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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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4

Status of Low-Dose Radiation Research

This chapter addresses the third charge of the Statement of Task, which calls for an assessment of the status of current low-dose radiation research in the United States and internationally. This chapter also provides background information to address the sixth charge of the Statement of Task on coordination of low-dose radiation research, which is explicitly addressed in Section 6.8 of this report as one of the seven essential elements of the low-dose radiation program.

The committee discusses the status of low-dose radiation research within the U.S. government (Section 4.1), national laboratories (Section 4.2), universities (Section 4.3), other U.S.-based entities (Section 4.4), and internationally (Section 4.5). The committee notes that currently within the United States there is no dedicated entity to lead, conduct, or otherwise support low-dose radiation research. Instead, a few entities as described in the following sections support research with low-dose radiation components or support research on higher doses of radiation but have expertise that is relevant to low-dose radiation research.

4.1 LOW-DOSE RADIATION RESEARCH IN THE U.S. GOVERNMENT

A few federal agencies within the United States have programs that support or conduct research on low-dose radiation relevant to the agency’s specific missions. However, these programs are not explicitly low-dose radiation research programs (see Table 4.1); therefore, estimating the relative commitment to low-dose radiation research and allocated funds is not

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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a straightforward task. A 2017 Government Accountability Office (GAO) report indicated that between 2012 and 2016, the Department of Energy (DOE) and the National Institutes of Health (NIH) were the two agencies supporting most of the low-dose radiation research in the United States. Within that period, the two agencies combined accounted for 98 percent of federal funding for low-dose radiation research. In 2016, the total funding for low-dose radiation research was about $35 million (GAO, 2017).

This section summarizes information on government agencies that support or conduct research on low-dose radiation or whose research is primarily focused on higher doses but have radiation subject-matter expertise. The information summarized below is primarily based on briefings representatives of these agencies provided to the committee during the September 24, 2021, and January 24, 2022, meetings or in follow-on written communications. In addition to the agencies described in this section, the committee also invited the National Institute of Environmental Health Sciences (NIEHS) to provide a briefing but was told that NIEHS does not currently conduct any research related to radiation health. The committee also asked for information in writing from the National Science Foundation (NSF) about its role in low-dose radiation research but did not receive a response. To the best of the committee’s knowledge, NSF does not support or conduct research in radiation health.

4.1.1 Department of Energy

Two offices within DOE have historically supported research in low-dose radiation: the Office of Science and the Office of Health and Safety.

Office of Science

The history of the Office of Science Biological and Environmental Research (BER) program’s management of the low-dose radiation program (1999–2016) and its current mission are described in Section 1.2. As noted, in support of its mission, BER has remained at the forefront of genome biology research and has also produced computational infrastructure and modeling capabilities that are run on DOE’s fastest supercomputers, which are among the most capable in the world (DOE, 2021b). BER supports three DOE Office of Science user facilities: the Atmospheric Radiation Measurement Climate Research Facility, the Environmental Molecular Sciences Laboratory, and the Joint Genome Institute. Additionally, four DOE Bioenergy Research Centers were established to pursue early-stage research on bio-based products, clean energy, and next-generation bioenergy technologies.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

TABLE 4.1 Federal Agencies That Support Low-Dose Radiation Research or Have Relevant Expertise

Low-Dose Radiation Researcha Considerable Radiation Health Expertise
Department of Energy
Office of Science Not explicitly No
Office of Health and Safety Not explicitly Yes
National Aeronautics and Space Administration Not explicitly Yes
National Institutes of Health
National Cancer Institute
Radiation Epidemiology Branch Not explicitly Yes
Radiation Research Program No Yes
National Institute of Allergy and Infectious Diseases No Yes
National Institute of Environmental Health Sciences No No
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health Not explicitly Yes
Radiation Studies Section Not explicitly Yes
Department of Defense
Defense Threat Reduction Agency Not explicitly Yes
Armed Forces Radiobiology Research Institute No Yes
Intelligence Advanced Research Projects Activity Not explicitly No
National Science Foundation No No

a Some agencies define “low dose” as a dose below 1 gray, which is not a low dose for the purposes of this report.

Despite authorization to start a low-dose radiation program and appropriation of funds, DOE’s Office of Science has not reestablished a low-dose radiation program of the scale and scope defined in the Consolidated Appropriations Act, 2021. Notably, the Biological Systems Science Division, the division within DOE’s Office of Science tasked with establishing the low-dose radiation program, issued its strategic planning report in April 2021 (DOE, 2021a) and did not mention the mandate from Congress to reestablish the low-dose radiation program.

In 2020, DOE’s Office of Science received $5 million in appropriations funds for low-dose research and directed it to three national laboratories (Argonne National Laboratory [ANL], Brookhaven National Laboratory [BNL], and Oak Ridge National Laboratory [ORNL]) for “the exploration of the potential for artificial intelligence [AI] and machine learning

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

to advance low-dose radiation biology research.”1 The RadBio-AI project built on models and methods used by the DOE-National Cancer Institute (NCI) collaborative project CANDLE (CANcer Distributed Learning Environment), which aims to develop deep learning methods on computing platforms to support cancer research and enable precision medicine (Peterson and Cooke, 2019). DOE has reported that researchers are adapting models and methods from CANDLE for low-dose radiation research in three areas:2

  1. Discovering, detecting, and characterizing molecular signatures of radiation damage in biological tissues and determining the potential differentiation of any signatures from radiation types, doses, and exposure patterns.
  2. Extracting from the literature and medical records information that can estimate dosing, exposure, and radiation types an individual has been exposed to as well as associated comorbidities.
  3. Searching for new methods that can be used to enhance detection sensitivity of molecular signatures, evidence of exposure, and outcomes.

In 2021, the same three DOE national laboratories received an additional $4.5 million to continue work on the RadBio-AI project.3 In both years, the grants to the national laboratories to support this project were non-competitive, non-peer reviewed, and solicitation was not made to the broad scientific community.

Office of Health and Safety

The mission of the Office of Health and Safety includes establishing DOE worker safety and health policy; conducting health studies to determine worker and public health effects from exposure to hazardous materials associated with DOE operations; implementing medical surveillance and screening programs for current and former workers; and supporting the operation and maintenance of several registries including the Comprehensive Epidemiologic Data Resource, the U.S. Transuranium and Uranium Registries, and the Beryllium-Associated Worker Registry.4 The Office of Domestic and International Health Studies, within the Office of Health and

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1 Email communication from Todd Anderson, DOE, to Ourania Kosti, National Academies, on September 21, 2021.

2 Email communication from Todd Anderson, DOE, to Ourania Kosti, National Academies, on September 21, 2021.

3 At the time of this writing (February 2022) publications from this project were not available.

4 See https://www.energy.gov/ehss/domestic-health-studies-and-activities.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

Safety, also supports research programs mandated by Congress or required by international agreement. These include5

  • The Marshall Islands Program, which provides annual medical surveillance and care, environmental monitoring and characterization, and dose assessment for the peoples of four atolls that were impacted by the U.S. nuclear testing.
  • The Russian Health Studies Program, which supports epidemiological studies, radiation dose reconstruction studies, and a tissue repository focused on workers at the Mayak Production Association (Mayak), and on the residents of the communities surrounding this facility, specifically the population living near the Techa River.
  • The Japan Program, which supports studies of the Japanese atomic bombing survivors of Hiroshima and Nagasaki carried out at the Radiation Effects Research Foundation (RERF; see Section 4.5.6).

