Building Confidence in New Evidence Streams for Human Health Risk Assessment

Building Confidence in New Evidence Streams for Human Health Risk Assessment

Author: National Academies of Sciences, Engineering, and Medicine

Publisher:

Published: 2023-08-25

Total Pages: 0

ISBN-13: 9780309700771

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As part of its core mission, the U.S. Environmental Protection Agency (EPA) is tasked with assessing the hazards and risks to human health from exposure to pollutants. While some pollutants are well studied, there are little or no data on the potential health effects for many thousands of chemicals that can make their way into the environment, such as PFAS. EPA still relies on laboratory mammalian studies as the foundation of most human health risk assessments, which are limited by high costs, long timelines, and other concerns. New approach methods (NAMs) in toxicology, for example new in vivo and in vitro strategies and computational systems biology, offer opportunities to inform timely decision-making when no data are available from laboratory mammalian toxicity tests or epidemiological studies. NAMs may also help inform efforts to protect susceptible and vulnerable populations by characterizing subtle health perturbations, better encompassing genetic diversity, and accounting for nonchemical stressors. While the promise and need for NAMs is clear, many barriers to their use remain. This report aims to bridge the gap between the potential of NAMs and their practical application in human health risk assessment. Building Confidence in New Evidence Streams for Human Health Risk Assessment draws lessons learned from laboratory mammalian toxicity tests to help inform approaches for building scientific confidence in NAMs and for incorporating such data into risk assessment and decision-making. Overall, the report recommendations aim to ensure a seamless handoff from the evaluation of NAM-based testing strategies in the laboratory to the incorporation of NAM data into modern, systematic-review-based risk assessments.


Book Synopsis Building Confidence in New Evidence Streams for Human Health Risk Assessment by : National Academies of Sciences, Engineering, and Medicine

Download or read book Building Confidence in New Evidence Streams for Human Health Risk Assessment written by National Academies of Sciences, Engineering, and Medicine and published by . This book was released on 2023-08-25 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: As part of its core mission, the U.S. Environmental Protection Agency (EPA) is tasked with assessing the hazards and risks to human health from exposure to pollutants. While some pollutants are well studied, there are little or no data on the potential health effects for many thousands of chemicals that can make their way into the environment, such as PFAS. EPA still relies on laboratory mammalian studies as the foundation of most human health risk assessments, which are limited by high costs, long timelines, and other concerns. New approach methods (NAMs) in toxicology, for example new in vivo and in vitro strategies and computational systems biology, offer opportunities to inform timely decision-making when no data are available from laboratory mammalian toxicity tests or epidemiological studies. NAMs may also help inform efforts to protect susceptible and vulnerable populations by characterizing subtle health perturbations, better encompassing genetic diversity, and accounting for nonchemical stressors. While the promise and need for NAMs is clear, many barriers to their use remain. This report aims to bridge the gap between the potential of NAMs and their practical application in human health risk assessment. Building Confidence in New Evidence Streams for Human Health Risk Assessment draws lessons learned from laboratory mammalian toxicity tests to help inform approaches for building scientific confidence in NAMs and for incorporating such data into risk assessment and decision-making. Overall, the report recommendations aim to ensure a seamless handoff from the evaluation of NAM-based testing strategies in the laboratory to the incorporation of NAM data into modern, systematic-review-based risk assessments.


Toxicity Testing in the 21st Century

Toxicity Testing in the 21st Century

Author: National Research Council

Publisher: National Academies Press

Published: 2007-11-05

Total Pages: 217

ISBN-13: 0309151732

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Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.


Book Synopsis Toxicity Testing in the 21st Century by : National Research Council

Download or read book Toxicity Testing in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2007-11-05 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.


Occupational Health and Safety in the Care and Use of Research Animals

Occupational Health and Safety in the Care and Use of Research Animals

Author: Committee on Occupational Safety and Health in Research Animal Facilities

Publisher: National Academies Press

Published: 1997-06-23

Total Pages: 167

ISBN-13: 0309520398

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Much has been written about the care of research animals. Yet little guidance has appeared on protecting the health and safety of the people who care for or use these animals. This book, an implementation handbook and companion to Guide For the Care and Use of Laboratory Animals, identifies principles for building a program and discusses the accountability of institutional leaders, managers, and employees for a program's success. It provides a detailed description of risks-- physical and chemical hazards, allergens and zoonoses, and hazards from experiments--which will serve as a continuing reference for the laboratory. The book offers specific recommendations for controlling risk through administrative procedures, facility design, engineering controls, and periodic evaluations. The volume focuses on the worker, with detailed discussions of work practices, the use of personal protective gear, and the development of an emergency response plan. This handbook will be invaluable to administrators, researchers, and employees in any animal research facility. It will also be of interest to personnel in zoos, animal shelters, and veterinary facilities.


