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It has been 65 years since the publication of Russell and Burch's "The Principles of Humane Experimental Technique," which established the '3Rs'--refinement, reduction, and replacement--as the key principles applicable to decision making about, and the use of, non-human animals in laboratory settings. The 3Rs are universally accepted by responsible scientists throughout the world and form the basis for many national legal and regulatory systems governing animal use in laboratories. This Article will discuss broadly how the 3Rs have evolved over the past seven decades since the publication of Russell and Burch's seminal work, and examine the 3Rs in light of the needs of the biomedical research challenges today and into the future. The Article also evaluates recent critiques of the 3Rs and assesses whether such critiques are warranted considering current research practices and societal concerns. To make the 3Rs maximally useful for the 21st century and beyond, additional principles should be added that take into consideration (1) the need to strengthen reproducibility and predictivity of animal-based research; (2) the recognition that animals are sentient beings whose basic needs must be met; and (3) the importance of a harm-benefit evaluation that addresses the benefits, risks, and harms to humans as well as animals. The 3Rs must evolve in these ways so that science can continue to develop, and laboratory animal use can be reduced or replaced. [ABSTRACT FROM AUTHOR]

The article discusses a study that applies the one health approach to show and address the issue of housing instability in Baltimore, Maryland, and extends the public health concept by connecting animal welfare and human health. It examines the hypothesis that people living in low income and vulnerable communities, who are at a high risk for housing loss through eviction, seek to surrender their pets before being evicted. It describes strategies to alleviate financial stress related to pets.

Animal models are currently the "gold standard" in biomedical research. However, new approaches that do not involve the use of nonhuman animals are evolving to address the public health and medical challenges for which animal models are less well suited. These alternatives represent important advancements and are being recognized as significant advances. There is a clear societal need to encourage such efforts, and there is widespread support to move away from animal-based research by the American public. The National Institutes of Health (NIH) funds the majority of biomedical research in the United States and should be a key player in developing new methods. There have been numerous bills introduced before the United States Congress that seek to change the way that NIH allocates its resources, with an emphasis on increasing funding for alternatives. To date, none of these bills have advanced in either the House of Representatives or the Senate. This Article examines how NIH could utilize the policy options available under its current laws and regulations to move toward a research environment that puts greater value on alternatives and, at the same time, moves away from animal models as the gold standard. The major advantages of this approach are that it can be implemented without changing current laws and regulations, is relatively straightforward, and can be executed relatively quickly. If adopted, these policy options have the potential to create a much-needed paradigm shift that will improve scientific research while responding to the societal desire to use fewer animals in the biomedical arena. [ABSTRACT FROM AUTHOR]

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. 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. [ABSTRACT FROM AUTHOR]

Scientists are usually good at teaching, sometimes even to lay audiences. But communicating with journalists, activists, or policymakers can be a different story - hesitancy to make mistakes as well as the temptation to disproportionally promote one's own case come into play. The multitude of social media and other web-based outlets has diversified and accelerated the communication of science. Real-time reactions, sharing of data, tools and results, increasing invitation of personal opinion, demand for transparency, political correctness, and loss of trust in experts are challenges to researchers in general. The field of alternatives to animal testing is more political and important to lay audiences than many others, so its scientists must be especially aware of these challenges. Public engagement offers the opportunity to form community and create wide support for non-animal research and its implementation. This requires scientists to step out of the ivory tower of higher education and engage with diverse interest groups by outreach activities, interviews, and press releases, etc. by employing tailored communication. [ABSTRACT FROM AUTHOR]

Developmental neurotoxicity testing (DNT) is perceived by many stakeholders to be an area in critical need of alternatives to current animal testing protocols and guidelines. To address this need, the [...]

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/[m.sup.3], IQR = 167-679 vs. Stockton Formation, median = 93 Bq/[m.sup.3], IQR = 52-178). In adjusted analysis, buildings using well water had 21% higher concentrations (β = 0.191, 95% CI: 0.184, 0.198). Buildings in cities (vs. townships) had lower concentrations (p = -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. http://dx.doi.org/10.1289/ehp.1409014, Introduction Exposure to radon-222--an inert, odorless, and carcinogenic gas--is the second leading cause of lung cancer worldwide (Darby et al. 2005; Pawel and Puskin 2004). The U.S. Environmental Protection Agency [...]

