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Re: The NRC's Fighter Jet Rule on KI



It is not often that I jump in with responses to issues on RadSafe.  However, there are several issues in this letter that need to be addressed.   I appreciate the passion with which Mr. Crane embraces the matter of KI, but, I'm afraid, in this instance, some of his passion, may have allowed him to misrepresent the facts a bit.  
      "In Poland, by contrast, health authorities gave out 18 million doses of KI and protected virtually all of the nation's 10.5 million children.  Polish authorities believe that the prompt administration of KI is a major reason that Poland has been spared a similar increase in cancer".   The fact is that KI administration did not begin until 2 to 4
 days AFTER the accident.  In order for KI to be effective from inhalation exposure, it needs to be administered either just before the release, concurrent with the release or immediately (within 6 hours) after the release.  For effective KI blocking from ingestion exposure, multiple doses of KI need to be administered over the several days of ingestion exposure.  In Poland, only single doses were administered.   There were  several factors contributed to the lack of increase of thyroid cancer among the Polish population, most notably was the lack of signficant iodine exposure/contamination in Poland.  The amount of iodines in Poland, as a result of the accident was negligible.  Epidemiologically, it would not be possible to see any increase in cancers from the small amounts of iodine dispersed in Poland.  Additionally, milk and sensitive food supplies were interdicted by the Polish authorities.   In Belarus, Russia and Ukraine, no protective actions were implemented for the s!
everal days after the accident.  The residents continued their normal activities; there was no sheltering, evacuation or food interdiction.    No efforts were made to restrict milk supplies for the first 10 days following the accident.   It is believed that the increases in thyroid cancer can be attributed mostly to ingestion.  Had the residents been evacuated promptly (within hours rather than days) and had the milk and sensitive food supplies been appropriately interdicted, it is likely that significant increases in thyroid cancers would not have occured. 
In the United States, the policy is to evacuate and interdict contaminated food supplies.  It has been demonstrated many times in the US that contaminated food can be quickly removed from the market or even prevented from reaching the market at all... witness the number of meat products yanked from the shelves as a result of E-coli contamination or the packing plants that shut down due to E-coli, and their products never reach the market.   Use of KI rather than interdiction of food supplies is not an option in this country.  The emergency preparedness infra-structure is very different in the US than in other parts of the world.  
It is also important as we discuss Chernobyl and TMI-2, to remember that during the TMI Unit 2 accident, the total amount of iodines released was 15 curies.  Contrast that to the 75 million curies released as a result of Chernobyl.   Approximately 10 million curies of noble gases were released at TMI-2 compared to the several hundred million released at Chernobyl.  KI would not protect the thyroid from the external irradiation by noble gases.  Mr. Crane attributes his own thyroid cancer to external irradiation of his tonsils as
a child.  No amount of KI will protect the thyroid from
external irradiation and ingestion of KI would not have protected Mr. Crane from his own thyroid cancer.  We cannot have people believe that KI is somehow a magic pill that will protect them radiation and prevent cancer, even thyroid cancer. KI is very limited in its application.    So the question remains, in this country, does requiring the use of KI make sense?    The probabilty of a severe nuclear power plant accident that would even require consideration of KI is very small, on the order of 10E-6 or smaller.    The fact is that we, in the United States,  have a finite amount of resources to draw from, does it make sense to take from the finite pool and force states and other government agencies to implement a KI program for severe nuclear power plant accident?  ( I am only addressing nuclear power plant accidents, to protect the populace from terrorist attacks would require administering KI to each indidivual person in this country as one could never be sure where a terro!
rist would attack!  I'm not sure that nuclear terrorist attacks fall under the purview of the NRC unless they occur at nuclear power plants) Would these resources be better utilised elsewhere?   There are some states now, who have implemented KI programs for their residents in areas around nuclear power plants.  They did not require a federal government order to dictate this implementation. 
Additionally, KI is available commercially and without a prescription to any member of the population who desires it.    I am sympathetic to Mr. Crane's cancer and his concern for others.   I  too, have had cancer and I watched my younger brother die from cancer, so I know, only too well, the devastating impact of the disease both on the afflicted as well as the family.  I wouldn't wish it on anyone.    But I think, that implementing federal  law for an issue with such a very small risk factor is something that needs to be considered very seriously and perhaps is best left up to each state to decided what is right for them and their residents.  For the record, I am also an NRC employee. 

