Last Updated: January 1st, 2003

The NRC's "Fighter Jet Rule" on KI STATEMENT before the POTASSIUM IODIDE (KI) WORKING GROUP of the RADIATION EMERGENCY PREPAREDNESS ADVISORY COMMITTEE (REPAC) NRC REVISES ITS REGULATIONS ON USE OF POTASSIUM IODIDE IN EMERGENCY RESPONSE - December 22, 2000 Peter Crane article, March 4, 2001 The NRC's "Fighter Jet Rule" on KI By: Peter Crane (Lawyer, recently retired from the U.S. Nuclear Regulatory Commission. Served with the NRC from early 1975 until October 1999. Except for a relatively brief period (1991-92) in which he was an administrative judge with the Nuclear Claims Tribunal in the Republic of the Marshall Islands.) Date: September 13, 1999 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. 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   STATEMENT OF PETER G. CRANE before the POTASSIUM IODIDE (KI) WORKING GROUP of the RADIATION EMERGENCY PREPAREDNESS ADVISORY COMMITTEE (REPAC) Hershey, Pennsylvania October 13, 1999 My name is Peter Crane, and I very much appreciate the invitation, extended on behalf of the Working Group by Professor Miller, to be here today. The Commonwealth of Pennsylvania, REPAC, and the Working Group are to be commended for their vigor in addressing a major issue of public health policy: the stockpiling of potassium iodide (KI) for use during and after nuclear accidents or acts of terrorism, to protect against thyroid cancer and other thyroid diseases. For the record, this statement is a revision of one that I submitted several weeks ago, before the Japanese criticality accident on September 30 gave new impetus to the reexamination of radiological emergency planning issues. If you have the earlier version, it can be discarded. I am neither a physician nor a scientist, and I don't pretend to be. I'm a lawyer, recently retired from the U.S. Nuclear Regulatory Commission. I served with the NRC from early 1975 until about two weeks ago, except for a relatively brief period (1991-92) in which I was an administrative judge with the Nuclear Claims Tribunal in the Republic of the Marshall Islands. Let me be up front about my own reason for becoming involved in the potassium iodide issue. In the late 40's, when I was two or three, I was among the more than 4000 children who received radiation to the head and neck at Michael Reese Hospital in Chicago for enlarged tonsils and adenoids. I first had thyroid cancer at 26. When I was 42, it recurred, requiring five hospitalizations for radiation treatment before I finally got a clean bill of health four years later. If you have to have cancer, thyroid cancer is one of the better ones to have, but my experience tells me that you would not wish it on your children or yourself. Ask any thyroid cancer patient you know and see if you get a different answer. There is more to illness than mortality rates alone can tell you. The principal argument against potassium iodide is that we don't need it, because accidents are so unlikely, in a country as technically advanced as ours, and even if an accident did occur, evacuation would be preferable. Put all your eggs in the basket of evacuation, the opponents of KI stockpiling will tell you, and don't trouble your heads for even a moment with the thought that evacuation might not do the job. In the last several weeks, however, we have had two new data points, Hurricane Floyd and the Japanese accident. Hurricane Floyd has caused the biggest evacuation in American history, and provided the best example of why it is risky to rely on evacuation alone. On paper, evacuations can work beautifully — people hop in their cars and zip away to safety in no time flat. In practice, it can mean endless lines of cars, crawling along the highways at walking speed. From the Japanese accident, we can see once again, if we are willing to face facts, a number of perhaps unpalatable truths. First, accidents can happen, even in a technically advanced society with a strong safety culture. Human error is a factor to be reckoned with in every place and time. Second, there may be situations in which evacuation is not feasible. In Japan, there were 320,000 people huddled indoors with the windows shut. Third, as we saw from the photos of little children with radiation monitors being held against their necks, a prime concern in any radiological emergency is likely to be the thyroids of the very young. The last of these is not news by any means. Indeed, the principal health lesson learned from the 1986 Chernobyl accident is the extreme sensitivity of children's thyroid glands to radioiodines. Since about 1991, medical authorities in Belarus, Russia, and Ukraine have been seeing an upsurge of childhood thyroid cancer. More than 2000 cases have been reported so far, and many thousands more are expected. Virtually all these cancer patients were four years old or younger (including in utero) at the time of the accident. That's an indication of just how sensitive to radiation very young children are. And in children, unlike adults, thyroid cancer tends to be aggressive. It spreads rapidly. Though fatality rates are relatively low, it is a disease with significant impacts on the quality of life. Surgery, post-surgical radiation treatment, and daily medication for life are the minimum