Review Of U S Epa S Ord Staff Handbook For Developing Iris Assessments

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Review of U. S. EPA's ORD Staff Handbook for Developing IRIS Assessments

Author : National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review EPA'S IRIS Assessment Handbook
Publisher : Unknown
Page : 120 pages
File Size : 48,8 Mb
Release : 2022-08-30
Category : Political Science
ISBN : 0309090881

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Review of U. S. EPA's ORD Staff Handbook for Developing IRIS Assessments by National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review EPA'S IRIS Assessment Handbook Pdf

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.

Review of EPA's Integrated Risk Information System (IRIS) Process

Author : National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review the IRIS Process
Publisher : National Academies Press
Page : 170 pages
File Size : 55,6 Mb
Release : 2014-06-25
Category : Political Science
ISBN : 9780309304177

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Review of EPA's Integrated Risk Information System (IRIS) Process by National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review the IRIS Process Pdf

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.

Review of EPA's Updated Problem Formulation and Protocol for the Inorganic Arsenic IRIS Assessment

Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Evaluate the IRIS Protocol for Inorganic Arsenic
Publisher : National Academies Press
Page : 28 pages
File Size : 47,6 Mb
Release : 2019-10-31
Category : Nature
ISBN : 9780309497022

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Review of EPA's Updated Problem Formulation and Protocol for the Inorganic Arsenic IRIS Assessment by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Evaluate the IRIS Protocol for Inorganic Arsenic Pdf

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. The EPA has been working on its IRIS assessment of inorganic arsenic (iAs) for many years, and recently released its plans for completing it in the Updated Problem Formulation and Protocol for the Inorganic Arsenic IRIS Assessment. Much of the update was made in response to recommendations in a 2013 report made by the National Academies of Sciences, Engineering, and Medicine. The National Academies recently convened another evaluation of whether the various elements of the IRIS iAs assessment plan are appropriate to synthesize the scientific evidence and quantitate estimates of iAs toxicity. Review of EPA's IRIS Assessment Plan for Inorganic Arsenic explores the EPA's approach to prioritizing health outcomes, EPA's systematic review methods, EPA's consideration of potential health effects from early life exposures, mode-of-action information to inform dose-response analyses, and various approaches to investigate dose-response relationships.

Air Pollution Calculations

Author : Daniel A. Vallero
Publisher : Elsevier
Page : 674 pages
File Size : 41,5 Mb
Release : 2023-09-17
Category : Science
ISBN : 9780443139888

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Air Pollution Calculations by Daniel A. Vallero Pdf

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

Author : A. Wallace Hayes,Tetyana Kobets
Publisher : CRC Press
Page : 2143 pages
File Size : 44,7 Mb
Release : 2023-07-03
Category : Medical
ISBN : 9781000875775

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Hayes' Principles and Methods of Toxicology by A. Wallace Hayes,Tetyana Kobets Pdf

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 2021: an International Conference Addressing Issues in Science and Regulation

Author : Robert McCunney,Nils Krueger,Len Levy,Kevin Driscoll,Paul Borm
Publisher : Frontiers Media SA
Page : 209 pages
File Size : 45,5 Mb
Release : 2023-01-30
Category : Medical
ISBN : 9782832510964

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Particles and Health 2021: an International Conference Addressing Issues in Science and Regulation by Robert McCunney,Nils Krueger,Len Levy,Kevin Driscoll,Paul Borm Pdf

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.

Peer Review Handbook

Author : Kerry L. Dearfield
Publisher : Unknown
Page : 136 pages
File Size : 48,6 Mb
Release : 1998
Category : Peer review
ISBN : UOM:39015043186348

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Peer Review Handbook by Kerry L. Dearfield Pdf

Critical Aspects of EPA's IRIS Assessment of Inorganic Arsenic

Author : Committee on Inorganic Arsenic,Board on Environmental Studies and Toxicology,Division on Earth and Life Studies,National Research Council
Publisher : National Academies Press
Page : 127 pages
File Size : 45,8 Mb
Release : 2013-11-20
Category : Nature
ISBN : 0309387671

