A Risk Characterization Framework For Decision Making At The Food And Drug Administration
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A Risk Characterization Framework For Decision Making At The Food And Drug Administration
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-06-26
A Risk Characterization Framework For Decision Making At The Food And Drug Administration written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-06-26 with Medical categories.
With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.
Risk Characterization Framework For Decision Making At The Food And Drug Administration
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Author :
language : en
Publisher:
Release Date : 2011
Risk Characterization Framework For Decision Making At The Food And Drug Administration written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with categories.
A Research Strategy For Environmental Health And Safety Aspects Of Engineered Nanomaterials
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2012-05-09
A Research Strategy For Environmental Health And Safety Aspects Of Engineered Nanomaterials written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-09 with Science categories.
The nanotechnology sector, which generated about $225 billion in product sales in 2009, is predicted to expand rapidly over the next decade with the development of new technologies that have new capabilities. The increasing production and use of engineered nanomaterials (ENMs) may lead to greater exposures of workers, consumers, and the environment, and the unique scale-specific and novel properties of the materials raise questions about their potential effects on human health and the environment. Over the last decade, government agencies, academic institutions, industry, and others have conducted many assessments of the environmental, health, and safety (EHS) aspects of nanotechnology. The results of those efforts have helped to direct research on the EHS aspects of ENMs. However, despite the progress in assessing research needs and despite the research that has been funded and conducted, developers, regulators, and consumers of nanotechnology-enabled products remain uncertain about the types and quantities of nanomaterials in commerce or in development, their possible applications, and their associated risks. A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials presents a strategic approach for developing the science and research infrastructure needed to address uncertainties regarding the potential EHS risks of ENMs. The report summarizes the current state of the science and high-priority data gaps on the potential EHS risks posed by ENMs and describes the fundamental tools and approaches needed to pursue an EHS risk research strategy. The report also presents a proposed research agenda, short-term and long-term research priorities, and estimates of needed resources and concludes by focusing on implementation of the research strategy and evaluation of its progress, elements that the committee considered integral to its charge.
Exposure Science In The 21st Century
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2012-10-28
Exposure Science In The 21st Century written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-28 with Nature categories.
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.
Acute Exposure Guideline Levels For Selected Airborne Chemicals
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2013-05-26
Acute Exposure Guideline Levels For Selected Airborne Chemicals written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-26 with Nature categories.
Extremely hazardous substances (EHSs) can be released accidentally as a result of result of chemical spills, industrial explosions, fires, or accidents involving railroad cars and trucks transporting EHSs. Workers and residents in communities surrounding industrial facilities where EHSs are manufactured, used, or stored and in communities along the nation's railways and highways are potentially at risk of being exposed to airborne EHSs during accidental releases or intentional releases by terrorists. Pursuant to the Superfund Amendments and Reauthorization Act of 1986, the U.S. Environmental Protection Agency (EPA) has identified approximately 400 EHSs on the basis of acute lethality data in rodents. As part of its efforts to develop acute exposure guideline levels for EHSs, EPA and the Agency for Toxic Substances and Disease Registry (ATSDR) in 1991 requested that the National Research Council (NRC) develop guidelines for establishing such levels. In response to that request, the NRC published Guidelines for Developing Community Emergency Exposure Levels for Hazardous Substances in 1993. Subsequently, Standard Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Substances was published in 2001, providing updated procedures, methodologies, and other guidelines used by the National Advisory Committee (NAC) on Acute Exposure Guideline Levels for Hazardous Substances and the Committee on Acute Exposure Guideline Levels (AEGLs) in developing the AEGL values. Using the 1993 and 2001 NRC guidelines reports, the NAC-consisting of members from EPA, the Department of Defense (DOD), the Department of Energy (DOE), the Department of Transportation (DOT), other federal and state governments, the chemical industry, academia, and other organizations from the private sector-has developed AEGLs for more than 270 EHSs. In 1998, EPA and DOD requested that the NRC independently review the AEGLs developed by NAC. In response to that request, the NRC organized within its Committee on Toxicology (COT) the Committee on Acute Exposure Guideline Levels, which prepared this report. This report is the fourteenth volume in that series. Acute Exposure Guideline Levels for Selected Airborne Chemicals: Volume 14 summarizes the committee's conclusions and recommendations.
Improving Health In The United States
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2011-10-14
Improving Health In The United States written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-14 with Science categories.