to be expected -- and that is for the lucky patient. We know that nuclear accidents or acts of terrorism can release radioactive iodine. We also know that this radioiodine, if inhaled or ingested, can cause thyroid cancer and other conditions, including mental retardation. Fortunately, there is a cheap and effective antidote: potassium iodide. It's the same chemical used to iodize salt. (Look at the ingredients list on the box of salt in your cupboard.) Known in scientific shorthand as "KI," potassium iodide works by saturating the thyroid with iodine in a harmless form. This blocks the uptake of harmful radioactive iodine. In Poland, during the Chernobyl accident, 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. Side effects were minimal. Only two people needed to be hospitalized, briefly. Both were adults with known iodine allergies, and both took the drug despite being warned not to. (You tend to know if you're allergic to iodine, because you can't eat seafood without having a reaction.) Allergic reactions are especially rare in children. Thousands of Poles had minor adverse reactions — upset stomachs, skin rashes — that did not require hospitalization. Now, the opponents of KI will sometimes argue that the Polish experience can be discounted. They claim that despite that heavy exposures to radioiodine in nearby areas of the Soviet Union, Poland did not receive enough radioiodine to have caused any thyroid cancer, with or without KI. Polish health authorities would argue the contrary. For present purposes, the issue is a red herring. Even if we were to assume for the sake of argument that radioactive iodine from Chernobyl completely missed Poland, while causing vast numbers of childhood thyroid cancer in nearby areas of Belarus, Russia, and Ukraine, what would that prove? The main point is that health authorities the world over think that having KI as a backup is sensible, because (1) radioiodines can cause thyroid cancer, (2) KI can block the uptake of radioiodines, and (3) KI is so cheap a way of providing additional protection. And we know from the Polish experience that the adverse health effects of a single dose of KI are few and minor. Americans tend to assume that public health protection for their children is second to none. This is not true in the case of KI -- far from it. In the international radiation protection community, we are at the back of the pack on this issue, thanks to the repeated failure of the United States Nuclear Regulatory Commission and the unrelenting political pressure of the U.S. nuclear industry. Twice in 20 years the NRC has made commitments to protect the American people with KI, only to break those commitments later. The first such commitment came in 1979, soon after the Three Mile Island accident. During the accident, at a point when a major release of radioactivity was feared, federal and state officials looked for supplies of KI and discovered there weren't any. An official at the Food and Drug Administration had to call a drug company executive at midnight and ask him to start up the KI production line. The first supplies of KI arrived in Harrisburg 24 hours later. Fortunately, as Pennsylvanians will remember, the accident was brought under control without a major release, and it was not necessary to use the drug. The Presidential commission that investigated the accident 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. Several years later, however, the NRC reversed itself. The result was the current U.S. policy on KI, put in place in 1985. It does not forbid the stockpiling of KI, but it discourages it, using the words like "not worthwhile." The policy is based on what purports to be a cost-benefit analysis. There is nothing wrong with the concept of cost-benefit analysis, so long as it is done with honesty and common sense. But this one was based exclusively on a dollar-for-dollar comparison between (1) the cost of KI pills and (2) the cost of treating the thyroid disease that would result from not having KI pills available if an accident occurred. Think about that for a moment. If you applied the same test to polio vaccination, your decision whether to immunize children would be based solely on a comparison between the cost of the vaccine and the cost of treating the polio cases that could be expected if vaccination stops. The fact that polio has other costs, which can't easily be reduced to money — life, liberty, and the pursuit of happiness — would not get a moment's consideration. My wife and I, like all the other parents we know, have our children vaccinated to protect theirhealth, not our bank account. There's no room for that kind of thinking in the current U.S. policy on preventing childhood thyroid cancer. It's strictly dollars and cents. Others may disagree, but I think that to decide against buying a medicine to prevent cancer on the grounds that it will be cheaper to let the disease occur and then treat it is nothing short of macabre. This cost-benefit approach was presented to the public and the NRC Commissioners in a public briefing by the NRC staff in 1983. You might think that in a discussion of a drug to prevent cancer, there would be some discussion of cancer. There wasn't. On the contrary, the word "cancer" was