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Controlled Human Inhalation-Exposure Studies at EPA

Controlled Human Inhalation-Exposure Studies at EPA
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 159
Release: 2017-05-10
Genre: Science
ISBN: 030945249X

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The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.


Controlled Human Inhalation-Exposure Studies at EPA

Controlled Human Inhalation-Exposure Studies at EPA
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 159
Release: 2017-04-10
Genre: Science
ISBN: 030945252X

Download Controlled Human Inhalation-Exposure Studies at EPA Book in PDF, ePub and Kindle

The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.


Review of the Environmental Protection Agency's Draft IRIS Assessment of Tetrachloroethylene

Review of the Environmental Protection Agency's Draft IRIS Assessment of Tetrachloroethylene
Author: National Research Council
Publisher: National Academies Press
Total Pages: 187
Release: 2010-03-18
Genre: Nature
ISBN: 0309152356

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Tetrachloroethylene is a volatile, chlorinated organic hydrocarbon that is widely used as a solvent in the dry-cleaning and textile-processing industries and as an agent for degreasing metal parts. It is an environmental contaminant that has been detected in the air, groundwater, surface waters, and soil. In June 2008, the U.S. Environmental Protection Agency released its draft Toxicological Review of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in Support of Summary Information on the Integrated Risk Information System (IRIS). The draft IRIS assessment provides quantitative estimates of cancer and noncancer effects of exposure to tetrachloreothylene, which will be used to establish airquality and water-quality standards to protect public health and to set cleanup standards for hazardous waste sites. At the request of EPA, the National Research Council conducted an independent scientific review of the draft IRIS assessment of tetrachloroethylene from toxicologic, epidemiologic, and human clinical perspectives. The resulting book evaluates the adequacy of the EPA assessment, the data and methods used for deriving the noncancer values for inhalation and oral exposures and the oral and inhalation cancer unit risks posed by tetrachloroethylene; evaluates whether the key studies underlying the draft IRIS assessment are of requisite quality, reliability, and relevance to support the derivation of the reference values and cancer risks; evaluates whether the uncertainties in EPA's risk assessment were adequately described and, where possible, quantified; and identifies research that could reduce the uncertainty in the current understanding of human health effects associated with tetrachloroethylene exposure.


Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes
Author: National Research Council
Publisher: National Academies Press
Total Pages: 226
Release: 2004-06-04
Genre: Science
ISBN: 0309166411

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The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.


The Inside Story

The Inside Story
Author: United States. Environmental Protection Agency. Office of Air and Radiation
Publisher:
Total Pages: 38
Release: 1995
Genre: Air quality
ISBN:

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Science and Judgment in Risk Assessment

Science and Judgment in Risk Assessment
Author: National Research Council
Publisher: National Academies Press
Total Pages: 668
Release: 1994-01-01
Genre: Science
ISBN: 030904894X

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The public depends on competent risk assessment from the federal government and the scientific community to grapple with the threat of pollution. When risk reports turn out to be overblownâ€"or when risks are overlookedâ€"public skepticism abounds. This comprehensive and readable book explores how the U.S. Environmental Protection Agency (EPA) can improve its risk assessment practices, with a focus on implementation of the 1990 Clean Air Act Amendments. With a wealth of detailed information, pertinent examples, and revealing analysis, the volume explores the "default option" and other basic concepts. It offers two views of EPA operations: The first examines how EPA currently assesses exposure to hazardous air pollutants, evaluates the toxicity of a substance, and characterizes the risk to the public. The second, more holistic, view explores how EPA can improve in several critical areas of risk assessment by focusing on cross-cutting themes and incorporating more scientific judgment. This comprehensive volume will be important to the EPA and other agencies, risk managers, environmental advocates, scientists, faculty, students, and concerned individuals.


Air Quality Criteria for Particulate Matter

Air Quality Criteria for Particulate Matter
Author: National Center for Environmental Assessment (Research Triangle Park, N.C.)
Publisher:
Total Pages: 1100
Release: 1996
Genre: Air quality
ISBN:

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Quality Criteria for Water, 1986

Quality Criteria for Water, 1986
Author: United States. Environmental Protection Agency. Office of Water Regulations and Standards
Publisher:
Total Pages: 456
Release: 1986
Genre: Water
ISBN:

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Section 304(a) (1) of the Clean Water Act 33 U.S.C. 1314(a) (1) requires the Environmental Protection Agency (EPA) to publish and periodically update ambient water quality criteria. These criteria are to accurately reflect the latest scientific knowledge (a) on the kind and extent of all identifiable effects on health and welfare including, but not limited to, plankton, fish shellfish, wildlife, plant life, shorelines, beaches, aesthetics, and recreation which may be expected from the presence of pollutants in any body of water including ground water; (b) on the concentration and dispersal of pollutants, or their byproducts, through biological, physical, and chemical processes; and (c) on the effects of pollutants on biological community diversity, productivity, and stability, including information on the factors affecting rates of eutrophication and organic and inorganic sedimentation for varying types of receiving waters. In a continuing effort to provide those who use EPA's water quality and human health criteria with up-to-date criteria values and associated information, the document was assembled. The document includes summaries of all the contaminants for which EPA has developed criteria recommendations.