 Peter Crane wrote: 
 "Officially, today is the last day to submit comments to the
 Nuclear
 Regulatory Commission on its proposed rule on potassium
 iodide in
 emergency planning.  However, the NRC will consider comments
 submitted
 after today "if it is practical to do so," which in reality
 means that
 commenters have some time to comment.  I urge Radsafers to
 consider
 making their voices heard, the sooner the better.

 Governments throughout the developed world recognize that the
 major
 health lesson learned from Chernobyl is the extreme
 sensitivity of
 children's thyroid glands to radioiodines:  thus the upsurge
 of
 childhood thyroid cancer in Belarus, Russia, and Ukraine.  In
 Poland, by
 contrast, health authorities gave out 18 million doses of KI,
 and
 protected virtually all of the nation's 10.5 million
 children.  Polish
 authorities believe that the prompt administration of KI is a
 major
 reason that Poland has been spared a similar increase in
 thyroid cancer.

 In the summer of 1998, I spoke to an international conference
 on
 "Radiation and Thyroid Cancer" at Cambridge University.  One
 of the
 speakers made the point that virtually all the thyroid
 cancers appearing
 in the former Soviet Union are in children who were four
 years old or
 younger at the time of the accident.  

 Let me be up front about my own reason for becoming involved
 in the KI
 issue.  In the late 40's, when I was two or three, I was
 among the 4000+
 children who received radiation to the head and neck at
 Michael Reese
 Hospital in Chicago for enlarged tonsils and adenoids.  At
 26, I first
 had thyroid cancer, and when I was 42, it recurred, requiring
 five
 courses of I-131 treatment (700 millicuries) before I finally
 got a
 clean bill four years later.  I'm well aware that thyroid
 cancer has a
 high cure rate, and that there are many worse diseases one
 can have. 
 But I also know from experience that it is not something that
 you would
 wish on your children or yourself.

 Americans tend to assume that public health protection for
 their
 children is second to none.  In the case of KI, this is not
 the case. 
 Twice in 20 years the NRC has made commitments to the
 American people on
 KI, only to renege on them afterwards.  As a result, we are
 still in a
 pre-Three Mile Island state of preparedeness on KI, when the
 drug is
 routinely stockpiled (and in some countries predistributed to
 individual
 houses) in many European countries, including France,
 Germany,
 Switzerland, the UK, Sweden, Norway, Austria, the Czech
 Republic,
 Slovakia, Poland, etc., plus Japan and Canada.  In my talk to
 the
 Cambridge conference, I laid out the 20-year history of the
 NRC's
 mishandling of the issue; it may be found on the NRC's
 rulemaking
 website, ruleforum@llnl.gov.

 The first commitment came in 1979.  During the TMI accident,
 at a point
 when a major release of radioiodines was feared, federal and
 state
 officials looked for supplies of KI (which had been declared
 "safe and
 effective" for radiation protection by the Food and Drug
 Administration
 the previous year) and discovered that none existed.  An FDA
 official,
 Jerome Halperin, made a midnight call to a drug company
 executive, who
 started up the production line at 3 a.m., with the result
 that the
 first  supplies of KI arrived in Pennsylvania 24 hours later.

 Fortunately, the accident was brought under control without a
 major
 release, and the drug was not needed.

 After the accident, the Presidential commission headed by Dr.
 John
 Kemeny castigated the NRC's failure to ensure adequate
 stockpiles of
 KI.  The NRC agreed with the criticism, in a document
 published in
 November 1979, and declared that it intended to require
 supplies of the
 drug to be established near every nuclear plant, as a part of
 emergency
 planning.  In 1982, the NRC staff recommended to the NRC
 Commissioners
 that they approve a draft federal policy statement favoring
 the
 stockpiling of KI.  Only three weeks later, the NRC staff
 reversed
 itself, withdrew its earlier recommendation, and said that it
 could
 produce a new memorandum asserting that KI was less
 "cost-effective"
 than previously thought.  

 On November 22, 1983, the NRC staff briefed the Commissioners
 and the
 public on KI.  The gist of its argument was that KI was not
 cost-effective:  that it would be cheaper in the long run not
 to buy KI,
 and spend the money thereby saved on treating any thyroid
 disease that
 might result from not having the drug.  The transcript shows
 NRC
 Chairman Nunzio Palladino objecting that if he survived an
 accident
 because of having taken KI, he would think the $.20 or
 whatever the drug
 cost to be money well spent.  The staff briefer assured him
 that
 "surviving is not the question."  Rather, the issue was one
 of "averting
 an illness," one that involved "a few days' loss."  Cancer
 was never
 mentioned; instead, the briefers talked of "nodules."  No one
 listening
 to the presentation would have imagined that 40% of the
 nodules would be
 cancerous, or that 5 to 10 percent of the cancers would be
 fatal. 