studiously avoided. KI was described as a drug that could prevent "nodules." No one mentioned that 40% of such nodules would be cancerous, or that some of the cancers would be fatal. The public and the Commissioners were told that the issue was whether it was worthwhile to be prepared to "avert an illness," which if it occurred would mean a "relatively simple operation" involving "a few days' loss." Today, all over the world, governments routinely stockpile KI for their children. France, Germany, Switzerland, Britain, Denmark, Norway, Austria, Sweden, the Czech Republic, Switzerland, Poland, Japan, Canada, Slovakia — the list goes on. For Armenia, a nation in dire economic distress, it is a sacrifice to protect their children with KI, but they do so. The richest country in the world, however, thinks it can't spare the money. How much money are we talking about? On the NRC's rulemaking website, you can find an e-mail from an Ohio state official, forwarding a message from a Swedish firm that offers KI in quantity at six cents a pill, with a guaranteed shelf life of ten years. That works out to six-tenths of a cent per year for each child protected. We're not even talking about protecting every child in the U.S., just those within a reasonable distance of nuclear power plants. This is a pittance. The money, I am afraid, is just an excuse. The real problem is that the U.S. nuclear industry thinks that KI is bad public relations, because it reminds the public of the inescapable, undeniable truth that major accidents may be unlikely but they are not impossible. In the interest of brevity, I'm going to leave out the bureaucratic ins and outs. I pursued this issue within the NRC from 1989 to 1994 and got nowhere. In 1995, acting as a private citizen, 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, for state stockpiles to be kept close to nuclear plants. On July 1, 1997, the NRC announced that it supported the draft policy, and declared explicitly, in a press release that you can find on the NRC website, at www.nrc.gov, "The NRC will provide the funding." Elements in the NRC staff remained passionately opposed to KI stockpiling, however. In support of a staff recommendation against stockpiling, they prepared a 40-page document, given the number NUREG-1633, which purported to be a technical analysis of the drug. You might think that the starting point would have been the Food and Drug Administration's 1978 finding that the drug was "safe and effective." Not so; that fact was left out of NUREG-1633. Instead, the document presented dire warnings of severe side effects of KI, culled from the Physician's Desk Reference. What no reader could have imagined was that those quotations did not refer to KI in the low-dose, over-the-counter form used for radiation protection, but to a vastly more concentrated drug: super-saturated KI, a prescription-only medication 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 in the Federal Register that the document was being revised in light of the "many useful" comments received. In 1998, over the NRC staff's objections, the NRC Commissioners reaffirmed their commitment to federal funding of stockpiles for any state that wanted one, and in September of that year, sent FEMA a draft Federal Register notice that would announce the new policy. But in October, 1998, the NRC got a new Commissioner, Jeffrey Merrifield, and with his arrival, the balance of power on the five-member Commission began to shift. The result, in April 1999, was that the NRC Commissioners spun 180 degrees on the funding of state stockpiles, on a 3-2 vote. Commissioner Dicus, a longtime opponent of state stockpiles, Commissioner Merrifield, and Chairman Jackson, who switched her vote, made up the majority. Commissioners Diaz and McGaffigan voted to stand by the NRC's decision. The Commission majority's April 1999 decision made clear that the NRC was against any federal funding of state stockpiles by the NRC. It left open the possibility of such funding by the Federal Emergency Management Agency. The Commission majority declared that it would support federal funding of regional stockpiles. The Commissioners of the majority were less than straightforward about their reversal. Regarding their past position, the Commissioners would acknowledge only that the NRC 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, as though it had never occurred. Given that states such as Ohio had been working for two years to implement a new KI policy on the strength of the promise contained in the Commission's press release, this attempt to rewrite history was no compliment to the intelligence of the states or the interested public. A FEMA official, learning of the NRC's action, was quoted in the New York Times as saying, "Those rascals." FEMA's Director, James Lee Witt, wrote to the NRC on April 29 that the NRC's plan of regional stockpiling would do more harm than good, and that FEMA had no intention of cooperating with it. He urged the NRC to stand by its often-repeated commitments to the federal community, the states, and the public. At this point I have to say a word in praise of FEMA and its Director. Though the Federal Government today is far from where I think it should be on the KI issue, we would