Re: civil penalty for medical violation

[carol marcus <csmarcus@ucla.edu>]

At 05:34 AM 7/20/00 -0500, you wrote:
>Well, if anyone understood my post to advocate non-compliance with 
>inconvenient rules, I guess I need to remember that sarcasm does not 
>translate well through e-mail.
>
>Anyway, this brings up an interesting subject.  Obviously the regs have 
>filled up with fluff over the years, probably in response to various isolated 
>events.  And that is just the rules themselves - does anyone believe that 
>most of the guidance documents are not de facto rules also?  Has anyone ever 
>considered approaching the regulatory agencies with a request for rulemaking 
>to roll back some of the more onerous requirements?  Has anyone done a 
>relatively well justified cost/benefit analysis to identify the requirements 
>that seem to have no significant basis?  If we are going to live with ALARA 
>as a regulatory requirement, why not make the regs pass muster under that 
>same requirement.  (Of course, ALARA might be the first one to go.)  If it is 
>not worth doing, let's go to the rulemakers and get rid of it.
>
>The process does exist - are they open to this sort of thing?  Is this a good 
>role for one of our societies?  The rules would seem to lie at the heart of 
>promoting safety.
>
>Lew LaGarde
>offtowy@aol.com
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Dear Lew and Radsafers:

The Society of Nuclear Medicine and the American College of Nuclear
Physicians have been trying to do this since 1985.  Not only have we been
unsuccessful, but things are getting much worse.  The new Part 35, which was
supposed to be an improvement over the previous mess, merely became a
mechanism for the NRC staff to ram in all kinds of junk that they wanted to
put in to INCREASE the nonsense, cost, and senseless busywork.  They also
concocted a bizarre and vicious structure that de facto turns human error
into about 3 "willful violations of safety requirements", setting up medical
entities for a vicious onslaught of NRC propaganda.  I don't think that
senior NRC management or the Commissioners even understand what is lurking
inside the combination of regs, licensing NUREGS, and a malevolent new
licensing policy, worked out in secret, kept from the public, and hidden
from NRC's medical advisory committee, the ACMUI.  The truth is, if things
were done correctly, the way the National Academy of Sciences-Institute of
Medicine Report of 1996 stated, most of the NRC bureaucrats who make their
living off the "medical" program would lose their jobs.  Unfortunately, the
Commissioners have no competence in nuclear medicine or nuclear pharmacy,
and succumb to whatever bullshit the staff and management con artists feed
them.  No bureaucracy ever made the decision to end its own jobs, and if the
Commissioners do not start personally reading and understanding the junk
they're signing, then the Congress is going to have to do what the NAS-IOM
recommended, which is to remove NRC's authority in the medical (including
pharmacy and medical research) field.  However, when the staff purposely
hands the Commissioners tomes reaching 800 or 900 pages in length, that
insures no one will read any of it.  That is such an old trick, but the
Commissioners fall for it every time.  How many of you have read the volumes
in the 1556 NUREG series that cover medical and pharmacy licensees,
including specific and broad licensees?  How many of you have read the NUREG
controlling manufacturers, where suddenly, out of the clear blue sky, a
second license for "distribution" is required of all of them, and that
license precludes them from distributing anything but FDA-approved products?
The Radiopharmacy Rule is effectively negated if NRC refuses to let
manufacturers sell you the radionuclides and radiochemicals you need.  Hugh
Thompson ordered the staff to fix it, but they stalled and stalled and Hugh
retired before it was fixed.  How many of you have read the 919
(approximately) page Scientech Report that is supposed to be a risk
analysis, but is really the purposeful wasting of User Fee funds to produce
pure, unadulterated, unscientific junk with which to "justify" NRC's
nonsense?  A competent Commission would have fired the NRC people
responsible, and sued Scientech for our money back.  Don't hold your breath!

I really think that if the medical physics, health physics, and state
regulatory folks (CRCPD) joined forces with the medical groups to stop this
runaway regulatory train, that it would work.  However, how many of the
medical physicists and health physicists and state regulators owe their jobs
to NRC's junk regulations, license conditions (the "secret" regulations),
and licensing and inspection policy?  Yes, well that's a problem, isn't it?

I know some of you object to my lack of respect for NRC's "medical" program,
but before you start criticising my comments, go back and read this material
with a critical eye.  You may find that my observations are very objective.
Look, I've got the National Academy of Sciences on my side.  That says
something, and perhaps you ought to read their whole book, "Radiation
Medicine, a Need for Regulatory Reform".  You can download it for free on
their website.  Don't trust the NRC summary about what it said, however, as
that summary was grossly and purposefully untruthful.  When one of the
members of the NAS-IOM committee volunteered to set Chairman Jackson
straight, Jackson refused to speak to her.  In fact, Jackson refused to
speak to any representatives of SNM and ACNP at all.  She kept telling us to
speak to management, and Don Cool and Carl Paperiello and Hugh Thompson kept
blaming her for the mess and telling us to talk to her.  And round and round
we go......!  Will Chairman Meserve get smart enough to cut through this
vicious circle, excrete Jackson's mess and continue the good work started by
Chairman Ivan Selin and Commissioner E. Gail de Planque?  We'll see.

Happy summer reading!

Ciao, Carol

Carol S. Marcus, Ph.D., M.D.
<csmarcus@ucla.edu>

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