The Office of Health and Safety does not have available funds to support competitive external grants and contracts.

A representative of the Office of Domestic and International Health Studies who briefed the committee did not describe a formal coordination of efforts with the previous low-dose program. However, both the DOE Office of Science and the Office of Environment, Health, Safety and Security supported the Million Person Study at different time periods and interacted during program meetings.6

4.1.2 National Aeronautics and Space Administration

The National Aeronautics and Space Administration’s (NASA’s) primary interest in radiation research is to characterize and mitigate the risk to astronauts’ health from space radiation. Space radiation is comprised primarily of galactic cosmic rays, solar particle events, and trapped radiation, making it both quantitatively and qualitatively different from terrestrial radiation (see NASEM, 2021c). The doses received over an astronaut’s career tend to be within the moderate-dose region and are expected to be higher (exceed 1 Sv) for long-duration Mars missions. However, low-dose radiation research is highly relevant for some NASA space missions, for example, to the International Space Station. Furthermore, the health outcomes of interest and the scientific approaches to understand the effect of radiation are consistent across the low- and moderate-dose regions.

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5 See https://www.energy.gov/ehss/international-health-studies-and-activities.

6 Anthony Pierpoint, DOE, presentation to the committee on August 26, 2021.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

NASA supports three research programs that investigate the effect of radiation on health (NASEM, 2019c):

  1. The Human Research Program (HRP), which aims to investigate and mitigate the risks to astronauts’ health and performance in support of exploration missions. HRP utilizes an Integrated Research Plan to identify research activities and approaches to address known risks to astronauts’ health (NASA, 2021), and these activities are undertaken by one of five HRP Elements.7 The main focus of the Space Radiation Element is the characterization and mitigation of radiation risk.
  2. The Space Biology Program, which examines how plants and animals regulate and sustain their growth in space.
  3. The Space Station Research and Technology Program, which conducts research on a large array of different experiments from biology and biotechnology to human health research relevant to exploration missions.

NASA has developed several databases and repositories for human and non-human data and samples to enable future experiments. The Lifetime Surveillance of Astronaut Health repository contains astronaut medical data for clinical use; the Life Science Data Archive contains data from astronauts collected by HRP for research purposes; the Ames Life Sciences Data Archive (ALSDA) contains data from mammalian and microbial experiments; and GeneLab contains space-related -omics data. According to the NASA representative who briefed the committee,8 usage of FAIR (findable, accessible, interoperable, and reusable) data principles (Wilkinson et al., 2016) for GeneLab and ALSDA help optimize the reusability of archived datasets and transform multiple databases to a knowledge-based system for risk modeling and risk assessment and for meta-analysis (see Figure 4.1).

Collaboration between NASA and DOE started with NASA’s support for operations of the Princeton Particle Accelerator and the Lawrence Berkeley National Laboratory (LBNL). Following the closing of the LBNL Bevalac accelerator, NASA and DOE signed agreements to ensure that beams of high-energy heavy ions continued to be available to simulate space radiation for physics and radiobiology research. NASA also had significant programmatic engagement with DOE’s low-dose program, likely more than any other federal agency. In 2002, DOE’s Office of Science and NASA’s Office of Biological and Physical Research under the Space Biology Program signed a memorandum of understanding (MOU) to establish

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7 See https://www.nasa.gov/hrp/elements.

8 Sylvain Costes, NASA, presentation to the committee on September 24, 2021.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×
Image
FIGURE 4.1 The National Aeronautics and Space Administration’s (NASA’s) knowledge-based system integrates information from multiple databases. The committee did not examine the effectiveness of the system.
NOTE: AI = artificial intelligence; ALSDA = Ames Life Sciences Data Archive; API = application programming interface; DB = database; DoD = Department of Defense; ML = machine learning; NIH = National Institutes of Health.
SOURCE: Sylvain Costes, NASA, presentation to the committee on September 24, 2021.

“formal scientific collaboration in understanding and predicting the effects and health risks resulting from low-dose and low-fluence radiation” (Schimmerling, 2011). Areas of common interest included relation between endogenous oxidative damage and low-dose radiation-induced damage, adaptive responses, bystander effects, and individual genetic susceptibility to low-dose radiation (Schimmerling, 2011). From 2003 to 2010, NASA and DOE jointly funded more than 50 projects that led to critical data generation and training of radiobiologists. The two agencies also co-funded workshops with international partners including RIKEN, Japan’s research institution in physics, engineering, chemistry, and computational science. According to the expert who briefed the committee, the reduction of funds at NASA for radiobiology research after 2010 along with the termination of DOE’s low-dose program eliminated opportunities for joint projects at that time.9

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9 Francis Cucinotta, University of Nevada, Las Vegas, presentation to the committee on August 26, 2021.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

4.1.3 National Institutes of Health

The committee received information on two programs within NCI and one within the National Institute of Allergy and Infectious Diseases (NIAID) that conduct or support research in low-dose radiation or have relevant expertise. The NCI programs on which the committee received information are the Radiation Epidemiology Branch (REB) within the Division of Cancer Epidemiology and Genetics, which is part of NCI’s intramural research program; and the Radiation Research Program within the Division of Cancer Treatment and Diagnosis, which is part of NCI’s extramural research program.10 The program within NIAID is the Radiation and Nuclear Countermeasures Program (RNCP), which is also an extramural program. The committee is also aware that NCI’s Environmental Epidemiology Branch within the Division of Cancer Control and Population Sciences supports extramural projects on low-dose chronic radiation exposures but did not have the opportunity to hear directly on that office’s research portfolio.

Radiation Epidemiology Branch, NCI

REB’s mission is to identify and quantify the risk of cancer in populations exposed to medical, occupational, or environmental radiation, and to advance understanding of radiation carcinogenesis. Some priority research areas within REB are quantifying the magnitude of the cancer risk at low doses and the impact of dose and dose rate, identifying the most radiosensitive populations, understanding the dose response for cardiovascular disease or cataracts, and pairing epidemiological studies with molecular studies to understand the mechanisms of radiation-related carcinogenesis.

REB has collaborated with several government agencies on low-dose radiation research. For example, together with DOE, it co-funded studies of health effects of the Japanese atomic bombing survivors and studies of workers employed at the Mayak Production Association, the first plutonium production plant in the former Soviet Union. REB has also collaborated with the National Institute for Occupational Safety and Health (NIOSH) on research studies such as the U.S. flight attendant cohort, and with the Environmental Protection Agency to co-fund events such as the National Academies’ Gilbert W. Beebe symposia, which aim to bring together the radiation science and radiation protection communities to discuss issues of radiation health. REB also collaborates in several studies with national and international academic and other organizations. For

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10 Intramural NCI research is carried out by NCI employees, and extramural research is carried out by universities and research centers across the United States and in some foreign countries by investigators who have been awarded grants through the NCI grant program.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

example, the UK-NCI computed tomography scan study with the University of Newcastle (Pearce et al., 2012); the U.S. Radiologic Technologists with the University of Minnesota (Kitahara et al., 2018; Little et al., 2020b, 2021b; Velazquez-Kronen et al., 2020); the Ukrainian Trios Study (Yeager et al., 2021) and the Ukrainian liquidators case-control studies (Gudzenko et al., 2022) with the National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine; and the U.S. interventional radiology physician cohort with the American Medical Association (Linet et al., 2017).