be in a far worse position if NRC irresponsibility had not repeatedly been countered by responsibility on FEMA's part. Since the Director's letter of April 29, however, FEMA has not been heard from on the KI issue. That's not altogether surprising -- FEMA has had a series of grievous natural disasters to contend with -- but there have been recent suggestions that the NRC has not given up on the idea of drawing FEMA into a compromise on regional stockpiling that would amount to a surrender on Director Witt's part. I am confident that this will not succeed, but it would be useful for FEMA to lay any such fantasies to rest with a clear statement that the April 29 letter remains the agency's position. You can readily see why Director Witt thought that the NRC's regional stockpile approach was unacceptable. 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 vicinity of the accident is time that will be lost getting the drug into the children who need it. 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 was quoted in the Keene (N.H.) Sentinel as explaining that the drug could be brought to the area of need by "fighter jet." I must admit that I have been somewhat hard on him in print over this statement, and let me take this opportunity to be a little fairer, perhaps, than I have been in the past. As I understand it, Commissioner Merrifield's support for regional stockpiles was based on the concern -- a valid one -- that if a radiological emergency occurred in a state that had no stockpile, emergency officials in that state should not be completely without recourse. As to "fighter jets," I think he was making the point that the Federal Government has ways of moving drugs and other supplies quickly in time of need. I would answer him, however, by saying that regional stockpiling makes excellent sense, but as a backup to state-run local stockpiles, not as a substitute for them. And with the NRC unwilling even to recommend state stockpiling unequivocally -- it uses instead an awkward circumlocution, and says that states may find KI to be reasonable and prudent under some specific circumstances -- the majority's approach is likely to slow the creation of state stockpiles. As to the speed of federal response, I can only say that it is self-evident that if there is KI in the nurse's office of your children's school, your kids' thyroids will be protected sooner and more completely in the event of an accident than if the drug is at some regional stockpile and must be transported to them. With children's thyroids and radioactive iodine, hours and minutes count. In an emergency, you will probably want to give the children a KI pill, put them on a bus, and get them out of harm's way as quickly as possible. Or, if evacuation is not feasible, you will want to give them a pill and shelter them, with doors and windows closed. In either case, you don't want to waste time waiting for drugs to arrive from far away -- especially when enough medicine to protect a thousand children costs $60 or $70, and only needs replacement every 7 to 10 years. If the foregoing analysis is wrong, I wish that someone from the NRC would explain -- very clearly, not with artful obfuscation that leaves you wondering what you just heard -- why it is wrong. Because the rest of the developed world thinks that having KI is a no-brainer. Consistent with the approach of regional stockpiling, the NRC issued a proposed rule in June, 1999. The rule will require states to "consider" KI, but suggested that many had already done so. It included, as I said, no recommendation that states stockpile. As to funding, it explained that the NRC had to deal with a declining budget, and therefore did not have funds left over for "new initiatives." Who would have imagined that a commitment made two years earlier would count as a "new initiative"? Twenty years of evasion, delay, and broken commitments are enough. The information is all there, and has been for many years. The American Thyroid Association has been pleading since 1989 for a more enlightened policy on KI. The World Health Organization advocated stockpiling in 1991, and is now 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. In the summer of 1998, I had the honor of addressing an international conference on radiation and thyroid cancer held at Cambridge University in England. When you talk to doctors and radiation protection specialists from other countries, they shake their heads in disbelief that the United States, with all its wealth, 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. But of course, the cost of KI is just an excuse. The NRC is willing to spend money like water trying to prove that KI is not cost-effective -- more money, in fact, than the KI itself would cost. In the effort to defeat KI, the industry and its allies have floated a score of arguments, one more fallacious than the next. One such claim, as I mentioned at the start, is that 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. It's not an either/or proposition. KI is a supplement and a fallback, for situations where evacuation is impracticable or fails to ensure sufficient protection. (You can inhale radioactive iodine while evacuating.) 