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Book Use of Mechanistic Information in Risk Assessment

Download or read book Use of Mechanistic Information in Risk Assessment written by Hermann M. Bolt and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: M. Pliftski Institute of Oceanography, GdaJisk University 46 Pilsudskiego Av. 81-378 Gdynia, Poland 2 The Baltic Sea with 366,000 km is only 0. 1% of the world's oceans but nevertheless, unique in many ways. The Baltic Sea is the largest area of brackish water in the world. As a formation of nature, it is a sea that in many ways resembles a lake. This makes its flora and fauna interesting and well adapted to the brackish water environment. The recent stage of biocoenosis composition is influenced by several features. Historically, during the last glaciation, when the Baltic was sometimes a huge marine bay and sometimes a large, freshwater lake, several ecosystems developed and were successively replaced. The flora and fauna composition of those previous biocoenosis was discovered from the geological layers corresponding to the Yoldic Sea, the Ancylus Lake and the Littorina Sea periods. Recently the marine influence has come from the North Sea water inflow, which greatly affects the salinity of the deep water. The freshwater influence comes from the fluvial water which gives the surface layer a lower salinity value. Salinity in the Baltic regions varies greatly - Gulf of Bothnia 2-4%0, the central Baltic proper 7-13%0, the Kattegat 15-300/00 in the surface water and 32- 34%0 in the bottom water, the Skagerrak 20-300/00 in the surface and 32-35%0 in the bottom water.

Book Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

Download or read book Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2007-11-19 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new field of toxicogenomics presents a potentially powerful set of tools to better understand the health effects of exposures to toxicants in the environment. At the request of the National Institute of Environmental Health Sciences, the National Research Council assembled a committee to identify the benefits of toxicogenomics, the challenges to achieving them, and potential approaches to overcoming such challenges. The report concludes that realizing the potential of toxicogenomics to improve public health decisions will require a concerted effort to generate data, make use of existing data, and study data in new waysâ€"an effort requiring funding, interagency coordination, and data management strategies.

Book On the Incorporation of Biokinetic and Mechanistic Data in Modeling for Risk Assessment

Download or read book On the Incorporation of Biokinetic and Mechanistic Data in Modeling for Risk Assessment written by Harvey J. Clewell and published by . This book was released on 2007 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of the studies described in this thesis was to foster the increased use of emerging scientific information and innovative methods in chemical risk assessments, in order to assure the protection of public health while limiting the economic and social consequences of over-regulation. The first part of the thesis presents three studies that were performed to demonstrate approaches for incorporating biokinetic and mechanistic data and mathematical modeling in risk assessment, focusing on mode of action evaluation, physiologically based biokinetic (PBBK) modeling, and benchmark dose-response (BMD) modeling. The second part of the thesis documents three studies that were performed to show the ability of PBBK modeling to describe the interaction between chemical-specific properties, physiology, and age-dependent biochemical processes and the resulting variability in risks across individuals in a population at different ages. The final part of the thesis describes three studies that attempted to make optimal use of available biokinetic and mechanistic data in cancer risk assessments for vinyl chloride, trichloroethylene, and perchloroethylene using the three methodologies discussed in the first section of the thesis. Overall, the research described in this thesis demonstrates that the use of mode-of-action evaluation, PBBK modeling, and quantitative dose-response modeling greatly increases the opportunity for the use of biokinetic and mechanistic data in risk assessment. The resulting risk assessment approaches are more appropriately tailored to the specific chemical and are likely to provide a more accurate assessment of the potential hazards associated with human exposures. The studies in this thesis also demonstrate that the application of PBBK models in risk assessment demands well-formulated statements about the chemical mode of action. It is this requirement for an explicit, mechanistic hypothesis that gives biologically motivated models their power, but at t

Book Science and Decisions

Download or read book Science and Decisions written by National Research Council and published by National Academies Press. This book was released on 2009-03-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.