Radiation Research Program, NCI

The Radiation Research Program is responsible for management of NCI’s research support for radiation science spanning clinical trials, combined-modality radiotherapy, experimental therapeutics, radiation treatment planning, radiobiology, physics, and technology. A “low dose” for radiation oncology programs is defined as a dose in the lower end of the therapeutic range, generally at least 1–2 gray (Gy). The program did not have formal collaboration with the previous low-dose radiation program but had informal interactions at professional scientific meetings.

Radiation and Nuclear Countermeasures Program, NIAID

NIAID’s RNCP supports basic research, preclinical development, and advanced development related to medical countermeasures, biodosimetry, and decorporation following radiation public health emergency scenarios (e.g., detonation of a nuclear bomb or improvised nuclear device, a nuclear power plant accident or attack, and radionuclide exposures). RNCP’s short-term focus is on triage and treatment of life-threatening, high-dose radiation exposures, and its long-term focus is on delayed effects of acute radiation exposure with limited focus on cancer (which is the primary focus of NCI). That is, through its mandate, RNCP typically researches the effects of doses higher than 1 Gy delivered acutely or cumulatively with low dose rate and has a limited portfolio on internal emitters for decorporation and biodosimetry purposes.

The representative who briefed the committee11 said that RNCP collaborates and shares funding with other government agencies including the Office of the Assistant Secretary for Preparedness and Response, the Armed Forces Radiobiology Research Institute (AFRRI), the Biomedical Advanced Research and Development Authority, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, NASA, and the

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11 Andrea DiCarlo-Cohen, NIAID, presentation to the committee on September 24, 2021.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

National Institute of Standards and Technology. NIAID also collaborates with other NIH institutes. For example, it funded the development of a computer program for individual organ dose calculations from radiological accidents or terrorist events and retrospective biodosimetry research at NCI (McKenna et al., 2019). NIAID also collaborates with nongovernmental and international organizations including the Radiation Injury Treatment Network, the World Health Organization’s Radiation Emergency Preparedness Action Network Collaborating Center, and many industry partners.

RNCP has hosted 26 scientific meetings since 2005, bringing together government agency representatives (funding agencies and regulators), researchers, and industry representatives, and shares the outcomes of these meetings through peer-reviewed publications. Some recent topics and publications included growth factors and cytokines for radiation injuries (Perez Horta et al., 2019), cutaneous radiation injuries (DiCarlo et al., 2020), neutron radiobiology and dosimetry (Stricklin et al., 2021), and polypharmacy approaches for acute radiation syndrome (Taliaferro et al., 2021).

RNCP has not had formal collaborations with DOE’s low-dose program but has had informal interactions at DOE and professional society meetings.

4.1.4 Centers for Disease Control and Prevention

The committee received briefings from two offices within CDC that support low-dose radiation research: NIOSH and CDC’s Radiation Studies Section.

National Institute for Occupational Safety and Health

NIOSH’s mission is to develop new knowledge relevant to occupational safety and health and to transfer that knowledge into practice. Two divisions within NIOSH conduct or support radiation research: (1) the Division of Field Studies and Engineering, Field Research Branch, conducts epidemiological studies of the health effects of occupational exposure to radiation and evaluates exposures to radiation and other chemical and physical exposures; (2) the Division of Compensation Analysis and Support reconstructs the occupational radiation dose for certain workers with cancer who file claims under the Energy Employees Occupational Illness Compensation Act (see Box 2.1). NIOSH radiation research priorities include quantifying and controlling for sources of uncertainty affecting dose-response relationships; improving individual exposure assessment; evaluating cancer incidence and non-cancer mortality and incidence; expanding research on neutrons, tritium, and plutonium; and investigating potential synergistic effects between radiation and other agents.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

Starting in 1990, NIOSH supported (both in intramural and extramural programs) epidemiological studies of workers at DOE nuclear facilities. This work was carried out under a MOU between DOE and the Department of Health and Human Services (HHS), which was put in place because of concerns about DOE’s independence and objectivity in conducting research related to radiation health effects (epidemiological studies and radiation exposure assessments). The MOU named DOE as the administrator and funding source for the radiation health effects research while HHS conducted the research (see NRC, 2006b, for more details). The MOU also included clauses for sharing of employment and dosimetry records on Atomic Energy Commission/DOE workers.12 An independent advisory board, the Advisory Committee for Energy-Related Epidemiologic Research (ACERER), was created to provide advice and strategic direction in conducting the program (see Section 6.2). The reports, peer-reviewed publications, and presentations were summarized and evaluated in a National Academies report (NRC, 2006b) and were distributed to workers and the public to increase transparency. Despite the expiration of the MOU between DOE and HHS, NIOSH continues to conduct radiation research, albeit on a more limited scale. This research includes epidemiological studies of aircrews (Grajewski et al., 2018; Pinkerton et al., 2018), uranium miners (Anderson et al., 2021), and DOE workers (Leuraud et al., 2021; Schubauer-Berigan et al., 2015). NIOSH also participates in analyses of international occupational cohorts including the Pooled Uranium Miner Analysis and the International Nuclear Workers Study and funds extramural research on low-dose radiation.

Radiation Studies Section

The mission of CDC’s Radiation Studies Section (formerly Radiation Studies Branch) is to assess radiation-related hazards of public health concern; develop evidence-based environmental public health strategies and interventions to protect the public from radiation-related hazards; and disseminate and translate best practices guidance, training, tools, and information to professional and lay audiences. Exposures to radiation of public health interest include medical exposures, environmental exposures, occupational exposures, and exposures from accidents or acts of terrorism. The Radiation Studies Section carries out work to find out what information

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12 The shift of the responsibility for epidemiological studies of radiation health effects from DOE to HHS was recommended by the independent Secretarial Panel for the Evaluation of Epidemiological Research Activities (SPEERA, 1990). The 1990 MOU between DOE and HHS was renewed every 5 years. Although the MOU expired in 2005, DOE continued to fund research for some years afterward.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

related to radiation exposures needs to be communicated to whom and how best to communicate it by doing message testing with focus groups, hosting roundtables with professionals and subject-matter experts, and conducting individual interviews and surveys. The representative who briefed the committee noted that CDC scientists from the Radiation Studies Section did not have formal interactions with DOE during the previous low-dose radiation program.13

4.1.5 Department of Defense

Two entities that are assets of the Department of Defense (DoD) conduct or support low-dose radiation research or have relevant expertise: AFRRI and the Defense Threat Reduction Agency (DTRA).

Armed Forces Radiobiology Research Institute

AFRRI is responsible for preserving and protecting the health and performance of U.S. military personnel operating in potential radiologically contaminated multidomain conventional or hybrid battle spaces and urban environments. AFRRI is the primary DoD entity dedicated to radiation health effects research, education, and operational training. Research areas include biodosimetry, internal contamination, radiation combined injury, radiation countermeasures, and prophylaxis and treatment. In 2014, AFRRI asked the National Academies to identify opportunities to advance its mission for understanding human health risks from exposure to low-dose radiation with special emphasis on DoD military operations and personnel. A report from the Institute of Medicine and the National Research Council concluded that performing substantive work in this area will first require changes in institutional culture and a reorienting of staff expertise, but it identified several opportunities for additional or expanded roles for AFRRI including in preparedness and response to nuclear or radiological emergencies, management of psychological effects associated with a nuclear or radiological emergency, development and management of DoD radiation protection instrumentation, workforce education for radiation professionals, and support of radiation epidemiology and risk research (IOM and NRC, 2014). Since the release of this report, AFRRI has initiated a low-dose radiation program, defining “low dose” as doses below 1 Gy. The expert who briefed the committee did not provide details on specific projects supported under this new program.14

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13 Armin Ansari, CDC, presentation to the committee on September 24, 2021.