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 coming to your aid in a crisis. As a practical matter, having KI available increases your options. Suppose that there is a major accident, and the highways fill up with traffic that is moving at four and a half miles an hour, as was the case during Hurricane Floyd. Suppose also that there is a plume of radioactivity heading toward the population as it evacuates. This is not a far-fetched scenario, if one accepts the premise that accidents can happen. If you have KI to give out, then you can deliver it to people on the road, as they are evacuating. Is that the ideal way to ensure timely administration of KI? Maybe not, but it's a lot better than having no options whatever, because you have no medicine stockpiled locally and all you can do is wait for supplies to arrive from a regional stockpile. Speaking for myself, if I had a child in school anywhere near a nuclear power plant, I would want to know that there was a supply of KI in that school. At the beginning of the year, the school could send home a note asking parents if there was any reason why their child should not receive this medicine in the unlikely event of an emergency. I would want to know that in an actual emergency, parents would not be descending on the schools with their own KI, because there was none in the school, thereby hampering the evacuation. One argument often used as a bogeyman to terrify states is the prospect of liability — all the people who will supposedly be harmed by the side effects of KI and will then sue the state for damages. That is far- fetched in the extreme. First of all, the Polish data tells us that the side effects are minimal. Second, what court and what jury would hold a state liable for doing what it could, in a radiological emergency, to prevent thyroid cancer among its citizens by giving out an over-the-counter medicine approved by the Food and Drug Administration? It's just not realistic. If state officials really want to worry about liability, they should think about the lawsuits that will result, and the grand juries that will be convened, if ever there is an accident and children suffer harm to their thyroids because, 20 years after Three Mile Island, KI isn'tavailable. 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 were so! 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. Is it unthinkable that someone would decide to make a nuclear power plant the target of an attack, just for the additional terror value that a release of radiation might have? I don't know; we didn't expect truck bomb attacks on the World Trade Center or the federal building in Oklahoma City until they happened. In 1996, Maine decided to adopt KI stockpiling, thereby joining Tennessee, Alabama, and Arizona. A member of the state's advisory committee on radiation explained, "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. Incidentally, Maine didn't wait for the federal government to buy it the KI; the state went out and bought it. New Hampshire, on the other hand, lost interest in stockpiling once the NRC said it did not intend to pay for the drug. Instead, the state is going to try to ensure that pharmacies in the vicinity of the Seabrook and Vermont Yankee plants will sell the drug over the counter. That is a well-intentioned measure, that puts responsibility on people to look out for themselves and their families, but ask yourself what that will mean in an actual emergency. It will probably mean that throngs of people who should be evacuating will instead be overwhelming the local drug stores. At the same time, parents who keep KI at home will be rushing to the schools to give the drug to their children, just as students are being put on buses to be evacuated. New Hampshire's plan thus seems to guarantee chaos if an accident ever occurs. It sends a message to the public that KI is valuable in an emergency, and to that extent it is sound, but it also ensures that large numbers of people, especially children, will not have the drug available to them in time of need. In the end, it's a very simple matter, despite years and years of efforts to make it seem terribly complicated. Having KI on hand may help in responding to an accident and it cannot hurt, and it is better to be safe than sorry. What should Pennsylvania do? It should buy KI, as cheaply as possible, here or abroad, and stockpile it: in schools, hospitals, fire stations, etc. The logistics of distribution, including possible predistribution, can be worked out later; the important first step is to have it on hand. Don't waste time waiting for the federal government to supply the drug. The NRC's delaying game has gone on for 20 years and could last 20 more, unless an accident occurs first. The drug is cheap enough that it should not be a serious dent in any state's budget. If the Nuclear Regulatory Commission has failed the nation's children on KI — and so far it has — don't let it also be said of this Commonwealth that its health and emergency planning authorities failed to protect Pennsylvania's children. Can we afford six-tenths of a cent per year to protect our children against radiation-caused thyroid cancer and retardation? Of course we can, and we should. Thank you. Peter Crane

Petition by Peter Crane to NRC that led to recent KI approval.

