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Re: Two NRC Issues: Release of I-131 Patients and PotassiumIodide
I am troubled by Mr. Crane's assertions that somehow I am differing from NRC policy or otherwise suggesting a groundswell rebellion of the NRC staff simply because I pointed out some facts that were not included on a KI web site developed by Shane Connor. For an individual to make the best informed decision for themselves and ultimately, the decision to ingest a drug in a very personal decision, then as much information as possible should be made available to these individuals:
The fact is there was only 15 curies of iodine released from TMI. The fact is, there are emergency sirens in place around nuclear power plants. (from my own point of view, I would think that it is preferable to listen to the siren system alarms rather than scan plant transmissions and call the plant every 15 minutes to see if they are releasing radioactive iodine. I'd rather have plant personnel tending to an emergency rather than answering phone calls from everyone in the 10 mile EPZ, but,hey, thats just my thought) The fact is that Poland did interdict food and milk supplies. The reference I used for contamination levels in Poland was "Iodine Prophylaxis in Poland After the Chernobyl Reactor Accident:Benefits and Risks" by Janus Nauman, MD PhD and Jan Wolff, PHd, MD. The FDA is revising KI guidance. I reference WHO guidance and it is more restrictive as I pointed out in my posting, (when I listed the doses WHO is recommending for children, for example) . I po!
int out the concern with a website suggesting ingestion of a drug without the necessary caveats to check with your doctor before taking this or any drug. I think this is prudent advice, and certainly from Mr. Connor's perspective, may be legally prudent that he put that disclaimer on his web site. It is a fact that an emergency at a nuclear power plant does not necessarily result in the release of radioactive iodine. It is also a fact that there are a great many more radionuclides released in a nuclear accident than radioiodine. None of these facts dispute or contradict the NRC Commissioners decisions in any way. It is also a fact that KI is not a magic radiation protection pill and members of the public need to understand that. MSNBC recently posted this article with the following headline "Feds slow in ordering radiation pills" the article further states "Not until 19 years after Three Mile Island did the Nuclear Regulatory Commission recommend that states and com!
munities near nuclear power plants stockpile a drug that could mititate the effects of radiation exposure". Members of the public could easily interpret this to mean the KI will protect them from radiation exposure. It is important that people be aware of the limited applications of this drug. The fact is, the application is are limited. If KI protected against all types of radiation exposure I'd be happy to say that. But that wouldn't be true! And its also a fact that external exposure to radiation can cause thyroid cancer.
Mr. Crane is concerned about integrity. And I am also concerned about integrity. And it seems to me, that a complete picture, with all of the debate and associated issues , presented to the public is the only way to insure integrity in this or any issue. If mentioning the above facts in my posting is wrong, or somehow suggests that I do not support the decisions made by the NRC Commissioners, then I am confused. It seems that suggesting that Mr. Connor include some additional FACTS (and they are facts) that would help make his web site more informative is wrong, because it disagrees with the agenda put forth by other individiuals. I always thought and was brought up to believe that a fully informed public makes the best decisions. It would be arrogant and duplicitous on my part to withold information or supress facts just to win a debate or prove a point.
and these are just my thoughts... PA Milligan, CHP, RPh.
>>> "Peter G. Crane" <pgcrane@erols.com> 11/02 4:37 PM >>>
Monday, November 1, 1999, marked the first full day in the
office for the Nuclear Regulatory Commission's new Chairman, Richard A.
Meserve. Dr. Meserve holds both a doctorate in physics and a law
degree.
November 1 was also the date of RADSAFE Digest 2743, which
included postings on not one but two topics on which Dr. Meserve's
predecessors at the NRC have allowed radiation protection in the United
States to fall below the International Basic Safety Standards. These
are: (1) release criteria for I-131 patients and (2) potassium iodide
(KI).
In an earlier posting, I described how the NRC staff secured the
approval of the Commissioners to change the release criteria for
patients treated with radiopharmaceuticals, never telling the
Commissioners that strict limitations -- for I-131 patients ONLY -- were
part of the International Basic Safety Standards to which the United
States nominally subscribed. Dr. Carol Marcus's recent posting on this
subject, to the extent I could understand it, seems to have confirmed
the point I was making: that by Dr. Marcus's account, the NRC staff,
rather than present its own proposal to the Commissioners, requested --
even demanded -- that Dr. Marcus submit the "petition for rulemaking,"
which the NRC staff then forwarded to the Commissioners, representing it
as a meritorious request from the interested public.
To put it mildly, this is not what Congress had in mind when it
enacted the Administrative Procedure Act. In my comments to the NRC, I
repeatedly raised the issue of the procedural illegitimacy of the
rulemaking, but these comments were studiously ignored by the NRC staff
and by the NRC's Office of General Counsel, which in an ideal world
would be offended by such violations of legal norms and would speak up.
If I had had the time, I would have filed a petition for review
in the Court of Appeals when the rule was promulgated, and I have
something of a bad conscience toward the radiation protection community
and the public at large that I did not do so. (I may yet file a
petition for rulemaking to undo the rule, insofar as it applies to I-131
patients, but if the NRC does not want to grant it, and does not want to
face an immediate test in court, it can simply delay acting on the
petition for a period of years, and for all practical purposes, there
will be nothing that I or anyone else can do about it.)