14 Alexandra Miller, AFRRI, presentation to the committee on September 24, 2021.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

Defense Threat Reduction Agency

DTRA is a combat support agency for countering weapons of mass destruction (WMDs). Established in 1998 as part of the 1997 Defense Reform Initiative, it has focused its basic research efforts in areas to reduce, eliminate, and counter the threat and mitigate the effects of WMDs, including those that are radiological in nature. Although the focus encompasses higher doses and dose rates of radiation, DTRA conducts research on single high-energy particle strikes and has provided limited funding for space radiation research (see Appendix D).

4.1.6 National Science and Technology Council

The American Innovation and Competitiveness Act of 2017 (Public Law 114-329) tasked the National Science and Technology Council (NSTC) with coordinating federal efforts related to radiation biology research and with formulating scientific goals for the future of low-dose radiation research in the United States. The report from this effort was publicly released in 2022 (NSTC, 2022). It recommends establishment of an interagency coordination mechanism within the federal government and with international partners for low-dose radiobiology research, with the overall goal to promote communication and a course of research that reduces uncertainty in risk estimates for adverse health outcomes and establishes the shape of the dose-response curve for adverse health outcomes at low doses and low dose rates of radiation (NSTC, 2022). The expert who briefed the committee noted that “defining the threshold of impact for low-dose and low-dose-rate” radiation is a priority for the NSTC committee.15

The NSTC report uses the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC) as an example of coordinating mechanism for radiation research and policy among federal agencies. CIRRPC was established in 1984 by the Office of Science and Technology Policy, with the mandate to coordinate radiation matters between agencies, evaluate research, and provide recommendations on the formulation of radiation policy. In 1994, CIRRPC became a subcommittee of the Committee on Health, Safety and Food, under the NSTC (Young, 2020). CIRRPC consisted of two components, a policy committee and a science panel of senior radiation scientists from member agencies. Technical and administrative support for the CIRRPC program was provided through a DOE contract with Oak Ridge Associated Universities. CIRRPC published 20 reports that addressed radiation research

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15 Kartik Sheth, White House Office of Science and Technology Policy, presentation to the committee on January 24, 2022.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

and policy issues such as radiation compensation, measurements, records, and controls; radiation exposure, dose, and risk assessment; and health effects of low levels of radiation (Young, 2020). It was dismantled in 1995 after 11 years of operation because of challenges with establishing consensus and coordinating agencies’ policies. According to a 1994 GAO report, CIRRPC’s interagency coordination of radiation protection policy was ineffective.

The expert who briefed the committee16 did not provide details on how a CIRRPC-type committee would operate to coordinate low-dose radiation research across the federal government. Specifically, details on membership of the committee, funding, and authority remain to be determined.

4.1.7 Intelligence Advanced Research Projects Activity

The Intelligence Advanced Research Projects Activity within the Office of the Director of National Intelligence invests in high-risk/high-reward projects. An unlikely radiation research agency, it recently launched the Targeted Evaluation of Ionizing Radiation Exposure (TEI-REX) program to establish novel minimally invasive biodosimetry methods for low doses of radiation (defined as doses below 0.75 Gy). The TEI-REX program asks research teams in several entities including the Los Alamos National Laboratory (LANL) and LBNL to develop novel approaches to detect radiation-induced changes in noninvasive samples such as skin, hair, nails, and saliva.17

4.2 LOW-DOSE RADIATION RESEARCH IN NATIONAL LABORATORIES

National laboratories have traditionally been a vital component of DOE’s research capabilities, including radiation research, enabling teams of scientists spanning biology, chemistry, physics, and computation to tackle scientific questions and develop technologies deployed nationally and internationally. For example, national laboratories supported DOE’s large radiobiology life-span studies of more than 200,000 mice, 40,000 rats, and 30,000 dogs that were exposed to varying doses, dose rates, and qualities of ionizing radiation. These animals were followed throughout their life span with incredible amounts of recorded experimental detail, pathologies, and reports of disease state (see Zander et al., 2019, for review). The life-span studies involved extensive coordination among the Inhalation Toxicology Research Institute for inhaled radionuclides in dogs and rats,

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16 Kartik Sheth, White House Office of Science and Technology Policy, presentation to the committee on January 24, 2022.

17 See https://discover.lanl.gov/news/stories/010522-biodosimetry.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

Pacific Northwest National Laboratory (PNNL) for injected and inhaled radionuclides in dogs, ORNL for mouse genetics studies, ANL for external beam exposures in dogs and mice, and two universities (University of Utah for inhaled radionuclides and University of California, Davis, for a variety of internal exposures). In addition to these studies, technology development in the national laboratories led to tools including flow cytometry, mass spectrometry, molecular cytogenetic methods, electron microscopy, and aspects of systems biology that can be applied worldwide to detect radiation-induced damage and define precise disease phenotypes. PNNL focused on the development of modern proteomic and systems biology, LANL and Lawrence Livermore National Laboratory (LLNL) focused on flow cytometry and sorting, and LBNL contributed to the development of electron microscopes for assessment of cellular ultrastructures.

During the previous low-dose program, national laboratories (primarily LBNL, ORNL, and PNNL) received about 60 percent of the total low-dose radiation program funding from DOE to conduct research in three scientific focus areas:18

  1. PNNL on linear and nonlinear tissue-signaling mechanisms in response to low-dose and low-dose-rate radiation,
  2. LBNL on a systems biology approach to assessment of responses to low-dose and low-dose-rate ionizing radiation, and
  3. ORNL on systems genetics approach to low-dose radiation.

In addition to the above-mentioned capabilities, DOE national laboratories supported radiation facilities suitable for inhalation studies, low-dose and low-dose-rate gamma-ray rooms, neutron exposure facilities, and other facilities relevant to low-dose radiation research that were at one time exceptional and recognized worldwide. However, these facilities are no longer operational due to lack of maintenance and eventual decommissioning.

To understand the current role of the national laboratories in low-dose radiation research supported by the federal government, if any, the committee requested from DOE a list of low-dose projects supported by national laboratories, including their scope and funding level. DOE provided to the committee a list of 49 projects carried out in 7 DOE national laboratories (ANL, BNL, LANL, LBNL, LLNL, ORNL, and PNNL) between 2015 and 2021 (see Appendix D). Upon the committee’s review, only a few of the projects, primarily those funded in 2016 (the final year of the previous low-dose program), were low-dose radiation projects as would be defined by the committee. The remaining projects aim to answer scientific questions

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18 See https://web.archive.org/web/20150906124306/http://lowdose.energy.gov/national_labs.aspx for additional information.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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not directly relevant to a mechanistic understanding of low-dose exposure. According to DOE, total funding for these projects was approximately $60 million for the 6-year period, and support for the projects came from DOE, NIH, NASA, Laboratory Directed Research and Development funds, or other sources. NASA was the largest funding source both in terms of number of projects supported and funding amount.

In addition to the information on projects carried out at national laboratories, DOE also provided to the committee some information on current national laboratory capabilities that are relevant to low-dose radiation research.

ORNL has capabilities to study the effects of radiation on two-dimensional cell culture models, three-dimensional spheroid cultures, and tissues-on-a-chip. In addition, ORNL has developed high-throughput DNA damage assays to evaluate the response to radiation with greater sensitivity using a dissociation-enhanced fluorescence immunoassay for detecting -H2AX formation in cell nuclei.

