Ultra low level radiation effects summit, final (Leo Gomez, David Brenner, Otto Raabe)

Final Report

Ultra-Low Level Radiation Effects Summit

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Table of Contents

Executive Summary.............................................................................................................1 Summit Report.....................................................................................................................5 Appendix A

Welcoming Remarks by Dr. Ines Triay.....................................................21

Appendix B

Breakout Groups

Group 1: Laboratory Animal Research Group......................................................25 Group 2: In Vitro Group.......................................................................................27 Appendix C

A Layperson’s View..................................................................................29

Appendix D

Plan Diagram for the Ultra-Low Level Radiation Biology Laboratory At WIPP.....................................................................................................33

List of Participants.............................................................................................................35

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Ultra-Low Level Radiation Biology Laboratory at the Waste Isolation Pilot Plant (WIPP) in Carlsbad, New Mexico EXECUTIVE SUMMARY

Background The United States is projected to spend $350 billion cleaning up radioactive contamination and waste derived from nuclear activities over a period of several decades. This cost for cleaning up nuclear sites has been collected from several US Government Agency reports and is based on current ionizing radiation protection standards established by the Environmental Protection Agency (EPA). The EPA set these standards using a linear extrapolation of World War II atomic bomb survivor data; however, no scientific data currently exist to verify this extrapolation. As a result, reports such as the Biological Effects of Ionizing Radiation VII (BEIR VII), acknowledge the need for more scientific data to better understand the biological effects of very low radiation doses. Such additional knowledge would enable regulatory bodies to set objective radiation cleanup standards.

any population there are confounding factors due to genetic and random variations that mask any possible effect of low levels of ionizing radiation. Consequently, epidemiological studies may not detect a small effect of low levels of ionizing radiation because of lack of statistical power, even if it exists.

The difficulty in obtaining scientific data at the EPA’s current ionizing radiation cleanup standards is that these standards are set at a small fraction above naturally occurring background levels. Studies have been conducted using small doses of ionizing radiation, which do not indicate that rates of cancer incidence have increased. The lack of an observable increase, however, does not preclude the possibility of an unobservable effect; for example, solid tumors and leukemia have a high spontaneous incidence that varies according to lifestyle and heredity. Since the possible increase in cancer incidence following irradiation is very low, large study populations are required to demonstrate statistically significant results. However, in

To explore ways in which the scientific basis for low-level ionizing radiation risk could be improved, DOE funded the “Low-Level Radiation Effects” (LLRE) Summit at the Waste Isolation Pilot Plant (WIPP) in Carlsbad, New Mexico, January 15-18, 2006.

The Summit was attended by 26 scientists highly regarded in the radiobiology research community and representing competing radiation effects hypotheses. The purpose of the LLRE Summit was not to decide whether one model was better or more accurate than another, but to identify the steps that must be taken to improve the science and lay the groundwork for scientifically-based radiation protection standards at low levels of exposure.

The BEIR VII Report concluded that current scientific evidence is consistent with the Linear No-Threshold hypothesis (LNT); however, the consensus of many researchers is that the issue of detrimental effects of low doses can only be resolved with a series of experiments conducted at near-zero levels of background radiation. An increase in current radiation protection dose level standards (more relaxed) as a result of creating scientifically supportable biological effects models could result in a savings of hundreds of billions of dollars in cleanup costs.

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• •

The Problem Currently, a laboratory facility does not exist in the United States for conducting relatively large scale research at very low doses of radiation. Thus, the radiation protection standards in use for very low dose exposure are not based on scientific data but rather on the relatively simple, straight line LNT hypothesis (Figure 1). Furthermore, this criterion appears to have been incorporated into the current standards by default, without supporting scientific evidence.

effects of a so-called “dirty bomb;” and improved acceptance of diagnostic radiology.

The current radiation protection standards, which are based on the LNT hypothesis, influence the cost to clean up radiation sites in the United States. These costs, as shown in Figure 2, would be significantly reduced if scientific studies determined that a relaxed standard would not increase the estimate of potentially adverse effects of radiation on people or the environment. Similarly, scientifically based standards will have significant impact on the cost of each of the five points listed above. There are, however, competing hypotheses to the LNT. The Threshold Non-Linear hypothesis describes a curvilinear dose response that, depending on the dose rate, results in little or no increased cancer risk at low dose rates. The Hormesis hypothesis proposes that low levels of radiation may be beneficial in strengthening natural barriers against disease, such as scavenging toxic agents, DNA repair, and removal of damaged cells from the exposed body, thus improving health.

Figure 1. Linear No-Threshold Hypothesis (Not to Scale).

The uncertainty in the health effects versus radiation levels is evidenced by the fact that no data exist near zero radiation levels. This uncertainty limits fact-based discussion of • • •

decommissioning of existing nuclear facilities; long-term storage facilities for nuclear waste; construction of new nuclear power facilities to reduce dependence on fossil fuels;

Figure 2. Cleanup Costs to Alternative Standards

2

The Solution Over the last few years, national and international scientific “consensus” groups have studied the LNT but have not reached an agreement on its validity. The community tends to default to the LNT because there is a tendency to remain conservative until science unequivocally justifies another model. The “Bridging Radiation Policy and Science” report states that: While regulatory decision-making was designed to protect the public health, in some ways it has become punitive and burdensome. The idea that any exposure to radiation may be harmful has led to public anxiety and to enormous economic expenditures that are disproportionate to the actual radiation risks involved. In the United States and some other countries, regulatory compliance costs are steadily growing, while desired public health benefits from added regulation are increasingly difficult to measure.

The Waste Isolation Pilot Plant (WIPP) in Carlsbad, New Mexico, offers the only site in the United States where a research facility could be established with virtually all background radiation eliminated. This site will allow scientific experiments to be conducted that, for the first time, produce a broad set of data on the biological significance at the lowest levels of radiation exposure. Data from experiments conducted in this ultra-low level radiation environment1 will lead to improved scientific models from which radiation standards can be promulgated.

LLRE Summit Results A poll was taken at the end of the Summit with the following results.

1

A background radiation level of 10 µ R/hr or less.

•

•

• •

• •

92% of the attendees agreed that in order to establish a scientific basis for radiation protection standards at low doses, a research environment is needed that allows for ultra-low dose experiments.

Due to the existence of “noisy” background radiation from naturally occurring sources, ultra-low dose radiation experiments cannot be conducted effectively on the Earth’s surface.

The ideal test environment would have zero to negligible levels of radiation.

The principal environments with ultra-low levels of natural radiation suitable for ultra-low dose experiments without adding extensive additional shielding are underground salt mines.

96% of the attendees agreed that WIPP is the ideal location to conduct these experiments.

Existing infrastructure at WIPP will assist development and minimize the construction cost of the proposed facility.

It should be noted that the dissenting votes did not disagree with the need to conduct experiments at near-zero levels of radiation at WIPP or with the importance of these experiments. The concern was with the budgetary impact on existing programs.

Recommendations WIPP is the world's first underground repository licensed to safely and permanently dispose of transuranic radioactive waste resulting from the research and production of nuclear weapons. Located in southeastern New Mexico, project facilities include disposal rooms mined 2,150 feet underground in a salt formation that has been stable for more than 200 million years.

The consensus of the participants of the LLRE Summit is that a laboratory facility be established at the WIPP, which will attempt to

resolve the radiation protection standard question. Since radiation levels in the underground salt beds are about 7% of the radiation background on the surface, WIPP is an ideal experimental site for ultra-low level radiation research. Simple shielding will reduce the radiation level at the WIPP site to near zero.

The goal of this facility would be to establish a scientifically-based standard that offers optimal protection of the public against the possibility of detrimental health effects of radiation while potentially realizing a savings to the United States of more than $200 billion in cleanup costs alone. Initial costs for creating an ultra-low level radiation effects facility at WIPP and operating it as a research laboratory for five years are estimated to be approximately $150 million.

Conclusion Establishing an improved scientific basis for setting an ionizing radiation standard has the

potential to save more than $200 billion in the cleanup of radiation sites nationwide.

Countless other billions of dollars could be saved in other areas affected by radiation standards (Figure 2).

For example, knowledge about the low-dose effects of radiation may help remove the stigma that currently restricts greater use of nuclear energy. More information on the effects of radiation levels will give policy makers and the general public a more realistic view of the consequence of nuclear events, accidents, or terrorist activities (dirty bombs).