NRC NEWS U.S. NUCLEAR REGULATORY COMMISSION Office of Public Affairs Telephone: 301/415-8200 Washington, DC 20555-001 E-mail: opa@nrc.gov Web Site: http://www.nrc.gov/OPA No. 00-186 December 22, 2000 NRC REVISES ITS REGULATIONS ON USE OF POTASSIUM IODIDE IN EMERGENCY RESPONSE The Nuclear Regulatory Commission is revising a section of its emergency preparedness regulations to require that consideration be given to include potassium iodide (KI) as a protective measure for the general public to supplement sheltering and evacuation in the event of a severe nuclear power plant accident. Reversing an earlier decision, the Commission has agreed to provide funding for a supply of KI for a State, or, in some cases, local governments designated by the State to request such funding, that choose to incorporate KI for the general public in their emergency plans. After funding the initial purchases of KI, the Commission may consider extending the program to fund stockpile replenishment, but has made no commitments in this regard. The NRC has set aside $400,000 in fiscal year 2001 for this purpose and will be requesting similar funding in fiscal year 2002. Potassium iodide, if taken in time, blocks the thyroid gland's uptake of radioactive iodine and thus would help prevent thyroid cancers and other thyroid diseases that might otherwise be caused by exposure to radioactive iodine that could be dispersed in a severe nuclear accident. Nuclear power plant emergency plans already provide for distribution of the drug to emergency workers and certain institutionalized populations, such as hospital patients within designated emergency planning zones. The rule change would add this sentence to Part 50.47(b) (10) of Title 10, Code of Federal Regulations: "In developing this range of actions, consideration has been given to evacuation, sheltering, and as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate." NRC is moving to amend this regulation as the result of a petition filed by Peter G. Crane, a retired NRC staff attorney who acted as a private citizen. The amendment should not be taken to imply that the NRC believes that the present generation of nuclear power plants is any less safe than previously thought. On the contrary, present indications are that nuclear power plant safety has been steadily improving. The Commission has found that KI can be a reasonable, prudent and inexpensive supplement to evacuation and sheltering for specific local conditions. The Commission has directed the NRC staff to work with the Federal Emergency Management Agency (FEMA) to find "the most efficient and cost-effective way to fund the stockpiles," for those States, or in some cases, local governments that elect to stockpile KI for use by the general public as part of their emergency plans. FEMA is the lead agency for drafting a federal policy on use of KI for thyroid protection in a radiological emergency at commercial nuclear power plants. The Food and Drug Administration (FDA) is the lead agency for the medical aspects of KI prophylaxis. The rule change, which will be published shortly in the Federal Register, will be available on the NRC Homepage at http://www.nrc.gov/NRC/rule.html # # # # # Statement of Commissioner Dicus Relating to Potassium Iodide (KI) Rulemaking in Response to Petitions for Rulemaking (Amendment to 10 CFR 50.47) December 22, 2000 The opening paragraph of the Rational for the Commission Decision on potassium iodide (KI) defines the difficulty former Commissioners have had in reaching finality on this issue. Each, (including the current Commissioners), has realized the importance of the use of KI as an adjunct to evacuation and sheltering. We are in agreement to its use under these circumstances. I differ only on the proper way to implement a national KI policy. I appreciate and respect the views of my fellow Commissioners. I believe the Federal Register Notice should have included some additional information and discussion of these various issues. For that reason, I have chosen to provide the following comments. Having previously had the responsibility for off-site emergency planning at Arkansas Nuclear One, the use of KI for the general population was considered, but rejected due to the utilization and effectiveness of other protective measures. Nevertheless, KI was provided and predistributed in areas for those individuals that could or would not be evacuated. These included: emergency workers; nursing home residents, critical care patients, and their care givers; and those incarcerated and the associated security staff. KI was placed in these locations. This was done as an extra