Intentional Human Dosing Studies For Epa Regulatory Purposes

Download or read book Intentional Human Dosing Studies for EPA Regulatory Purposes written by National Research Council and published by National Academies Press. This book was released on 2004-06-04 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Controlled Human Inhalation-Exposure Studies at EPA written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-04-10 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Controlled Human Inhalation-Exposure Studies at EPA written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-05-10 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Recognition and Management of Pesticide Poisonings (5th Ed. ) written by J. Routt Reigart and published by DIANE Publishing. This book was released on 2009-06 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 5th ed. is an update and expansion of the 1989 4th ed. This EPA manual provides health professionals with information on the health hazards of pesticides currently in use, and current consensus recommendations for management of poisonings and injuries caused by them. As with previous updates, this new ed. incorporates new pesticide products that are not necessarily widely known among health professionals. Contents: (1) General Information: Introduction; General Principles in the Management of Acute Pesticide Poisonings; Environmental and Occupational History; (2) Insecticides; (3) Herbicides; (4) Other Pesticides; (5) Index of Signs and Symptoms; Index of Pesticide Products. Charts and tables.

Download or read book Reference Manual on Scientific Evidence written by National Research Council and published by National Academies Press. This book was released on 2011-10-26 with total page 1034 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Reference Manual on Scientific Evidence, Third Edition, assists judges in managing cases involving complex scientific and technical evidence by describing the basic tenets of key scientific fields from which legal evidence is typically derived and by providing examples of cases in which that evidence has been used. First published in 1994 by the Federal Judicial Center, the Reference Manual on Scientific Evidence has been relied upon in the legal and academic communities and is often cited by various courts and others. Judges faced with disputes over the admissibility of scientific and technical evidence refer to the manual to help them better understand and evaluate the relevance, reliability and usefulness of the evidence being proffered. The manual is not intended to tell judges what is good science and what is not. Instead, it serves to help judges identify issues on which experts are likely to differ and to guide the inquiry of the court in seeking an informed resolution of the conflict. The core of the manual consists of a series of chapters (reference guides) on various scientific topics, each authored by an expert in that field. The topics have been chosen by an oversight committee because of their complexity and frequency in litigation. Each chapter is intended to provide a general overview of the topic in lay terms, identifying issues that will be useful to judges and others in the legal profession. They are written for a non-technical audience and are not intended as exhaustive presentations of the topic. Rather, the chapters seek to provide judges with the basic information in an area of science, to allow them to have an informed conversation with the experts and attorneys.

Download or read book Code of Federal Regulations written by and published by . This book was released on 1998 with total page 828 pages. Available in PDF, EPUB and Kindle. Book excerpt: Special edition of the Federal Register, containing a codification of documents of general applicability and future effect as of July 1, ... with ancillaries.

Download or read book Tainted written by Kristin Shrader-Frechette and published by Oxford University Press. This book was released on 2014-09-15 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: Three-fourths of scientific research in the United States is funded by special interests. Many of these groups have specific practical goals, such as developing pharmaceuticals or establishing that a pollutant causes only minimal harm. For groups with financial conflicts of interest, their scientific findings often can be deeply flawed. To uncover and assess these scientific flaws, award-winning biologist and philosopher of science Kristin Shrader-Frechette uses the analytical tools of classic philosophy of science. She identifies and evaluates the concepts, data, inferences, methods, models, and conclusions of science tainted by the influence of special interests. As a result, she challenges accepted scientific findings regarding risks such as chemical toxins and carcinogens, ionizing radiation, pesticides, hazardous-waste disposal, development of environmentally sensitive lands, threats to endangered species, and less-protective standards for workplace-pollution exposure. In so doing, she dissects the science on which many contemporary scientific controversies turn. Demonstrating and advocating "liberation science," she shows how practical, logical, methodological, and ethical evaluations of science can both improve its quality and credibility -- and protect people from harm caused by flawed science, such as underestimates of cancers caused by bovine growth hormones, cell phones, fracking, or high-voltage wires. This book is both an in-depth look at the unreliable scientific findings at the root of contemporary debates in biochemistry, ecology, economics, hydrogeology, physics, and zoology -- and a call to action for scientists, philosophers of science, and all citizens.