Currently, no facility exists in the US that provides the necessary environment for conducting the ultra-low level radiation experiments proposed in this report. Funding an ultra-low level radiation facility at WIPP will ultimately generate data crucial to understanding ultra-low level radiation effects on biological systems and provide a scientific basis for setting radiation protection standards.

Ultra-Low Level Radiation Biology Laboratory at the Carlsbad, New Mexico Waste Isolation Pilot Plant (WIPP) SUMMIT REPORT Mission Statement Based upon the consensus of the participants at the Low-Level Radiation Effects Summit, a unique subterranean radiobiology research laboratory with a nearzero radiation level is proposed to be established at the Waste Isolation Pilot Plant (WIPP) for the study and clarification of fundamental biological processes associated with ultra-low levels of ionizing radiation. Understanding the biological significance of very small amounts of radiation, including possible beneficial effects, will provide a dramatic step forward towards establishing a scientific basis for improved radiation protection standards, as well as for future peaceful uses of radiation.

Background The United States will spend billions of dollars to maintain ionizing radiation safety standards for the protection of the American public. The best estimate is that more than $350 billion will be needed for cleaning up the radioactive contamination and waste caused by the nuclear activities of previous decades.

An additional $60 billion will be spent controlling radiation exposure from the highlevel nuclear waste facility at Yucca Mountain, Nevada. The major problem with this situation is the insufficient knowledge about the biological risks/benefits of low-dose ionizing radiation exposure to arrive at scientifically justified protection standards for public exposure to these low ionizing radiation doses. This lack of scientific knowledge has led to the use of the unproven “linear no-threshold� (LNT) hypothesis, (Figure 1). The LNT hypothesis assumes that adverse health effects from exposure to low levels of radiation can be extrapolated linearly from data obtained from survivors of the World War II atomic bombs, but the hypothesis has never been verified experimentally. Regulatory mandates based on this assumption are estimated to eventually cost

the American people hundreds of billions of dollars. The purpose of this report is to recommend a solution to the cost of cleaning up contaminated sites under standards based on unproven hypotheses.

While low-dose radiation is generally defined as 100 milliSieverts (mSv) or 10 rem 2, a level at which excess cancer risks have not been proven, US radiation standards protect the public from human-generated exposures in the range of 1 mSv or 100 millirem (mrem) per year or less. This regulatory range is in the lowest portion of the low-level radiation exposure range. The low-level range includes natural background radiation, which varies locally in the United States but averages about 3 mSv (300 mrem) per year. At exposure levels equivalent to or below background radiation levels, radiation is commonly considered to be a relatively weak source of cancer risk [1]. Figure 3 shows the sources of background radiation.

2

The units mSv and rem are, respectively, the international and US measures of biological dose from ionizing radiation.

Figure 3. Sources of Background Radiation

Radiation Health Effects Hypotheses The mechanisms that lead to adverse health effects after exposure to ionizing radiation are not fully understood; however, ionizing radiation has sufficient energy to change the structure of molecules, including DNA, within the cells of the human body. While some molecular changes may be difficult for the body’s repair mechanisms to mend correctly, evidence shows that only a very small fraction of such changes result in cancer or other adverse effects [2].

Below certain levels, the effects of radiation are unknown. At those levels, for lack of a better model, US radiation standards for public protection are based on the LNT model, under which even the smallest radiation exposure is viewed to carry a cancer risk. The model is controversial among scientists and the past two decades of research have indicated that low dose effects cannot be predicted by the extrapolation of effects from high doses. Nevertheless, the EPA has set

cleanup standards for public annual exposure at 0.15 mSv (15 mrem) based on this model [1]. The NRC uses a cleanup standard for decommissioning of nuclear power plants for potential public exposure of 0.25 mSv (25 mrem) per year.3 Competing hypotheses related to the LNT model argue that low doses of radiation have either little or no effect on the human body.

One hypothesis, the “threshold non-linear” curve (TNL) shown in Figure 4, argues for a curvilinear dose response that results in few or no cancers at low dose rates. This hypothesis is based on the cells’ ability to repair their DNA and remain healthy at very low dose rates. This hypothesis is supported by evidence that shows the ability of the populationat-large to be exposed to back-ground levels of radiation without developing cancer. This 3

The cleanup standard is the hypothetical maximum possible annual dose of ionizing radiation that might be received by a member of the public after the cleanup of a nuclear facility is completed.

implies a threshold below which few cancers, if any, will be induced. The more controversial Hormesis4 hypothesis, [2] states that low levels of radiation stimulate the effectiveness of natural barriers against disease, such as protection against certain toxic agents, repair of DNA damage, and removal of damaged cells, including cancer cells from the body, and thus promote health as shown in Figure 4.

In contrast to the BEIR VII report, a commission was established by the French Academy of Sciences. The French Academy concluded that At low doses and low dose rates of ionizing radiation, the pro-apoptotic5 effect dominates and the damaged cells, of which there are only a few, can be eliminated or controlled [3, 4].

Health Effects Research Approaches Two important types of research studies into low-level radiation effects have been conducted. The first is the epidemiological study, which follows the long-term health of individuals in large populations exposed to radiation, seeking statistically significant patterns of elevated cancer risks from the radiation exposure. The second type is the radiobiological study, which subjects animals, cells, or tissue cultures to radiation, seeking biological evidence of radiation effects.

Figure 4. Graphical representation of three competing hypotheses for biological effects of exposure to ionizing radiation The US National Research Council completed the BEIR VII study of low dose and low dose rate health effects. The conclusion of BEIR VII was: A comprehensive review of available biological and biophysical data led the commission to conclude that the risk would continue in a linear fashion at lower doses without a threshold and that the smallest dose has the potential to cause a small increase in risk to humans [2].

Existing Epidemiological Studies According to some scientists, epidemiological studies may never conclusively prove or disprove the LNT model. Epidemiological studies have been a key basis for the LNT model and include research evidence accumulated on over 85,000 survivors of the Hiroshima and Nagasaki atomic bombings.

The study of A-bomb survivors has documented the effects of radiation at high exposure levels well above 100 mSv (10,000 mrem). Epidemiologists have extrapolated from high dose exposures to the low-level radiation range of less than 0.01 mSv per year (1.0 mrem per year) with considerable inherent uncertainty. In addition to the problems with extrapolation, scientists have also raised concerns due to the nature of the radiation exposure (acute versus protracted), its neutron component, and dose rate. Specific epidemiological research correlating natural

4

At low levels, the cancer risk is negative, i.e, there is a level that is beneficial to health.

5

Apoptosis – Programmed cell death

background levels in the United States and around the world with cancer rates has also been inconclusive and has shown mixed results due to the inability to isolate naturallyoccurring cancer from the relatively rare radiation-induced cancer [1].

The difficulty in obtaining epidemiological data at the radiation protection standard levels established by the EPA is because the standard represents only a small increment over the naturally-occurring background levels of radiation. Epidemiological studies conducted using small doses of radiation have detected no excess of cancers; however, the lack of an increase does not preclude the possibility of a small, immeasurable excess of cancers. Solid tumors and leukemia have a high spontaneous incidence that varies according to a person’s lifestyle and heredity. Moreover, the possible increase in this incidence, following irradiation, is sufficiently low so that studies require large populations to have sufficient statistical power. Unfortunately, large populations contain confounding factors. While these factors may be taken somewhat into account using appropriate statistical methods, their specific effect is still much greater than the effect of radiation. Consequently, the detection of the small effect, if any, due to lowlevel radiation remains impossible in these studies due to lack of statistical power [3].

Existing Low Dose Radiobiological Studies Over the past two or three decades low-dose effects studies using new techniques have indicated that biological systems respond to low doses in ways that are mechanistically different from the responses at high doses. In order to better understand the new data, DOE established a radiobiological research program to address the low-dose radiation effect problem. The DOE Low Dose Radiation Research Program is a 10-year program (1998–2008) designed to support low-dose studies. This program funds basic research to determine the responses induced by ionizing radiation exposures at doses of 10 rad (0.1 Gy)6 and below. The research is international in scope and is intended to provide a scientific underpinning for future radiation protection standards. Currently about 60% of the projects are funded through universities and 30% through DOE national laboratories. The funding is focused on determining the mechanisms involved in the interaction of low doses of radiation with biological systems.

These mechanistic studies are focused on DNA damage and repair, endogenous versus radiation-induced oxidative damage, various kinds of adaptive responses, bystander effects, genomic instability, and genetic susceptibility.

