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

Published: 2017-04-10

Total Pages: 159

ISBN-13: 030945252X

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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

Published: 2017-05-10

Total Pages: 159

ISBN-13: 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.

Intentional Human Dosing Studies for EPA Regulatory Purposes
Intentional Human Dosing Studies for EPA Regulatory Purposes

Author: National Research Council

Publisher: National Academies Press

Published: 2004-06-04

Total Pages: 226

ISBN-13: 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.

America's Children and the Environment
America's Children and the Environment

Author: U.s. Environmental Protection Agency

Publisher: Createspace Independent Publishing Platform

Published: 2017-05-31

Total Pages: 502

ISBN-13: 9781547052585

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"America's Children and the Environment (ACE)" is EPA's report presenting data on children's environmental health. ACE brings together information from a variety of sources to provide national indicators in the following areas: Environments and Contaminants, Biomonitoring, and Health. Environments and Contaminants indicators describe conditions in the environment, such as levels of air pollution. Biomonitoring indicators include contaminants measured in the bodies of children and women of child-bearing age, such as children's blood lead levels. Health indicators report the rates at which selected health outcomes occur among U.S. children, such as the annual percentage of children who currently have asthma. Accompanying each indicator is text discussing the relevance of the issue to children's environmental health and describing the data used in preparing the indicator. Wherever possible, the indicators are based on data sources that are updated in a consistent manner, so that indicator values may be compared over time.

WHO Guidelines for Indoor Air Quality
WHO Guidelines for Indoor Air Quality

Author:

Publisher: World Health Organization

Published: 2010

Total Pages: 488

ISBN-13:

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This book presents WHO guidelines for the protection of public health from risks due to a number of chemicals commonly present in indoor air. The substances considered in this review, i.e. benzene, carbon monoxide, formaldehyde, naphthalene, nitrogen dioxide, polycyclic aromatic hydrocarbons (especially benzo[a]pyrene), radon, trichloroethylene and tetrachloroethylene, have indoor sources, are known in respect of their hazardousness to health and are often found indoors in concentrations of health concern. The guidelines are targeted at public health professionals involved in preventing health risks of environmental exposures, as well as specialists and authorities involved in the design and use of buildings, indoor materials and products. They provide a scientific basis for legally enforceable standards.

Waste Incineration and Public Health
Waste Incineration and Public Health

Author: National Research Council

Publisher: National Academies Press

Published: 2000-10-21

Total Pages: 336

ISBN-13: 030906371X

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Incineration has been used widely for waste disposal, including household, hazardous, and medical wasteâ€"but there is increasing public concern over the benefits of combusting the waste versus the health risk from pollutants emitted during combustion. Waste Incineration and Public Health informs the emerging debate with the most up-to-date information available on incineration, pollution, and human healthâ€"along with expert conclusions and recommendations for further research and improvement of such areas as risk communication. The committee provides details on: Processes involved in incineration and how contaminants are released. Environmental dynamics of contaminants and routes of human exposure. Tools and approaches for assessing possible human health effects. Scientific concerns pertinent to future regulatory actions. The book also examines some of the social, psychological, and economic factors that affect the communities where incineration takes place and addresses the problem of uncertainty and variation in predicting the health effects of incineration processes.

Air Emissions from Animal Feeding Operations
Air Emissions from Animal Feeding Operations

Author: National Research Council

Publisher: National Academies Press

Published: 2003-04-07

Total Pages: 286

ISBN-13: 0309168643

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Air Emissions from Animal Feeding Operations: Current Knowledge, Future Needs discusses the need for the U.S. Environmental Protection Agency to implement a new method for estimating the amount of ammonia, nitrous oxide, methane, and other pollutants emitted from livestock and poultry farms, and for determining how these emissions are dispersed in the atmosphere. The committee calls for the EPA and the U.S. Department of Agriculture to establish a joint council to coordinate and oversee short - and long-term research to estimate emissions from animal feeding operations accurately and to develop mitigation strategies. Their recommendation was for the joint council to focus its efforts first on those pollutants that pose the greatest risk to the environment and public health.