.  In the license application, the product
containing the non-exempt quantity of radioactive material must be fully
described; its containment/encapsulation described; the shock, thermal,
and other stress tests that have been done to test the degree of
containment of the radioactive material, etc., all fully described in
extreme detail.  The NRC HQ office of "generally licensed devices" then
fully analyzes this information and basically ends of either approving
or disapproving the device based on their judgment as to whether or not
the device appears to not compromise public health and safety and
whether it appears to meet the applicable portions of 10 CFR 19, 20,
etc. 
        If the office of "licensable devices" approves the
manufacturer's application, then the manufacturer will then hold a
normal specific license to have the much larger quantities of
radioactive material on-hand to make the individual devices in which the
non-exempt devices are manufactured.  The device, itself, once
manufactured, is "generally licensed."  This means, from the NRC's view,
that they in effect have been the "approving authority" that judged the
device to meet the spirit of 10 CFR 19, 20--general rad safety
requirements, etc., and in so doing have permitted the device to be sold
to the public.  From the standpoint of the public, any member of the
public, thanks to the NRC blessing the device as being "safe" under 10
CFR 19, 20, etc., can then freely buy as many devices as he/she wants
WITHOUT any legal need to have any sort of NRC/Agreement State license. 
So in the end, the manufacturer of the device is "licensed" in the sense
that the manufacturer holds a real, normal "specific" license from the
NRC; the device, upon NRC blessing, is "generally licensed" which
operationally means "authorized for distribution to the general
public."  A member of the public does not need any sort of license from
the NRC to buy such devices. 
        An analogous procedure is in place in other parts of federal
law.  Specifically, the FDA has set forth its requirements for TV sets
in 21 CFR 1020.10 wherein any TV set manufactured by any foreign or
domestic corporation must emit no more than 0.5 mR/hr at 5cm from any
point on the external surface of the set.  If the TV set meets this
radiation emission requirement, it can be freely marketed in this
country and purchased by you and I without any sort of license. 
Similarly, under 21 CFR 1020.40, you and I as members of the consuming
public, can buy a cabinet x-ray machine and use it in our homes if we
wish.  The FDA has merely mandated that such x-ray systems (like the
ones used to check baggage at airports) emit no more than 0.5 mR in 1 hr
at any point 5 cm outside the external surface.  If such items meet this
radiation emission limit, they can be freely sold to the public without
license; the users of such devices to not have to be provided individual
dosimetry, etc. 
        Obviously, the NRC does not have any legal authority to regulate
machine radiation producing devices or incidental x-ray producing
devices like cabinet x-ray machines or TV sets.  But if they did, they
probably would have made these devices "generally licensed" analogous to
the confusing way in which they have generally licensed non-exempt
quantities of
licensable radioactive material.  While the public really does not
understand the NRC's general licensing system, they don't really have a
need to understand it.  But you and I and RSOs out there do basically
understand it, and when compared to the NRC's normal "specific"
licensing system, the general licensing system is a bit confusing.  My
take on the general licensing system is that it is a system wherein the
NRC has set itself up to be both judge and jury as to whether or not a
particular device containing non-exempt quantities of licensable
material can be freely sold to the public.  The NRC both requires the
manufacturer to submit full, extensive information about the device as
well as approves the device as abiding by the applicable portions of 10
CFR 19, 20, etc.  In contrast, in the "specific" licensing system, the
NRC approves the license application, but then the institution through
the designated, NRC-approved RSO, is responsible to complying with the
letter/spirit of 10 CFR 19, 20, etc. 
        In summary, under the "general licensing" system, the NRC has
itself approved the device for distribution to the public; it has
approved any labelling requirements for the device (or exemptions
therefrom), and in its "judge and jury" setup in effect concluded that
there is no need to perform contamination surveys, or employee
training.  Regarding disposal, the NRC would have required any such
instructions to be placed on any labels on the device itself.  I think
then that since the NRC has set up this general licensing system which
is substantially different from the specific licensing system, that RSOs
should, when the occasion arises, give the NRC a dose of its own
medicine.  Remembering that even an RSO can buy for his own home use a
static eliminator device and that the RSO probably does not perform any
radiation surveillance or family member training once the device is
located in his home, the RSO probably should not do any different when
such generally licensed devices are in his/her specific NRC-licensed
facility.  It would probably be appropriate for the RSO to have some
degree of knowledge as to the numbers, types, and locations of such
generally licensed items in his facility--but NOT to inventory such
items quarterly or semiannually as may be required for other radioactive
material under the specific license.  Do not wipe test such generally
licensed items on any particular frequency, just let them be.  If and
when the generally licensed item should break and produce contamination
that is directly attributable to the device, itself, then the RSO should
obviously clean up the contamination and provide a courtesy report to
the NRC whereby the NRC becomes aware that a generally licensed device
design that they have previously approved as "safe" had now ruptured,
which may induce them to re look at the manufacturing techniques used by
the manufacturer.  In short, do NOT treat the radioactive material
contained in generally licensed items as if it were radioactive material
possessed under the specific license, just as we, as private systems, do
not treat a Po-210 static elimination device in our own homes as if were
raw Po-210 possessed in the workplace.

Cheers,
Wes
PS Sorry this was so long, but I did not want to shorten any one's
responses.  :)
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