The research is conducted at all levels of biological organization from molecule to organism. Like the other programs and research efforts, this program is affected by naturally-occurring background radiation levels significantly in excess of the ultra-low levels that will be studied at the proposed Ultra-Low Level Radiation Biology Laboratory at WIPP.

6

The units rad and gray (Gy) are the US and international measures of radiation absorbed dose, respectively

The Problem At a 1999 conference on “Bridging Radiation Policy and Science” [5], some participants believed that science would not likely answer fundamental questions about radiation effects mechanisms at low radiation levels. This conference expanded on the goals of the successful Wingspread Conference held in 1997 [6]. In the overview, the “Bridging Radiation Policy and Science” report, as quoted above in the Executive Summary, states that while regulatory decision-making was designed to protect public health, the idea that any exposure to radiation may be harmful has led to public anxiety and steadily growing regulatory compliance costs for health benefits that are increasingly difficult to measure [5].

Radiation protection standards, including those of the EPA, which are based on the best science available to date, but still unproven and controversial, will eventually cost the US taxpayers hundreds of billions of dollars. If the LNT hypothesis is correct, then the burden must be born. If the LNT hypothesis is not correct, then the full extent of the burden is probably unnecessary. A position paper from the Health Physics Society [7] presents the perspective that the current regulatory framework for establishing and enforcing public health safety standards is inconsistent, inefficient, and unnecessarily expensive.

Currently, there is no conclusive evidence of any radiation effects on humans at total exposures below about 100 mSv (10,000 mrem) [8]. However, in the General Accounting Office (GAO) 2000 Report to Senator Pete Domenici (R-NM), the following statement is made: …even the smallest radiation exposure carries a quantifiable cancer risk. The model, which has been endorsed by national and international radiation protection organizations and used for many years as a preferred model in regulating low-level radiation, is a

fundamental basis for U.S. radiation standards. [1] Several specific areas affected by these regulations are discussed below.

Nuclear Energy The DOE’s Strategic Plan dated 30 September 2003 [9] charts the Department’s course for the next 25 years. This Plan calls for the development and use of all available resources: oil, natural gas, coal, nuclear energy, hydropower, and renewable energy, through conservation and energy efficiency.

The DOE Plan states that the role of the Federal Government is to promote competitive energy markets, not to choose the energy sources for the country. The DOE’s aim is to assist the private sector in developing technologies capable of providing a diverse supply of reliable, affordable energy that is environmentally sound. At a February 23–24, 2006 “Conference on Sustainability” in Albuquerque, New Mexico, Senator Domenici stated that 18 pre-applications have been submitted for new nuclear power plants in the United States. Standards based on an improved understanding of ultra-low level effects of ionizing radiation will provide a firm scientific basis for the DOE to judge the safety of nuclear workers and the general public, as well as environmental impacts of existing and future nuclear power sources.

Decommissioning Nuclear Power Plants The US nuclear power industry anticipates the decommissioning of 100 nuclear power plants operating in 31 states at the end of their operational lifespan. This decommissioning will create a significant expense that will be borne by the American public. Whether the burden is carried by the US taxpayers or the US consumers, the impact is the same: it is ultimately carried by the American people.

The Nuclear Energy Institute has estimated

the cost of cleaning these reactor sites to be $38 billion [1].

Nuclear Weapons Facilities The DOE is facing the monumental problem of cleaning up Cold War nuclear weapons facilities. Public safety requires the application of appropriate radiological safety standards in the cleanup of these outdated facilities, most of which were operated by the US government and its contractors. In 1996, DOE estimated the cost of cleaning up these facilities at upwards of $265 billion and rising.

Rocky Flats alone cost $7 billion. By 2002, a report by the DOE Office of Environmental Management adjusted the cost to $300 billion.

Using a conservative 3% inflation rate to adjust to 2006 dollars, $338 billion is now the estimated cost of cleaning up the nuclear weapons sites. Given the observed rate of cost increases in the past, $338 billion is deemed a conservative estimate.

High-Level Nuclear Waste Disposal The second problem resulting from the Cold War weapons program is the disposal of highlevel radioactive waste. DOE has committed to constructing an underground repository at Yucca Mountain, Nevada to provide for permanent disposal of much of the nation’s highly radioactive waste, the cost of which has been estimated to be $55 billion. The EPA and the NRC disagree on the public exposure standard to be used at the Yucca Mountain repository. The central issue between these two agencies is potential groundwater trace contamination. EPA’s groundwater requirements are equivalent to a calculated exposure that is a fraction of an mrem per year and their approach has been viewed as technically unsupported by other recommended standards for the repository. Nonetheless, EPA considers its groundwater protection approach for the repository to be justified based on the LNT hypothesis [1].

Nuclear Fear The concept that any amount of radiation exposure, no matter how small, is harmful has caused a significant fear in the American public. This is due partially to the rapid communication of news and data through global transmission media such as the Internet and satellite television, and partially to geographic proximity. Events such as the Chernobyl disaster and the Three Mile Island meltdown have triggered a level of anxiety within the general public that has allegedly been responsible for an increased number of aborted pregnancies in the months following these nuclear power plant accidents [10]. The International Atomic Energy Agency (IAEA) estimates that up to 200,000 Chernobylrelated abortions were performed in Western Europe due to fears of low-level radiation.

The highest rate of induced abortions for Pennsylvania women was 23.1 per 1,000 in 1980 [11]. The NRC has estimated that the above-background level radiation dose to the public was only 10 µSv (1 mrem) at Three Mile Island [12].

Terrorist Attacks Since September 11, 2001, America has changed. The threat of terrorist attacks on our homeland, once unthinkable, is now real. The first time many Americans heard the term “dirty bomb” was in 2002 after the arrest of an individual who was plotting to detonate a device containing both high explosives and radioactive material. The US Attorney General stated that a dirty bomb “spreads radioactive material that is highly toxic to humans and can cause mass death and injury” [13]. Many experts believe that a radiological dispersion device (RDD) or “dirty bomb” is more likely to inflict fear and economic damage to the United States than to cause death or injuries beyond the area destroyed by the high explosives in the RDD. The economic and psychosocial damage due to Americans’ fear of ionizing radiation, even

low exposure levels, would probably be the most serious long-term effects from the use of an RDD [14].

The economic impact on a major city from a successful RDD attack has been estimated to be at least equal to that of the 9/11 attacks in New York City and Washington, DC [13].

Much of that cost would stem from the decontamination of the affected area. The current decontamination standards of the EPA and NRC limit the public’s exposure to postterrorist attack radiation to levels far below the increased risk levels accepted daily by most Americans. Because of this difference in standards, calls have been made to examine the process for changing the regulatory standards for residual radiation left following an attack in the United States. Zimmerman and Loeb of the National Defense University’s Center for Technology and National Security Policy (CTNSP) state: To reduce economic disruption, the permitted level of residual radioactivity after cleanup from an attack (not ordinary radiological accidents) should be raised by a factor of ten. If this requires legislation, the Administration should develop a bill and send it to Congress. Acceptance of the increased levels of residual radiation will require a program of public education about the risk that should begin soon [13].

The Economic Consequence While the scope of the problem is great, no single cause has been found that adequately characterizes the magnitude of the costs.

However, using sources described above, an estimate can be made. First, a 2002 DOE estimate of the cleanup cost for the nuclear weapons related-facilities was $300 billion ($338 billion when adjusted for 2006 dollars).

The Nuclear Energy Institute has estimated the decommissioning cost for the nation’s

aging nuclear plants to be $38 billion [1, 15].

Finally, the cost of the Yucca Mountain highlevel storage facility is estimated to be $55 billion. While these numbers sum to a higher figure and it is widely felt that the figure will continue to rise, this report has used a more conservative sum of $350 billion. Few studies have been conducted on the costs to meet the standards of different Federal agencies.

However, the DOE estimated a 600% increase in cost at the Nevada Test Site (NTS) to reduce the radiation cleanup standard from 1 mSv (100 mrem) per year to 0.15 mSv (15 mrem) per year. The DOE also estimated the rise in cost at the Brookhaven facility to be 274%. Finally, the NRC estimated the rise in cost for remediating soil using the 0.15 mSv (15 mrem) per year cleanup standard to be 155%. Using the middle value from NRC and the $350 billion total cost estimate, the result is a cost increment of $220 billion as a result of the 0.15 mSv (15 mrem) per year standard (Table 1).

