THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE
Division on Earth and Life Studies
Board on Environmental Studies and Toxicology
Committee on Assessing Toxicologic Risks to Human Subjects Used
in Controlled Exposure Studies of Environmental Pollutants
Controlled Human Inhalation-Exposure Studies at EPA
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.
This new report, from the National Academies of Sciences, Engineering, and Medicine, 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.
These briefings were for members of Congress and congressional staff only. The report was publicly released on March 28, 2017 and can be found, in its entirety, on the Web site of the National Academies Press.