The NASA Space Radiation Laboratory at BNL develops computational models, methodologies, and biological models to support NASA’s missions, but these tools also have some applications at low doses. BNL also supports testing of electronic equipment (often the components of satellites) and of radiation detectors and charged-particle radiation beams as cancer treatment options.

LANL has developed transcriptomics, proteomics, and bioinformatics capabilities. LANL also has numerous platforms for single-cell studies (isolation and flow cytometry).

ANL generates radioisotopes at its Low-Energy Accelerator Facility for medical, national security, basic science, and industrial applications and uses the Argonne Tandem Linac Accelerator System facility for cell experimentation.

PNNL’s Radiology Exposure and Metrology laboratory supports radiation dosimetry for radiation worker protection and other applications, as well as microdosimetry and shielding effectiveness studies. The Radiation Dosimetry Lab supports male and female anthropomorphic phantoms for external-beam dose studies, including radiation protection garments. PNNL’s Environmental Testing Lab provides for concurrent combinations of temperature, humidity, and radiation exposures.

Although important, these capabilities highlight the refocus of the national laboratories on research areas other than low-dose radiation mechanisms and effects.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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4.3 LOW-DOSE RADIATION RESEARCH IN UNIVERSITIES

The late William F. Morgan, laboratory fellow at PNNL, presented at a 2014 National Academies meeting a slide (see Figure 1.2) indicating research support by the low-dose radiation program to about 30 universities in the United States and more internationally. Today, much of the funding support for radiation research is provided by NASA for individual investigator-driven projects or collaborative projects on a focused research goal. NASA provides integration for the different projects it funds at annual meetings. NASA also provides physics support for programs that require it, particularly with regard to using the NASA Space Radiation Laboratory at BNL.

Additional radiation research at universities is supported through funding by NIH, DoD, and other agencies, although the vast majority of this work is on high radiation doses and effects relevant to radiation therapy.

4.4 SUPPORT FOR LOW-DOSE RADIATION RESEARCH BY OTHER U.S. ENTITIES

This section summarizes several entities that have an interest in low-dose radiation research and support it in different ways through their activities.

4.4.1 National Council on Radiation Protection and Measurements

The mission of the National Council on Radiation Protection and Measurements (NCRP) is to support radiation protection by providing independent scientific analysis, information, and consensus recommendations. NCRP has not directly addressed low-dose radiation research priorities, but a number of recent NCRP publications address low-dose radiation issues. These include the following:

  • A commentary on the implications of recent epidemiological studies for the linear no-threshold (LNT) model and radiation protection (NCRP, 2018a).
  • A report on medical doses to patients in the United States (NCRP, 2019), which provides an update regarding medical doses in a previous report on the broader topic on radiation doses to the U.S. population (NCRP, 2009a).
  • A report on approaches for integrating radiation biology and epidemiology for enhancing low-dose risk assessment (NCRP, 2020b). The report includes a discussion of the appropriateness of the
Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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    adverse outcome pathway (AOP) methodology19 for the assessment of radiation effects.

  • A commentary on naturally occurring radioactive material (NORM) and technologically enhanced NORM from the oil and gas industry (NCRP, 2020a).

NCRP remains interested in assessing the current status of the radiation professionals’ workforce and is updating its 2015 statement titled Where Are the Radiation Professionals? (NCRP, 2015b).

4.4.2 Electric Power Research Institute

The Electric Power Research Institute (EPRI) is an international member organization that conducts research and development related to the generation and use of electricity. EPRI has published several documents related to low-dose radiation (EPRI, 2011, 2014, 2020) and has been involved in activities such as the appropriateness of the AOP methodology used to evaluate the biological and toxicological effects of chemicals to provide a framework for the assessment of radiation effects. In 2016, it established the International Dose Effect Alliance to organize workshops with participation from national and international researchers to discuss research agendas, programs, and priorities in low-dose radiation research.

4.4.3 Health Physics Society

The Health Physics Society (HPS) supports radiation protection professionals in the practice of their profession and promotes excellence in the science and practice of radiation safety. In 2017, Oak Ridge Associated Universities and DOE’s ORNL in partnership with HPS hosted a workshop to address radiation protection research needs. The research needs were summarized in a recent report authored by an HPS Task Force (HPS, 2021) and were broken down into nine broad areas as follows: nuclear fuel cycle and nuclear power production, radiation protection through improved estimates of radiation effects and risk at low doses, use of radiation for medical care, improved measurement of radiation through instrument development, decontamination and decommissioning of nuclear facilities, exploration of

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19 AOP is a conceptual framework developed by the Organisation for Economic Co-operation and Development (OECD) to describe a sequence of causally linked events that occur in response to a stressor and lead to an adverse health outcome relevant to risk-based evaluations and management, and regulatory decision-making. The AOP framework is widely used in chemical toxicity testing and there is a growing interest in applying it for radiation effects.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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space, national defense, emergency response to nuclear events, and prediction of the fate and effects of radionuclides in the environment.

The HPS Task Force report did not attempt to prioritize the research needs but instead recommended that several factors be integrated in the prioritization process, including the magnitude of risk reduction, potential resource savings, and operational and medical impacts.

4.4.4 American Nuclear Society

The American Nuclear Society (ANS) is an international member organization that promotes the field of nuclear engineering and related disciplines. In 2017, ANS participated in a membership-wide effort to identify “the technical nuclear challenges that need to be resolved by 2030 in order to help solve some of the economic, sociological, or political issues that we face as a society” (ANS, 2017). In this initiative, the ANS membership identified that establishing a modern scientific basis and guidelines for health effects of low-dose radiation regulation is a top-most priority. In 2020, ANS released an updated position statement and recently supplemented it with technical background (ANS, 2022). In this statement, ANS notes that the LNT model used in radiation protection may not adequately describe the relationship between harm and exposure and that long-term research in low-level radiation exposure is needed to improve risk-informed decision-making.

4.5 SUPPORT FOR LOW-DOSE RADIATION RESEARCH INTERNATIONALLY

Several international entities support low-dose radiation research. The committee had the opportunity to learn about some of these programs or initiatives and summarizes them in the following sections. The entities described here are the Multidisciplinary European Low-Dose Initiative (MELODI); the International Commission on Radiological Protection (ICRP); the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR); the Nuclear Energy Agency/Organisation for Economic Co-operation and Development (NEA/OECD); and programs in Canada and Japan. This list is not exhaustive, and other international entities and countries not described in this section may support low-dose radiation research.20 The committee discusses the possibility of joint efforts

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20 For example, in India, the Bhabha Atomic Research Centre carries out work on high natural background radiation, and in Russia, the Southern Ural Biophysics Institute and the Urals Research Centre Radiation Medicine carry out some low-dose radiation research.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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with these and other international programs and possible cost sharing for low-dose radiation projects in Section 6.8.

4.5.1 Multidisciplinary European Low-Dose Initiative

MELODI21 is a European research platform dedicated to low-dose radiation health risk research, and is one of six such platforms covering the range of disciplines relevant to radiation protection that operate under the European umbrella organization MEENAS (MELODI, EURADOS, EURAMED, NERIS, ALLIANCE, SHARE).22 MELODI was established in 2010 following the recommendations of the High Level Expert Group on European Low-Dose Risk Research. Currently, MELODI has more than 40 members from 18 countries who represent national bodies, universities, and research institutes committed to low-dose radiation research. While neither MELODI nor MEENAS provides funding for research, support is provided to the research community to ensure that it is able to respond to funding opportunities, especially those issued by the European Commission’s Euratom program. For example, the CONCERT European Joint Programme was a large-scale program that supported nine specific research projects, three of which specifically relate to low-dose health risk.