Summary The economic impact of using the LNT model in establishing radiation protection standards and its impact on the perception of radiation exposure by the American public cannot be ignored. A better understanding of the effects of low-dose radiation would allow radiation safety standards to be based on improved scientific data, thus allowing standards and costs to be lowered, if appropriate. Furthermore, this better understanding can be used to provide information to the American public, which will ensure that more informed decisions can be made about fundamental energy and resource issues affecting our nation’s future.

THE SUMMIT BEIR VII Report The “Biological Effects of Ionizing Radiation Report (BEIR VII)” of the National Academy

of Sciences released in June 2005 concludes that the current scientific evidence is consistent with the hypothesis that there is a linear, no-threshold doseresponse relationship between exposure to ionizing radiation and the development of cancer in humans.

The BEIR VII Report also recognizes that more research should be conducted and specifically recommended continued research on the following problems [2]: • Determination of the level of various molecular markers of DNA damage as a function of low dose ionizing radiation.

• Determination of DNA repair fidelity especially as regards double and multiple strand breaks at low radiation doses and whether repair capacity is independent of dose.

• Evaluation of the relevance of adaptation, low dose hypersensitivity, by-stander effects, and genomic instability for radiation carcinogenesis.

• Identification of molecular mechanisms for postulated hormetic effects at low doses.

• Tumorigenic mechanisms.

• Genetic factors in radiation cancer risk.

• Heritable genetic effects of radiation.

• • • •

Future occupational radiation studies.

Future environmental radiation studies.

Japanese atomic bomb survivor studies.

Epidemiologic studies in general.

Low-Level Radiation Effects Summit ORION International Technologies, Inc., was contracted to host the Low-Level Radiation Effects (LLRE) Summit to assess the feasibility and desirability of constructing a radiobiology research facility in the ultra-low level radiation background at the Waste Isolation Pilot Plant (WIPP). In January 2006, the LLRE Summit was convened in Carlsbad, New Mexico, bringing together a group of internationally recognized radiation scientists to consider the desirability of establishing such a research facility. This group of 26 scientists was carefully chosen to be of sufficient stature to make definitive recommendations and to reflect the wide variety of views within the scientific community regarding risks of very low levels of radiation.

The intent of this Summit was to address problems relating to the biological effects of ionizing radiation at ultra-low doses and low dose rates. Co-chairs for the Summit were Leo Gómez, PhD, ORION; David Brenner, PhD, Columbia University; and, Otto Raabe PhD, University of California, Davis. The LLRE Summit organizers felt it was critical to the

Table 1. Projected Costs and Savings ($ billions) of Different Cleanup Standards Source

DOE Brookhaven NRC DOE NTS

0.15 mSv/yr (15 mrem/yr) $350 $350

0.25 mSv/yr (25 mrem/yr)

1 mSv/yr (100 mrem/yr)

Estimated Savings

$226 $175

$150 $131

$200 $220

$350

$117

$156

$294

success of the Summit that a significant number of renowned international scientists with differing perspectives on the low dose question participate. The participants’ opinions were divided approximately equally between those who support the LNT hypothesis as the most appropriate model to describe radiation effects at very low levels, and those who support other hypotheses to explain biological effects at low levels of exposure. A list of the scientists attending the Summit appears at the end of this report.

The LLRE Summit participants laid out workable experimental procedures for seeking answers to the key biological questions in order to set realistic and credible radiological protection standards. The emphasis of these studies will be on the evaluation of biological processes related to carcinogenesis since cancer risk is the primary criterion for public radiation safety standards.

Inés Triay, PhD, Chief Operating Officer, Office of Environmental Management at DOE, set the agenda for the Summit in her opening address. Acknowledging that even the lowest level of radiation can cause damage to biological systems, she posed the following questions for the Summit: Can biological damage caused by radiation be repaired by the same process and with the same efficiency as the normal oxidative process? Further, is there a threshold below which radiological damage can be consistently repaired? The scientists at the Summit were thus challenged to determine what research is needed to test the LNT model. The goal of this research is to allow international radiation safety levels to be set based on uncontroversial scientific data. The full text of Dr. Triay’s presentation is given in Appendix A. The Keynote Address was presented by Hank Jenkins-Smith, PhD, Professor of Public Policy at the George Bush School of Government and Public Service at Texas A&M

University. The title of Dr. Jenkins-Smith’s well-received presentation was “Public Perceptions of Radiation Research.” The intent of the Keynote Address was to illustrate that an understanding of public perceptions about radiation research is just as important as the experimental results from that research.

The Solution The National Research Council [2] estimates that “At doses below 40 times the average yearly background exposure…statistical limitations make it difficult to evaluate cancer in humans.” At natural background levels, averaging 2.4 mSv per year worldwide, this would be greater than 100 mSv (10,000 mrem), well above the 0.15 to 0.25 mSv (15 to 25 mrem) per year standards set by EPA and NRC, respectively. The key, then, to establishing sound knowledge about the low dose effects of radiation is to be able to do research in an ultra-low level radiation environment, where the normal background radiation exposure has been removed or reduced to near-zero levels. The effects of low radiation doses can then be studied directly without the confounding effects of the natural radiation background. The lack of an ultra-low level radiation biology facility is significant in explaining why, despite much study, radiation risks at very low radiation doses are still largely unknown.

Waste Isolation Pilot Plant The most practical way to undertake radiobiological studies where the natural background radiation has been adequately reduced is to develop laboratories deep underground where natural cosmic rays from outer space cannot reach them and where the surrounding rocks themselves contain only trace amounts of radionuclides. Underground salt mines provide the best US locations that meet these requirements. The Waste Isolation Pilot Plant (WIPP) near Carlsbad, New Mexico, fulfills such requirements. It is 2,150

feet below ground in an ancient deposit of almost pure salt. WIPP has the surface and underground infrastructure to support such laboratories.

Radiation levels in the underground environment at WIPP have been determined

by Sandia National Laboratories as being about one order of magnitude lower than the normal, natural radiation background levels of about 10 microroentgens7 per hour (ÎźR/hr) on the surface. Sandia, in a document published in 1983 [16] stated that the dose rate underground at WIPP averaged 0.7 ÎźR/hr with potassium-40 (40K) the only identifiable contributor to the dose rate in the WIPP mine.

The 40K contributed about 28% of the WIPP surface level dose rate, natural uranium daughters contributed about 64%, and cesium137 (137Cs) from weapons testing fallout contributed about 8%. The radiation background in the mine, therefore, is only 7% of the radiation background on the surface of the WIPP site and can be reduced further with a small amount of shielding. The ultra-low levels of radiation at the WIPP are possibly lower than any easily accessible location in the US. Participants at the Summit were taken on a half-day tour of the WIPP facilities (Figure 5), both on the surface and underground. Mr. Roger Nelson, DOE WIPP science advisor, arranged the tour and provided a comprehensive description of the WIPP facilities and its history. Summit participants expressed surprise at the size, safety, and efficiency of the WIPP operation. All participants were better able to discuss future experiments with their first-hand knowledge of the WIPP facilities.

Other nuclear waste disposal sites exist, notably several located in Germany. Asse, a former salt mine, was converted into a research mine to evaluate salt as a disposal 7

A roentgen is a measure of air ionization.

Figure 5. LLRE participants on tour of the WIPP underground. medium. From 1967 to 1978 low and medium level nuclear waste was emplaced in the Asse mine, which is now being decommissioned.

The Gorleben salt dome has been studied since 1979 as a prospective repository for radioactive wastes of all kinds; however, in 2000, exploration activities were interrupted for a 3- to 10-year period to clarify the safety and technical questions of the German government. The Morsleben potash and rock salt mine was used to store low-level radioactive waste from 1981 to 1998, but in 1997, the German government announced its intention to close down the Morsleben repository. In addition to salt repositories, the German government pursues another repository program in a former iron ore mine (Konrad). However, the natural radiation levels in an iron mine are considerably higher than those in a salt mine due to the elevated levels of natural radionuclides in rocks. There are currently no plans for low-level radiobiology studies at these sites.

At the Gran Sasso National Laboratory (LNGS) in Italy, research has been conducted on the influence of a low background radiation environment on biochemical and biological

responses in V79 cells [17]. The LNGS is located 1450 m deep in the dolomite rocks of Gran Sasso Mountain. Reported dose rates are similar to those found in the WIPP salt formation. The mission of the LNGS is to host astroparticle physics and nuclear astrophysics that require a low radiation background environment. Other scientific disciplines can also use the LHGS facilities.

