Controlled Human Inhalation-Exposure Studies at EPA

Controlled Human Inhalation-Exposure Studies at EPA PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030945252X
Category : Science
Languages : en
Pages : 159

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Book Description
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 PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030945252X
Category : Science
Languages : en
Pages : 159

Get Book Here

Book Description
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 PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030945249X
Category : Science
Languages : en
Pages : 159

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Book Description
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.

Formaldehyde Toxicity

Formaldehyde Toxicity PDF Author: James E. Gibson
Publisher: Toxicology-Sci
ISBN:
Category : Medical
Languages : en
Pages : 350

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Book Description


Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309166411
Category : Science
Languages : en
Pages : 226

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Book Description
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 PDF Author:
Publisher:
ISBN:
Category : Air quality
Languages : en
Pages : 40

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Book Description


Review of the National Ambient Air Quality Standards for Particulate Matter

Review of the National Ambient Air Quality Standards for Particulate Matter PDF Author:
Publisher:
ISBN:
Category : Air
Languages : en
Pages : 0

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Book Description


Air Emissions from Animal Feeding Operations

Air Emissions from Animal Feeding Operations PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309168643
Category : Science
Languages : en
Pages : 286

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Book Description
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.

Health Effects Assessment Summary Tables

Health Effects Assessment Summary Tables PDF Author:
Publisher:
ISBN:
Category : Health risk assessment
Languages : en
Pages : 414

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Book Description


Toxicological Profile for Nitrophenols

Toxicological Profile for Nitrophenols PDF Author:
Publisher:
ISBN:
Category : Nitro compounds
Languages : en
Pages : 136

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Book Description


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

Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 030921193X
Category : Science
Languages : en
Pages : 204

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Book Description
Formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily. Formaldehyde is used to produce a wide array of products, particularly building materials; it is emitted from many sources, including power plants, cars, gas and wood stoves, and cigarettes; it is a natural product in come foods; and it is naturally present in the human body as a metabolic intermediate. Much research has been conducted on the health effects of exposure to formaldehyde, including effects on the upper airway, where formaldehyde is deposited when inhaled, and effects on tissues distant from the site of initial contact. The U.S. Environmental Protection Agency (EPA) released noncancer and cancer assessments of formaldehyde for its Intergated Risk Information System (IRIS) in 1990 and 1991, respectively. The agency began reassessing formaldehyde in 1998 and released a draft IRIS assessment in June 2010. Given the complexity of the issues and the knowledge that the assessment will be used as the basis of regulatory decisions, EPA asked the National Research Council (NRC) to conduct an independent scientific review of the draft IRIS assessment. In this report, the Committee to Review EPA's Draft IRIS Assessment of Formaldehyde first addresses some general issues associated with the draft IRIS assessment. The committee next focuses on questions concerning specific aspects of the draft assessment, including derivation of the reference concentrations and the cancer unit risk estimates for formaldehyde. The committee closes with recommendations for improving the IRIS assessment of formaldehyde and provides some general comments on the IRIS development process.