Book Science and Judgment in Risk Assessment

Download or read book Science and Judgment in Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 1994-01-01 with total page 668 pages. Available in PDF, EPUB and Kindle. Book excerpt: The public depends on competent risk assessment from the federal government and the scientific community to grapple with the threat of pollution. When risk reports turn out to be overblownâ€"or when risks are overlookedâ€"public skepticism abounds. This comprehensive and readable book explores how the U.S. Environmental Protection Agency (EPA) can improve its risk assessment practices, with a focus on implementation of the 1990 Clean Air Act Amendments. With a wealth of detailed information, pertinent examples, and revealing analysis, the volume explores the "default option" and other basic concepts. It offers two views of EPA operations: The first examines how EPA currently assesses exposure to hazardous air pollutants, evaluates the toxicity of a substance, and characterizes the risk to the public. The second, more holistic, view explores how EPA can improve in several critical areas of risk assessment by focusing on cross-cutting themes and incorporating more scientific judgment. This comprehensive volume will be important to the EPA and other agencies, risk managers, environmental advocates, scientists, faculty, students, and concerned individuals.

Book Cancer Mechanism and Risk Assessment

Download or read book Cancer Mechanism and Risk Assessment written by and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Scientific Frontiers in Developmental Toxicology and Risk Assessment

Download or read book Scientific Frontiers in Developmental Toxicology and Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2000-12-21 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific Frontiers in Developmental Toxicology and Risk Assessment reviews advances made during the last 10-15 years in fields such as developmental biology, molecular biology, and genetics. It describes a novel approach for how these advances might be used in combination with existing methodologies to further the understanding of mechanisms of developmental toxicity, to improve the assessment of chemicals for their ability to cause developmental toxicity, and to improve risk assessment for developmental defects. For example, based on the recent advances, even the smallest, simplest laboratory animals such as the fruit fly, roundworm, and zebrafish might be able to serve as developmental toxicological models for human biological systems. Use of such organisms might allow for rapid and inexpensive testing of large numbers of chemicals for their potential to cause developmental toxicity; presently, there are little or no developmental toxicity data available for the majority of natural and manufactured chemicals in use. This new approach to developmental toxicology and risk assessment will require simultaneous research on several fronts by experts from multiple scientific disciplines, including developmental toxicologists, developmental biologists, geneticists, epidemiologists, and biostatisticians.

Book Risk Assessment and Management at Deseret Chemical Depot and the Tooele Chemical Agent Disposal Facility

Download or read book Risk Assessment and Management at Deseret Chemical Depot and the Tooele Chemical Agent Disposal Facility written by National Research Council and published by National Academies Press. This book was released on 1997-10-04 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Casarett   Doull s Essentials of Toxicology

Download or read book Casarett Doull s Essentials of Toxicology written by CURTIS. WATKINS KLAASSEN (JOHN.) and published by . This book was released on 2015-09-16 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Toxicokinetics and Risk Assessment

Download or read book Toxicokinetics and Risk Assessment written by John C. Lipscomb and published by CRC Press. This book was released on 2016-04-19 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Toxicokinetics in Risk Assessment discusses the noncancer risk assessment process and its reliance on uncertainty factors in order to facilitate the continued study and refinement of the scientific basis for health risk assessment. This text clearly demonstrates the application of physiologically-based pharmacokinetic (PBPK) modeling in human healt

Book EPA 630 R

Download or read book EPA 630 R written by and published by . This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book A Systems Biology Approach to Advancing Adverse Outcome Pathways for Risk Assessment

Download or read book A Systems Biology Approach to Advancing Adverse Outcome Pathways for Risk Assessment written by Natàlia Garcia-Reyero and published by Springer. This book was released on 2018-02-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Social pressure to minimize the use of animal testing, the ever-increasing concern on animal welfare, and the need for more human-relevant and more predictive toxicity tests are some of the drivers for new approaches to chemical screening. This book focuses on The Adverse Outcome Pathway, an analytical construct that describes a sequential chain of causally linked events at different levels of biological organization that lead to an adverse health or ecotoxicological effect. While past efforts have focused on toxicological pathway-based vision for human and ecological health assessment relying on in vitro systems and predictive models, The Adverse Outcome Pathway framework provides a simplified and structured way to organize toxicological information. Within the book, a systems biology approach supplies the tools to infer, link, and quantify the molecular initiating events and the key events and key event relationships leading to adverse outcomes. The advancement of these tools is crucial for the successful implementation of AOPs for regulatory purposes.

