Download or read book Review of the Environmental Protection Agency s Draft IRIS Assessment of Tetrachloroethylene written by National Research Council and published by National Academies Press. This book was released on 2010-04-18 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tetrachloroethylene is a volatile, chlorinated organic hydrocarbon that is widely used as a solvent in the dry-cleaning and textile-processing industries and as an agent for degreasing metal parts. It is an environmental contaminant that has been detected in the air, groundwater, surface waters, and soil. In June 2008, the U.S. Environmental Protection Agency released its draft Toxicological Review of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in Support of Summary Information on the Integrated Risk Information System (IRIS). The draft IRIS assessment provides quantitative estimates of cancer and noncancer effects of exposure to tetrachloreothylene, which will be used to establish airquality and water-quality standards to protect public health and to set cleanup standards for hazardous waste sites. At the request of EPA, the National Research Council conducted an independent scientific review of the draft IRIS assessment of tetrachloroethylene from toxicologic, epidemiologic, and human clinical perspectives. The resulting book evaluates the adequacy of the EPA assessment, the data and methods used for deriving the noncancer values for inhalation and oral exposures and the oral and inhalation cancer unit risks posed by tetrachloroethylene; evaluates whether the key studies underlying the draft IRIS assessment are of requisite quality, reliability, and relevance to support the derivation of the reference values and cancer risks; evaluates whether the uncertainties in EPA's risk assessment were adequately described and, where possible, quantified; and identifies research that could reduce the uncertainty in the current understanding of human health effects associated with tetrachloroethylene exposure.

Download or read book Review of the Environmental Protection Agency s Draft IRIS Assessment of Formaldehyde written by National Research Council and published by National Academies Press. This book was released on 2011-05-31 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

Download or read book Controlled Human Inhalation Exposure Studies at EPA written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-04-10 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.

Download or read book Toxicological Profile for Tetrachloroethylene written by and published by . This book was released on 1997 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Download or read book Chemical Assessments written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2018-01-24 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System

Download or read book Progress Toward Transforming the Integrated Risk Information System IRIS Program written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-04-11 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

Download or read book Toxicological Profile for Trichloroethylene written by and published by . This book was released on 1997 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Hidden Costs of Energy written by National Research Council and published by National Academies Press. This book was released on 2010-05-26 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the many benefits of energy, most of which are reflected in energy market prices, the production, distribution, and use of energy causes negative effects. Many of these negative effects are not reflected in energy market prices. When market failures like this occur, there may be a case for government interventions in the form of regulations, taxes, fees, tradable permits, or other instruments that will motivate recognition of these external or hidden costs. The Hidden Costs of Energy defines and evaluates key external costs and benefits that are associated with the production, distribution, and use of energy, but are not reflected in market prices. The damage estimates presented are substantial and reflect damages from air pollution associated with electricity generation, motor vehicle transportation, and heat generation. The book also considers other effects not quantified in dollar amounts, such as damages from climate change, effects of some air pollutants such as mercury, and risks to national security. While not a comprehensive guide to policy, this analysis indicates that major initiatives to further reduce other emissions, improve energy efficiency, or shift to a cleaner electricity generating mix could substantially reduce the damages of external effects. A first step in minimizing the adverse consequences of new energy technologies is to better understand these external effects and damages. The Hidden Costs of Energy will therefore be a vital informational tool for government policy makers, scientists, and economists in even the earliest stages of research and development on energy technologies.

