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

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

Author: National Research Council

Publisher: National Academies Press

Published: 2014-06-25

Total Pages: 227

ISBN-13: 0309304172

DOWNLOAD EBOOK →

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.

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

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

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-04-11

Total Pages: 130

ISBN-13: 0309474949

DOWNLOAD EBOOK →

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.

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

Published: 2011-05-31

Total Pages: 204

ISBN-13: 0309211964

DOWNLOAD EBOOK →

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.

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

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

Author: National Academies of Sciences, Engineering, and Medicine (U.S.). Committee to Review Advances Made to the IRIS Process

Publisher:

Published: 2018

Total Pages: 119

ISBN-13:

DOWNLOAD EBOOK →

"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 dose‒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" -- Publisher's description

EPA Chemical Assessments: Process Reforms Offer the Potential to Address Key Problems

EPA Chemical Assessments: Process Reforms Offer the Potential to Address Key Problems PDF

Author: John B. Stephenson

Publisher: DIANE Publishing

Published: 2009-12

Total Pages: 13

ISBN-13: 1437917968

DOWNLOAD EBOOK →

The EPA Integrated Risk Info. System (IRIS) contains EPA's scientific position on the potential human health effects of exposure to more than 540 chemicals. Toxicity assessments in the IRIS database constitute the first two critical steps of the risk assessment process. Thus, IRIS is a critical component of EPA's capacity to support scientifically sound environmental decisions, policies, and regulations. This testimony discusses: (1) the findings from a March 2008 report ¿Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA's Integrated Risk Info. System¿ and related testimonies; and (2) a preliminary evaluation of the revised IRIS assessment process EPA issued on May 21, 2009.

Review of U. S. EPA's ORD Staff Handbook for Developing IRIS Assessments

Review of U. S. EPA's ORD Staff Handbook for Developing IRIS Assessments PDF

Author: National Academies of Sciences, Engineering, and Medicine

Publisher:

Published: 2022-08-30

Total Pages: 120

ISBN-13: 9780309090889

DOWNLOAD EBOOK →

The U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) program develops human health assessments that focus on hazard identification and dose-response analyses for chemicals in the environment. The ORD Staff Handbook for Developing IRIS Assessments (the handbook) provides guidance to scientists who perform the IRIS assessments in order to foster consistency in the assessments and enhance transparency about the IRIS assessment process. At the request of the EPA, this report reviews the procedures and considerations for operationalizing the principles of systematic reviews and the methods described in the handbook for determining the scope of the IRIS assessments, evidence integration, extrapolation techniques, dose-response analyses, and characterization of uncertainties.

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

Review of the Environmental Protection Agency's Draft IRIS Assessment of Tetrachloroethylene PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2010-03-18

Total Pages: 187

ISBN-13: 0309152356

DOWNLOAD EBOOK →

Tetrachloroethylene is a volatile, chlorinated organic hydrocarbon that is widely used as a solvent in the dry-cleaning and textile-processing industries and as an agent for degreasing metal parts. It is an environmental contaminant that has been detected in the air, groundwater, surface waters, and soil. In June 2008, the U.S. Environmental Protection Agency released its draft Toxicological Review of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in Support of Summary Information on the Integrated Risk Information System (IRIS). The draft IRIS assessment provides quantitative estimates of cancer and noncancer effects of exposure to tetrachloreothylene, which will be used to establish airquality and water-quality standards to protect public health and to set cleanup standards for hazardous waste sites. At the request of EPA, the National Research Council conducted an independent scientific review of the draft IRIS assessment of tetrachloroethylene from toxicologic, epidemiologic, and human clinical perspectives. The resulting book evaluates the adequacy of the EPA assessment, the data and methods used for deriving the noncancer values for inhalation and oral exposures and the oral and inhalation cancer unit risks posed by tetrachloroethylene; evaluates whether the key studies underlying the draft IRIS assessment are of requisite quality, reliability, and relevance to support the derivation of the reference values and cancer risks; evaluates whether the uncertainties in EPA's risk assessment were adequately described and, where possible, quantified; and identifies research that could reduce the uncertainty in the current understanding of human health effects associated with tetrachloroethylene exposure.

EPA's Integrated Risk Information System

EPA's Integrated Risk Information System PDF

Author:

Publisher:

Published: 2009

Total Pages: 4

ISBN-13:

DOWNLOAD EBOOK →

The Integrated Risk Information System (IRIS) is a U.S. Environmental Protection Agency (EPA) database that contains information on human health effects that may result from exposure to chemical substances in the environment. IRIS is maintained by EPA's Office of Research and Development. The IRIS process consists of development of a draft Toxicological Review for the chemical, internal and external scientific reviews of the draft document, EPA responses to review comments, and development and posting on the IRIS web site of an IRIS Summary and final Toxicological Review. EPA is announcing revisions to the IRIS process. Highlights of the new IRIS development process include a streamlined review schedule, ensuring that the majority of assessments are posted on IRIS within two years of the start date.

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 PDF

Author: National Academies Of Sciences Engineeri

Publisher: National Academies Press

Published: 2021-11-16

Total Pages:

ISBN-13: 9780309683869

DOWNLOAD EBOOK →

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.