Book Assessing the Human Health Risks of Trichloroethylene

Download or read book Assessing the Human Health Risks of Trichloroethylene written by National Research Council and published by National Academies Press. This book was released on 2007-01-08 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trichloroethylene is a chlorinated solvent widely used as a degreasing agent in industrial and manufacturing settings. It is also used as a chemical intermediate in making other chemicals and is a component of products such as typewriter correction fluid, paint removers, adhesives, and spot removers. In 2001, EPA issued a draft health risk assessment and proposed exposure standards for trichloroethylene. PA's Scientific Advisory Board (SAB) reviewed the draft and it was issued for public comment. A number of scientific issues were raised during the course of these reviews. Assessing the Human Health Risks of Trichloroethylene identifies and assesses the key scientific issues relevant to analyzing the human health risks of trichloroethylene, considering pertinent toxicologic, epidemiologic, population susceptibility, and other available information, including relevant published scientific literature, EPA's 2001 draft health risk assessment of trichloroethylene, scientific and technical comments received by EPA from public and private sources, and additional relevant information to be provided by the sponsoring agencies. This report highlights issues critical to the development of an objective, realistic, and scientifically balanced trichloroethylene health risk assessment. Guidance for hazard characterization of trichloroethylene is presented in Chapters 2 through 10. Chapter 2 provides guidance for evaluating large sets of epidemiologic data. In Chapter 3, the committee applies this guidance as an example in its evaluation of the epidemiologic data on trichloroethylene and kidney cancer, and this example should help guide evaluations of other cancer risks. Chapter 3 also assesses new information on the kidney toxicity of trichloroethylene and its metabolites and potential modes of action. Chapters 4, 5, 6, 7, and 8 evaluate the key issues regarding liver toxicity and cancer, reproductive and developmental toxicity, neurotoxicity, respiratory tract toxicity and cancer, and immunotoxicity, respectively. However, the committee's review focused on mode-of-action information to understand how trichloroethylene might affect certain processes differently in different species. Chapter 9 discusses susceptibility to trichloroethylene and its metabolites, and Chapter 10 describes important factors in considering trichloroethylene in mixtures. Physiologically based pharmacokinetic models are evaluated in Chapter 11, and guidance is provided on future directions for model development. Finally, Chapter 12 considers issues related to dose-response assessment and quantitative assessment of risk.

Book Toxicity Pathway Based Risk Assessment

Download or read book Toxicity Pathway Based Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2010-06-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2007, the National Research Council envisioned a new paradigm in which biologically important perturbations in key toxicity pathways would be evaluated with new methods in molecular biology, bioinformatics, computational toxicology, and a comprehensive array of in vitro tests based primarily on human biology. Although some considered the vision too optimistic with respect to the promise of the new science, no one can deny that a revolution in toxicity testing is under way. New approaches are being developed, and data are being generated. As a result, the U.S. Environmental Protection Agency (EPA) expects a large influx of data that will need to be evaluated. EPA also is faced with tens of thousands of chemicals on which toxicity information is incomplete and emerging chemicals and substances that will need risk assessment and possible regulation. Therefore, the agency asked the National Research Council to convene a symposium to stimulate discussion on the application of the new approaches and data in risk assessment. The symposium was held on May 11-13, 2009, in Washington, DC, and included presentations and discussion sessions on pathway-based approaches for hazard identification, applications of new approaches to mode-of-action analyses, the challenges to and opportunities for risk assessment in the changing paradigm, and future directions.

