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Pages 86-126

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From page 86...
... The committee simplified Lave's typology into four basic frameworks -- negligible risk, lowest feasible risk, net risk, and cost-benefit balancing -- and discusses each framework briefly below. Although these frameworks are only part of the radiation protection risk governance, this discussion illustrates the importance of low-dose radiation knowledge and therefore research in low-dose radiation health effects to inform radiation protection regulation and guidance.
From page 87...
... The concept of negligible risk originated in food law where exceptions were needed to allow minute concentrations of chemical additives or contaminants in food or animal feed that pose at most a negligible risk of cancer to the public. In food law the threshold for fatal cancer was defined as a 1 in 1,000,000 chance on a lifetime basis when an LNT model is used to compute risk (FDA, 1977)
From page 88...
... Concerning fatal cancer risk, OSHA has not precisely defined a level of negligible risk but has indicated that cancer death risk levels above 1 in 1,000 for a career are "significant" enough to justify rulemaking, and risks below 1 in 100,000 might be considered safe (Sunstein, 2002)
From page 89...
... , recent research following the 2011 Fukushima nuclear power plant accident suggests that evacuations intended to avoid radiation exposure may trigger both immediate and longer-term risks in the impacted communities. At the same time, the risks of staying in the contaminated area due to damaged infrastructure, interruptions in food and medical supplies, human assistance, and other factors have not been sufficiently quantified.
From page 90...
... Feasibility-like concepts influence radiation protection at the U.S. NRC, but they have evolved differently from those at OSHA and EPA.
From page 91...
... , EPA estimated that radon is responsible for about 21,000 lung cancer deaths every year (EPA, 2003) , only 160 of them due to inhalation of radon that evaporated from drinking water.
From page 92...
... , monetization techniques will also be necessary for those health effects. When radiation protection measures are analyzed in medicine, the VSL approach to monetization is rarely used (IOM, 2006)
From page 93...
... . To the committee's knowledge, comprehensive estimates of overall costs to federal agencies and society to comply with current radiation protection standards and guidelines are unavailable.
From page 94...
... . Although the committee does not provide a quantitative estimate of the potential economic impacts of the low-dose radiation program, it assesses whether knowledge from low-dose radiation research can affect the decision-making frameworks in the federal regulatory system and how.
From page 95...
... risk estimates at low doses are accurate, underestimated, or overestimated. This evidence may impact radiation protection by confirming that current regulations and guidance sufficiently protect human health or by supporting either more restrictive or less restrictive regulations and guidance.
From page 96...
... Finding 3: The committee is unable to quantify the low-dose radiation program's economic impacts because comprehensive estimates of over all costs to comply with current radiation standards are unavailable. Additionally, any changes to the current estimates will depend on new information on adverse health effects that will be generated by the low-dose radiation research program.
From page 97...
... 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.
From page 98...
... 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.
From page 99...
... 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.
From page 100...
... . DOE has reported that researchers are adapting models and methods from CANDLE for low-dose radiation research in three areas:2 1.
From page 101...
... , 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)
From page 102...
... 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)
From page 103...
... 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 9 Francis Cucinotta, University of Nevada, Las Vegas, presentation to the committee on August 26, 2021.
From page 104...
... 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.
From page 105...
... . 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.
From page 106...
... 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.
From page 107...
... 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 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)
From page 108...
... conduct or support low-dose radiation research or have relevant expertise: AFRRI and the Defense Threat Reduction Agency (DTRA)
From page 109...
... 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)
From page 110...
... 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.
From page 111...
... 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.
From page 112...
... 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.
From page 113...
... 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 investigatordriven projects or collaborative projects on a focused research goal.
From page 114...
... 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 19 AOP is a conceptual framework developed by the Organisation for Economic Co-opera tion 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.
From page 115...
... . 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.
From page 116...
... .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.
From page 117...
... 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 radiationrelated 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.
From page 118...
... 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.
From page 119...
... the development and use of the AOP framework in radiation research and regulation, and (3) the implementation of a communication
From page 120...
... 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.
From page 121...
... TABLE 4.3 Research Themes Under the COHERE Strategic Research Agenda Globalized Cancer Non-Cancer Data Sharing/ Capacity Epidemiological Themes Effects Effects Consolidation Building Studies Research Conduct mechanistic-based Develop Test new Link lines studies to examine dose- expertise technologies/ occupational response relationships and in the area approaches data to cancer/ links to adverse outcomes of data for identifying mortality data management low-dose and response interpretation effects Priority Lung cancer Cataracts Adverse Optical International areas (radon) , (high and outcome spectroscopy, pooled studies, kidney low linear pathway, 3D organoid uranium miners, cancer energy systematic models, other radon (uranium)
From page 122...
... Embedded within the projects are training opportunities for mastersand 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)
From page 123...
... 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)
From page 124...
... 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.
From page 125...
... 125 SOURCE: Robert Ullrich, Radiation Effects Research Foundation, presentation to the committee on January 24, 2022.
From page 126...
... 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.


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