Satta, et al. [17] conclude “the experiment here described represents the first systematic study concerning the effects on mammalian cells, and for a variety of biological endpoints, of different levels of chronic exposures to ionizing radiation, such as those related to natural background.” Even though Satta et al. cite the need for more experiments, they suggest that the responses they observed “may be more complex than that predicted by a linear relationship with the dose.” They also call for “further studies in order to ascertain possible implications for the estimation of risks to chronic exposures presently assumed for radiation protection purposes.”

LLRE Summit Results The scientists participating in the Summit represented a spectrum of current hypotheses on the effects of low-level radiation on biological systems. The purpose of the Summit was not to change any of the participant’s personal views on low-level radiation effects but rather to determine • • • •

whether a facility is needed to further research into low-level radiation effects on biological systems, whether the WIPP is the best site to build such a facility if the need is demonstrated, what types of experiments might be conducted at a low-level radiation facility if one existed, and how the general research requirements would translate into a facility whose cost could be measured.

The participants were surveyed as part of the discussions on the above topics and a near consensus was obtained.

•

•

• •

•

92% of the attendees agreed that in order to establish a scientific basis for radiation exposure standards, a research environment is needed that allows for low dose experiments Due to the existence of “noisy” background radiation from naturally occurring sources, required low-dose radiation experiments cannot be conducted accurately on the Earth’s surface The ideal test environment has near-zero levels of radiation The only known environments in the US with ultra-low levels of natural radiation, suitable for the needed low-dose experiments are underground salt mines 96% of the attendees agreed that WIPP is the place to conduct these experiments

As noted, there were dissenting votes. The basis of the dissention was a concern that the DOE’s Low Dose Radiation Research Program not be diluted to support the proposed WIPP facility. It was the unanimous conclusion of the participants that the WIPP facility is an ideal testbed for the near-zero radiation studies, that both programs are important, need to work in parallel, and would complement each other.

The LLRE Summit was a mix of informal presentations and discussions, as well as two

working group discussions: a) in vitro – cells and tissue culture and b) laboratory animals – mice, in which specific experiments that can be conducted at an LLRE facility were discussed. Approximately half of the participants attended each discussion group.

Summaries of the two breakout groups are given in Appendix B. These summaries include specific experiments the scientists felt were needed to establish sound radiation standards. One participant added at the conclusion of the Summit “An excellent forum for discussion on a topic of great interest. All opinions catered for and general consensus arrived at. This was clearly the best way to do it.”

Gwyneth Cravens, author of Power to Save the World, attended the Summit and has offered a layperson’s view. She emphasized the impending catastrophe of ignoring the ecological impact of energy from fossil fuels and the role of public perceptions of nuclear energy. She also saw an important role for the proposed WIPP facility in combating the public misperception of the danger of low doses of radiation. The full text of her comments can be found in Appendix C. Cost The goal of the Ultra-Low Level Radiation Biology facility is to determine a realistic standard that offers optimal protection to the public against the detrimental health effects of radiation while realizing a potential savings to the United States of billions of dollars in cleanup costs. Initial cost estimates for establishing a low-level radiation effects facility at WIPP and operating it as a research facility for a five-year total estimate of $151.5 million. This funding would allow for the development of baseline results that could be used for obtaining additional funding from other research agencies. Table 2 shows the initial cost estimates for the proposed facility.

The architectural concept of the underground test facility is shown in Appendix D. Table 2: Initial Cost Estimates for Research Facility at WIPP Facility Need Construction Excavation

Cost ($ millions) 64.5 2.0

Research equipment

25.0

Facility support (5 yr)

10.0

Research staff (5 yr)

50.0

Total

151.5

Summary It is proposed that an Ultra-Low Level Radiation Biology Laboratory be designed, planned, and located at WIPP. The facility will allow radiation standards to be safely and scientifically established with full scientific consensus. The economic benefits of relaxing current safety standards that are based on an unproven, conservative LNT model would far outweigh the cost of this facility. The benefit of replacing current perceptions in the minds of the American public with data collected in an ultra-low radiation environment will allow progress especially towards increasing the use and efficiency of nuclear energy and reducing our reliance on fossil fuels, with all of their accompanying international and ecological problems.

Cancer is a fact of life. DNA damage is one of the causes of cancer. Natural mechanisms exist that either repair the damaged DNA or signal the cell to die (apoptosis); however, in carcinogenesis some mechanisms fail.

Research conducted in an environment where most confounding factors can be controlled, such as the proposed ultra-low level radiation laboratory, should contribute immensely to the understanding of carcinogenesis, with a potential to contribute information to preventing and curing cancer.

The Waste Isolation Pilot Plant in Carlsbad, New Mexico provides a unique opportunity to recognize these gains. The ultra-low level radiation biology laboratory would be a major

international research facility with the unique opportunity to answer longstanding and fundamental questions that have remained unresolved for decades.

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REFERENCES 1. General Accounting Office, Radiation Standards. Scientific Basis Inconclusive, and EPA and NRC Disagreement Continues, Report to the Honorable Pete Domenici, US Senate, GAO/RCED-00-152, General Accounting Office, June 2000.

2. Health Risks From Exposure to Low Levels of Ionizing Radiation: BEIR VII–Phase 2, National Research Council of the National Academies, The National Academies Press, Washington, DC. June 2006 3. Tubiana, M., The Report of the French Academy of Sciences: Problems assoc-iated with the effects of low doses of ionising radiation, J. Radiol. Prot., 18:4, 243-248, 1998.

4. Tubiana, M. et al, Dose-effect relation-ships and estimation of the carcinogenic effects of low doses of ionizing radiation, French Academy of Sciences, French National Academy of Medicine, March, 2005.

5. Mossman, Kenneth L., et al., Final Report, Bridging Radiation Policy and Science, An International Conference, Airlie House Conference Center, Warrenton, VA, 1-5 Dec 1999. January 2000.

6. Council of Scientific Society Presidents, Creating a Strategy for Science-Based National Policy: Addressing Conflicting Views on the Health Risks of Low-Level Ionizing Radiation, Wingspread Conference, Racine, WI, 31 July−3August 1997.

Final Report 1998.

7. Health Physics Society, Compatibility in Radiation-Safety Regulations, Position Paper of the Health Physics Society, Reaffirmed March 2001.

8. Health Physics Society, Radiation Risks in Perspective, Position Paper of the Health Physics Society, Revised August 2004.

9. The Department of Energy Strategic Plan, Protecting National, Energy, and Economic Security with Advanced Science and Technology and Ensuring Environmental

Cleanup, Department of Energy/ME-0030, September 30, 2003.

10. Castronova, Frank Jr., Teratogen Update: Radiation and Chernobyl, Teratology, Vol 60, pp 100-106, 1999.

11. Pennsylvania Past and Present: Pennsylvania Maturity, 1945-2003, The Pennsylvania Manual, Section 1, Pennsylvania Department of General Services, Harrisburg, PA, 2002.

12. Nuclear Regulatory Commission, Fact Sheet on the Accident at Three Mile Island, Nuclear Regulatory Com-mission, Revised March 2005. http://www.nrc.gov/readingrm/doc-collections/fact-sheets/3mileisle.html 13. Zimmerman, Peter and Cheryl Loeb, Dirty Bombs: The Threat Revisited, Defense Horizons, No.38, Center for Technology and National Security Policy, National Defense University, January 2004.

14. Philips, G.W., D.J. Nagel, and T. Coffey, A Primer on the Detection of Nuclear and Radiological Weapons, Center for Technology and National Security Policy, National defense University, Washington DC, May 2005.

15. General Accounting Office, Radiation Standards, Scientific Basis Inconclusive, and EPA and NRC Disagreement Continues, Statement Before the Subcommittee on Energy and Environment, Committee on Science, US House of Representatives, GAO/T-RCED-00-252, July 18, 2000.

16. Minnema, D.M. and L.W. Brewer, Background Radiation Measurements at the Waste Isolation Pilot Plant (WIPP) Site, Carlsbad, New Mexico, SAND83-1296, Sandia National Laboratories, 1983.

17. Satta, L., et al., “Influence of a low background radiation environment on biochemical and biological responses in

V79 cells,� Radiat Environ September; 41(3): 217-24, 2002.

