Establishing a communication and engagement strategy to facilitate the adoption of the adverse outcome pathways in radiation research and regulation.

BACKGROUND: Studies on human health and ecological effects of ionizing radiation are rapidly evolving as innovative technologies arise and the body of scientific knowledge grows. Structuring this information could effectively support the development of decision making tools and health risk models to complement current system of radiation protection. To this end, the adverse outcome pathway (AOP) approach is being explored as a means to consolidate the most relevant research to identify causation between exposure to a chemical or non-chemical stressor and disease or adverse effect progression. This tool is particularly important for low dose and low dose rate radiation exposures because of the latency and uncertainties in the biological responses at these exposure levels. To progress this aspect, it is essential to build a community of developers, facilitators, risk assessors (in the private sector and in government), policy-makers, and regulators who understand the strengths and weaknesses of, and how to appropriately utilize AOPs for consolidating our knowledge on the impact of low dose ionizing radiation. Through co-ordination with the Organisation of Economic Co-operation and Development (OECD) Nuclear Energy Agency (NEA) High-Level Group on Low-Dose Research (HLG-LDR) and OECD's AOP Programme, initiatives are under way to demonstrate this approach in radiation research and regulation. Among these, a robust communications strategy and stakeholder engagement will be essential. It will help establish best practices for AOPs in institutional project development and aid in dissemination for more efficient and timely uptake and use of AOPs. In this regard, on June 1, 2021, the Radiation and Chemical (Rad/Chem) AOP Joint Topical Group was formed as part of the initiative from the NEA's HLG-LDR. The topical group will work to develop a communication and engagement strategy to define the target audiences, establish the clear messages and identify the delivery and engagement platforms. CONCLUSION: The incorporation of the best science and better decision making should motive the radiation protection community to develop, refine and use AOPs, recognizing that their incorporation into radiation health risk assessments is critical for public health and environmental protection in the 21st century.

Personalized Cancer Risk Assessments for Space Radiation Exposures.

Individuals differ in their susceptibility to radiogenic cancers, and there is evidence that this inter-individual susceptibility extends to HZE ion-induced carcinogenesis. Three components of individual risk: sex, age at exposure, and prior tobacco use, are already incorporated into the NASA cancer risk model used to determine safe days in space for US astronauts. Here, we examine other risk factors that could potentially be included in risk calculations. These include personal and family medical history, the presence of pre-malignant cells that could undergo malignant transformation as a consequence of radiation exposure, the results from phenotypic assays of radiosensitivity, heritable genetic polymorphisms associated with radiosensitivity, and postflight monitoring. Inclusion of these additional risk or risk reduction factors has the potential to personalize risk estimates for individual astronauts and could influence the determination of safe days in space. We consider how this type of assessment could be used and explore how the provisions of the federal Genetic Information Non-discrimination Act could impact the collection, dissemination and use of this information by NASA.

Ten Fundamental Legal Terms and Concepts That Are Useful in Understanding Laboratory Animal Law Across Nations.

Almost all researchers, veterinarians, technicians, and students who work with laboratory animals are familiar with the laws, regulations, and policies governing the use of animals in their jurisdictions. This knowledge can be learned in an academic setting, but is often gained by "on the job" training conducted by facilities and institutions where these professionals work. In addition, these laws and regulations exist along a continuum; some countries have detailed and expansive animal law regimes, while others have few, if any laws. Accordingly, those who carry out research involving animals know local laws and regulations, but might not be aware of the laws, regulations, and policies of other jurisdictions.As scientific research becomes increasingly globalized, there is a growing need to gain an understanding of the laws and regulations of other countries. This article seeks to help bridge this gap in knowledge by defining 10 fundamental legal terms and concepts that are important in understanding the similarities and differences among the legal traditions of different nations and international agreements that impact laboratory animal research. The article focuses on Western law terms and concepts, because many laboratory animal statutes that have been enacted in these countries and international treaties and protocols can be viewed through a Western legal lens.

Predictors of Indoor Radon Concentrations in Pennsylvania, 1989-2013.

BACKGROUND: Radon is the second-leading cause of lung cancer worldwide. Most indoor exposure occurs by diffusion of soil gas. Radon is also found in well water, natural gas, and ambient air. Pennsylvania has high indoor radon concentrations; buildings are often tested during real estate transactions, with results reported to the Department of Environmental Protection (PADEP). OBJECTIVES: We evaluated predictors of indoor radon concentrations. METHODS: Using first-floor and basement indoor radon results reported to the PADEP between 1987 and 2013, we evaluated associations of radon concentrations (natural log transformed) with geology, water source, building characteristics, season, weather, community socioeconomic status, community type, and unconventional natural gas development measures based on drilled and producing wells. RESULTS: Primary analysis included 866,735 first measurements by building, with the large majority from homes. The geologic rock layer on which the building sat was strongly associated with radon concentration (e.g., Axemann Formation, median = 365 Bq/m3, IQR = 167-679 vs. Stockton Formation, median = 93 Bq/m3, IQR = 52-178). In adjusted analysis, buildings using well water had 21% higher concentrations (ß = 0.191, 95% CI: 0.184, 0.198). Buildings in cities (vs. townships) had lower concentrations (ß = -0.323, 95% CI: -0.333, -0.314). When we included multiple tests per building, concentrations declined with repeated measurements over time. Between 2005 and 2013, 7,469 unconventional wells were drilled in Pennsylvania. Basement radon concentrations fluctuated between 1987 and 2003, but began an upward trend from 2004 to 2012 in all county categories (p < 0.001), with higher levels in counties having ≥ 100 drilled wells versus counties with none, and with highest levels in the Reading Prong. CONCLUSIONS: Geologic unit, well water, community, weather, and unconventional natural gas development were associated with indoor radon concentrations. Future studies should include direct environmental measurement of radon, as well as building features unavailable for this analysis. CITATION: Casey JA, Ogburn EL, Rasmussen SG, Irving JK, Pollak J, Locke PA, Schwartz BS. 2015. Predictors of indoor radon concentrations in Pennsylvania, 1989-2013. Environ Health Perspect 123:1130-1137; http://dx.doi.org/10.1289/ehp.1409014.