Factoring health and related costs into decision making is essential to confronting the nation's health problems and enhancing public well-being. Some policies and programs historically not recognized as relating to health are believed or known to have important health consequences. For example, public health has been linked to an array of policies that determine the quality and location of housing, availability of public transportation, land use and street connectivity, agricultural practices and the availability of various types of food, and development and location of businesses and industry. Improving Health in the United States: The Role of Health Impact Assessment offers guidance to officials in the public and private sectors on conducting HIAs to evaluate public health consequences of proposed decisions-such as those to build a major roadway, plan a city's growth, or develop national agricultural policies-and suggests actions that could minimize adverse health impacts and optimize beneficial ones. Several approaches could be used to incorporate aspects of health into decision making, but HIA holds particular promise because of its applicability to a broad array of programs, consideration of both adverse and beneficial health effects, ability to consider and incorporate various types of evidence, and engagement of communities and stakeholders in a deliberative process. The report notes that HIA should not be assumed to be the best approach to every health policy question but rather should be seen as part of a spectrum of public health and policy-oriented approaches. The report presents a six-step framework for conducting HIA of proposed policies, programs, plans, and projects at federal, state, tribal, and local levels, including within the private sector. In addition, the report identifies several challenges to the successful use of HIA, such as balancing the need to provide timely information with the realities of varying data quality, producing quantitative estimates of health effects, and engaging stakeholders.
Environmental Decisions In The Face Of Uncertainty
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-06-20
Environmental Decisions In The Face Of Uncertainty written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-20 with Political Science categories.
The U.S. Environmental Protection Agency (EPA) is one of several federal agencies responsible for protecting Americans against significant risks to human health and the environment. As part of that mission, EPA estimates the nature, magnitude, and likelihood of risks to human health and the environment; identifies the potential regulatory actions that will mitigate those risks and protect public health1 and the environment; and uses that information to decide on appropriate regulatory action. Uncertainties, both qualitative and quantitative, in the data and analyses on which these decisions are based enter into the process at each step. As a result, the informed identification and use of the uncertainties inherent in the process is an essential feature of environmental decision making. EPA requested that the Institute of Medicine (IOM) convene a committee to provide guidance to its decision makers and their partners in states and localities on approaches to managing risk in different contexts when uncertainty is present. It also sought guidance on how information on uncertainty should be presented to help risk managers make sound decisions and to increase transparency in its communications with the public about those decisions. Given that its charge is not limited to human health risk assessment and includes broad questions about managing risks and decision making, in this report the committee examines the analysis of uncertainty in those other areas in addition to human health risks. Environmental Decisions in the Face of Uncertainty explains the statement of task and summarizes the findings of the committee.
Application Of Modern Toxicology Approaches For Predicting Acute Toxicity For Chemical Defense
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-09-01
Application Of Modern Toxicology Approaches For Predicting Acute Toxicity For Chemical Defense written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-01 with Nature categories.
The US Department of Defense (DOD) is faced with an overwhelming task in evaluating chemicals that could potentially pose a threat to its deployed personnel. There are over 84,000 registered chemicals, and testing them with traditional toxicity-testing methods is not feasible in terms of time or money. In recent years, there has been a concerted effort to develop new approaches to toxicity testing that incorporate advances in systems biology, toxicogenomics, bioinformatics, and computational toxicology. Given the advances, DOD asked the National Research Council to determine how DOD could use modern approaches for predicting chemical toxicity in its efforts to prevent debilitating, acute exposures to deployed personnel. This report provides an overall conceptual approach that DOD could use to develop a predictive toxicology system. Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense reviews the current state of computational and high-throughput approaches for predicting acute toxicity and suggests methods for integrating data and predictions. This report concludes with lessons learned from current high-throughput screening programs and suggests some initial steps for DOD investment.
Rethinking The Components Coordination And Management Of The U S Environmental Protection Agency Laboratories
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2014-09-03
Rethinking The Components Coordination And Management Of The U S Environmental Protection Agency Laboratories written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-09-03 with Political Science categories.
The Environmental Protection Agency (EPA) applies scientific results that have been provided by various parts of its own organization and by external organizations. The agency requires substantial high-quality inhouse scientific expertise and laboratory capabilities so that it can answer questions related to regulation, enforcement, and environmental effects of specific chemicals, activities, and processes. It is also usually faced with situations in which research or analytic work is time-critical, so it maintains dedicated laboratory staff and facilities that can respond quickly to such needs. In recent years, EPA has made several changes to improve the efficiency and effectiveness of its laboratories, such as the designation of national program directors to align the work of research laboratories with the needs of the agency's regulatory program offices. The agency is currently undertaking an integrated evaluation of it laboratories to enhance the management effectiveness and efficiency of its laboratory enterprise and to enhance its capabilities for research and other laboratory-based scientific and technical activities. The results of EPA's evaluation are expected to include options for colocation and consolidation of laboratory facilities. Rethinking the Components, Coordination, and Management of U.S. Environmental Protection Agency Laboratories assesses EPA's highest-priority needs for mission-relevant laboratory science and technical support, develops principles for the efficient and effective management of EPA's laboratory enterprise to meet the agency's mission needs and strategic goals, and develops guidance for enhancing efficiency and effectiveness now and during the next 10 years. EPA's laboratories play a vital role in the agency's work. The findings and recommendations of this report will help EPA to develop an implementation plan for the laboratory enterprise.
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-07-30
Ethical And Scientific Issues In Studying The Safety Of Approved Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-30 with Medical categories.
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.