Biophys.

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APPENDIX A

Low Dose Radiation Effects Research Summit January 15, 2005 -Carlsbad, NM Welcoming Remarks by Dr. Ines Triay, PhD

It is my great honor to welcome all of you to Carlsbad and to host this historic meeting. The Department of Energy and the Waste Isolation Pilot Plant look forward to participating in your deliberations over the next few days. We are truly pleased that your desire to understand the effects of low dose and dose rate radiation on living things has led you to WIPP's doorstep. We believe that the WIPP underground provides an international research opportunity for a broad range of science that requires a low-to-no radiation environment in which to conduct experiments.

Why the DOE Supports Low Dose Radiation Research The understanding of how ionizing radiation manifests its biological impact is important to the Department of Energy. Of course, this understanding is important in other areas as well, such as medical applications of radiation, nuclear power production and food irradiation. But the Office of Environmental Management of DOE, which is charged with the clean-up of the nation's nuclear weapons complex, believes that understanding low dose effects is critical to its mission. WIPP's uniquely low-to-no dose setting may provide a laboratory in which the biological effects of low dose radiation can be tested.

As leading researchers in radiation biology, you know that even low levels of radiation can induce biological damage. However, an important question is whether this biological

change is repaired by the same cellular processes, and with the same efficiency as normal oxidative damage, that is a way of life for every living cell. If so, does this result in a threshold for adverse effects induced by low doses of radiation? And what is an adverse effect? Biological systems are complex and extremely non-linear. What is harmful to one part of the system may be beneficial to others, or the system as a whole.

Is it possible to answer these questions through experiments conducted at doses and dose rate levels well below that to which all living organisms are routinely exposed from background radiation? Recent advances in cell and molecular biology and concomitant advances in chemical and biological technology have created an extraordinary opportunity to perform experiments thought impossible as recent as 10-15 years ago. It may now be possible to understand normal processes that repair oxidative and radiation-induced damage at the molecular, cellular and organism levels. It may also be possible to evaluate molecular processes that modify the expression of these changes during cancer growth and to determine the role of low dose and dose rate in these processes.

Why is WIPP an Important Laboratory for Low Dose Research It is ironic that an underground, deep geologic facility created for the express purpose of permanently isolating radioactive waste from

Final Report

the environment could be a low dose research laboratory. While the waste is radioactive, the underground areas are segregated and the vast majority of the underground enjoys background radiation levels far below levels found at the surface of the earth, even when employing large shielding chambers.

In WIPP, a half-mile of overburden eliminates virtually all cosmic-ray induced radiation sources, and the salt rock itself contains only trace amounts of naturally-occurring radioactive elements. Thus the radioactivity environment within the repository is ultra-low —possibly lower than any other easily accessible location in the world. This makes it possible to conduct sensitive measurements (of many kinds) that would otherwise be confounded by the presence of typical background radiation.

Ultra-Low Level Radiation Effects Summit

or dismiss hormetic effects. Regardless of the outcome of this research, society, and the regulatory agencies charged with protection from the harmful effects of radiation, will be better able to carry out their mission.

International radiation protection standards may finally be placed on an uncontroversial scientific basis.

The dose rate, or ionizing energy deposition rate in the WIPP underground is typically 1/10 that at the surface. This ten-fold reduction is found everywhere underground in WIPP, without any effort to shield the small amount of radioactivity that does emanate from the trace elements in the rock salt. With minor effort, using some thin-walled shielding, dose rates hundreds of times smaller than surface background levels can be easily achieved.

With a little more effort, dose rates approaching absolute zero are possible.

The Local Benefit of Support for Low Dose Research In addition to the desire to further our understanding of low dose radiation effects, the conduct of such research underground at WIPP would serve other purposes. The US taxpayer has invested a great deal of money in the safe, permanent isolation of radioactive waste by building WIPP. If the repository setting can also use its unique physical characteristics for other purposes to help society, then its value increases. A bonus of conducting low dose radiation research in WIPP is the beneficial public image it portrays. While the waste disposal operation is safe, and the repository will permanently isolate the material for geologic time, the public's perception of safety and confidence in WIPP would be even further enhanced if the facility were employed for this work.

Conducting the lowest dose rate experiments possible from around the world, right next to mega-curies of radioactive waste, sends a message to the public that WIPP is truly safe.

With such a low-to-no dose rate laboratory setting available, this meeting was proposed as a first step in identifying specific research that could test the linear no-threshold hypothesis of radiation dose response. After visiting the WIPP site tomorrow, you will begin deliberations on experimental designs that may demonstrate the absence or existence of a threshold. If a threshold dose and/or dose rate can be identified, the research may also provide understanding on how and why the threshold can vary across different biological systems. Some experiments may even identify

Finally, the DOE recognizes the economic spin-off benefits to our host community that would be enjoyed if significant low dose radiation biology research were carried out in WIPP and the surrounding areas. Some of this research may require highly trained local staff.

WIPP operations over the past 25-years have resulted in a unique Carlsbad workforce with many related skills that would be available to support this research. Jobs, supplies, animal caretakers, and laboratory facilities would all contribute to the local economic benefit from the research.

Conclusion In conclusion, the science of radiation biology has been active since the discovery of radiation itself, more than 100 years ago. Yet we still do not truly understand the doseresponse relation for exposure to low levels of radiation. Mainstream biological research in the past few decades has made extraordinary discoveries and resulted in incredible advances in health, longevity, and the

treatment of disease. Now it is time for the little known and understood field of radiation biology to also contribute at the same level.

One of you may confirm or reject the no threshold dose response in an experiment performed underground in WIPP. This would have major societal implications. The DOE wishes you every success as you discuss these possibilities over the next few days.

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APPENDIX B

BREAKOUT GROUPS 1Recommendations of the Laboratory Animal Research Group Discussions of the WIPP Ultra-Low Level Radiation Biology Research Laboratory Breakout Group 1: Discussion Leader – Otto G. Raabe, PhD Rationale Continuous exposure to substantial levels of natural ionizing radiation occurs to everyone on the surface of the earth, from cosmic rays and from natural radioactive material in soil, rock, air, and food. There is currently no definitive scientific understanding of the effects on living creatures of really low levels of ionizing radiation. That missing information makes impossible accurate estimates of risks, if any, at levels typical of natural background, or for proposed radiation safety standards for the public which are typically only a small increment above natural levels.

The group supported the need for, and the potential significant value of, establishing an Ultra-Low Level Radiation Biology Laboratory below ground at the WIPP for conducting small laboratory animal studies of the effects of near-zero levels of ionizing radiation in contrast with normal surface levels. It is only through the study of living animals that the complete biological response to ionizing radiation or its absence can be studied. It was pointed out that "if we are going to look at human health, we need an animal model.�

Two-Phased Approach The importance of laboratory animal studies was the basis for recommending a two-phased approach. Phase 1 would begin with initial pilot studies in a well-targeted animal model with a relatively small number of animals.

Phase 2 would follow about two years later with several concurrent laboratory animal studies with more animals. This will provide

an opportunity to work out the special procedures that will be needed for these unique studies before larger studies are initiated.

General Plan The group agreed that traditional lifetime studies with small animals, such as for cancer, would not be fruitful because of the statistical power limitations of studies with limited numbers of animals. However, well-targeted studies using special animal models are expected to demonstrate important biological responses with high sensitivity using relatively small groups of animals. Emphasis of the discussion was on the use of transgenic mice in order to optimize the experimental power of studies with animal models. All animal studies will be conducted underground in the WIPP facility.

Radiation Levels Two radiation levels will be used in the experimental studies. The near-zero level will be achieved by shielding the few gamma rays that may be emitted by traces of potassium-40 in the rock salt walls. The external radiation level is expected to be about 1% of the outdoor surface level or about 1 mrem per year. The positive control animals will be housed in isolated holding rooms with walls doped with potassium-40 to provide an external radiation level in the control room that is about equal to the natural external level found in the environs of Carlsbad, New Mexico, of about 100 mrem per year. All

laboratory animals used in these studies will be bred underground in their respective radiation environments.