Also on November 1, there was a RADSAFE posting from Patricia
Milligan, identifiable as an NRC employee by her web address. It is
another example of the struggles that have gone on within the NRC over
KI for many years, in which elements of the NRC staff have fought all
attempts to make stockpiling a reality, even if that meant explicitly or
implicitly attacking the policy decisions of the Commissioners from whom
they nominally take direction.
In a previous posting to RADSAFE, I have described the history
of the NRC's consideration of this issue, and I don't want to
recapitulate the whole story here. For present purposes, it is enough
that in June 1998, the NRC Commissioners, rejecting a recommendation
from the NRC staff that my petition be denied, declared that they would
issue a proposed rule requiring states to CONSIDER stockpiling potassium
iodide. Just weeks later, the NRC staff issued draft NUREG-1633, the
"assessment" of KI that it had prepared in support of its position that
my petition should be turned down. (This was the 40-page supposedly
scientific analysis of the safety and effectiveness of KI, prepared
under the direction of NRC's Dr. Frank Congel, that did not see fit to
mention the FDA's 1978 finding that KI is "safe and effective.") In an
apparent gesture of defiance, the NRC staff's Federal Register notice
omitted any mention the Commissioners' action of the previous month.
Though the Commissioners had authorized publication of the
document, it took the first scathing comments, including those from the
health departments of New York and Ohio, to make them aware how
seriously slanted it was. At that point, they ordered it withdrawn, and
taken off the NRC's website. On October 12, 1998, the trade publication
"Inside NRC" quoted Commissioner McGaffigan as follows: "As one staffer
said to me, it [NUREG-1633] was never intended to be supportive of the
policy the commission established in its June 26 SRM, but was instead a
justification for the policy (not granting the revised petition for
rulemaking which the staff had advocated and the commission rejected."
The NRC staff is currently engaged in revising the document; if
I am not mistaken, Ms. Milligan (also known as Patricia Sullivan) is
part of the group conducting that work.
If one compares Ms. Milligan's message with the June 14, 1999,
notice of proposed rulemaking approved by the Commissioners, the
differences of substance and tone are readily apparent. On point after
point, Ms. Milligan, though she is nominally criticizing Shane Connor's
posting, is tacitly disparaging the Commissioners' policy decision, as
reflected in the June 14 notice. (In my comments on the June 14 notice,
which in large part was excellent, I said that its quality was such that
one would hardly believe that the same agency that produced it had also
issued NUREG-1633.) Most or all of Ms. Milligan's criticisms of Mr.
Connor could equally be leveled at the June 14 notice: its emphasis on
the particular hazards of radioactive iodine; its citation of the TMI
experience; its refusal to rely exclusively on existing emergency
preparedness measures, etc.
Mr. Connor should not be too quick, by the way, to accept all
Ms. Milligan's criticisms as gospel. For example, the Poles who were
involved in the response to Chernobyl do not believe the inhalation dose
was negligible. Perhaps Ms. Milligan can supply a source for her
assertion.
Ms. Milligan states, "The FDA is revising the KI guidance." So
it is -- and like the World Health Organization, it is moving in the
direction of MORE aggressive intervention with KI, especially for
children. (Dr. Congel did his best to dissuade WHO from taking this
step, as I learned from a WHO representative at the "Radiation and
Thyroid Cancer" conference in England last year; he gave me a copy of
Dr. Congel's letter.)
It's not my intent to debate here every item on Ms. Milligan's
list. The point, rather, is that on the issue of KI, there is reason to
question whether elements within the NRC staff recognize a
responsibility to follow Commission direction, or are instead pursuing
their own quest for self-vindication, regardless of what the
Commissoners, the World Health Organization, the International Basic
Safety Standards, FDA, FEMA, or anyone else may say.
It is perhaps for that reason that the NRC's consideration of
the KI issue has taken so extraordinarily long. I filed my petition for
rulemaking in 1995; the KI subcommittee of the Federal Radiological
Preparedness Coordinating Committee pleaded with the NRC to act on it
swiftly in 1996, when it proposed a new federal KI policy, under which
the federal government would buy KI for any state wishing to stockpile.
But the proposed new federal policy is still on the shelf, kept
to a standstill for three full years, thanks to a brilliant bureaucratic
delaying game on the part of the NRC staff. (Students of Roman history
will remember Fabius Cunctator -- "Fabius the Delayer" -- whose greatest
achievement was his avoidance of battles he knew he would lose.) The
rulemaking has also moved only very slowly.
The blame for this situation by no means rests only on the NRC
staff members involved; there has also been a failure of management up
to the highest levels that has allowed it to persist uncorrected year
after year, despite ample evidence that the NRC's handling of the KI
issues had turned into a shambles.
In short, today's separate postings on the release of I-131
patients and on potassium iodide suggest that Dr. Meserve will have his
work cut out for him, if the NRC is to be, as it should be, an agency
where scientific integrity and legal rectitude are the standard.
Peter Crane
pgcrane@erols.com
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