Book Synopsis Occupational Health and Safety in the Care and Use of Research Animals by : Committee on Occupational Safety and Health in Research Animal Facilities

Download or read book Occupational Health and Safety in the Care and Use of Research Animals written by Committee on Occupational Safety and Health in Research Animal Facilities and published by National Academies Press. This book was released on 1997-06-23 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: Much has been written about the care of research animals. Yet little guidance has appeared on protecting the health and safety of the people who care for or use these animals. This book, an implementation handbook and companion to Guide For the Care and Use of Laboratory Animals, identifies principles for building a program and discusses the accountability of institutional leaders, managers, and employees for a program's success. It provides a detailed description of risks-- physical and chemical hazards, allergens and zoonoses, and hazards from experiments--which will serve as a continuing reference for the laboratory. The book offers specific recommendations for controlling risk through administrative procedures, facility design, engineering controls, and periodic evaluations. The volume focuses on the worker, with detailed discussions of work practices, the use of personal protective gear, and the development of an emergency response plan. This handbook will be invaluable to administrators, researchers, and employees in any animal research facility. It will also be of interest to personnel in zoos, animal shelters, and veterinary facilities.


Guidelines for the Humane Transportation of Research Animals

Guidelines for the Humane Transportation of Research Animals

Author: National Research Council

Publisher: National Academies Press

Published: 2006-08-14

Total Pages: 165

ISBN-13: 0309101107

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Arranging the transportation of animals at research facilities is often an ordeal. There is a confusing patchwork of local, national, and international regulations; a perceived lack of high-quality shipping services; a dearth of science-based good practices; and a lack of biosafety standards. It's a challenge â€"and an impediment to biomedical research. Guidelines for the Humane Transportation of Research Animals identifies the current problems encountered in the transportation of research animals and offers recommendations aimed at local and federal officials to rectify these problems. This book also includes a set of good practices based on the extensive body of literature on transportation of agricultural animals, universal concepts of physiology, and a scientific understanding of species-specific needs and differences. Good practices were developed by the committee to address thermal environment, space requirements, food and water requirements, social interaction, monitoring of transportation, emergency procedures, personnel training, and biosecurity. Guidelines for the Humane Transportation of Research Animals is an essential guide for all researchers, animal care technicians, facilities managers, administrators, and animal care and use committees at research institutions.


Book Synopsis Guidelines for the Humane Transportation of Research Animals by : National Research Council

Download or read book Guidelines for the Humane Transportation of Research Animals written by National Research Council and published by National Academies Press. This book was released on 2006-08-14 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: Arranging the transportation of animals at research facilities is often an ordeal. There is a confusing patchwork of local, national, and international regulations; a perceived lack of high-quality shipping services; a dearth of science-based good practices; and a lack of biosafety standards. It's a challenge â€"and an impediment to biomedical research. Guidelines for the Humane Transportation of Research Animals identifies the current problems encountered in the transportation of research animals and offers recommendations aimed at local and federal officials to rectify these problems. This book also includes a set of good practices based on the extensive body of literature on transportation of agricultural animals, universal concepts of physiology, and a scientific understanding of species-specific needs and differences. Good practices were developed by the committee to address thermal environment, space requirements, food and water requirements, social interaction, monitoring of transportation, emergency procedures, personnel training, and biosecurity. Guidelines for the Humane Transportation of Research Animals is an essential guide for all researchers, animal care technicians, facilities managers, administrators, and animal care and use committees at research institutions.