Research Topics It was hypothesized that the process of carcinogenesis can be altered by the virtual elimination of ionizing radiation in contrast to normal levels. This can be readily tested with a relatively small number of transgenic mice who are highly susceptible to cancer and who all develop cancer at an early age. These and other animals will be used to address other responses as well. A whole battery of important cancer-related biological endpoints will be evaluated. These endpoints include but are not limited to: (a) physiological changes, (b) biochemical markers, (c) gene expression, (d) DNA damage, double-strand breaks, (e) DNA repair, (f) mutagenesis, (g) genomic instability, (h) apoptosis, (i) cancer, (j) cellular sub-population studies, e.g., of lymphocytes, (k) stress markers, and (l) aging.

Pilot Study Funding There is currently a paucity of preliminary data for studies at really low radiation levels.

The normal channels of research funding require preliminary data. Hence the group recommended that along with allocations for construction and infrastructure costs, there needs to be a pool of Phase 1 and Phase 2 research money for about five years of initial studies, beginning with the opening of the ultra-low level research facility. That funding

level was anticipated to be about $10 million per year.

Personnel and support needs Although all animal experiments will be conducted below ground, there will be a support laboratory above ground at the WIPP that will include a receiving and quarantine facility for animal arrivals. About six doublesided cage racks will be needed in the underground laboratories and two in the above-ground facility. There needs to be a full-time veterinarian trained in laboratory animal care and one or two laboratory animal care specialists, depending on the number of animals at the facility. Local scientific support personnel and facilities will also be needed.

Conclusions While in vitro studies with cells and tissue cultures are helpful in studying the underlying mechanisms associated with various components of biological responses to ionizing radiation, it is the study of living animals that provides information on the overall responses and the basis for predicting the responses of the human body. For this reason early, well-focused in vivo pilot studies with small numbers of small laboratory animals (transgenic mice) should be part of Phase 1 of the operation of the Ultra LowLevel Radiation Biology Laboratory at the WIPP, along with well-targeted limited cellular and tissues in vitro studies. More extensive studies will begin about two years later in Phase 2.

Summary of In Vitro Group Discussions of the Ultra-Low Dose Radiation Biology Facility Breakout Group 2: Discussion Leader – David J. Brenner, PhD The group unanimously concluded that there was a strong rationale for an ultra-low dose radiation biology facility in order to understand the potential effects, both harmful and beneficial, of very low doses of ionizing radiation.

Specifically, the group felt that there was still insufficient understanding of the biological effects of very low doses of radiation to be able to generate credible or realistic radiological risk protection standards at these low doses. It was concluded that both costeffective cleanup of past nuclear sites and future development of nuclear power were being considerably impeded by the uncertainty surrounding the biological effects of very low doses of radiation.

The group discussed at length the reasons why, despite a considerable investment in resources both in the US and elsewhere, so little was understood about the effects of very low doses of radiation. The group concluded that one of the key problems that prevented more progress has been the presence of the normal “natural” radiation background doses, and that this dose is “swamping” the effects of the much lower doses of interest in this proposal. Thus, the group saw the Ultra-Low Dose Radiation Biology Facility at WIPP as representing a unique opportunity to conduct key ultra-low dose radiation biology studies.

The group anticipated a phased approach in which in vitro studies are initiated first in the facility, with in vivo studies added during Phase 2, perhaps 18 months after Phase 1 studies begin. In terms of in vitro (cellular and molecular) studies, there are many endpoints to consider, all targeted towards understanding

the balance between potentially harmful and beneficial mechanisms at very low radiation doses. Most in vitro studies will involve longterm culturing experiments.

Positive radiation controls were considered essential. Specifically, in addition to the virtually zero dose facility, it will be essential to provide essentially identical facilities in which cells/animals are exposed to approximately the same photon dose rate as above ground, about 1.5 mGy/yr, and a third facility in which cells/animals are exposed to a slightly higher dose than background. A reasonable value was considered to be twice background, about 3 mGy/yr. In summary, the group saw the need for three underground laboratories representing different dose rates.

Each in vitro laboratory should be a minimum of about 3,000 sq ft.

It was considered essential that the three laboratories should be made as similar as possible to one another in order to ensure credible radiation control studies. The most practical room designs were considered to be: 1) the “near-zero” room, which would have metal walls to shield the few gamma rays emerging from the salt walls, and 2) the two “positive radiation control” rooms, which would have walls made of potassium chloride (KCl) sandwiched between plastic sheets, the radiation dose coming from the 1.3-1.4 MeV photons emitted from 40K. From the perspective of the cellular DNA, the fundamental energy deposition pattern from this scenario would be similar to that on the surface or from occupational exposure. It will be essential to undertake a complete computation simulation of the rooms, the radiation sources, and their contents using

Monte Carlo techniques in order to characterize and optimize uniformity of radiation exposure rates.

In order to reduce the possibility of crosscontamination, it was considered optimal for each of the three in vitro laboratories to be divided into about five separate, essentially identical, rooms, each of which would contain about five double incubators, benches for other equipment such bioreactors (automated cell culture systems), and a cell-handling hood. A very low dose rate external radiation source, such as a cobalt or cesium irradiator, will be essential as supplementary experiments with higher radiation doses will be necessary to elucidate the very low dose mechanisms.

Because of the long-term nature of most of the experiments that will be conducted at the facility, it will be essential to have a skilled on-site staff, in that external scientists will need to leave their samples at the WIPP lowdose laboratories for long-term irradiation and monitoring. The best estimate for the minimum staffing is two PhD. biology faculty members, one at the professor/associate professor level and one at the post-doctoral level; one PhD. level or health-physics trained physicist; and, three technicians. It was considered that this staff of six would be the minimum to create a critical mass of research excellence at the WIPP ultra-low dose laboratories.

In addition to funds for the facility development, central to the success of this

program will be a minimum of a five-year commitment to fund research at the facility.

The background here is that the targeted research at the facility is unlikely to receive NIH support in its initial years because (a) there will not be preliminary results from this unique facility and, most importantly (b) the research here will be highly targeted towards specific issues relating to occupational exposure to very low doses of radiation. We anticipate that a five-year commitment of about $12 million per year would be needed to support the initial research.

The choice of an appropriate organization to administer this program will be critical, both to ensure maximum efficiency and maximum credibility. The organization would oversee the development of the facility, set up requests for research proposals, and set up peer-review study sections to review proposals. Likely options are a major US university, a government agency such as the NCI, or an independent institution such as the National Academies.

The group strongly recommended that the WIPP ultra-low dose radiation facility should be the focal point of a new Center for Excellence in low dose radiation biology located at Carlsbad, New Mexico. This Center of Excellence should be associated with one of the major US universities and should feature training programs at the graduate and doctoral levels, to ensure an ongoing expertise in the field, an essential component of the future development of nuclear power in the US.

APPENDIX C A Layperson’s View – Gwyneth Cravens Gwyneth Cravens is the author of Power to Save the World. (Alfred A Knoff, New York 2007) and of “Terrorism and Nuclear Energy: Understanding the Risks” (Brookings Institution Review, 2002).

The risk of radiation is the most misunderstood and misused aspect in the controversy about nuclear power and the disposal of nuclear waste. The consequences are enormous. This became strikingly clear to me while attending Leo Gómez’s longplanned international Low Dose Radiation Effects Summit in Carlsbad.

The majority of attendees did not appear to find low dose radiation a threat. In a recent survey, over 80% of scientists polled think that below a certain threshold radiation does not harm the body thanks to innate defense mechanisms. The epidemiological proof: the survival of many populations in areas where natural background radiation far exceeds present radiation protection standards. The French, who get 80% of their electricity from emissions-free nuclear power, have already revised their standards to reflect what they consider a more realistic approach. However, a great deal of research remains to be done, and perhaps WIPP will be the setting.

What’s at stake? Ultimately, the fate of human civilization and of thousands of plant and animal species are likely to be terribly compromised by catastrophic global warming.

When I began my tour through the nuclear world, my assumptions about radiation exposure were typical of those expressed by the general public and, as I was to learn, with

little or no foundation in science. Nevertheless, such assumptions form policy. I was astonished to learn that although radiation has been studied for over 100 years, and much is known about damage to health from high doses, effects caused by doses below 10,000 millirem remain a mystery. Extrapolation about what occurs at much higher doses suggests to a minority of scientists in the field that similar damage may also be occurring in a linear fashion in the realm into which no one has been able to peer because of the veil of natural background radiation. That linear, nonthreshold hypothesis, which underlies our regulations about radiation protection and, therefore, the way we build and manage nuclear plants and nuclear waste facilities and the way we clean up contamination, is without scientific basis and has been questioned by many with field experience in radiation protection. Meanwhile, the public has learned that all radiation is bad, no matter how small the dose. People are frightened by the prospect of the tiniest exposure to radioactive material if it comes from a nuclear facility. (They are OK about high doses for diagnostic medical and therapeutic purposes.) That alarm is rooted in the conclusions derived from the conservative linear non-threshold hypothesis.

