January 11, 2006

To Rules Docket Clerk
Office of the General Counsel
Federal Emergency Management Agency
Room 840, 500 C Street S.W.
Washington, D.C. 20472

RE: Docket #: DHS-2004-0029
Docket #: Z-RIN 1660-ZA02

FEMA-RULES@dhs.gov

We agree that flexibility is required in responding to incidents involving radiological dispersal device (RDD) or improvised nuclear device (IND). It is critical that actions taken do more good than harm. The dangers of panic, the shut-down of essential services, and disruption of the economy and social arrangements could vastly outweigh the supposed dangers of an increased exposure to radiation, particularly in the event of the use of an RDD.

We are disappointed that the document does not explicitly recognize that current radiation protection standards are based on the linear no-threshold (LNT) theory of radiation carcinogenesis. This theory calculates casualties based on collective doses. The assumptions are the equivalent of saying that if one person dies from ingesting one thousand aspirin tablets all at once, that one person will die if each one of the thousand persons ingests one aspirin tablet each. In fact, all actual evidence indicates that radiation, like most other potentially adverse exposures, exhibits a biphasic dose-response curve. While high levels are damaging or lethal, within a certain range at the lower end of the scale there is a seemingly paradoxical stimulatory or protective effect. Persons with accidental or occupational exposures within this “hormetic” range have a lower incidence of cancer and birth defects, and have had an increase in longevity as well. Thus, measures to “protect” people against exposures in this range may deprive them of a beneficial health effect, as well as harming them through excessive costs or deprivation of the other potential benefits of technology.

The ALARA principle may actually not be in people’s best interest. I commend the department for recognizing, however, that the lowest reasonably achievable dose is much higher in the event of the terrorist use of a nuclear device than during normal peace time.

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. 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.

On p. 187, the footnote from Risks from Low-Level Environmental Exposure to Radionuclides, Federal Guidance Report 13, U.S. Environmental Protection Agency January 1998, EPA 402-R-97-014, states that the estimated risk of fatal cancer for workers exposed to 10 rems is 0.6%. This may be estimated from the linear no-threshold hypothesis. However, actual data show that this is a gross overestimate, and that levels of this magnitude may actually be protective.

It is stated on p. 188, that “no individual should be forced to perform a rescue action that involves substantial personal risk.” We believe it should also be stated that no one should be forcibly prevented from undertaking lifesaving or property-preservation actions that constitute an acceptable risk to the worker or owner, from his own perspective, when balanced against the benefits of his action. Moreover, assessments of risk should be based on actual data rather than on the implausible and discredited linear no-threshold hypothesis.

Many references are made in this document to “stakeholders.” This term is not precisely defined but probably includes special-interest groups, such as those who espouse a political agenda designed to severely limit the use of nuclear technology. It also includes occupational groups whose jobs might be threatened if the linear no-threshold hypothesis were no longer relied upon in setting safety standards. Business and property owners should not be prevented from performing their jobs, recovering their investments, or remaining in their homes because of interests of “stakeholders” whose own lives or property are not at risk.

In the section on "Analyzing the Risk," it is stated that “the objective scientific basis of risk and procedures for making inferences in the absence of adequate data” are important. We respectfully submit that a hypothesis, namely the linear no-threshold hypothesis, should not be able to trump the very substantial scientific data that have been presented to demonstrate the biphasic dose-response curve with respect to radiation. It should also be recognized that despite vast accumulations of data, there really are no objective data to confirm the predictions of the LNT, in contrast to the substantial data refuting it.

In appointing technical advisory committees, it would appear important to include persons whose reputation is not strongly invested in the linear no-threshold hypothesis, who would thus find it difficult or impossible to change their position. A full range of views must be heard and not suppressed by a “consensus” process that strongly pressures participants to approve a predetermined position and excludes those who do not.

We think it is critical that the United States government should not enable terrorists to destroy a large area of the country and cripple its economy by exploiting unwarranted fears. Instead, we need to be prepared to mitigate the damage should efforts at interdiction fail.

Respectfully Submitted,

Jane M. Orient, M.D.
President, Physicians for Civil Defense
1601 N. Tucson Blvd. Suite 9
Tucson, AZ 85716
(520) 325-2680
www.physiciansforcivildefense.org


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