Neurotoxicity of Halogenated Organic Compounds

Neurotoxicity of Halogenated Organic Compounds

Author:

Publisher: Elsevier

Published: 2023-10-26

Total Pages: 464

ISBN-13: 0443133417

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Neurotoxicity of Halogenated Organic Compounds, Volume 10 covers three groups of Halogenated Organic Compounds (Chlorinated, Brominated, and Fluorinated Compounds) that are legacy and emerging contaminants, providing background information, characteristics, physicochemical properties, environmental contamination, and human exposure. Specific chapters covered in this release include Perspective on Halogenated Organic Compounds, The Neurotoxicity of Polychlorinated Biphenyls (PCBs), Neuroendocrine Effects of Polychlorinated Biphenyls (PCBs), Mechanisms of PCB Neurotoxicity: AHR and THR Dogma meet RYR reality, Microbiome and the Neurotoxicity of Brominated Flame Retardants (BFRs), and much more. Other chapters cover Neuroendocrine Effects of Brominated Flame Retardants (BFRs), Focused on Polybrominated Diphenyl Ethers (PBDEs), Neurochemical Effects of Halogenated Organic Compounds: Possible Mode(s) of action and Structure-Activity Relationships, The Neurotoxic Effects of Perfluoroalkyl Substances (PFAS) in Animal Models and Human Cohorts, Neurochemical Mechanisms of Perfluoroalkyl Substances (PFAS) Neurotoxic Action, and Future Directions and Regulatory aspects of Halogenated Organic Compounds. Presents the latest on the Neurotoxicity of Halogenated Organic Compounds: Epidemiological, Behavioral and other effects Covers Neurochemical and Neuroendocrine effects of Halogenated Organic Compounds Provides Regulatory aspects of Halogenated Organic Compounds


Book Synopsis Neurotoxicity of Halogenated Organic Compounds by :

Download or read book Neurotoxicity of Halogenated Organic Compounds written by and published by Elsevier. This book was released on 2023-10-26 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neurotoxicity of Halogenated Organic Compounds, Volume 10 covers three groups of Halogenated Organic Compounds (Chlorinated, Brominated, and Fluorinated Compounds) that are legacy and emerging contaminants, providing background information, characteristics, physicochemical properties, environmental contamination, and human exposure. Specific chapters covered in this release include Perspective on Halogenated Organic Compounds, The Neurotoxicity of Polychlorinated Biphenyls (PCBs), Neuroendocrine Effects of Polychlorinated Biphenyls (PCBs), Mechanisms of PCB Neurotoxicity: AHR and THR Dogma meet RYR reality, Microbiome and the Neurotoxicity of Brominated Flame Retardants (BFRs), and much more. Other chapters cover Neuroendocrine Effects of Brominated Flame Retardants (BFRs), Focused on Polybrominated Diphenyl Ethers (PBDEs), Neurochemical Effects of Halogenated Organic Compounds: Possible Mode(s) of action and Structure-Activity Relationships, The Neurotoxic Effects of Perfluoroalkyl Substances (PFAS) in Animal Models and Human Cohorts, Neurochemical Mechanisms of Perfluoroalkyl Substances (PFAS) Neurotoxic Action, and Future Directions and Regulatory aspects of Halogenated Organic Compounds. Presents the latest on the Neurotoxicity of Halogenated Organic Compounds: Epidemiological, Behavioral and other effects Covers Neurochemical and Neuroendocrine effects of Halogenated Organic Compounds Provides Regulatory aspects of Halogenated Organic Compounds


EPA 630/R

EPA 630/R

Author:

Publisher:

Published: 1998

Total Pages: 94

ISBN-13:

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Book Synopsis EPA 630/R by :

Download or read book EPA 630/R written by and published by . This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:


Guide for the Care and Use of Laboratory Animals

Guide for the Care and Use of Laboratory Animals

Author: National Research Council

Publisher: National Academies Press

Published: 2011-01-27

Total Pages: 246

ISBN-13: 0309154006

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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.


Book Synopsis Guide for the Care and Use of Laboratory Animals by : National Research Council

Download or read book Guide for the Care and Use of Laboratory Animals written by National Research Council and published by National Academies Press. This book was released on 2011-01-27 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


The Use of Systematic Review in Epa's Toxic Substances Control ACT Risk Evaluations

The Use of Systematic Review in Epa's Toxic Substances Control ACT Risk Evaluations

Author: National Academies Of Sciences Engineeri

Publisher: National Academies Press

Published: 2021-11-16

Total Pages:

ISBN-13: 9780309683869

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Systematic review - a scientific investigation that focuses on a specific question and uses explicit, prespecified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies - has become the foundation for assessing evidence to be used for decision making in a variety of health contexts, including health care and public health. At the request of the Environmental Protection Agency (EPA), this publication reviews EPA's 2018 guidance document Application of Systematic Review in TSCA (Toxic Substances and Control Act) Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent.


