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Cover of Controlled Human Inhalation-Exposure Studies at EPA

Controlled Human Inhalation-Exposure Studies at EPA

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Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-45249-6ISBN-10: 0-309-45249-X

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.

Contents

This activity was supported by Contract No. EP-C-14-005 from the U.S. Environmental Protection Agency. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2017. Controlled Human Inhalation-Exposure Studies at EPA. Washington, DC: The National Academies Press. doi: 10.17226/24618.

Copyright 2017 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK436085PMID: 28617568DOI: 10.17226/24618

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