 For more than 10 years, I have been saying, in writing, that
 the staff
 misinformed the Commissioners and the public on that
 occasion, by
 seriously understating the consequences of radiation-caused
 thyroid
 disease.  For more than 10 years, the NRC has steadfastly
 refused to
 examine whether or not that is the case.  At a Commission
 meeting on KI
 in November 1997 -- the first such meeting in 14 years --
 Commissioner
 Ed McGaffigan asked the staff what its response was to the
 charge of
 misinformation.  The staff's response was that it "had no
 answer."

 In 1989, after the NRC staff declared that the Chernobyl
 accident was
 not grounds for altering course on KI, I filed a "differing
 professional
 opinion" urging that new information called for stockpiling
 KI, and that
 in any case, the existing policy was defective, as it was
 based on
 misinformation to the Commissioners and the public.  (I am a
 lawyer for
 the NRC, but this message, like my other work on KI, is
 written in my
 private capacity, at home, on my own time.)  

 In 1994, the NRC staff sent a memorandum to the Commission
 that
 recommended stockpiling of KI as a "reasonable and prudent"
 measure,
 adding that it was so cheap, at just a few cents a pill, that
 it would
 cost less to stockpile the drug than to go on studying
 whether the drug
 was worthwhile.  But the Commissioners split 2-2, and under
 NRC rules,
 that means the status quo stays in place.

 In 1995, therefore, I filed a petition for rulemaking, asking
 that the
 NRC make KI stockpiling, along with evacuation and
 sheltering, part of
 its emergency planning rules.  At the same time, I wrote to
 the Federal
 Emergency Management Agency, pointing out the flaws in
 current U.S.
 policy on KI.  FEMA acted swiftly, and the result, in 1996,
 was that the
 Federal Radiological Preparedness Coordinating Committee,
 chaired by
 FEMA, recommended a new federal policy, under which the U.S.
 Government
 would provide the drug at federal cost to any state
 requesting it.  On
 July 1, 1997, the NRC announced that it supported the draft
 policy, and
 declared explicitly, "The NRC will provide the funding."  

 On November 5, 1997, at the NRC Commission meeting referred
 to earlier,
 I made a tactical decision -- foolish, in retrospect -- to
 offer a
 compromise, because I could see that my 1995 petition was
 headed to
 another 2-2 defeat.  I said I would accept a strong
 recommendation in
 favor of stockpiling, coupled with a requirement that states
 "consider"
 KI in their emergency plans, because when this was joined
 with the offer
 of federally-funded KI, no sensible state would turn the
 offer down.

 Elements in the NRC staff remained passionately opposed to KI
 stockpiling.  In support of a recommendation against
 stockpiling, they
 prepared a document, given the number NUREG-1633, which
 purported to be
 a technical analysis of the drug.  One might have thought
 that the
 starting point would have been the FDA's 1978 declaration
 that the drug
 was "safe and effective."  Amazingly, NUREG-1633, in all its
 40 pages,
 never mentioned that fact.  Instead, it included dire
 warnings of severe
 side effects of KI, gleaned from the pages of the Physician's
 Desk
 Reference.  What no reader could have imagined was that those
 quotations
 did not refer to KI in the low doses used for radiation
 protection, but
 for a prescription-only drug, orders of magnitude more
 concentrated,
 used for certain pulmonary illnesses.  After searing comments
 from the
 health departments of New York and Ohio, the NRC
 Commissioners ordered
 NUREG-1633 withdrawn.  It was also taken off the NRC website.
  Eager to
 save face, the NRC staff explained that it was being revised
 in light of
 the "many useful comments" received.

 In 1998, the NRC reaffirmed its commitment to
 federally-funded
 stockpiling, and in September of that year, sent FEMA a draft
 Federal
 Register notice that would announce the new policy.  But in
 October, the
 NRC got a new Commissioner, Jeffrey Merrifield, a young
 staffer to
 Senator Bob Smith of New Hampshire, who has been in the news
 in 1999 for
 quitting not one but two political parties.  Commissioner
 Merrifield
 told his colleagues that if he had been at the Commission
 when the KI
 decision was made, he would not have approved it, and he set
 out to
 overturn the Commission's decision.

