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

Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde
Author: National Research Council
Publisher: National Academies Press
Total Pages: 204
Release: 2011-05-31
Genre: Science
ISBN: 0309211964

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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.


Review of EPA's Integrated Risk Information System (IRIS) Process

Review of EPA's Integrated Risk Information System (IRIS) Process
Author: National Research Council
Publisher: National Academies Press
Total Pages: 170
Release: 2014-06-25
Genre: Political Science
ISBN: 0309304172

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The Integrated Risk Information System (IRIS) is a program within the US Environmental Protection Agency (EPA) that is responsible for developing toxicologic assessments of environmental contaminants. An IRIS assessment contains hazard identifications and dose-response assessments of various chemicals related to cancer and noncancer outcomes. Although the program was created to increase consistency among toxicologic assessments within the agency, federal, state, and international agencies and other organizations have come to rely on IRIS assessments for setting regulatory standards, establishing exposure guidelines, and estimating risks to exposed populations. Over the last decade, the National Research Council (NRC) has been asked to review some of the more complex and challenging IRIS assessments, including those of formaldehyde, dioxin, and tetrachloroethylene. In 2011, an NRC committee released its review of the IRIS formaldehyde assessment. Like other NRC committees that had reviewed IRIS assessments, the formaldehyde committee identified deficiencies in the specific assessment and more broadly in some of EPA's general approaches and specific methods. Although the committee focused on evaluating the IRIS formaldehyde assessment, it provided suggestions for improving the IRIS process and a roadmap for its revision in case EPA decided to move forward with changes to the process. Congress directed EPA to implement the report's recommendations and then asked the National Research Council to review the changes that EPA was making (or proposing to make) in response to the recommendations. Review of EPA's Integrated Risk Information System (IRIS) Process provides an overview of some general issues associated with IRIS assessments. This report then addresses evidence identification and evaluation for IRIS assessments and discusses evidence integration for hazard evaluation and methods for calculating reference values and unit risks. The report makes recommendations and considerations for future directions. Overall, Review of EPA's Integrated Risk Information System Process finds that substantial improvements in the IRIS process have been made, and it is clear that EPA has embraced and is acting on the recommendations in the NRC formaldehyde report. The recommendations of this report should be seen as building on the progress that EPA has already made.


Review of Epa's 2022 Draft Formaldehyde Assessment

Review of Epa's 2022 Draft Formaldehyde Assessment
Author: National Academies of Sciences Engineering and Medicine
Publisher:
Total Pages: 0
Release: 2024-05-09
Genre:
ISBN: 9780309706551

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Formaldehyde is widely present in the environment and is one of the highest production chemicals by volume, used in manufactured goods including wood products, permanent press fabrics, and household products. It is also formed by combustion sources and is present in smoke from cigarettes and other tobacco products, and in emissions from gas stoves and open fireplaces. In carrying out its mission to protect human health, the U.S. Environmental Protection Agency (EPA) identifies and characterizes the health hazards of chemicals found in the environment through its Integrated Risk Information System (IRIS) Program, which has reviewed the human health hazards resulting from formaldehyde exposure in several assessments. This report is a continuation of guidance from the National Academies on draft IRIS assessments of formaldehyde and other aspects of the IRIS program. This report reviews the 2022 Draft Assessment with regard to its adequacy and transparency in evaluating the scientific literature, use of appropriate methods to synthesize the current state-of-the science, and presentations of conclusions that are supported by the scientific evidence. The report concludes that the 2022 Draft Assessment follows the advice of prior National Academies reports and that its findings on hazard and quantitative risk are supported by the evidence identified. However, revisions are needed to ensure that users can find and follow the methods used in each step of the assessment for each health outcome.


Progress Toward Transforming the Integrated Risk Information System (IRIS) Program

Progress Toward Transforming the Integrated Risk Information System (IRIS) Program
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 130
Release: 2018-04-11
Genre: Political Science
ISBN: 0309474949

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Over the past several years, the US Environmental Protection Agency (EPA) has been transforming the procedures of its Integrated Risk Information System (IRIS), a program that produces hazard and doseâ€'response assessments of environmental chemicals and derives toxicity values that can be used to estimate risks posed by exposures to them. The transformation was initiated after suggestions for program reforms were provided in a 2011 report from the National Academies of Sciences, Engineering, and Medicine that reviewed a draft IRIS assessment of formaldehyde. In 2014, the National Academies released a report that reviewed the IRIS program and evaluated the changes implemented in it since the 2011 report. Since 2014, new leadership of EPA's National Center for Environmental Assessment (NCEA) and IRIS program has instituted even more substantive changes in the IRIS program in response to the recommendations in the 2014 report. Progress Toward Transforming the Integrated Risk Information System Program: A 2018 Evaluation reviews the EPA's progress toward addressing the past recommendations from the National Academies.


Chemical Assessments

Chemical Assessments
Author: United States Government Accountability Office
Publisher: Createspace Independent Publishing Platform
Total Pages: 90
Release: 2018-01-24
Genre:
ISBN: 9781984159397

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Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Information System


EPA 630/R

EPA 630/R
Author:
Publisher:
Total Pages: 94
Release: 1998
Genre: Health risk assessment
ISBN:

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Science for Environmental Protection

Science for Environmental Protection
Author: National Research Council
Publisher: National Academies Press
Total Pages: 188
Release: 2012-12-21
Genre: Political Science
ISBN: 0309264898

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In anticipation of future environmental science and engineering challenges and technologic advances, EPA asked the National Research Council (NRC) to assess the overall capabilities of the agency to develop, obtain, and use the best available scientific and technologic information and tools to meet persistent, emerging, and future mission challenges and opportunities. Although the committee cannot predict with certainty what new environmental problems EPA will face in the next 10 years or more, it worked to identify some of the common drivers and common characteristics of problems that are likely to occur. Tensions inherent to the structure of EPA's work contribute to the current and persistent challenges faced by the agency, and meeting those challenges will require development of leading-edge scientific methods, tools, and technologies, and a more deliberate approach to systems thinking and interdisciplinary science. Science for Environmental Protection: The Road Ahead outlines a framework for building science for environmental protection in the 21st century and identified key areas where enhanced leadership and capacity can strengthen the agency's abilities to address current and emerging environmental challenges as well as take advantage of new tools and technologies to address them. The foundation of EPA science is strong, but the agency needs to continue to address numerous present and future challenges if it is to maintain its science leadership and meet its expanding mandates.


Risk Assessment in the Federal Government

Risk Assessment in the Federal Government
Author: National Research Council
Publisher: National Academies Press
Total Pages: 206
Release: 1983-02-01
Genre: Medical
ISBN: 0309033497

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The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.


The Use of Systematic Review in Epa's Toxic Substances Control ACT Risk Evaluations

The Use of Systematic Review in Epa's Toxic Substances Control ACT Risk Evaluations
Author: National Academies Of Sciences Engineeri
Publisher: National Academies Press
Total Pages:
Release: 2021-11-16
Genre: Nature
ISBN: 9780309683869

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Systematic review - a scientific investigation that focuses on a specific question and uses explicit, prespecified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies - has become the foundation for assessing evidence to be used for decision making in a variety of health contexts, including health care and public health. At the request of the Environmental Protection Agency (EPA), this publication reviews EPA's 2018 guidance document Application of Systematic Review in TSCA (Toxic Substances and Control Act) Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent.