NRC's Patient Release Rule

[Peter Crane <pgcrane@erols.com>]

A recent RADSAFE posting asked how the NRC came to relax its rules on
releasing patients with I-131 in their systems.  The answer is not
pretty, but perhaps it will be helpful to those who want to understand
how regulatory decisions really get made.  I was an NRC lawyer from 1975
until a month ago, but what I am describing is public information.

The Riverside incident in the mid-1970's alerted the NRC to the fact
that it was hospitals, not nuclear power plants, where members of the
public were actually suffering harm from radiation in the U.S.  Some 400
patients were overexposed at Riverside because of an error in
calculating the decay of the source.  In the aftermath of that event,
the NRC Commissioners established, over strong NRC staff protest, the
rule that required misadministrations to be reported to the NRC and the
patient.

After the failure of repeated NRC staff efforts to get the Commission to
repeal or water down aspects of Part 35, the staff realized that there
was a better way to accomplish this goal:  to arrange for the proposal
to be submitted nominally by a member of the regulated community.  Then
the NRC staff could go through the motions of evaluating the proposal
and forward it to the Commissioners, ostensibly as a request from the
interested public.  

Dr. Carol Marcus has alleged in print, many times, that the former head
of the NRC's medical section, Mr. Richard Cunningham, assigned an NRC
staff member, Mr. Norman McElroy, to work with her in drafting such a
petition.  See for example her letter of November 9, 1992, to the NRC
docket in PRM-20-20, PRM-35-10, etc., responding to my letter to the
docket of October 31, 1992:

"Mr. Crane's naiveté concerning the first Petition I wrote in June,
1989, with Mr. McElroy's help, is surprising.  Mr. Cunningham instructed
Mr. McElroy to help me write the petition.  I didn't know how to write
regulatory language, and it was Mr. McElroy's job to help me do that. 
NRC had written some very poor quality and dangerous regulations in
1987, and Mr. Cunningham realized that the language had to be fixed, and
asked us to do it together.  It was an 'inside' job from the start."

When the Commission became aware of this, it put in place a new rule,
barring such assistance to petitioners by the NRC staff.  Mr. McElroy,
the unfortunate staff member who had allegedly worked with Dr. Marcus,
left the NRC, an apparent scapegoat.

To judge from Dr. Marcus's account, if it is accurate -- and I see no
reason to doubt that it is -- old practices died hard.  According to the
same letter quoted above, she received a telephone call late in 1990
from Mr. Hal Peterson, then of the NRC staff.  The NRC had recently
amended 10 CFR Part 20, and a question had arisen whether its 100
millirem standard for exposures to the general public had the effect of
amending Part 35 as well.  To quote Dr. Marcus:

"My Petition was written at the request of Hal Peterson, who was
embarrassed at the uncorrected errors in 10 CFR Part 20, and who urged
me to 'write a petition YESTERDAY'.  At the time, the new Part 20 was
supposed to go into effect 1 Jan 92, and we did not have many months to
waste.  I argued at the time that I did not want to write another
petition (I wonder why?), but he insisted it was the only option open,
and that is how I spent Christmas Eve, 1990.  It was hastily done, and
recommended honoring the methodology of NCRP no. 37, getting rid of the
'30 mCi rule' for all radionuclides other than I-131, and retaining the
5 mSv maximum for members of the public from patient sources....Much
later, after discussing the issues at leisure in much more detail with
members of NRCP, ACNP, SNM, and NRC, I wrote an addendum covering the
'30mCi" issue.  Do to the fact that the '30mCi' value was embarrassingly
based on a naive mistake by the AEC in the early 1950's and never fixed
thereafter, and due also to the fact it is not mentioned anywhere in
NRCP no. 37 (nor should it have been), I made a scientifically valid
case for a 'default' value of I-131 patient discharge which came out to
33 mCi.  However, there is excellent reason to raise that number,
especially for athyreotic carcinoma patients with normal renal
function.  NRCP no. 37 lists limits of 50 mCi for certain home
situations and 80 mCi for even more restrictive home situations.  Mr.
Crane should familiarize himself with these qualifiers, because he is
obviously unfamiliar with these long-accepted concepts.  NRCP no. 37 is
the law in California; the '30 mCi rule" does not exist here.  We in
California try to base our policies on scientifically valid health
physics."

