To: Rules Docket Clerk,

I am a retired diagnostic radiologist and I am submitting this comment regarding Protective Action Guidelines for Radiologic Disperal Device (RDD) and Improvised Nuclear Device (IND).

We are all familiar with the idea that there can be too much of a good thing. A perfect example is HIPPAA, the end product of a massive over-reaction to privacy concerns that impedes vital communication between physicians and hospitals, creates Kafka-esque volumes of paperwork and serves as a monstrous time, energy and cost sink (We even had to create a Compliance Officer for our medical group to 'enforce' and document our privacy policy).

You can see where I'm heading: Like privacy safeguards, radiation protection can exceed the point of diminishing returns. Specifically, in the event of the explosion/dispersal of a radioactive device, if an exaggerated concern for radiation exposure prevents the rescue of injured victims---including self-rescue---or other emergency measures such as fire suppression, or if it creates unwarranted long term geographic, physical or psychological impairment, then it has clearly done more harm than good.

Michael Crichton ( http://www.crichton-official.com/ ) puts it far better than I can in a 2005 article entitled, "Fear, Complexity and Environmental Management in the 21st Century":

"Some of you know I have written a book that many people find controversial. It is called State of Fear, and I want to tell you how I came to write it. Because up until five years ago, I had very conventional ideas about the environment and the success of the environmental movement.

The book really began in 1998, when I set out to write a novel about a global disaster. In the course of my preparation, I rather casually reviewed what had happened in Chernobyl, since that was the worst manmade disaster in recent times that I knew about. 
 
What I discovered stunned me.  Chernobyl was a tragic event, but nothing remotely close to the global catastrophe I imagined.  About 50 people had died in Chernobyl, roughly the number of Americans that die every day in traffic accidents.  I don't mean to be gruesome, but it was a setback for me. You can't write a novel about a global disaster in which only 50 people die. 
 
Undaunted, I began to research other kinds of disasters that might fulfill my novelistic requirements.  That's when I began to realize how big our planet really is, and how resilient its systems seem to be. Even though I wanted to create a fictional catastrophe of global proportions, I found it hard to come up with a credible example.  In the end, I set the book aside, and wrote Prey instead.
 

But the shock that I had experienced reverberated within me for a while.  Because what I had been led to believe about Chernobyl was not merely wrong-it was astonishingly wrong.  Let's review the data.

The initial reports in 1986 claimed 2,000 dead, and an unknown number of future deaths and deformities occurring in a wide swath extending from Sweden to the Black Sea. As the years passed, the size of the disaster increased; by 2000, the BBC and New York Times estimated 15,000-30,000 dead, and so on·

Now, to report that 15,000-30,000 people have died, when the actual number is 56, represents a big error....But, of course, you think, we're talking about radiation: what about long-term consequences?  Unfortunately here the media reports are even less accurate.

 The chart shows estimates as high as 3.5 million, or 500,000 deaths, when the actual number of delayed deaths is less than 4,000.  That's the number of Americans who die of adverse drug reactions every six weeks. Again, a huge error.

But most troubling of all, according to the UN report in 2005, is that "the largest public health problem created by the accident" is the "damaging psychological impact [due] to a lack of accurate information·[manifesting] as negative self-assessments of health, belief in a shortened life expectancy, lack of initiative, and dependency on assistance from the state."

In other words, the greatest damage to the people of Chernobyl was caused by bad information. These people weren't blighted by radiation so much as by terrifying but false information.  We ought to ponder, for a minute, exactly what that implies. We demand strict controls on radiation because it is such a health hazard.  But Chernobyl suggests that false information can be a health hazard as damaging as radiation. I am not saying radiation is not a threat. I am not saying Chernobyl was not a genuinely serious event.
 

But thousands of Ukrainians who didn't die were made invalids out of fear. They were told to be afraid. They were told they were going to die when they weren't. They were told their children would be deformed when they weren't. They were told they couldn't have children when they could. They were authoritatively promised a future of cancer, deformities, pain and decay. It's no wonder they responded as they did."