Book Synopsis The Use of Systematic Review in Epa's Toxic Substances Control ACT Risk Evaluations by : National Academies Of Sciences Engineeri

Download or read book The Use of Systematic Review in Epa's Toxic Substances Control ACT Risk Evaluations written by National Academies Of Sciences Engineeri and published by National Academies Press. This book was released on 2021-11-16 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Systematic review - a scientific investigation that focuses on a specific question and uses explicit, prespecified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies - has become the foundation for assessing evidence to be used for decision making in a variety of health contexts, including health care and public health. At the request of the Environmental Protection Agency (EPA), this publication reviews EPA's 2018 guidance document Application of Systematic Review in TSCA (Toxic Substances and Control Act) Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent.


Guide for the Care and Use of Laboratory Animals

Guide for the Care and Use of Laboratory Animals

Author: Institute of Laboratory Animal Resources (U.S.). Committee on Care and Use of Laboratory Animals

Publisher:

Published: 1978

Total Pages: 84

ISBN-13:

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Book Synopsis Guide for the Care and Use of Laboratory Animals by : Institute of Laboratory Animal Resources (U.S.). Committee on Care and Use of Laboratory Animals

Download or read book Guide for the Care and Use of Laboratory Animals written by Institute of Laboratory Animal Resources (U.S.). Committee on Care and Use of Laboratory Animals and published by . This book was released on 1978 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:


Exposure Science in the 21st Century

Exposure Science in the 21st Century

Author: National Research Council

Publisher: National Academies Press

Published: 2012-10-28

Total Pages: 210

ISBN-13: 0309264685

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From the use of personal products to our consumption of food, water, and air, people are exposed to a wide array of agents each day-many with the potential to affect health. Exposure Science in the 21st Century: A Vision and A Strategy investigates the contact of humans or other organisms with those agents (that is, chemical, physical, and biologic stressors) and their fate in living systems. The concept of exposure science has been instrumental in helping us understand how stressors affect human and ecosystem health, and in efforts to prevent or reduce contact with harmful stressors. In this way exposure science has played an integral role in many areas of environmental health, and can help meet growing needs in environmental regulation, urban and ecosystem planning, and disaster management. Exposure Science in the 21st Century: A Vision and A Strategy explains that there are increasing demands for exposure science information, for example to meet needs for data on the thousands of chemicals introduced into the market each year, and to better understand the health effects of prolonged low-level exposure to stressors. Recent advances in tools and technologies-including sensor systems, analytic methods, molecular technologies, computational tools, and bioinformatics-have provided the potential for more accurate and comprehensive exposure science data than ever before. This report also provides a roadmap to take advantage of the technologic innovations and strategic collaborations to move exposure science into the future.


Book Synopsis Exposure Science in the 21st Century by : National Research Council

Download or read book Exposure Science in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2012-10-28 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the use of personal products to our consumption of food, water, and air, people are exposed to a wide array of agents each day-many with the potential to affect health. Exposure Science in the 21st Century: A Vision and A Strategy investigates the contact of humans or other organisms with those agents (that is, chemical, physical, and biologic stressors) and their fate in living systems. The concept of exposure science has been instrumental in helping us understand how stressors affect human and ecosystem health, and in efforts to prevent or reduce contact with harmful stressors. In this way exposure science has played an integral role in many areas of environmental health, and can help meet growing needs in environmental regulation, urban and ecosystem planning, and disaster management. Exposure Science in the 21st Century: A Vision and A Strategy explains that there are increasing demands for exposure science information, for example to meet needs for data on the thousands of chemicals introduced into the market each year, and to better understand the health effects of prolonged low-level exposure to stressors. Recent advances in tools and technologies-including sensor systems, analytic methods, molecular technologies, computational tools, and bioinformatics-have provided the potential for more accurate and comprehensive exposure science data than ever before. This report also provides a roadmap to take advantage of the technologic innovations and strategic collaborations to move exposure science into the future.