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.

"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 dose‒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" -- Publisher's description

Emerging Contaminants: Anticipating Developments examines the factors that have led "new" environmental contaminants to emerge in the past and combines the lessons learned to anticipate potential new developments. The analyses described in this book originate in multiple disciplines: the science of toxicology; environmental law and regulation; the field of product stewardship; and the social science which explains why ideas take hold. Over a dozen case studies of contaminants that emerged as environmental issues over the last hundred years illustrate crucial points. The results of the analyses in this book support a step-by-step method to assess the potential for a contaminant to emerge, and a framework to apply those conclusions to managing site liabilities. Features: Describes an unprecedented understanding of why contaminants emerge as issues, based on a multidisciplinary analysis Makes abstract concepts tangible, basing analyses on data and illustrating key points with case studies Enables readers to anticipate and prepare to manage future challenges associated with emerging chemicals Presents an analytical framework for companies to assess and manage business risks Written for regulators, policymakers, industry professionals with responsibility for contaminated site management, as well as attorneys, and consultants, this book provides a framework for anticipating the emergence of new contaminants so that the risks–whether to human health and the environment or to a business–can be anticipated and appropriately managed.

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.

The National Toxicology Program (NTP) conducted a systematic review of the evidence of adverse neurodevelopmental and cognitive effects of fluoride exposure. NTP's conclusions are summarized in the monograph Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects. At the request of NTP, a committee convened by the National Academies reviewed their monograph to ensure the integrity of that report. It is important to note that the committee was tasked with reviewing the monograph and focused its efforts on evaluating whether evidence as presented in the monograph supported NTP's conclusions. Thus, it did not conduct its own independent evaluation of the evidence, and it did not conduct a data audit. However, it did review some key literature to enable its review of the monograph. Review of the Draft NTP Monograph contains findings and suggestions for improvements and some overarching findings concerning methods, assessment of animal and human evidence, and NTP's hazard conclusion.

Traffic-Related Air Pollution synthesizes and maps TRAP and its impact on human health at the individual and population level. The book analyzes mitigating standards and regulations with a focus on cities. It provides the methods and tools for assessing and quantifying the associated road traffic emissions, air pollution, exposure and population-based health impacts, while also illuminating the mechanisms underlying health impacts through clinical and toxicological research. Real-world implications are set alongside policy options, emerging technologies and best practices. Finally, the book recommends ways to influence discourse and policy to better account for the health impacts of TRAP and its societal costs. Overviews existing and emerging tools to assess TRAP’s public health impacts Examines TRAP’s health effects at the population level Explores the latest technologies and policies--alongside their potential effectiveness and adverse consequences--for mitigating TRAP Guides on how methods and tools can leverage teaching, practice and policymaking to ameliorate TRAP and its effects

Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to five separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 2: Toxicologic Pathology in Safety Assessment is an essential part of the most authoritative reference on toxicologic pathology principles and techniques for assessing product safety and human risk. Volume 2 describes the integration of product-induced structural and functional changes in tissues and the interpretation of their biological implications. Completely revised with many new chapters, Volume 2 of the Fourth Edition covers product safety assessment from many angles including current and emerging issues in toxicologic pathology for many product classes. Volume 2 of the Handbook of Toxicologic Pathology is a key resource for pathologists, toxicologists, research scientists, and regulators who use toxicologic pathology methods to study and make decisions on product safety. Previous chapters on such topics as drug discovery and development, toxicity and carcinogenicity testing, report preparation, and risk assessment and communication have undergone extensive revision that includes in-depth discussion of new developments in the field New chapters consider fundamental attributes for additional product classes including protein therapeutics, nucleic acid pharmaceutical agents, gene therapy and gene editing, stem cell and other cell therapies, vaccines, agricultural and bulk chemicals, and assigning adversity Chapters dealing with product-specific practices address pathology and regulatory issues Chapters offer high-quality and up-to-date content in a trusted work written by the collaborative efforts of many leading international subject matter experts Hundreds of full-color images and diagrams are featured in both the print and electronic versions of this book to illustrate classic examples and highlight difficult concepts