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Critical Aspects of EPA's IRIS Assessment of Inorganic Arsenic by Committee on Inorganic Arsenic,Board on Environmental Studies and Toxicology,Division on Earth and Life Studies,National Research Council Pdf

The US Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) program develops toxicologic assessments of environmental contaminants. IRIS assessments provide hazard identification and dose-response assessment information. The information is then used in conjunction with exposure information to characterize risks to public health and may be used in risk-based decisionmaking, in regulatory actions, and for other risk-management purposes. Since the middle 1990s, EPA has been in the process of updating the IRIS assessment of inorganic arsenic. In response to a congressional mandate for an independent review of the IRIS assessment of inorganic arsenic, EPA requested that the National Research Council convene a committee to conduct a two-phase study. Critical Aspects of EPA's IRIS Assessment of Inorganic Arsenic is the report of the first phase of that study. This report evaluates critical scientific issues in assessing cancer and noncancer effects of oral exposure to inorganic arsenic and offers recommendations on how the issues could be addressed in EPA's IRIS assessment.

Progress Toward Transforming the Integrated Risk Information System (IRIS) Program

Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review Advances Made to the IRIS Process
Publisher : National Academies Press
Page : 130 pages
File Size : 43,8 Mb
Release : 2018-04-11
Category : Political Science
ISBN : 9780309474948

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Progress Toward Transforming the Integrated Risk Information System (IRIS) Program by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review Advances Made to the IRIS Process Pdf

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.

Interior, Environment, and Related Agencies Appropriations for 2017

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Interior, Environment, and Related Agencies
Publisher : Unknown
Page : 1140 pages
File Size : 50,7 Mb
Release : 2016
Category : United States
ISBN : IND:30000137272526

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Interior, Environment, and Related Agencies Appropriations for 2017 by United States. Congress. House. Committee on Appropriations. Subcommittee on Interior, Environment, and Related Agencies Pdf

Environmental Health Perspectives

Author : Anonim
Publisher : Unknown
Page : 646 pages
File Size : 49,6 Mb
Release : 2000
Category : Environmental health
ISBN : MINN:31951P006992595

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Environmental Health Perspectives by Anonim Pdf

Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde

Author : National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review EPA's Draft IRIS Assessment of Formaldehyde
Publisher : National Academies Press
Page : 204 pages
File Size : 46,6 Mb
Release : 2011-05-31
Category : Science
ISBN : 9780309211963

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Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde by National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review EPA's Draft IRIS Assessment of Formaldehyde Pdf

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.

Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations for 2004

Author : United States. Congress. House. Committee on Appropriations. Subcommittee on VA, HUD, and Independent Agencies
Publisher : Unknown
Page : 1486 pages
File Size : 53,7 Mb
Release : 2003
Category : United States
ISBN : STANFORD:36105050319883

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Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations for 2004 by United States. Congress. House. Committee on Appropriations. Subcommittee on VA, HUD, and Independent Agencies Pdf

Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene

Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review DOD's Approach to Deriving an Occupational Exposure Limit for TCE
Publisher : National Academies Press
Page : 77 pages
File Size : 43,8 Mb
Release : 2020-01-13
Category : Nature
ISBN : 9780309499248

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Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review DOD's Approach to Deriving an Occupational Exposure Limit for TCE Pdf

Trichloroethylene (TCE) is a solvent that is used as a degreasing agent, a chemical intermediate in refrigerant manufacture, and a component of spot removers and adhesives. It is produced in mass quantities but creates dangerous vapors and is an environmental contaminant at many industrial and government facilities, including facilities run by the U.S. Department of Defense (DoD). It is important to determine the safe occupational exposure level (OEL) for the solvent in order to protect the health of workers who are exposed to its vapors. However, there are concerns that the current occupational standards insufficiently protect workers from these health threats. Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene makes recommendations to improve the DoD's approach to developing an OEL for TCE, strengthen transparency of the process, and improve confidence in the final OEL value. This report reviews the DoD's approach using a literature review, evidence synthesis based on weight of evidence [WOE], point-of-departure derivation, physiologically based pharmacokinetic modeling, extrapolation tools, and explores other elements of the process of deriving an OEL for TCE. It examines scientific approaches to developing exposure values and cancer risk levels, defining the scope of the problem, and improving hazard identification.