In my comments to the NRC on the petition, I stressed the special
character of I-131, which made it more dangerous than other commonly
used radiopharmaceuticals, and highlighted the danger to the public from
vomitus.  (I also pointed out that the NRC staff, by Dr. Marcus's
account, was passing judgment on what was actually its own proposal.) 
To quote my letter of October 31, 1992:

"In addition, one of the most common effects of I-131 treatment is
nausea. ... As an inpatient, one is instructed to call the nurses'
station at the first sign of nausea, so that appropriate medication may
be given.  Vomiting presents problems for hospital Radiation Safety
departments, because they must enter the radiologically contaminated
room in order to clean up.  Consider, however, how much worse it would
be if the patient is at home, vomiting, and unprotected family members,
rather than Radiation Safety personnel with rubber gloves and other
protective gear, are having to clean up, probably without thinking for a
moment, under the stress of the situation, of the radiological
implications. ... What about the patient, traveling home by public
transportation....?"

I also pointed to the then recent report in the New York Times that a
World Health Organization team was finding unexpected childhood thyroid
cancer deaths near Minsk among children exposed to radioiodines from
Chernobyl, and suggested that this was "not the time for the NRC to be
approving regulatory changes that will have the effect of exposing
American children to more I-131."  (In her reply, Dr. Marcus
sarcastically criticized me for "quoting such incontrovertibly superb
scientific sources as the New York Times for data on childhood thyroid
cancer near Chernobyl.")

Concerns similar to mine were expressed by the health authorities of six
states.  New York State drew attention to the dangers of exposure from
vomitus, and it expressed concern about releasing any patient after a
dose of more than 80 mCi.  (This number may have come from the same
source cited by Dr. Marcus.)  But when the NRC issued the proposed rule,
it was as though those six states and I had never filed comments at
all.  There was no identification of the special character of I-131 as
an issue; no mention of vomitus; and -- this was no surprise -- no
mention of the issue of whether the NRC staff had played a role in
inspiring the petition.

I filed comments once again, making all these points, quoting the
comments of the six states, and adding that it was discouraging to feel
that if one's comments went counter to the NRC staff's proposal, they
would simply be ignored.  I pointed out the disparity between the
proposed rule and the International Basic Safety Standards to which the
United States nominally subscribes.  I pointed to a comment from NIH,
which said that it knew that despite all precautionary warnings, its
I-131 patients frequently went right to the airport and boarded planes
after their release.  If that was a problem under the 30 mCi limit, how
much worse would it be if that limit was lifted? 

But all these comments were ignored once again, and when the
Commissioners received the NRC staff memorandum ostensibly analyzing the
comments, and proposing a final rule for the Commission's adoption, none
of these issues were addressed.  Apparently, the NRC staff was confident
that no Commissioner or Commissioner's assistant would bother to read
the actual comments filed.  As far as the Commissioners knew, the issue
for them to decide was an easy one:  whether the exposure level to
members of the public should be 100 millirem or 500.  The Commissioners
voted their approval, and the final rule duly went forth.

As a result, the Commissioners approved a major deregulation of I-131
treatments without, I suspect, fully appreciating what they were doing. 
They had not been told of the concerns of New York and other states;
they knew nothing of the risk of vomitus; they did not understand that
I-131 was in a class by itself; and they did not realize that Dr.
Marcus's petition was, by her own account, filed only because the NRC
staff demanded it. 

The NRC staff paper, and all the filings in the docket, are publicly
available; I am revealing no secrets here.  By the way, all the comments
that I filed, on the petition and the proposed rule, I wrote on my own
time, and submitted in my capacity as a private citizen.  I had been a
thyroid cancer patient, receiving two outpatient and five inpatient
treatments, and being aware of just what extraordinary precautions
hospitals take with their I-131 patients, I thought it was the height of
irresponsibility to enact a regulatory change that would allow patients
with large doses of I-131 in them to walk out the door.  But I might has
well have saved the money I spent on stamps.

The recent reports on RADSAFE of patients vomiting up I-131, and of
passengers on a city bus walking through the vomit, should come as no
surprise.  Not only were such problems predictable, they were predicted.

Last month, shortly after my retirement from the NRC, I happened to meet
a senior physician at one of the great medical centers in the east. 
Without signaling my own views, I asked him what he thought of the NRC's
patient release rule.  Without hesitation, he answered:  "Probably the
biggest mistake the NRC has made in 35 years."

Peter Crane
pgcrane@erols.com
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