Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity


Book Description

The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research).




How Tobacco Smoke Causes Disease


Book Description

This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products.




Intentional Human Dosing Studies for EPA Regulatory Purposes


Book Description

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.




Scientific Frontiers in Developmental Toxicology and Risk Assessment


Book Description

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.




Aquatic Ecotoxicology


Book Description

Aquatic Ecotoxicology: Advancing Tools for Dealing with Emerging Risks presents a thorough look at recent advances in aquatic ecotoxicology and their application in assessing the risk of well-known and emerging environmental contaminants. This essential reference, brought together by leading experts in the field, guides users through existing and novel approaches to environmental risk assessment, then presenting recent advances in the field of ecotoxicology, including omics-based technologies, biomarkers, and reference species. The book then demonstrates how these advances can be used to design and perform assays to discover the toxicological endpoints of emerging risks within the aquatic environment, such as nanomaterials, personal care products, PFOS and chemical mixtures. The text is an invaluable reference for any scientist who studies the effects of contaminants on organisms that live within aquatic environments. - Provides the latest perspectives on emerging toxic risks to aquatic environments, such as nanomaterials, pharmaceuticals, chemical mixtures, and perfluorooctane sulfonate (PFOS) - Offers practical guidance on recent advances to help in choosing the most appropriate toxicological assay - Presents case studies and information on a variety of reference species to help put the ecotoxicological theory into practical risk assess




Toxicological Risk Assessment and Multi-System Health Impacts from Exposure


Book Description

Toxicological Risk Assessment and Multisystem Health Impacts From Exposure highlights the emerging problems of human and environmental health attributable to cumulative and multiple sources of long-term exposure to environmental toxicants. The book describes the cellular, biological, immunological, endocrinologic, genetic, and epigenetic effects of long-term exposure. It examines how the combined exposure to nanomaterials, metals, pharmaceuticals, multifrequency radiation, dietary mycotoxins, and pesticides accelerates ecotoxicity in humans, animals, plants, and the larger environment. The book goes on to also offer insights into mixture risk assessments, protocols for evaluating the risks, and how this information can serve the regulatory agencies in setting safer exposure limits. The book is a go-to resource for scientists and professionals in the field tackling the current and emerging trends in modern toxicology and risk assessment. - Bridges basic research with clinical, epidemiological, regulatory, and translational research, conveying both an introductory understanding and the latest developments in the field - Evaluates real-life human health risk assessment for long-term exposures to xenobiotic mixtures and the role they play in contributing to chronic disease - Discusses advances in predictive (in silico) toxicology tools and the benefits of using omics technologies in toxicology research




Environmental Epigenetics


Book Description

This book examines the toxicological and health implications of environmental epigenetics and provides knowledge through an interdisciplinary approach. Included in this volume are chapters outlining various environmental risk factors such as phthalates and dietary components, life states such as pregnancy and ageing, hormonal and metabolic considerations and specific disease risks such as cancer cardiovascular diseases and other non-communicable diseases. Environmental Epigenetics imparts integrative knowledge of the science of epigenetics and the issues raised in environmental epidemiology. This book is intended to serve both as a reference compendium on environmental epigenetics for scientists in academia, industry and laboratories and as a textbook for graduate level environmental health courses. Environmental Epigenetics imparts integrative knowledge of the science of epigenetics and the issues raised in environmental epidemiology. This book is intended to serve both as a reference compendium on environmental epigenetics for scientists in academia, industry and laboratories and as a textbook for graduate level environmental health courses.




Animal Experimentation


Book Description

Animal Experimentation: Working Towards a Paradigm Change critically appraises current animal use in science and discusses ways in which we can contribute to a paradigm change towards human-biology based approaches.




Arsenic in Drinking Water


Book Description

Having safe drinking water is important to all Americans. The Environmental Protection Agency's decision in the summer of 2001 to delay implementing a new, more stringent standard for the maximum allowable level for arsenic in drinking water generated a great deal of criticism and controversy. Ultimately at issue were newer data on arsenic beyond those that had been examined in a 1999 National Research Council report. EPA asked the National Research Council for an evaluation of the new data available. The committee's analyses and conclusions are presented in Arsenic in Drinking Water: 2001 Update. New epidemiological studies are critically evaluated, as are new experimental data that provide information on how and at what level arsenic in drinking water can lead to cancer. The report's findings are consistent with those of the 1999 report that found high risks of cancer at the previous federal standard of 50 parts per billion. In fact, the new report concludes that men and women who consume water containing 3 parts per billion of arsenic daily have about a 1 in 1,000 increased risk of developing bladder or lung cancer during their lifetime.