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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

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

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

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.

Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene

Review of DOD's Approach to Deriving an Occupational Exposure Level for Trichloroethylene PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309499240
Category : Nature
Languages : en
Pages : 77

Book Description
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.

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

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.

Definition of Pain and Distress and Reporting Requirements for Laboratory Animals

Definition of Pain and Distress and Reporting Requirements for Laboratory Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309072913
Category : Science
Languages : en
Pages : 131

Book Description
In this first in a proposed series of workshops on regulatory issues in animal care and use, the Institute for Laboratory Animal Research (ILAR) has addressed the existing and proposed requirements for reporting pain and distress in laboratory animals. The Animal Welfare Act, administered by the Animal and Plant Health Inspection Service of the United States Department of Agriculture (USDA), mandates that pain and distress in laboratory animals be minimized. USDA is considering two policy changes with regard to this specific mandate. Firstly, since there has been no functional definition of "distress," USDA has prepared such a definition and requested feedback from the scientific community on its usefulness for regulatory and reporting requirements. The second issue concerns the pain and distress categorization scheme for reporting to USDA. Various groups and individuals have questioned the efficacy of the current categories, and specific changes have been proposed by the Humane Society of the United States. USDA is considering these and other potential changes to the existing scheme. Thus, given these potential changes to animal welfare policy, the aim of the ILAR/NIH joint workshop was to provide feedback to the USDA. The speakers were asked to address these two issues as well as to comment upon whether the information contained in the 1992 ILAR report Recognition and Alleviation of Pain and Distress in Laboratory Animals is still useful to investigators in assisting them to comply with regulations. The speakers provided perspectives based on their individual expertise in the areas of science of pain and distress, animal welfare policy, protocol review, and/or as representatives of relevant organizations or institutions. The following proceedings are an edited transcript of their presentations.

Recognition and Alleviation of Distress in Laboratory Animals

Recognition and Alleviation of Distress in Laboratory Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309108179
Category : Science
Languages : en
Pages : 137

Book Description
Scientific advances in our understanding of animal physiology and behavior often require theories to be revised and standards of practice to be updated to improve laboratory animal welfare. This new book from the Institute for Laboratory Animal Research (ILAR) at the National Research Council, Recognition and Alleviation of Distress in Laboratory Animals, focuses on the stress and distress which is experienced by animals when used in laboratory research. This book aims to educate laboratory animal veterinarians; students, researchers, and investigators; animal care staff, as well as animal welfare officers on the current scientific and ethical issues associated with stress and distress in laboratory animals. It evaluates pertinent scientific literature to generate practical and pragmatic guidelines. Recognition and Alleviation of Distress in Laboratory Animals focuses specifically on the scientific understanding of the causes and the functions of stress and distress, the transformation of stress to distress, and the identification of principles for the recognition and alleviation of distress. This book discusses the role of humane endpoints in situations of distress and principles for the minimization of distress in laboratory animals. It also identifies areas in which further scientific investigation is needed to improve laboratory animal welfare in order to adhere to scientific and ethical principles that promote humane care and practice.

The Development of Science-based Guidelines for Laboratory Animal Care

The Development of Science-based Guidelines for Laboratory Animal Care PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309165547
Category : Science
Languages : en
Pages : 262

Book Description
The Development of Science-based Guidelines for Laboratory Animal Care is the summary of an international workshop held in Washington, DC, in November 2003 to bring together experts from around the world to discuss the available knowledge that can positively influence current and pending guidelines for laboratory animal care, identify gaps in that knowledge in order to encourage future research endeavors, and discuss the scientific evidence that can be used to assess the benefits and costs of various regulatory approaches affecting facilities, research, and animal welfare.

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 : 145

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.

Using 21st Century Science to Improve Risk-Related Evaluations

Using 21st Century Science to Improve Risk-Related Evaluations PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309453488
Category : Nature
Languages : en
Pages : 201

Book Description
Over the last decade, several large-scale United States and international programs have been initiated to incorporate advances in molecular and cellular biology, -omics technologies, analytical methods, bioinformatics, and computational tools and methods into the field of toxicology. Similar efforts are being pursued in the field of exposure science with the goals of obtaining more accurate and complete exposure data on individuals and populations for thousands of chemicals over the lifespan; predicting exposures from use data and chemical-property information; and translating exposures between test systems and humans. Using 21st Century Science to Improve Risk-Related Evaluations makes recommendations for integrating new scientific approaches into risk-based evaluations. This study considers the scientific advances that have occurred following the publication of the NRC reports Toxicity Testing in the 21st Century: A Vision and a Strategy and Exposure Science in the 21st Century: A Vision and a Strategy. Given the various ongoing lines of investigation and new data streams that have emerged, this publication proposes how best to integrate and use the emerging results in evaluating chemical risk. Using 21st Century Science to Improve Risk-Related Evaluations considers whether a new paradigm is needed for data validation, how to integrate the divergent data streams, how uncertainty might need to be characterized, and how best to communicate the new approaches so that they are understandable to various stakeholders.

Neurotoxicity of Halogenated Organic Compounds

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

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