I have also been in communication with my physician colleague, Dr Jane Orient, and I am in complete agreement with her view that, in the event of a terrorist attack using a nuclear device, we should not apply the same radiation exposure limits that are appropriate in a peacetime nuclear accident. In the interests of clarity, I would like to quote from her earlier comments to you as follows:

As the department recognizes, doses above 5 rems may be unavoidable.  It should also be recognized that doses less than 100 rems are unlikely to lead to any acute symptoms. Indeed, a significant long-term increase in death rates of atomic bomb survivors has been shown only for those receiving doses greater than about 200 rads. (See Kondo S, Health Effects of Low-Level Radiation, Medical Physics Publishing, Madison, Wis., 1993).  Indeed, at "low" or "intermediate" levels of exposure, there was apparently a beneficial effect on longevity. 

The expectation that emergency workers should receive less than 5 rems would have the effect of a significant increase in casualties among persons who could be rescued and saved if emergency workers were permitted to do their normal jobs.

According to Table 1, Protective Action Guides, the public would be relocated if the projected dose in the first year were 2 rems or subsequent annual doses after that were 500 mrem per year.  It should be noted that the average background dose on the Colorado plateau is 600 mrem per year, and in some areas of the world, much higher than that.  For example, in Ramasari, Iran, the average background is about 48 rems per year_that is 4,800 mrem per year_without noticeable adverse health effects. Forced resettlement, on the other hand, would cause many billions of dollars in damage to the economy as well as social upheaval.  Because of widespread public fear of low-dose radiation, many people might choose to be resettled than face such increased exposure, but persons should not be forced to abandon their homes, personal property, and businesses based upon unfounded fears. 

 The use of 2 mrem/hr as the level at which to control access to radiation areas is unrealistically and unnecessarily low.  At a level of 0.1 rem/hr, or 100 mrem/hr, it will take about 41 days to accumulate a dose of 100 rems, the lowest dose that is likely to cause acute sickness, even if received instantaneously.  That calculation presumes that the dose will remain high, whereas in fact it may be rapidly declining with time, depending upon the mixture of isotopes used.  With fallout from the detonation of a nuclear device, radiation levels should be one-tenth of the initial level after about 7 hours (the "7/10 Rule"). 

Emergency workers need to have instruments that will enable them to distinguish between 2 mrem/hr and doses that can be quickly lethal.  Instruments available at the present time may read in microrads and be off-scale in a range when rescue operations could be carried out with a minimal risk to the worker.

We agree completely with the statement in Table 1A that lack of action_due to unclear, overly complicated, or reactive guidelines_has a high possibility of causing unintended consequences.  One reason for lack of action will be lack of appropriate radiation monitoring instruments, or the use of inappropriate instruments.  In fact, instruments with too low a dose range may be even worse than not having any instruments at all. 

With respect to Table 1B, we reiterate that a dose of 100 rems is probably the lowest at which any acute radiation sickness symptoms are to be expected.  We agree that in the case of a very serious incident such as use of an IND, incident commanders may well need to increase the dose above the 25 rems that is suggested in Table 1B.

Finally, I would like to point out that there is a body of work that suggests that, in small doses, radiation can have a beneficial (so called "hormetic") effect. A "debate" on the issue was published in the January 2005 issue of the British Journal of Radiology. The articles, with links to numerous references, can be found online at:  http://bjr.birjournals.org/content/vol78/issue925/

One of the participants in the debate, the late John Cameron of the University of Wisconsin (  http://www.medphysics.wisc.edu/~vrm  ) makes the case for radiation hormesis with particular clarity as follows:

Moderate dose rate ionizing radiation increases longevity
J R Cameron, PhD
Departments of Medical Physics, Radiology and Physics, University of Wisconsin, Madison WI, USA

This paper presents little-known data to support the hypothesis that we need increased background radiation to improve our health. Attention will be drawn to results that demonstrate health benefits of ionizing radiation that have been largely ignored by the news media.