 The result, in April 1999, was that the NRC reversed its
 position on
 funding of state stockpiles.  (As to its past position, the
 NRC would
 acknowledge only that it had said in the past that funding
 for state
 stockpiles would "probably" come from NRC; the statement in
 the 1997
 press release that the NRC would provide the funding was
 passed over in
 silence.)  Instead, the NRC would support federal funding of
 REGIONAL
 stockpiles.

 Regional stockpiles of a drug that needs to be given before
 or just
 after exposure to be useful?  The World Health Organization
 has said
 that the drug should be kept locally, in schools, hospitals,
 fire
 stations, and the like.  The time spent transporting the drug
 from
 regional stockpiles to the area of need is time lost getting
 the drug
 into the children who need it, and it cannot fail to
 translate into
 increased numbers of childhood thyroid cancers in the event
 -- the
 unlikely event, to be sure -- of a major accident or act of
 terrorism.

 Commissioner Merrifield had an answer to this, however.  In
 an interview
 with the Keene (N.H.) Sentinel, he suggested that the drug
 could be
 brought to the area of need by "fighter jet."

 Consistent with this approach, the NRC issued a proposed rule
 in June. 
 It will require states to "consider" KI, but suggested that
 many had
 already done so.  It included no recommendation that states
 stockpile. 
 As to funding, it explained that the NRC had to deal with a
 declining
 budget, and that it did not have funds left over for "new
 initiatives."

 It is indicative of how badly the NRC has failed to inform
 the public
 and the states on the KI issue that at a public meeting at
 FEMA in 1996,
 an official of a large and populous state declared one reason
 for his
 state's opposition to KI stockpiling:  that "Loss of the
 thyroid is not
 life-threatening."  (When I criticized this statement in
 comments to the
 NRC, a more senior official of that state angrily responded
 that
 "hundreds of thousands of people live normal, healthy lives
 without
 functioning thyroid glands.")

 The American Thyroid Association has been pleading since 1989
 for a more
 enlightened policy on KI.  The World Health Organization is
 moving
 toward recommending more aggressive intervention with KI. 
 The
 international Basic Safety Standards, to which the U.S. is a
 signatory,
 call for KI to be part of emergency planning. 
 Internationally, the
 NRC's penny-pinching on KI is bringing no glory to U.S.
 radiation
 protection efforts.  If you talk to doctors and radiation
 protection
 specialists from other countries, they shake their heads in
 disbelief
 that the United States believes it cannot afford the million
 or two or
 three dollars it would take to bring its children's
 protection up to
 world standards.  (The international community can also see,
 from the
 frequency with which NRC Commissioners jet around the world,
 that the
 NRC is not completely strapped for funds.)

 The issue is not whether evacuation is better than KI.  Of
 course, it is
 better to get children and adults out of harm's way, if you
 can.  But as
 the rest of the developed world seems to understand, it is
 better to
 have three arrows in your quiver than two.  Accidents are by
 their
 nature unpredictable.  It is better to have life preservers
 on your
 boat, and a first aid kit in your car, than to count on
 someone flying
 to your aid in a crisis.

 How cheap is KI?  On the NRC's rulemaking website, you can
 find an
 e-mail from an Ohio state official, forwarding an e-mail from
 a Swedish
 firm that offers KI in quantity at six cents a pill, with a
 guaranteed
 shelf life of ten years.    

 The only argument against having KI close to reactors that
 would make
 sense, if it were true, is that big accidents will not
 happen.  If only
 we knew that!  Big accidents are unlikely, to be sure, but
 complacency
 is a dangerous path to follow.  If we knew that accidents
 would never
 happen, we could scrap all of emergency planning, including
 sirens and
 drills.  Moreover, all the estimates of accident probability
 deal with
 unintended accidents; in today's world, terrorism is a wild
 card for
 which we have no probability estimates.

 In 1996, Maine decided to adopt KI stockpiling.  A member of
 the state's
 advisory committee on radiation said, "Knowing what we know,
 ten years
 from now, I'd rather say that we erred on the side of
 caution."  20
 years after TMI, it's time for the federal government to show
 the same
 good sense.

 For those who read to the bottom of this long message, thanks
 for your
 attention, and I hope you'll consider sending your views to
 the NRC. 
 I'm sure that perspectives from other countries would also be
 valuable."

 Peter Crane
 pgcrane@erols.com 
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