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National Academies of Sciences, Engineering, and Medicine
Author : National Academies of Sciences, Engineering, and Medicine Publisher : Page : 120 pages File Size : 39,56 MB Release : 2022-08-30 Category : Political Science ISBN : 9780309090889
The U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) program develops human health assessments that focus on hazard identification and dose-response analyses for chemicals in the environment. The ORD Staff Handbook for Developing IRIS Assessments (the handbook) provides guidance to scientists who perform the IRIS assessments in order to foster consistency in the assessments and enhance transparency about the IRIS assessment process. At the request of the EPA, this report reviews the procedures and considerations for operationalizing the principles of systematic reviews and the methods described in the handbook for determining the scope of the IRIS assessments, evidence integration, extrapolation techniques, dose-response analyses, and characterization of uncertainties.
National Academies of Sciences, Engineering, and Medicine
Author : National Academies of Sciences, Engineering, and Medicine Publisher : National Academies Press Page : 130 pages File Size : 30,41 MB Release : 2018-04-11 Category : Political Science ISBN : 0309474949
Over the past several years, the US Environmental Protection Agency (EPA) has been transforming the procedures of its Integrated Risk Information System (IRIS), a program that produces hazard and doseâ€'response assessments of environmental chemicals and derives toxicity values that can be used to estimate risks posed by exposures to them. The transformation was initiated after suggestions for program reforms were provided in a 2011 report from the National Academies of Sciences, Engineering, and Medicine that reviewed a draft IRIS assessment of formaldehyde. In 2014, the National Academies released a report that reviewed the IRIS program and evaluated the changes implemented in it since the 2011 report. Since 2014, new leadership of EPA's National Center for Environmental Assessment (NCEA) and IRIS program has instituted even more substantive changes in the IRIS program in response to the recommendations in the 2014 report. Progress Toward Transforming the Integrated Risk Information System Program: A 2018 Evaluation reviews the EPA's progress toward addressing the past recommendations from the National Academies.
Understand the fundamentals of human risk assessment with this introduction and reference Human risk assessments are a precondition for virtually all industrial action or environmental regulation, all the more essential in a world where chemical and environmental hazards are becoming more abundant. These documents catalog potential environmental, toxicological, ecological, or other harms resulting from a particular hazard, from chemical spills to construction projects to dangerous workplaces. They turn on a number of variables, of which the most significant is the degree of human exposure to the hazardous agent or process. Human and Ecological Risk Assessment combines the virtues of a textbook and reference work to introduce and analyze these vital documents. Beginning with the foundational theory of human health risk assessment, it then supplies case studies and detailed analysis illustrating the practice of producing risk assessment documents. Fully updated and authored by leading authorities in the field, the result is an indispensable work. Readers of the second edition of Human and Ecological Risk Assessment will also find: Over 40 entirely new case studies reflecting the latest in risk assessment practice Detailed discussion of hazards including air emissions, contaminated food and soil, hazardous waste sites, and many more Case studies from multiple countries to reflect diverse international standards Human and Ecological Risk Assessment is ideal for professionals and advanced graduate students in toxicology, industrial hygiene, occupational medicine, environmental science, and all related subjects.
Air Pollution Calculations: Quantifying Pollutant Formation, Transport, Transformation, Fate and Risks, Second Edition enhances the systems science aspects of air pollution, including transformation reactions in soil, water, sediment and biota that contribute to air pollution. This second edition will be an update based on research and actions taken since 2019 that affect air pollution calculations, including new control technologies, emissions measurement, and air quality modeling. Recent court cases, regulatory decisions, and advances in technology are discussed and, where necessary, calculations have been revised to reflect these updates. Sections discuss pollutant characterization, pollutant transformation, and environmental partitioning. Air partitioning, physical transport of air pollutants, air pollution biogeochemistry, and thermal reactions are also thoroughly explored. The author then carefully examines air pollution risk calculations, control technologies and dispersion models. The text wraps with discussions of economics and project management, reliability and failure, and air pollution decision-making. Provides real-life current cases as examples of quantitation of emerging air pollution problems Includes straightforward derivation of equations, giving practitioners and instructors a direct link between first principles of science and applications of technologies Presents example calculations that make scientific theory real for the student and practitioner
Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.
Particles and Health is an international conference taking place in October 2021 addressing issues in science and regulation. Regulatory initiatives in the European Union (EU) have suggested uniform hazard classifications for all poorly soluble low toxicity particles (PSLTs). Examples of PSLTs include carbon black, titanium dioxide and iron oxide, among others. Approaches have also been proposed for setting workplace exposure limits for PSLTs such as those of the German MAK Commission. The conference will include specific sections over a two day period of about 25 presentations, associated with PSLTs regarding the following major topics: (1) human studies, (2) animal inhalation studies associated with lung cancer,(3) animal and human studies associated with non pulmonary impacts, including reproductive, genetic and cardiac effects, and (4) regulatory application of scientific studies. This conference will include presentations regarding: Definition of PSLT’s with attention to both similarities and differences among these substances. • Address scientific studies regarding human health effects of PSLTs. The value of human studies over animal studies-when human-exposed populations can be studied adequately- will be emphasized. • Address translational toxicology challenges, including the appropriateness of rats as models for human lung pathogenesis (particularly lung cancer) in light of lung overload phenomena and species differences. • Serve as a platform to present current scientific information about PSLTs important for regulatory action. • Publication of pertinent conference presentations in the peer reviewed scientific literature will allow the presentations to live beyond the conference and subsequently be reviewed part of regulatory deliberations. • Establish an interdisciplinary setting for industry, academia and regulatory professionals to interact on an important topic. Such interaction can facilitate enhanced understanding of the science and ideally, more appropriate regulations, appropriate classification and labeling as well as for setting exposure limits, among others. • Recommend areas for further clarifying research regarding the significance of the rat as a model for translation toxicology. The goal of this conference is to present current scientific evidence regarding the numerous dimensions of particles and health and to facilitate interaction and discussions among attendees with expertise in toxicology, epidemiology, occupational and pulmonary medicine and exposure assessment. Interactions between these disciplines will aid in the sound and evidence-based scientific underpinning of regulatory considerations regarding PSLTs. Although regulatory concern regarding PSLTs has focused on lung cancer risk as a result of rat inhalation overload studies, this conference will address all relevant health end points, including genetic and reproductive issues as well, consistent with ECHA guidelines. Sample of Topics related to substances that may be characterized as PSLTs, including carbon black, coal, titanium dioxide, cerium oxide, aluminum oxide barium sulfate and iron oxide, among others. • Defining PSLTs • Epidemiological studies of PSLTs • Inhalation studies evaluating human cellular response to particles • Basic research studies on inflammatory to malignancy pathways • Animal studies, PLSTs and human risk: “New Insights into old data.” • New studies on PSLTs; 2 year carcinogenicity assays • Animal studies and gender specific responses to PSLTs. How does the USA National Cancer Institute (NCI) and National Institute of Environmental Health Sciences (NIEHS) address this challenge of extrapolating rodent data to human risk assessment? • Role of the rodent model in human risk assessment of PSLTs and lung cancer risk • Adverse Outcome Pathways (AOPs) and Modes of Action (MOA): identification and recommendations for closing gaps in knowledge for rodents and humans. • Are there lessons to be learned from how the pharmaceutical industry’s approach to translational science (safety and efficacy) as evolved in recent years? • Setting exposure limits for PSLTs and Translational Toxicology. • Genotoxicity and Reproductive toxicity studies of PSLTs.
Systematic review - a scientific investigation that focuses on a specific question and uses explicit, prespecified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies - has become the foundation for assessing evidence to be used for decision making in a variety of health contexts, including health care and public health. At the request of the Environmental Protection Agency (EPA), this publication reviews EPA's 2018 guidance document Application of Systematic Review in TSCA (Toxic Substances and Control Act) Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent.
Formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily. Formaldehyde is used to produce a wide array of products, particularly building materials; it is emitted from many sources, including power plants, cars, gas and wood stoves, and cigarettes; it is a natural product in come foods; and it is naturally present in the human body as a metabolic intermediate. Much research has been conducted on the health effects of exposure to formaldehyde, including effects on the upper airway, where formaldehyde is deposited when inhaled, and effects on tissues distant from the site of initial contact. The U.S. Environmental Protection Agency (EPA) released noncancer and cancer assessments of formaldehyde for its Intergated Risk Information System (IRIS) in 1990 and 1991, respectively. The agency began reassessing formaldehyde in 1998 and released a draft IRIS assessment in June 2010. Given the complexity of the issues and the knowledge that the assessment will be used as the basis of regulatory decisions, EPA asked the National Research Council (NRC) to conduct an independent scientific review of the draft IRIS assessment. In this report, the Committee to Review EPA's Draft IRIS Assessment of Formaldehyde first addresses some general issues associated with the draft IRIS assessment. The committee next focuses on questions concerning specific aspects of the draft assessment, including derivation of the reference concentrations and the cancer unit risk estimates for formaldehyde. The committee closes with recommendations for improving the IRIS assessment of formaldehyde and provides some general comments on the IRIS development process.
Author : National Research Council Publisher : National Academies Press Page : 422 pages File Size : 44,45 MB Release : 2009-03-24 Category : Political Science ISBN : 0309120462
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.