Science progresses by interpreting new data not by accepting unfounded assumptions. Arthur Conan Doyle cautioned against making assumptions until one has enough data on which to base the assumption. The International Commission on Radiological Protection failed to follow that advice when it adopted the linear assumption of radiation risk in 1977, primarily to simplify radiation protection regulations. Conan Doyle also pointed out that a premature assumption results in a tendency to interpret data to agree with the assumption. I believe this is one of the reasons the linear assumption has survived for so long.

Few radiologists, or other healthcare workers involved with radiation, are aware that billions of their cells are bombarded daily by natural ionizing radiation, much of it from ~9 kBq of natural radioactivity in their bodies. Nearly all the trillions of cells in our body are hit each year, many more than once. Despite this huge amount of radiation damage, cancer is primarily a disease of the elderly. It is reasonable to assume that our very early ancestors solved the problem of cellular repair billions of years ago and that we now have highly efficient repair mechanisms. Cells beyond repair undergo controlled destruction by lysis (apoptosis). According to Cohen [1] if all cancers were curable, longevity would only be increased by about 3 years. It is illogical to suggest that radiation damage to one cell may cause cancer. The probability of one damaged cell causing cancer is infinitesimal - less than ones chance of winning a World lottery if everyone had a ticket. Scientists should not base health effects on assumptions that cannot be proved or disproved. The linear assumption of radiation risk was made to simplify radiation protection regulations. It is unfortunate that many persons have accepted the assumption as a scientific truth despite the contradictory evidence of lower cancer mortality in high background areas.

Population studies

There is much evidence that radiation induction of cancer is not linear with dose and that a threshold dose rate of the order of 1 Gy year-1 must be exceeded to induce cancer. In addition, recent studies of radiation workers show that moderate dose rate radiation produces a very significant reduction in death rate from non-cancer. The increase in longevity in two studies of radiation workers was about 3 years, about equal to the increase in longevity if all cancer were curable [2].

If ionizing radiation is as dangerous as many now believe, it seems impossible for life to have evolved. I have suggested that ionizing radiation may be an "essential trace energy" analogous to the many essential trace elements we need for good health [3].

A report by the US Atomic Energy Commission in 1973 showed that the population in the six US States with the highest radiation background had 15% lower cancer death rates than the average for the 48 States [4]. In 1998 the results of this study were confirmed by a comparison of the cancer mortality and background radiation of three mountain States to those of three Gulf States [5]. The annual level of natural background radiation in the three Rocky Mountain States (Idaho, Colorado and New Mexico) is 3.2 times that in three Gulf Coast States (Louisiana, Mississippi and Alabama), but the overall age-adjusted cancer death rate in the Gulf States is 1.26 times higher. Thus the difference from proportionality is a factor of 4.0.

For lung and bronchus cancer mortality there is a strong negative correlation with natural radon levels (the main cause of the difference in background levels) - factors of 5.7 to 7.0.

In such studies, the possibility of confounding factors must always be considered. However, to quote from Jagger's paper "It is possible that confounding factors such as smoking, poverty or environmental pollution, contribute to the differences in cancer mortality between Rocky Mountain and Gulf Coast States. However, the factor of disproportion is so great (4.0-7.5) that it strains credulity that such confounding factors could reverse this negative correlation".

Although this finding was published in a well-read journal, it attracted no attention from the news media.

The 100-year study of British radiologists (1897-1997) is the most important study of health effects of moderate dose rate radiation ever published [6, 7]. It compared the death rates of British radiologists from cancer, non-cancer and all causes to those of all male non-radiologist physicians in England and Wales, hereafter referred to as controls. The study showed that radiologists who joined a radiological society between 1897-1920 had 75% greater cancer mortality than the controls. It is not possible to make close estimates of doses received by radiologists at that time. Braestrup [8] estimated average accumulated doses to US radiologists in the 1920s and 1930s using non-protective equipment at about 1 Gy year-1 (in modern units). 75% of the dose arose from fluoroscopy (assumed at 1 h day-1), the remainder was equally divided between diagnostic radiography and therapy. There is no doubt that the significant cancer increase (p<0.001) was due to high radiation doses in those early years of radiology.

The increased radiation had a significant beneficial effect that was not noticed at the time. The radiologists' death rate from non-cancer was 14% lower (p<0.05) than the controls. Their deaths from all causes were slightly less than the controls, that is to say the longevity of the earliest radiologists was not reduced despite their 75% increase in cancer death rate. British radiologists who joined a radiological society after 1920 have never shown a statistically significant excess of cancer mortality compared with the controls. This dramatic contradiction of the linear assumption has been largely ignored. The abrupt decrease in cancer deaths after 1920 suggests that X-ray induction of cancer has a threshold as suggested by two earlier studies [9, 10].

With the introduction of beam collimation and personal protection, and much later image intensifiers, doses to radiologists fell dramatically. By the late 1950s the average had fallen to about 0.01 Gy year-1 and by the 1990s to about 0.5 mGy year-1 [11]. The healthiest British radiologists were those who joined a radiological society between 1955 and 1979. Their death rate from cancer was 29% lower (not significant); from non-cancer was 36% lower (p<0.001) and from all causes was 32% lower (p<0.001) than the controls. Their increase in longevity over the controls is estimated to be about 3 years.

The best epidemiological study of radiation workers ever done is the US nuclear shipyard worker study - NSWS (1980-1988) - supported by the US Department of Energy [12]. I was a member of the Technical Advisory Panel (TAP) that met twice a year to review progress and to suggest improvements. TAP comprised eight well-qualified scientists who unanimously approved the draft of the final report of the NSWS in early 1988. It is unfortunate that the details of this important study have not yet appeared in a peer reviewed scientific journal. I am sure that if the results had supported the linear hypothesis of radiation risk the details would have been published promptly. I am the co-author of a review article on the NSWS that has not yet been accepted by a journal [13].

The scientists who performed the study selected about 28 000 nuclear shipyard workers with the largest cumulative doses. They had a death rate from cancer 15% lower (p<0.01); from non-cancer 31% lower (p<10-16) and from all causes 24% lower (p<10-16) than 32 500 age-matched and job-matched unexposed shipyard workers. No other study of radiation workers has had the important advantage of job-matched controls. The very significant reduction in non-cancer deaths is in agreement with a similar reduction of deaths from non-cancer of British radiologists who joined a radiological society between 1955 and 1979 referred to earlier [6]. Since the nuclear shipyard worker study had not been published, the authors of the 100-year study were apparently unaware of the striking similarity of the results. Neither the 100-year study of British radiologists nor the nuclear shipyard worker study emphasised the strong evidence that moderate dose radiation stimulates the immune system.

It is a mystery to me why some radiologists and other healthcare workers involved with radiation still believe that diagnostic X-ray doses much lower than annual background radiation carry a risk of inducing cancer. None of the above studies proves that moderate dose radiation increases longevity but they do provide strong evidence that moderate dose radiation is beneficial to the health. I have suggested that valuable information on this question of longevity could be obtained from a double blind study using increased background radiation of about 10 mGy year-1 to half of a population of senior citizen volunteers. This dose rate is lower than that to British radiologists in the second quarter of the last century where there was no significant increase in cancer. I have suggested such a double blind might be carried out in the US Gulf States where the population seems to be suffering from "radiation deficiency" [3].

Conclusion

The linear model is often defended as a conservative assumption. It is not conservative if we need a moderate dose rate of radiation to stimulate our immune system. Too little radiation appears to result in an earlier death. The analogy would be to reduce essential trace elements in our diet because they are poisonous in large quantities. The great statistical strength of the studies on the reduction in non-cancer deaths of the British radiologists and the US nuclear shipyard workers should not continue to be ignored.

Thank you for your consideration,

Paul E. Morris, M.D.

Oakland, CA