Purpose: Radiation risk communication is a critical component of radiation protection and the public's understanding of radiation risks and benefits. Risk communication becomes even more complicated when considering cultural and language differences. In the US, many diverse communities face risk communication challenges. We obtained radon testing data to evaluate patterns of radon testing in Allentown, the third largest city in Pennsylvania. Radon exposure is the second leading cause of lung cancer after smoking and is associated with over 21,000 lung cancer deaths in the US annually. It is estimated that 1 in every 15 homes in the US has elevated radon levels above the recommended action level set by the US Environmental Protection Agency. Allentown has some of the highest reported levels of indoor radon in the country, yet only a small portion of the population has tested their homes. This is true particularly among self-identified Hispanics, who make up nearly half of the city's population. This study seeks to (1) characterize the difference in testing rates between self-identified Hispanics and non-Hispanics in Allentown, (2) quantify the level of radon awareness and knowledge, (3) identify potential obstacles to radon testing among the Allentown population that self-identifies as Hispanic, and (4) determine whether more effective risk communication is needed. Method: Radon test results in Allentown were analyzed to better understand the nature of radon testing. To evaluate radon awareness and knowledge, a cross-sectional study was conducted using a face-to-face survey. This data was informative in assessing testing and mitigation practices, ethnicity, income level, age, education level, homeowner status, zip code and primary language. Results: Ethnicity was an independent predictor of radon awareness and knowledge. Statistically significant differences were found between the number of self-identified Hispanics (39%) and non-Hispanics (84%) who indicated that they had ever heard of radon; 13% of Hispanics and 49% of non-Hispanics knew that they lived in an area with typically high radon levels. There was a statistically significant association between self-reported ethnicity and radon testing with non-Hispanics (43%) more likely to test their homes for radon than Hispanics (32%). Conclusion: Individual and community understanding of the risks of exposure to radiation sources such as radon is dependent upon communication that informs and spurs appropriate action. This study demonstrates the need for culturally appropriate radon risk communication strategies targeted to a Hispanic population. Successful communication will raise awareness and knowledge that can lead to better public health protection. [ABSTRACT FROM AUTHOR]

The article focuses on integrating radiation epidemiology and radiobiology for protection of the public after exposure to low doses of ionizing radiation. Topics discussed include human health effects of ionizing radiation; rising trend of radiation-associated malignancy; and biological responses to ionizing radiation in cellular and molecular in vitro systems.

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 postfight 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. [ABSTRACT FROM AUTHOR]

The article focuses on how the toxicity testing reform for U.S. chemicals laws fits into the legal and policy landscape. It informs that the U.S. federal system that controls the use of chemicals consist of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and their regulations. It mentions that many evolutionary changes in toxicology provide for regulatory revolution for evaluating chemical hazards for chemicals.

Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new products (such as nanoparticles or cell therapies), the limited predictivity of traditional tests for human health effects, duration and costs of current approaches, and animal welfare considerations. The latter holds especially true in the context of the scheduled 2013 marketing ban on cosmetic ingredients tested for systemic toxicity. Based on a major analysis of the status of alternative methods (Adler et al., 2011) and its independent review (Hartung et al., 2011), the present report proposes a roadmap for how to overcome the acknowledged scientific gaps for the full replacement of systemic toxicity testing using animals. Five whitepapers were commissioned addressing toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, and reproductive toxicity testing. An expert workshop of 35 participants from Europe and the US discussed and refined these whitepapers, which were subsequently compiled to form the present report. By prioritizing the many options to move the field forward, the expert group hopes to advance regulatory science. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

The article offers information on a research program sponsored by the U.S. Department of Energy which aims to gain a better understanding of how low-dose radiation affects cellular functioning. Three implementation challenges are discussed including one that involves explaining low-dose effects in a systems biology model, another that arises when issues of population susceptibility are juxtaposed against molecular and mechanistic studies, and another one that concerns integrating the results of radiation epidemiology.

One of the most important challenges facing risk mangers in the coming decades is the joint management of chemical and radiological wastes. Born out of different traditions, radiation and chemical risk approaches can differ sharply. Radiation protection generally focuses on establishing effective dose levels across media and utilizes an approach that incorporates the philosophy of ALARA. In contrast, chemical risk management strategies are medium specific and risk based. In practice these differences can complicate decision making and potentially lead to duplicative efforts. We have undertaken a series of case studies to determine the extent and nature of the barriers that exist with regard to the potential harmonization of risk management approaches. Built upon the results of an interactive workshop held in June 1998, these case studies examine how cleanup decisions were made at a series of contaminated sites around the United States. It is anticipated that these case studies will demonstrate (1) the areas of greatestdiscord among chemical and radiological risk management approaches, and (2) how gaps in approaches could be bridged. This presentation will review the important conclusions of these case studies and (if possible) offer suggestions about how chemical and radiation risk management can be harmonized. [ABSTRACT FROM AUTHOR]

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.