Historical trends in radiation protection, policy and communications: 1964 to the present.

The past 50 y have seen substantial developments in radiation epidemiology, technology, dosimetry, regulations, and protection efforts. During the last five decades, radiation communication has also evolved, growing more sophisticated as communication science and practice have advanced and matured. This talk covers the trends in radiation protection over the past 50 y, illustrated by progress in science and practice of risk communication and changes in societal expectations, and examines challenges that will confront radiation risk communication in the future.

A replacement-first approach to toxicity testing is necessary to successfully reauthorize TSCA.

The Toxic Substances Control Act is the principal US law governing industrial chemicals. Over the past three and one half decades, it has become clear that a considerable toxicological information gap exists about chemicals in commerce. The current provisions of the US TSCA law have failed to fill, and perhaps even exacerbated, that gap. For at least the past 5 years, bills have been introduced before the US Congress to reauthorize TSCA.Filling the toxicological information gap has been one of the driving forces for this call for substantial change. This article describes efforts to modernize TSCA, with an emphasis on the new provisions that would be put into place if the legislation became law. The article shows that only by implementing a "replacement-first" strategy - a strategy that is not currently incorporated into TSCA reauthorization efforts - can TSCA modernization efforts potentially fill the toxic data voids.

Communication of radiation benefits and risks in decision making: some lessons learned.

This paper is focused on summarizing the "lessons learned" from discussions at the 2010 NCRP Annual Meeting on effective communications on the subject of radiation benefits and risks in public exposures. Five main lessons learned are discussed in regard to effective methods of public communication: the use of new social media communication tools such as Facebook and Twitter, emergency situations that require rapid societal and personal messaging, medical radiological procedures where benefits must be described in comparison to long-term health risks of radiation exposures, and information that should be provided to stakeholders in situations such as environmental radionuclide contamination to which members of the public may be exposed. It is concluded that effective communications in which radiation benefits are contrasted with health risks of exposure are an important aspect of making and implementing decisions on employing radiation health protection procedures.

Implementing the National Academy's Vision and Strategy for Toxicity Testing: opportunities and challenges under the U.S. Toxic Substances Control Act.

In 2007, the U.S. National Academy of Sciences, National Research Council (NRC), issued the report Toxicity Testing in the 21st Century: A Vision and a Strategy. This report, which was commissioned by the U.S. Environmental Protection Agency (EPA), called for the U.S. EPA to develop a new approach for how this agency evaluates the toxicity of compounds. The report recommended that the agency move from its current testing system, which is based largely on traditional toxicology, to a testing system that is based primarily on human cell lines and in vitro systems. Successful implementation of the report's vision and strategy will require that scientists, lawyers, and policymakers work together to bridge the gap among disciplines. An important step in building this bridge requires an analysis of the U.S. legal system that frames toxicity testing. If the U.S. laws, regulations, and policies erect barriers that would prevent or impede the U.S. EPA adoption of the NRC vision and strategy, it is important to identify these challenges. At the same time, if existing laws, regulations, and policies are fertile ground for these recommendations, opportunities should be documented. This article discusses and evaluates the challenges and opportunities that arise under key provisions of one major U.S. toxics law, the Toxics Substances Control Act (TSCA).

Incorporating information from the U.S. Department of Energy low-dose program into regulatory decision-making: three policy integration challenges.

The U.S. Department of Energy (U.S. DOE) sponsors a research program aimed at gaining a better understanding of how low-dose radiation affects cellular functioning and progression toward disease. There have been calls to incorporate into regulatory decision-making the scientific information that this program has produced. After a discussion of the evolution of radiation protection law and the weight-of-evidence approach that agencies employ, this paper offers some preliminary thoughts about how to approach this complex and important policy question. Three implementation challenges are identified and discussed. The first implementation challenge involves explaining low-dose effects in a systems biology model. The second challenge arises when issues of population susceptibility are juxtaposed against molecular and mechanistic studies, such as those that make up much of the U.S. DOE low-dose program. The third challenge concerns integrating the results of radiation epidemiology, especially epidemiologic studies among cohorts that are exposed to low dose and low-dose rate radiation, with the results of U.S. DOE low-dose studies.