precaution because these individuals could be expected to be in a contaminated environment for a prolonged period. The general population, however, was expected to be evacuated from this environment. They would also be protected from contaminated food. Following the Chernobyl accident, Polish authorities provided KI to the population some days after the event. However foods, including milk, that might be contaminated with radioactive iodine or other radioactive materials were embargoed almost immediately. The combination of these actions resulted in minimal thyroid health impacts on children and adults in Poland. This was not the case in other Chernobyl-impacted areas where neither protective measure was implemented in a timely manner. Thyroid health impacts in these areas were significant. Due to the importance of embargoing contaminated food, I am disappointed that the Federal Register Notice (FRN) does not give at least a brief explanation of this important and effective emergency protective measure. In emergency exercises, off-site decision-making authorities can be evaluated (and often are) on their ability to make a decision about food embargos. Evaluations are also made on the timeliness of that decision. One of the issues raised supporting state stockpiles is that unless KI is provided very quickly, it will not be effective. The experience in Poland suggests that if other protective measures are implemented in a timely fashion, it may not be necessary to supply KI immediately or within a few hours of the event. For chemical and biological agents, regional stockpiles of protective pharmaceuticals have been determined to be appropriate, and one presumes, that the logistics for rapid deployment of these pharmaceuticals have been established. In some cases, these protective pharmaceuticals must be administered quickly and in some cases there are few other protective measures that can be implemented. In light of the above, it appears to me that the argument that regional stockpiles of KI would be ineffective is neutralized. As a final comment, the new source term adopted by the NRC suggests that if radioactive iodine is released as the result of an event, it will be in the elemental form as Cesium iodide. As such, uptake by the body through inhalation will be minimal -- further underscoring that the primary pathway will be ingestion. The current KI policy adopted by the Commission may result in a patchwork quilt of protection for the American public. Unless the CDC or another Federal Agency chooses to stockpile KI, there will be no Federal stockpile (regional or centrally located) for use anywhere in the country, should it be necessary. I believe this to be a questionable public heath policy. I believe that Federal Funding for a stockpile would better serve the public because States could fund their own stockpiles and a federal stockpile would serve as a prudent backup measure for States whose stockpile proves to be insufficient, or where a State has elected not to stockpile KI. Accordingly, I believe that funding a federal stockpile would be an effective use of Federal funds and would be more consistent with the allocation of responsibility between the Federal government and the States for all other emergency matters. The Commission has chosen to place a disclaimer in the FRN addressing the NRC's liability regarding the use of KI. The disclaimer states in part that "...the NRC and any of its employees are not to be held responsible for any activity connected with transporting, storing, distributing, administering, using, or determining the proper doses of KI for adults or children." This disclaimer has been included for legal purposes presumably because a pharmaceutical is involved in this NRC action. It should be noted that the NRC has little or no responsibility for the actions listed in the disclaimer. It is my view that the disclaimer is not to be interpreted to mean that the NRC is involved in the decision-making authority of the State, and where appropriate, local governments. The decision to stockpile KI and the decision to recommend its use rests entirely with state and/or local decision-making authorities. The decision by a member of the public to follow a recommendation to take KI remains a voluntary action of that member of the public. The NRC is not involved in these decisions. This decision regarding KI has been a difficult one and it has taken some time to come to finality on the issue. Going forward, it is important that the implementation of the policy is efficient and effectively provides an adjunct protective measure, as appropriate, for the American public.