Download or read book Review of the Environmental Protection Agency s State of the Science Evaluation of Nonmonotonic Dose Response Relationships as they Apply to Endocrine Disruptors written by National Research Council and published by National Academies Press. This book was released on 2014-05-27 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: Potential health effects from chemicals that disrupt endocrine function pose an environmental health concern because of their ability to interfere with normal hormone function in human and wildlife populations. The endocrine system regulates biological processes throughout the body and is sensitive to small changes in hormone concentrations. Endocrine-disruptor research has focused primarily on chemicals that affect three hormone pathways that play important roles in reproduction and development - the estrogen, androgen, and thyroid hormone pathways. Some of this research has identified dose-response relationships that have nonmonotonic curves. Nonmonotonic dose-response curves (NMDRs) are of concern because they do not follow the usual assumption made in toxicology that as dose decreases the response also decreases. The existence of NMDRs has been a controversial topic for decades, and there has been considerable debate about their implications for how chemicals are tested and for how risks from such chemicals are assessed. Toxicity tests are designed to identify hazards and to characterize dose-response relationships, so tests are aimed at finding a (high) dose that elicits a response, and dose-response is explored by testing lower doses spaced to identify statistically a no- or lowest-observed-adverse-effect level. The concern for NMDRs is that such studies, as currently designed, might not detect the inflection of the dose-response curve if only a few doses are tested or if the change in inflection occurs below the range of doses tested. Another concern is that some NMDRs are found for biological effects that are not usually evaluated in toxicity tests. If current testing strategies are inadequate to account for NMDRs, changes to risk assessment practices might be necessary. To help address these issues, the U.S. Environmental Protection Agency (EPA) developed a draft State-of-the-Science Evaluation: Nonmonotonic Dose Responses as they Apply to Estrogen, Androgen, and Thyroid Pathways and EPA Testing and Assessment Procedures. EPA asked the National Research Council to conduct an independent review of this evaluation to ensure that it is scientifically sound and of high quality. Review of Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response as they Apply to Endocrine Disrupters evaluates whether EPA's evaluation presents a scientifically sound and high-quality analysis of the literature on NMDRs. This report reviews how well the EPA evaluation described how the assessment was performed, whether consistent methods and criteria were applied in the analysis of different evidence streams, and whether appropriate methods were applied to evaluating the evidence. The report makes recommendations to improve EPA's process and strengthen the evaluation.

Download or read book Using 21st Century Science to Improve Risk Related Evaluations written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-02-16 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last decade, several large-scale United States and international programs have been initiated to incorporate advances in molecular and cellular biology, -omics technologies, analytical methods, bioinformatics, and computational tools and methods into the field of toxicology. Similar efforts are being pursued in the field of exposure science with the goals of obtaining more accurate and complete exposure data on individuals and populations for thousands of chemicals over the lifespan; predicting exposures from use data and chemical-property information; and translating exposures between test systems and humans. Using 21st Century Science to Improve Risk-Related Evaluations makes recommendations for integrating new scientific approaches into risk-based evaluations. This study considers the scientific advances that have occurred following the publication of the NRC reports Toxicity Testing in the 21st Century: A Vision and a Strategy and Exposure Science in the 21st Century: A Vision and a Strategy. Given the various ongoing lines of investigation and new data streams that have emerged, this publication proposes how best to integrate and use the emerging results in evaluating chemical risk. Using 21st Century Science to Improve Risk-Related Evaluations considers whether a new paradigm is needed for data validation, how to integrate the divergent data streams, how uncertainty might need to be characterized, and how best to communicate the new approaches so that they are understandable to various stakeholders.

Download or read book Acute Exposure Guideline Levels for Selected Airborne Chemicals written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-09-26 with total page 195 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extremely hazardous substances can be released accidentally as a result of chemical spills, industrial explosions, fires, or accidents involving railroad cars and trucks transporting EHSs. Workers and residents in communities surrounding industrial facilities where these substances are manufactured, used, or stored and in communities along the nation's railways and highways are potentially at risk of being exposed to airborne EHSs during accidental releases or intentional releases by terrorists. Pursuant to the Superfund Amendments and Reauthorization Act of 1986, the U.S. Environmental Protection Agency (EPA) has identified approximately 400 EHSs on the basis of acute lethality data in rodents. Acute Exposure Guideline Levels for Selected Airborne Chemicals, Volume 20 reviews and updates the technical support document on acute exposure guideline levels (AEGLs) for selected chloroformates. This update focuses on establishing AEGL-3 values for n-propyl chloroformate and isopropyl chloroformate, but will also consider whether any new data are available that would affect the proposed values for the other 10 chloroformates. AEGLs represent threshold exposure limits (exposure levels below which adverse health effects are not likely to occur) for the general public and are applicable to emergency exposures ranging from 10 minutes (min) to 8 h. Three levels - AEGL-1, AEGL-2, and AEGL-3 - are developed for each of five exposure periods (10 min, 30 min, 1 h, 4 h, and 8 h) and are distinguished by varying degrees of severity of toxic effects. This report will inform planning, response, and prevention in the community, the workplace, transportation, the military, and the remediation of Superfund sites.

Download or read book Refinements to the Methods for Developing Spacecraft Exposure Guidelines written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-05-07 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Human spaceflight is inherently risky, with numerous potential hazards posed at each phase of a mission. Potential health risks during spaceflights include short-term health consequences from being in microgravity, as well as long-term health consequences that arise, or continue, months or years after a flight. Additional health considerations are risks posed by exposure to environmental contaminants onboard spacecraft. Because the International Space Station and spacecraft are closed environments that require recirculation of air and water supplies, some contamination of the air and water will occur. Even with onboard air and water purification systems, chemicals will accumulate in the air and water as they recirculate or are recycled onboard. Therefore, it is necessary for the National Aeronautics and Space Administration (NASA) to identify hazardous contaminants and determine exposure levels that are not expected to pose a health risk to astronauts. NASA uses spacecraft maximum allowance concentrations (SMACs) and spacecraft water exposure guidelines (SWEGs) to provide guidance on acceptable exposures to air and water contaminants during normal operations and emergency situations. Refinements to the Methods for Developing Spacecraft Exposure Guidelines updates the methods for establishing SMACs and SWEGs and assists NASA with identifying chemicals that need updated SMACs or SWEGs and new chemicals for which these guidelines should be developed.

Download or read book Acute Exposure Guideline Levels for Selected Airborne Chemicals written by National Research Council and published by National Academies Press. This book was released on 2015-04-09 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extremely hazardous substances can be released accidentally as a result of chemical spills, industrial explosions, fires, or accidents involving railroad cars and trucks transporting EHSs. Workers and residents in communities surrounding industrial facilities where these substances are manufactured, used, or stored and in communities along the nation's railways and highways are potentially at risk of being exposed to airborne EHSs during accidental releases or intentional releases by terrorists. Pursuant to the Superfund Amendments and Reauthorization Act of 1986, the U.S. Environmental Protection Agency (EPA) has identified approximately 400 EHSs on the basis of acute lethality data in rodents. Acute Exposure Guideline Levels for Selected Airborne Chemicals, Volume 19 identifies, reviews, and interprets relevant toxicologic and other scientific data for selected AEGL documents for cyanide salts, diketene, methacrylaldehyde, pentaborane, tellurium hexafluoride, and tetrafluoroethylene in order to develop acute exposure guideline levels (AEGLs) for these high-priority, acutely toxic chemicals. AEGLs represent threshold exposure limits (exposure levels below which adverse health effects are not likely to occur) for the general public and are applicable to emergency exposures ranging from 10 minutes (min) to 8 h. Three levels - AEGL-1, AEGL-2, and AEGL-3 - are developed for each of five exposure periods (10 min, 30 min, 1 h, 4 h, and 8 h) and are distinguished by varying degrees of severity of toxic effects. This report will inform planning, response, and prevention in the community, the workplace, transportation, the military, and the remediation of Superfund sites.

Download or read book Research Progress on Environmental Health and Safety Aspects of Engineered Nanomaterials written by National Research Council and published by National Academies Press. This book was released on 2013-11-25 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the increase in funding for research and the rising numbers of peer-reviewed publications over the past decade that address the environmental, health, and safety aspects of engineered nanomaterials (ENMs), uncertainty about the implications of potential exposures of consumers, workers, and ecosystems to these materials persists. Consumers and workers want to know which of these materials they are exposed to and whether the materials can harm them. Industry is concerned about being able to predict with sufficient certainty whether products that it makes and markets will pose any environmental, health or safety issues and what measures should be taken regarding manufacturing practices and worldwide distribution to minimize any potential risk. However, there remains a disconnect between the research that is being carried out and its relevance to and use by decision-makers and regulators to make informed public health and environmental policy and regulatory decisions. Research Progress on Environmental, Health, and Safety Aspects of Nanomaterials evaluates research progress and updates research priorities and resource estimates on the basis of results of studies and emerging trends in the nanotechnology industry. This report follows up the 2012 report A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which presented a strategic approach for developing the science and research infrastructure needed to address uncertainties regarding the potential environmental, health, and safety risks posed by ENMs. This new report looks at the state of nanotechnology research, examines market and regulatory conditions and their affect on research priorities, and considers the criteria for evaluating research progress on the environmental, health, and safety aspects of nanotechnology.