Building Confidence in New Evidence Streams for Human Health Risk Assessment

Building Confidence in New Evidence Streams for Human Health Risk Assessment PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher:
ISBN: 9780309700771
Category : Science
Languages : en
Pages : 0

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Book Description
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.

Building Confidence in New Evidence Streams for Human Health Risk Assessment

Building Confidence in New Evidence Streams for Human Health Risk Assessment PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher:
ISBN: 9780309700771
Category : Science
Languages : en
Pages : 0

Get Book Here

Book Description
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 PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309151732
Category : Nature
Languages : en
Pages : 217

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Book Description
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 PDF Author: Committee on Occupational Safety and Health in Research Animal Facilities
Publisher: National Academies Press
ISBN: 0309520398
Category : Business & Economics
Languages : en
Pages : 167

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Book Description
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.

Education and Training in the Care and Use of Laboratory Animals

Education and Training in the Care and Use of Laboratory Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309043824
Category : Science
Languages : en
Pages : 152

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Book Description
Federal law now requires that institutions provide training for anyone caring for or using laboratory animals. This volume provides the guidelines and resources needed to coordinate a quality training program, as well as to meet all legal requirements. A core module for all personnel takes no more than four hours to present. Most staff then proceed to one or more additional skills-development modules including the species-specific module that can be customized to any species in use at the institution, the pain management module, and the surgery module. The volume provides content information for required topics-from ethics to record keeping-and lists sources of additional publications, audiovisual programs, and computerized teaching aids. Included are: Ready-to-use teaching outlines, with detailed instructions for presenting material. Practical guidelines on logistics, covering scheduling, budgeting, and more. Guidelines on how to design training for adults and how to work with investigators who may resist taking training courses. This practical guidebook will be necessary for research institutions, particularly for staff members responsible for training coordination.

Guidelines for the Humane Transportation of Research Animals

Guidelines for the Humane Transportation of Research Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309101107
Category : Science
Languages : en
Pages : 165

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Book Description
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.

EPA 630/R

EPA 630/R PDF Author:
Publisher:
ISBN:
Category : Health risk assessment
Languages : en
Pages : 94

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Book Description


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 PDF Author: National Academies Of Sciences Engineeri
Publisher: National Academies Press
ISBN: 9780309683869
Category : Nature
Languages : en
Pages :

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Book Description
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.

Exposure Science in the 21st Century

Exposure Science in the 21st Century PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309264685
Category : Nature
Languages : en
Pages : 210

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Book Description
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.

Review of the Draft NTP Monograph

Review of the Draft NTP Monograph PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030967316X
Category : Nature
Languages : en
Pages : 61

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Book Description
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.

Neurotoxicity of Halogenated Organic Compounds

Neurotoxicity of Halogenated Organic Compounds PDF Author:
Publisher: Elsevier
ISBN: 0443133417
Category : Science
Languages : en
Pages : 464

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Book Description
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