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Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309166411
Category : Science
Languages : en
Pages : 226

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.

Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309166411
Category : Science
Languages : en
Pages : 226

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.

Animal Models in Toxicology

Animal Models in Toxicology PDF Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 142001420X
Category : Medical
Languages : en
Pages : 950

Book Description
Reflecting more than a decade's worth of changes, Animal Models in Toxicology, Second Edition is a practical guide to the common statistical problems encountered in toxicology and the methodologies that are available to solve them. The book presents a historical review of the use of animal models and an overview of broad considerations of me

Scientific Frontiers in Developmental Toxicology and Risk Assessment

Scientific Frontiers in Developmental Toxicology and Risk Assessment PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309070864
Category : Nature
Languages : en
Pages : 348

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.

Toxicity Testing for Assessment of Environmental Agents

Toxicity Testing for Assessment of Environmental Agents PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309164869
Category : Nature
Languages : en
Pages : 270

Book Description
Toxicity testing in laboratory animals provides much of the information used by the Environmental Protection Agency (EPA) to assess the hazards and risks associated with exposure to environmental agents that might harm public health or the environment. The data are used to establish maximum acceptable concentrations of environmental agents in drinking water, set permissible limits of exposure of workers, define labeling requirements, establish tolerances for pesticides residues on food, and set other kinds of limits on the basis of risk assessment. Because the number of regulations that require toxicity testing is growing, EPA called for a comprehensive review of established and emerging toxicity-testing methods and strategies. This interim report reviews current toxicity-testing methods and strategies and near-term improvements in toxicity-testing approaches proposed by EPA and others. It identifies several recurring themes and questions in the various reports reviewed. The final report will present a long-range vision and strategic plan to advance the practices of toxicity testing and human health assessment of environmental contaminants.

Science, Medicine, and Animals

Science, Medicine, and Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309101174
Category : Science
Languages : en
Pages : 23

Book Description
Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

Small Animal Toxicology

Small Animal Toxicology PDF Author: Patricia A. Talcott
Publisher: Elsevier Health Sciences
ISBN: 0323241980
Category : Medical
Languages : uk
Pages : 955

Book Description
- 20 new chapters have been added - New topics include a list of toxicants affecting body systems, management of toxins in pregnancy, diagnostic toxicology, bacterial toxins, and cosmetic/toilet articles - Snake-bite injuries are treated in two separate, expanded chapters: Pit Vipers and Coral Snakes - Section on pharmaceuticals includes bromides, anticonvulsants, tricycle antidepressants, monoamine oxidize inhibitors, B-adrenergic toxicities, and vitamins A and D - Additional specific toxicants are covered, including Amitraz, hydramethylon, ethanol, mercury, toad toxins, poisonous frogs, salamanders, newts and venomous arthropods•Additional specific toxicants are covered, including Amitraz, hydramethylon, ethanol, mercury, toad toxins, poisonous frogs, salamanders, newts and venomous arthropods.

Animal Experimentation: Working Towards a Paradigm Change

Animal Experimentation: Working Towards a Paradigm Change PDF Author: Kathrin Herrmann
Publisher: BRILL
ISBN: 9004391193
Category : Philosophy
Languages : en
Pages : 749

Book Description
Animal experimentation has been one of the most controversial areas of animal use, mainly due to the intentional harms inflicted upon animals for the sake of hoped-for benefits in humans. Despite this rationale for continued animal experimentation, shortcomings of this practice have become increasingly more apparent and well-documented. However, these limitations are not yet widely known or appreciated, and there is a danger that they may simply be ignored. The 51 experts who have contributed to Animal Experimentation: Working Towards a Paradigm Change critically review current animal use in science, present new and innovative non-animal approaches to address urgent scientific questions, and offer a roadmap towards an animal-free world of science.

Veterinary Toxicology

Veterinary Toxicology PDF Author: Ramesh C Gupta
Publisher: Elsevier
ISBN: 0080481604
Category : Medical
Languages : en
Pages : 1233

Book Description
Veterinary Toxicology, 2nd edition is a unique single reference that teaches the basic principles of veterinary toxicology and builds upon these principles to offer an essential clinical resource for those practicing in the field. This reference book is thoroughly updated with new chapters and the latest coverage of topics that are essential to research veterinary toxicologists, students, professors, clinicians and environmentalists. Key areas include melamine and cyanuric acid, toxicogenomics, veterinary medical geology, toxic gases, toxicity and safety evaluation of new veterinary pharmaceuticals and much more. The 2nd edition of this popular book represents the collective wisdom of leading contributors worldwide and continues to fill an undeniable need in the literature relating to veterinary toxicology. - New chapters covering important and timely topics such as melamine and cyanuric acid, toxicogenomics, toxic gases and veterinary medical geology - Expanded look at international topics, such as epidemiology of animal poisonings, regulatory guidelines and poisonous plants in Europe - Heavily contributed book with chapters written by qualified and well-experienced authorities across all areas of veterinary toxicology - Problem solving strategies are offered for treatment as well as in-depth knowledge of the basic mechanisms of veterinary toxicology

Guide for the Care and Use of Laboratory Animals

Guide for the Care and Use of Laboratory Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309154006
Category : Science
Languages : en
Pages : 246

Book Description
A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.

Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity

Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309073162
Category : Nature
Languages : en
Pages : 261

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).