Two NRC Issues: Release of I-131 Patients and Potassium Iodide

["Peter G. Crane" <pgcrane@erols.com>]

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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