MELODI has made major contributions to focusing European research efforts through the development and regular updating of a strategic research agenda. The latest agenda (MELODI, 2021) proposes research in four main areas: Dose- and dose-rate dependence of cancer risk, risk for non-cancer effects, individual variation in risk, and effects of spatial- and temporal-variation in dose delivery. MELODI supports annual workshops from which several publications have been produced (see, e.g., Averbeck et al., 2020; Gomolka et al., 2020; Kreuzer and Bouffler, 2021; Pasqual et al., 2021; Seibold et al., 2020; Tapio et al., 2021) and has working groups to address research infrastructure needs as well as education and training.

From 2015 to 2020, CONCERT was operating as an umbrella structure for the research initiatives of several European radiation protection research platforms including MELODI. CONCERT supported 3 emergency preparedness and response projects (total of 50 partners funded at the level of e11.2 million over 3 years); 3 radiobiology projects (total of 16 partners funded at the level of e5.5 million over 3 years); 2 dosimetry projects (total of 17 partners funded at the level of e2.1 million over 2 years); and 1 stakeholder engagement project (13 partners funded at the level of e0.8 million over 2 years).23 Pianoforte, the follow-on project from CONCERT,

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21 See https://melodi-online.eu.

22 See https://eu-meenas.net/doku.php.

23 See https://www.concert-h2020.eu/concert-info/about-concert.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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is currently in contract negotiations and is expected to fund radiation protection projects at a level estimated to be on the order of e4.1 million per year over 5 years.

4.5.2 International Commission on Radiological Protection

ICRP is an independent, nongovernmental organization tasked with radiation protection; its recommendations form the basis of standards, regulations, and practice of radiological protection worldwide. ICRP initiated a review of the system of radiological protection to address changes in scientific knowledge as well as the use of ionizing radiation in different applications including in medicine, industry, and research (Clement et al., 2021). This review is expected to take a decade to complete and could result in revisions to the system and general recommendations to supersede ICRP Publication 103 (ICRP, 2007). ICRP includes in its strategic plan a priority to identify areas of research to support the system of radiological protection. The latest priorities list was published in 2021 (Laurier et al., 2021) and is summarized in Table 4.2.

4.5.3 United Nations Scientific Committee on the Effects of Atomic Radiation

UNSCEAR has been involved in examination of radiation effects for more than 60 years and has provided reports on a variety of radiation-related topics including effects and risks from ionizing radiation, epidemiological evaluation of radiation-induced cancers, biological effects at low radiation doses, combined effects of radiation and other agents, and levels and effects of radiation exposure following the Chernobyl and Fukushima accidents. In 2021, UNSCEAR published a report that examined biological mechanisms relevant to the inference of cancer risks following low-dose and low-dose-rate exposures, dose-response relationships, integration of data at different levels of organization, and modeling of cancer mechanisms, and offered directions for future research. The report was limited to mechanisms relating to cancers and did not consider those relating to non-cancer outcomes (UNSCEAR, 2021).

In the context of this report, the most notable conclusions of the UNSCEAR report are as follows (UNSCEAR, 2021):

  • There are limited robust data that can be identified at this time that would prompt the need to change the current approach taken for low-dose radiation cancer risk inference as used for radiation protection purposes.
Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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TABLE 4.2 International Commission on Radiological Protection’s Research Priorities to Support the Radiation Protection System

Short Term/Midterm (up to 10 years) Longer Term (beyond 10 years)
Research to support radiation risk assessment Appropriateness of the classification of radiation health effects to tissue reactions and stochastic effects. Basic research, for example, on mechanisms of low-dose effects at molecular, cellular, and tissue levels including non-targeted effects; identification of radiation signatures for cancer; integration of approaches such as considering adverse outcome pathways.
Characterization of tissue reactions. Effects of combined exposures.
Characterization of stochastic effects and radiation detriment, specifically cancer risk models and tissue weighting factors; dose-rate effects and cancer; impact of non-radiation factors in detriment calculations; potential impact of the circulatory system; effects of radiation from in utero exposure; heritable effects of radiation on offspring and next generations; uncertainty analysis.
Individual response of humans to radiation.
Radiation effects on non-human biota.
Research to support dosimetry Relative biological effectiveness, quality factor, and radiation weighting. Definition of dosimetric targets in organs and tissues.
Appropriate dosimetric quantities for medicine and other applications. Strengthening dosimetric targets and methodology for the protection of the environment.
Dosimetry in emergency situations. Biokinetic models of radionuclides and radioactive substances in human tissues.
Research to support the application/implementation of radiation protection system Development and use of radiation technologies.
Ecosystem protection.
Research needs for the application of the system of radiological protection.
Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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  • There remains good justification for the use of a non-threshold model for risk inference for radiation protection purposes, given the present knowledge of the role of mutation and chromosomal aberrations in carcinogenesis.
  • The implications of the studies on the induction of transmissible genomic instability, bystander effects, abscopal effects, and adaptive responses are still not clear. Adaptive response studies remain without a confirmed mechanistic basis and are of mixed outcome.
  • The recommended approach for combining a mechanistic understanding of low-dose radiation carcinogenesis with epidemiological studies is to use mathematical modeling integrating data from experimental systems (e.g., dose-response data for induction of key mutations or epimutations). The use of AOP approaches can help define and formalize key mechanistic steps in carcinogenesis following low-dose exposures.
  • Experimental investigations may identify cancer risk indicators that, when validated, could be integrated into epidemiological investigations to improve statistical power or be used for population screening.

4.5.4 Nuclear Energy Agency/Organisation for Economic Co-operation and Development

NEA is an intergovernmental agency that operates within the framework of OECD with the mission to provide assistance to member countries in maintaining and further developing the scientific, technological, and legal bases required for safe, environmentally friendly, and economical use of nuclear energy for peaceful purposes. Coordination and cooperation among member countries is central to the agency’s mission. In 2018, participants of an NEA/OECD scoping meeting concluded that global coordination in low-dose radiation research has the potential to improve cost-effectiveness and efficiency, increase international awareness of research, and facilitate data sharing and access to unique facilities. To address these and other issues, participants of the NEA/OECD scoping meeting recommended the establishment of a high-level group by NEA/OECD to support the development of a global coordination initiative in low-dose research. The high-level group in low-dose research (HLG-LDR) was put in place in 2021 and formed three topical groups to carry out its work tasked with (1) the creation of an online register of ongoing or planned low-dose research projects, (2) the development and use of the AOP framework in radiation research and regulation, and (3) the implementation of a communication

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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strategy. Representatives of the HLG-LDR who briefed the committee provided information on the status of these three efforts.24

The low-dose research register (named the Global Register of Low Dose Radiation Research Projects) will include current and in-planning research projects in radiation biology, epidemiology, dosimetry, social sciences, and ecotoxicology and a simple description of research projects and contact information for the principal investigators. Collection of data will begin in 2022. Access to the register will be free and is expected to provide researchers with an efficient tool to identify possible collaboration opportunities, avoid unnecessary duplication of efforts, encourage international cooperation in low-dose research, and assist funding agencies in the selection of projects.

The HLG-LDR is undertaking an international effort to evolve the development and use of the AOP framework in radiation research and regulation. As part of these efforts, the group conducted a survey to gather insights on the challenges related to low-dose radiation research, risk assessment, and regulatory decision-making, and then plans to rank the priority questions. More than 250 questions or challenges were received and their categorization and ranking by a steering committee helped to prioritize the set of questions to the top 25 (unpublished).