Book Regulatory Toxicology

    Book Details:
  • Author : Franz-Xaver Reichl
  • Publisher : Springer
  • Release : 2014-03-27
  • ISBN : 9783642353734
  • Pages : 0 pages

Download or read book Regulatory Toxicology written by Franz-Xaver Reichl and published by Springer. This book was released on 2014-03-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.

Book Review of EPA s Integrated Risk Information System  IRIS  Process

Download or read book Review of EPA s Integrated Risk Information System IRIS Process written by National Research Council and published by National Academies Press. This book was released on 2014-06-25 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Integrated Risk Information System (IRIS) is a program within the US Environmental Protection Agency (EPA) that is responsible for developing toxicologic assessments of environmental contaminants. An IRIS assessment contains hazard identifications and dose-response assessments of various chemicals related to cancer and noncancer outcomes. Although the program was created to increase consistency among toxicologic assessments within the agency, federal, state, and international agencies and other organizations have come to rely on IRIS assessments for setting regulatory standards, establishing exposure guidelines, and estimating risks to exposed populations. Over the last decade, the National Research Council (NRC) has been asked to review some of the more complex and challenging IRIS assessments, including those of formaldehyde, dioxin, and tetrachloroethylene. In 2011, an NRC committee released its review of the IRIS formaldehyde assessment. Like other NRC committees that had reviewed IRIS assessments, the formaldehyde committee identified deficiencies in the specific assessment and more broadly in some of EPA's general approaches and specific methods. Although the committee focused on evaluating the IRIS formaldehyde assessment, it provided suggestions for improving the IRIS process and a roadmap for its revision in case EPA decided to move forward with changes to the process. Congress directed EPA to implement the report's recommendations and then asked the National Research Council to review the changes that EPA was making (or proposing to make) in response to the recommendations. Review of EPA's Integrated Risk Information System (IRIS) Process provides an overview of some general issues associated with IRIS assessments. This report then addresses evidence identification and evaluation for IRIS assessments and discusses evidence integration for hazard evaluation and methods for calculating reference values and unit risks. The report makes recommendations and considerations for future directions. Overall, Review of EPA's Integrated Risk Information System Process finds that substantial improvements in the IRIS process have been made, and it is clear that EPA has embraced and is acting on the recommendations in the NRC formaldehyde report. The recommendations of this report should be seen as building on the progress that EPA has already made.

Book Causal Analytics for Applied Risk Analysis

Download or read book Causal Analytics for Applied Risk Analysis written by Louis Anthony Cox Jr. and published by Springer. This book was released on 2018-06-19 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: Causal analytics methods can revolutionize the use of data to make effective decisions by revealing how different choices affect probabilities of various outcomes. This book presents and illustrates models, algorithms, principles, and software for deriving causal models from data and for using them to optimize decisions with uncertain outcomes. It discusses how to describe and summarize situations; detect changes; evaluate effects of policies or interventions; learn what works best under different conditions; predict values of as-yet unobserved quantities from available data; and identify the most likely explanations for observed outcomes, including surprises and anomalies. The book resents practical techniques for causal modeling and analytics that practitioners can apply to improve understanding of how choices affect probabilities of consequences and, based on this understanding, to recommend choices that are more likely to accomplish their intended objectives.The book begins with a survey of modern analytics methods, focusing mainly on techniques useful for decision, risk, and policy analysis. Chapter 2 introduces free in-browser software, including the Causal Analytics Toolkit (CAT) software, to enable readers to perform the analyses described and to apply modern analytics methods easily to their own data sets. Chapters 3 through 11 show how to apply causal analytics and risk analytics to practical risk analysis challenges, mainly related to public and occupational health risks from pathogens in food or from pollutants in air. Chapters 12 through 15 turn to broader questions of how to improve risk management decision-making by individuals, groups, organizations, institutions, and multi-generation societies with different cultures and norms for cooperation. These chapters examine organizational learning, community resilience, societal risk management, and intergenerational collaboration and justice in managing risks.