Is it valid? Nobody knows. Epidemiological studies do not bear it out.

Specialists schooled in the details of radioactive decay and the body’s response to it tend to assume that people really ought to educate themselves about these matters and stop panicking, and they get riled by lay people’s emotional reactions to what we assume may kill us. This attitude does not build trust. Instead of guesswork, what if we

had accurate knowledge about what radiation does to the body in a setting that removes the veil of natural background radiation? What if research in such a place could lead to more substantial proof, one way or another, about our degree of vulnerability to radiation?

Perhaps, as some believe, we’re not protecting ourselves enough, or perhaps we’re being overly cautiousat great expense.

Today many facilities must satisfy an EPA requirement that they emit no more than 15 millirem a year. But the natural background radiation in the US is, on average, 240 millirem a year and, in some places, as much as 1700 millirem a year. To meet the rather arbitrary 15-millirem a year standard, billions of dollars have been spent. Meanwhile, vacationers who fly from New York to Colorado and ski at Vail may be getting an increased exposure of hundreds of millirem.

Furthermore, the US Capitol Building exceeds local background radiation dose rates, and emits 550% of the typical dose rate allowed around nuclear plants, about 13,000 times more than the average individual dose rate from nuclear power production worldwide.

Our Congress spends its time in a building that has a much higher dose rate than the Yucca Mountain high-level nuclear waste facility will be permitted. Should Congress relocate?

Should we spend a trillion dollars to fortify Yucca Mountain and shield its high-level waste with many barriers on the assumption that they’ll protect a hypothetical passerby in the very remote future from less radiation than Mother Nature showers upon people living today in northeastern Washington State? And what about low dose exposure from dirty bombs? Should New Yorkers permanently abandon midtown Manhattan if they’re receiving 25 or 50 millirem a year more than they were before a radiological dispersal device went off? Actual science about these assumptions would have the effect of guiding

some of these debates out of the realm of speculation.

If we continue in our present, rather ignorant mode, we may bring about a much greater risk by upholding certain assumptions based on hypothetical worst-case scenarios while ignoring disastrous events unfolding before us in the real world. To keep up with a growing demand for electricity, we have only two large-scale resources: fossil fuel combustion and nuclear power. Waste from coal combustion alone causes 26,000 thousands of deaths annually in the US as well as hundreds of thousands of cases of pulmonary and cardiovascular disease. In its gaseous form, fossil fuel waste is also accelerating catastrophic global climate change, with consequences which are very hard to predict with specificity but which, according to scientific consensus, will have a significant, enduring impact on the way we live. Deaths from nuclear power generation in the US in 50 years of operation: zero. Trillions of tons of greenhouse gases have been avoided thanks to nuclear power.

Most electricity in developing countries comes from fossil fuel, and in the US it makes over 75% of our energy, with nuclear power providing only 20%. Worldwide, nuclear power has the fewest deaths per terawatt hour of any large-scale form of electricity generation. The US, lacking energy independence and, because of public perception, doesn’t have enough nuclear plants to make electricity to meet the growing demand. We are likely to continue to be the greatest contributor to greenhouse gases while sending American soldiers abroad to ensure the uninterrupted flow of gas and oil to the US. Because of ignorance about rays and particles, we are supporting energy policies that are harming the planet and dimming prospects for our children and grandchildren.

A few years ago, DOE began a low dose radiation investigation. Antone Brooks, its science advisor, predicted beforehand that nothing new would turn up. He now cheerfully admits that he was wrong. A number of new phenomena, like the bystander effect, have been uncovered, in part thanks to innovations in molecular biology and technology. Preliminary evidence indicates that low levels of radiation exposure may not be as harmful as the linear hypothesis has assumed, that DNA repair mechanisms are stimulated and that certain findings may help cancer treatment. But these studies have been limited by the absence of a near-zero background radiation level of the kind WIPP offers.

I support any studies that might reassure a nervous public of the safety of nuclear power, which does not produce greenhouse gas emissions. Fossil fuel combustion is not only accelerating global climate disruption but also

emitting far more low-dose radiation than nuclear plants do. The observations and remarks made by Dr. Gómez, Dr. Brooks, and other scientists at the Summit have persuaded me that an experimental setting at WIPP is worthwhile. So have the warning of the Intergovernmental Panel on Climate Change that we have only a short time to mitigate the effects of greenhouse gases and the warning of Jim Hansen, head of earth sciences at NASA, that if nothing is done then today’s children could face a rise in the ocean level of up to 80 feet.

It is important to take the long view. This summit is a preliminary step. The execution of this plan would require several years, and by then technology may have improved further, permitting us to peer even further behind the veil. In the meantime, information coming from early studies might do much to reassure the public about risk from low-dose radiation

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APPENDIX D Plan Diagram of the Proposed Ultra Low-Level Radiation Biology Laboratory at WIPP. Among the attendees of the LLRE Summit were architects from the firm SMPC Architects.

These architects were experienced in biology research laboratory design. After touring the WIPP facilities and discussing laboratory needs with LLRE Summit researchers, the architects designed a conceptual plan for an Ultra-Low Radiation Biology Laboratory at the WIPP. This conceptual design will be modified as funding for the proposed laboratory is made available. For more details about this conceptual design please contact the Chief Engineer or the Principal Scientist for Low Dose Radiobiology at ORION International Technologies, Inc. at 505-998-4000.

LIST OF PARTICIPANTS

Sally Amundson, PhD Associate Professor of Radiation Oncology Center for Radiological Research Columbia University Medical Ctr. David Brenner, PhD Professor of Radiation Oncology Center for Radiological Research Columbia University Antone Brooks, PhD Professor Department of Environmental Science Washington State University Tri-Cities John Dicello, PhD Director of Medical Physics Radiation Oncology Dept.

Johns Hopkins University Evan Douple, PhD Scholar Nuclear and Radiation Studies Board The National Academies Ludwig Feinendegen, PhD, MD Professor Emeritus Brookhaven National Laboratory, Medical Dept.

Raymond Guilmette, PhD Past President, Health Physics Society Coordinator, Radiation Dosimetry Science Los Alamos National Laboratory Charles Hobbs, DVM Director of Toxicology, Toxicology Dept.

Lovelace Respiratory Research Institute Michael Joiner, PhD Professor & Head School of Medicine-Radiation Oncology Wayne State University Karmanos Cancer Institute, Martin Lavin, PhD Professor of Molecular Oncology Queensland Institute of Medical Research Australia William Morgan, PhD Professor & Director University of Maryland School of Medicine Kenneth Mossman, PhD Past President, Health Physics Society Professor of Health Physics Arizona State University

Leo Gomez, PhD Principal Scientist ORION International Technologies, Inc.

Carmel Mothersill, PhD Professor Medical Physics & Applied Radiation Sciences - McMaster University, Canada

Dudley Goodhead, PhD Ex-Director Radiation & Genome Stability Unit Medical Research Council United Kingdom

David Murray, PhD Director Experimental Oncology Cross Cancer Institute Canada

Herwig Paretzke, PhD Professor GSF-National Laboratory for Environmental & Health Research Germany Jerome Puskin, PhD Director Radiation Protection Division Environmental Protection Agency

Colin Seymour, PhD Professor Medical Physics & Applied Radiation Sciences - McMaster University, Canada Marianne Sowa, PhD Senior Research Scientist Pacific Northwest National Laboratory Tore Straume, PhD Chief Scientist, Life Sciences Division NASA Ames Research Center

Otto Raabe, PhD Past President, Health Physics Society Professor Emeritus Center for Health & the Environment University of California - Davis

Julian Whitelegge, PhD Associate Professor University of California - Los Angeles Dept. of Chemistry

J. Leslie Redpath, PhD Past President, Radiation Research Society Professor, Dept. of Radiation Oncology University of California – Irvine School of Medicine

Gayle Woloschak, PhD Professor Department of Radiology/Cell & Molecular Biology Northwestern University Medical School

Bobby Scott, PhD Senior Scientist Lovelace Respiratory Research Institute

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