HLG-LDR aims to improve communication on low-dose risks and uncertainties and adapt it to a targeted audience. To achieve that, the group will identify the available data and tools that can help in making communication more efficient, exercise how to translate technical results into policy-oriented messages, and create a fast track between research results and science-based policies and regulations.

4.5.5 Support for Low-Dose Radiation Research in Canada

The Canadian government and nuclear industry have increasingly directed resources toward low-dose radiation research. The committee describes a joint effort from Health Canada and the Canadian Nuclear Safety Commission (CNSC) and another effort from the CANDU Owners Group (COG).

Canadian Organization on Health Effects from Radiation Exposure

In 2020, Health Canada in partnership with CNSC established COHERE (Canadian Organization on Health Effects from Radiation Exposure)

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24 Jacqueline Garnier-Laplace, NEA/OECD, and Dominique Laurier, French Institute for Radiological Protection and Nuclear Safety, presentation to the committee on September 24, 2021.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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with four primary goals: improve alignment of the two organizations’ research priorities to focus and leverage resources; maintain and enhance expertise in dosimetry, radiobiology, and epidemiology; provide informed and consistent messages to the public and stakeholders on matters involving low-dose and low-dose-rate ionizing radiation; and strengthen Canada’s contributions toward international efforts.

COHERE published its strategic research agenda in 2020 and identified five research themes (see Table 4.3). The strategic research agenda will be reviewed every 3 years or at a frequency determined by the participating organizations. Following this review, COHERE will revise the research themes with input from stakeholders and based on available resources and national and international developments of interest to the program. COHERE does not currently have dedicated funding.

TABLE 4.3 Research Themes Under the COHERE Strategic Research Agenda

Themes Cancer Effects Non-Cancer Effects Globalized Data Sharing/Consolidation Capacity Building Epidemiological Studies
Research lines Conduct mechanistic-based studies to examine dose-response relationships and links to adverse outcomes Develop expertise in the area of data management and interpretation Test new technologies/approaches for identifying low-dose-response effects Link occupational data to cancer/mortality data
Priority areas Lung cancer (radon), kidney cancer (uranium), organ-level cancers (tritium) Cataracts (high and low linear energy transfer), kidney toxicity (uranium) Adverse outcome pathway, systematic reviews, benchmark dose modeling Optical spectroscopy, 3D organoid models, stem cell regeneration, phenotypic assays, dosimetry, -omics technology International pooled studies, uranium miners, other radon cohorts

SOURCE: Canadian Nuclear Safety Commission, https://www.cnsc-ccsn.gc.ca/eng/resources/research/cohere/strategic-research-agenda-cohere.cfm.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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CANDU Owners Group

A second effort within Canada to understand risks at low doses of radiation was initiated in 2017 by COG, a private, not-for-profit corporation funded voluntarily by international CANDU operating utilities, Canadian Nuclear Laboratories, and supplier participants. Motivation for this program was the decreasing political support for nuclear power, negative public attitude toward the future deployment of small modular reactors in Canada, cuts in investment and development in nuclear power, and increased industry operating and life-cycle costs. The scientific questions to be addressed by the program are driven by public concerns regarding low doses of radiation as identified by a social science project undertaken by the Centre for the Study of Science and Innovation Policy within the University of Saskatchewan. The representative who briefed the committee noted that the program is expected to generate information that can be used by those responsible for radiation protection and industry.

The operations of the program are facilitated by an advisory committee of academics and representatives of several Canadian government agencies. Tasks of the advisory committee include review of project progress, recommendations for project changes or initiation of new projects, and approval of manuscripts for journal submission. Project progress is summarized in an annual report to the program funders that is not made publicly available.

The budget for the program is approximately $1.5 million per year and currently supports 16 projects conducted primarily by Canadian universities. Embedded within the projects are training opportunities for masters- and doctoral-level research fellows.

4.5.6 Support for Low-Dose Radiation Research in Japan

The committee received briefings from three institutions in Japan that conduct radiation research: RERF, the National Institutes for Quantum Science and Technology (QST), and the Institute for Environmental Sciences (IES). Although RERF does not exclusively conduct low-dose radiation research, the other two organizations focus on low-dose radiation research questions. Japan is investing in a new project called PLANET, which aims to establish an all-Japan network among regulators, academia, research institutes, industrial partners, and other stakeholders with the objective to propose strategies to improve current understanding of low-dose and low-dose-rate risk.

Radiation Effects Research Foundation

Studies of the atomic bombing survivors of Hiroshima and Nagasaki began in 1947 with the founding of the Atomic Bomb Casualty Commission

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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(ABCC) by the National Academy of Sciences. In 1975 the ABCC was reorganized into RERF, a joint U.S.–Japan research organization supported with funding from the Japanese Ministry of Health, Labour and Welfare and DOE’s Office of Health and Safety; the National Academies continue to support RERF research activities through a cooperative agreement with DOE.

The Life Span Study (LSS) is the major epidemiological study conducted at RERF that was initiated in 1950 and continues today. It follows approximately 120,000 men and women of all ages who were atomic bombing survivors and residents of Hiroshima and Nagasaki (exposed individuals) or were not in either city at the time of the bombings (unexposed individuals). Demographically, the cohort consists of about 82,000 individuals from Hiroshima and 38,000 from Nagasaki; about 50,000 are males and 70,000 are females (Ozasa et al., 2018). As of 2017, 25 percent of the LSS was alive, and the average age was 81. The Adult Health Study is a clinical examination program of about 20,000 members of the LSS who were invited to participate in biennial health examinations beginning in 1958. RERF also conducts in utero studies and follow-up studies of the children of the survivors (F1 and F1 clinical studies) conceived after the bombings (Ozasa et al., 2019).

The atomic bombing survivor studies have made extensive efforts to estimate individual doses, based on data obtained from interviews with survivors or their surrogates regarding their exposure conditions and a detailed dosimetry system known as Dosimetry System 2002 (DS02, Cullings et al., 2006, 2017). These individual-level doses have made it possible to quantify risk (primarily cancer) as a function of dose and to investigate the dependency of the dose response on factors such as age and sex. Since 1950, RERF and its predecessor organization have published 14 reports on mortality among the atomic bombing survivors, 3 reports on cancer incidence, and several papers on cancer risks for individual sites (see Table 4.4 for the most recent publications on cancer incidence). For in utero exposures, the latest update found that atomic bomb radiation was associated with mortality from solid cancer for females but not males (Sugiyama et al., 2021). However, only a small portion (14 percent) of the survivors exposed in utero had died at the end of follow-up, so this cohort is expected to continue to provide valuable information on the effects of in utero exposure and cancer mortality later in life. Excess occurrences of leukemia have not been observed. Findings on untoward pregnancies are summarized in Section 2.2.6. Non-cancer effects such as cardiovascular disease, stroke, diabetes, chronic kidney disease, and cataracts are also under study.

