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.
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 : 2013-01-28
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 2013-01-28 with Science categories.
At the request of the Department of Defense and the Environmental Protection Agency, the National Research Council has reviewed the relevant scientific literature compiled by an expert panel and established Acute Exposure Guideline Levels (AEGLs) for several chemicals. AEGLs represent exposure levels below which adverse health effects are not likely to occur and are useful in responding to emergencies, such as accidental or intentional chemical releases in community, workplace, transportation, and military settings, and for the remediation of contaminated sites. Three AEGLs are approved for each chemical, representing exposure levels that result in: 1) notable but reversible discomfort; 2) long-lasting health effects; and 3) life-threatening health impacts. Acute Exposure Guideline Levels for Selected Airborne Chemicals: Volume 13 includes AEGLs for boron trifluoride, bromoacetone, chloroacetone, hexafluoroacetone, perchloryl fluoride, piperidine, propargyl alcohol, trimethoxysilane and tetramethoxysilane, and trimethylbenzenes.
Environmental Decisions In The Face Of Uncertainty
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-05-20
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 2013-05-20 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.
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.
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.
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.
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.
Review Of The Environmental Protection Agency S State Of The Science Evaluation Of Nonmonotonic Dose Response Relationships As They Apply To Endocrine Disruptors
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2014-05-27
Review Of The Environmental Protection Agency S State Of The Science Evaluation Of Nonmonotonic Dose Response Relationships As They Apply To Endocrine Disruptors 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 2014-05-27 with Nature categories.
Potential health effects from chemicals that disrupt endocrine function pose an environmental health concern because of their ability to interfere with normal hormone function in human and wildlife populations. The endocrine system regulates biological processes throughout the body and is sensitive to small changes in hormone concentrations. Endocrine-disruptor research has focused primarily on chemicals that affect three hormone pathways that play important roles in reproduction and development - the estrogen, androgen, and thyroid hormone pathways. Some of this research has identified dose-response relationships that have nonmonotonic curves. Nonmonotonic dose-response curves (NMDRs) are of concern because they do not follow the usual assumption made in toxicology that as dose decreases the response also decreases. The existence of NMDRs has been a controversial topic for decades, and there has been considerable debate about their implications for how chemicals are tested and for how risks from such chemicals are assessed. Toxicity tests are designed to identify hazards and to characterize dose-response relationships, so tests are aimed at finding a (high) dose that elicits a response, and dose-response is explored by testing lower doses spaced to identify statistically a no- or lowest-observed-adverse-effect level. The concern for NMDRs is that such studies, as currently designed, might not detect the inflection of the dose-response curve if only a few doses are tested or if the change in inflection occurs below the range of doses tested. Another concern is that some NMDRs are found for biological effects that are not usually evaluated in toxicity tests. If current testing strategies are inadequate to account for NMDRs, changes to risk assessment practices might be necessary. To help address these issues, the U.S. Environmental Protection Agency (EPA) developed a draft State-of-the-Science Evaluation: Nonmonotonic Dose Responses as they Apply to Estrogen, Androgen, and Thyroid Pathways and EPA Testing and Assessment Procedures. EPA asked the National Research Council to conduct an independent review of this evaluation to ensure that it is scientifically sound and of high quality. Review of Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response as they Apply to Endocrine Disrupters evaluates whether EPA's evaluation presents a scientifically sound and high-quality analysis of the literature on NMDRs. This report reviews how well the EPA evaluation described how the assessment was performed, whether consistent methods and criteria were applied in the analysis of different evidence streams, and whether appropriate methods were applied to evaluating the evidence. The report makes recommendations to improve EPA's process and strengthen the evaluation.