Analyses of the atomic bombing survivor cohorts have identified radiation health effects, primarily for cancer mortality and cancer incidence, at higher doses with relative confidence (Grant et al., 2017; Ozasa et al.,

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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2012). However, estimating the health effects of low-dose or low-dose-rate radiation exposures using this cohort have been challenging. First, statistical uncertainties in health effects at low doses must account for errors that arise due to uncertainty in dosimetry parameters and measurement error in radiation exposure data. Currently, dose estimates for atomic bombing survivors do not fully account for all these sources of uncertainty. Second, while lifetime follow-up allows for a detailed ascertainment of health outcomes, competing risks between outcomes and how those outcomes might be differentially associated with radiation dose can impact the shape of the estimated dose-response association. Third, the LSS has only a limited collection of potential confounders and other risk factors to which small effects at low doses could be particularly sensitive. Therefore, identification of radiation-induced health effects at low doses cannot be based on the LSS alone.

A unique asset of RERF is the longitudinally collected biosamples donated by study participants. Close to 2 million biosample tubes have been collected today and stored at RERF. These samples provide important opportunities to identify potential biomarkers and study in detail the pathogenesis of both cancer and non-cancer effects using a range of -omics approaches. The biosample collection includes 1,000 parent–child trios, in which parents will have varied levels of exposure, suitable for the investigation of heritable genetic effects of parental radiation exposure. Today, biosamples at RERF remain largely underutilized. The foundation is taking steps to assess the ethical, legal, and social implications of human genome studies using these biosamples (Noda et al., 2021) and aims to initiate large-scale genomic and epigenomic analyses to identify differences in exposed and unexposed individuals in 2023.

National Institutes for Quantum Science and Technology

QST’s Department of Radiation Effects Research conducts research on the risk of carcinogenesis from low-dose radiation exposure using several animal models on identification of radiation signatures (Ishida et al., 2010; Tsuruoka et al., 2021). These studies have been driven by increasing anxiety regarding the impacts of long-term exposure to low doses of radiation in the context of nuclear accidents as well as medical radiation use. QST also collaborates in dosimetry for the epidemiological study of health effects in Fukushima nuclear emergency workers (Kitamura et al., 2018). The economic and practical limitations of conducting large-scale experiments as well as the ethical considerations led QST to the decision to store and share the pathological data and samples of the animal experiments for future use by constructing an archive called the Japan-Storehouse of Animal Radiobiology Experiments.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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TABLE 4.4 Summary of Cancer Incidence in the Life Span Study

Site Total Incidence of Cases (m; f) Sex-Averaged ERR at 1 Gy (95% CI) Effect Modification by ATB, AA Adjusted Life Style and Other Factors Publication
All solid 10,473; 12,065 0.47 (0.39, 0.55) 30, 70* Smoking Grant et al., 2017
Esophagus 394; 92 0.30 (0.06, 0.66) 30, – Smoking, drinking Sakata et al., 2019
Stomach 3,090; 2,571 0.33 (0.20, 0.47) –, 70 Smoking Sakata et al., 2019
Colon 782; 1,132 0.63 (0.34, 0.98) 30, 70 Smoking, drinking, meat intake, BMI Sugiyama et al., 2020
Rectum 518; 528 0.025 (−0.087, 0.14) 30, 70 Smoking, drinking, meat intake, BMI Sugiyama et al., 2020
Liver 1,166; 850 0.58 (0.27, 0.95) 30, 70 Smoking, drinking, BMI Sadakane et al., 2019
Pancreas 306; 417 0.45 (0.07, 0.92) 30, 70 Smoking, drinking, BMI Sadakane et al., 2019
Lung 1,445; 1,001 0.81 (0.51, 1.18) 30, 70 Smoking Cahoon et al., 2017
Female breast 1,470 1.12 (0.73, 1.59) 30, 70 Smoking, BMI, menarche, menopause, pregnancy-delivery Brenner et al., 2018
Uterine corpus 224 0.73 (0.03, 1.87) –, – Smoking, first pregnancy, menopause Utada et al., 2018
Uterine cervix 982 0.00 (−0.22, 0.31) –, – BMI, pregnancy-delivery, menopause Utada et al., 2018
Urinary tract, bladder 493; 297 1.4 (0.82, 2.1) 30, 70 Smoking Grant et al., 2020
Ovary 288 0.30 (−0.22, 1.11) –, – None of life style or reproductive factors Utada et al., 2020
Prostate 851 0.57 (0.21, 1.00) –, – None Mabuchi et al., 2020
Central nervous system 99; 186 1.40 (0.61, 2.57) –, – None Brenner et al., 2020

* Risk estimates for ATB of 30 years and AA of 70 years.

NOTE: AA = attained age; ATB = at the time of the bomb; BMI = body mass index; CI = confidence interval; ERR = excess relative risk; Gy = gray.

SOURCE: Robert Ullrich, Radiation Effects Research Foundation, presentation to the committee on January 24, 2022.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
×

Institute for Environmental Sciences

IES was established in 1990 with the mission to monitor radioactive releases and their effect on the environment and human health from the Spent Nuclear Fuel Recycling Plant in Rokkasho Village, Aomori Prefecture. IES accomplishes this mission by carrying out research activities at the Radioecology and Radiation Biology Departments. The institute currently has two mouse facilities conducting experiments on long-term low-dose-rate (0.05, 1, and 20 milligrays per day [mGy/day]) and medium-dose-rate (200 and 400 mGy/day) exposures to gamma rays, which are comparable to the doses accumulated by radiation workers. These facilities are available to outside investigators upon request. Studies conducted at IES include changes in somatic effects, transgenerational effects, and mechanisms following low-dose exposures. Future directions include studies on individual radiosensitivity including the effect of sex, age, diet, environment, and genetic background; epigenetic changes; neurobiological changes; and tritium internal exposures.

4.6 CHAPTER SUMMARY

A few federal agencies within the United States (primarily DOE, NASA, NIH, CDC, and DoD) have programs that support or conduct research on low-dose radiation relevant to the agency’s specific missions. Some offices within these agencies have relevant expertise but the research they support is primarily on higher doses and exposures. National laboratories have traditionally been a vital component of DOE’s research capabilities, including radiation research, enabling teams of scientists spanning biology, chemistry, physics, and computation to tackle scientific questions and develop technologies deployed nationally and internationally. Since termination of the previous low-dose radiation research program, national laboratory capabilities have been refocused on research areas other than low-dose radiation mechanisms and effects. Radiation research at universities is primarily supported by NASA for individual investigator-driven projects or collaborative projects on a focused research goal relative to NASA’s missions. There is currently no explicitly low-dose radiation research program in the United States. Internationally, several countries and regions, including Canada, Europe, and Japan, have focused low-dose radiation programs.

Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Suggested Citation:"4 Status of Low-Dose Radiation Research." National Academies of Sciences, Engineering, and Medicine. 2022. Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States. Washington, DC: The National Academies Press. doi: 10.17226/26434.
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Radiation exposure at low doses (below 100 milligray) or low-dose rates (less than 5 milligray per hour) occurs in a wide range of medical, industrial, military, and commercial settings. The effects of exposure at these levels are not fully understood, but there are long-standing concerns that such exposure could negatively affect human health. Although cancer has been linked to low-dose radiation exposure for decades, there is increasing evidence that low-dose radiation exposure may also be associated with cardiovascular disease, neurological disorders, immune dysfunction, and cataracts.

Recent advances in research, new tools, and a coordinated multidisciplinary research program could help fill knowledge gaps about the health impacts of low-dose radiation exposures. This report calls for the development of a U.S. research program to study how low doses of radiation affect cancer, cardiovascular disease, neurological disorders, and other disease risks. Research should also better define the impacts of radiation doses, dose rates, types of radiation, and exposure duration. The report estimates $100 million annually for the next 15 years would be required to conduct epidemiological and biological research, and to establish an infrastructure for research.

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