Society For Risk Analysis Annual Meeting 2012

Advancing Analysis

Session Schedule & Abstracts

* Disclaimer: All presentations represent the views of the authors, and not the organizations that support their research. Please apply the standard disclaimer that any opinions, findings, and conclusions or recommendations in abstracts, posters, and presentations at the meeting are those of the authors and do not necessarily reflect the views of any other organization or agency. Meeting attendees and authors should be aware that this disclaimer is intended to apply to all abstracts contained in this document. Authors who wish to emphasize this disclaimer should do so in their presentation or poster. In an effort to make the abstracts as concise as possible and easy for meeting participants to read, the abstracts have been formatted such that they exclude references to papers, affiliations, and/or funding sources. Authors who wish to provide attendees with this information should do so in their presentation or poster.

Common abbreviations

Symposium: New Directions in Risk Assessment with Roadmap for Success

Room: Pacific Concourse K   3:30 - 5 PM

Chair(s): Kenneth Olden, Abdel-Razak Kadry

Sponsored by DRSG

EPA's Integrated Risk Information System (IRIS) is a human health assessment program that evaluates health effects information on chemicals found in the environment. IRIS provides the highest quality science-based human health assessments to support the Agency’s regulatory activities. The IRIS database contains information for more than 550 chemical substances. EPA has made several changes to this important Program over the past few years including streamlining the assessment development process, improving transparency, and creating efficiencies within the Program. In April 2011, the National Research Council (NRC) made several recommendations to EPA for improving the development of IRIS assessments, including: 1. General guidance for the overall process 2. Evidence identification (literature collection and collation phase) 3. Evidence evaluation ( hazard identification and dose-response modeling) 4. Weight-of-evidence evaluation (synthesis of evidence for hazard identification). EPA has been implementing the NRC’s recommendations to streamline assessments, making them more concise and readable, and using more appendices and tables. Additional initiatives that address specific NRC recommendations are also underway. This symposium will discuss the NRC’s recommendations for the IRIS Program, steps taken by EPA to implement them, lessons learned from similar experiences, and stakeholder’s observation and input on EPA’s progress.

W4-B.1  15:30  A “Roadmap“ for Revising IRIS: Recommendations from the National Research Council. Samet JM*; University of Southern California

Abstract: The National Research Council was asked by the Environmental Protection Agency (EPA) to review the agency’s draft IRIS assessment of formaldehyde. In its 2011 report, the resulting Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde provided specific comments related to revising the draft and also commented on the IRIS process more broadly, motivated by problems identified in the draft that reflected general deficiencies in the process. This presentation describes the committee’s general findings with regard to the IRIS process and its recommendations for improving the process, as set out in the concluding chapter, “A Roadmap for Revision.” The general problems identified by the present committee are not unique to the formaldehyde assessment and have been reported previously. Problems with clarity and transparency of the methods appear to be a repeating theme over the years. In general, the committee found that the draft was not prepared in a consistent fashion, lacked clear links to an underlying conceptual framework; and did not contain sufficient documentation on methods and criteria for identifying evidence from epidemiologic and experimental studies, for critically evaluating individual studies, for assessing the weight of evidence, and for selecting studies for derivation of the RfCs and unit risk estimates. In response, the committee offered a several-page roadmap for changes in the process. The term roadmap was used because the topics that need to be addressed are set out, but detailed guidance was not provided. Thus, the committee provided general guidance for the overall process and more specific guidance on the specific steps of evidence identification, evidence evaluation, weight-of-evidence evaluation, selection of studies for derivation of RfCs and unit risk, and calculation of RfCs and unit risks.

W4-B.2  15:50  The IRIS rogram – a key resource for public health risk assessment. Salmon A*, Marty M, Zeise L; Cal/EPA Office of Environmental Health Hazard Assessment, Oakland, CA

Abstract: The USEPA’s IRIS risk assessment program offers the states an unparalleled resource for understanding the potential public health impacts of environmental contaminants. The states are on the frontline assessing statewide and localized environmental contamination, and making decisions to reduce exposure and mitigate risk from environmental contaminants. The in-depth analyses undertaken in the IRIS program for important environmental contaminants can be used by the states in their environmental protection programs, and help further methodologies that can be adopted by the states in their development of assessments. Thus, the states rely on the IRIS program for informed decision making at the state and local levels. A few key examples will be presented, including use of the recent EPA TCE analysis, and the assessment of the cancer risk from PCBs in California programs.

W4-B.3  16:10  Retooling of IRIS: What Progress Has Actually Been Made Over the Last 20 Months? Becker RA*, Pottenger LH, Fensterheim RJ, Wise K; American Chemistry Council

Abstract: Retooling EPA’s Integrated Risk Information System (IRIS) to address long-standing shortcomings in IRIS policies & practices for conducting assessments has been catalyzed by a highly critical April 2011 NRC report, stakeholder recommendations, GAO reviews, 2011 Congressional hearings, & the bipartisan FY2011-2012 budget law (enacted 12/2011). While EPA stated its intention to implement all NRC recommendations, progress has been slow (see EPA’s April 2012 Report to Congress). Unfortunately, EPA has not yet established a transparent plan (and timeline) to implement many of the critical improvements; without these upgrades, the same significant scientific deficiencies noted in the NRC April 2011 report will likely continue to plague IRIS assessments. Implementing the following recommendations will help meet the scientific benchmarks laid out by NRC & Congress and significantly advance the IRIS process: 1) Improve the design & data acquisition phase by specifying key issues to be assessed, methods/evaluation procedures to be used, and holding a dialogue with stakeholders on these; 2) Use consistent, scientifically objective data evaluation procedures for each study type; 3) Modernize weight of evidence determinations by adopting and applying a consistent, comprehensive framework to establish mode of action, cause & effect, and determine cancer/non-cancer risks at environmentally relevant exposures; 4) Provide a complete hazard characterization, including evaluation of background/endogenous exposures, extrapolation using available mode of action information, including a threshold model whenever default linear extrapolation is used; 5) Develop a range of risk values, including central tendency estimates in addition to upper bound calculations; and 6) Improve peer-review by providing meaningful opportunities for stakeholder input on charge questions and by upgrading procedures to assure full accountability for completely addressing public comments & peer-review findings.

W4-B.4  16:30  NGO Perspective on IRIS Process and Progress. Janssen SJ*; Natural Resources Defense Council (NRDC)

Abstract: The NRC has issued several sentinel reports in the past several years which have made strong recommendations for improving the IRIS process. In two recent reports, Science and Decisions: Advancing Risk Assessment and Phthalates and Cumulative Risk Assessment, the NRC issued recommendations to regulatory agencies to improve the chemical risk assessment process to reflect current science, to make the process more responsive to policy needs, and to better protect people from adverse health effects resulting from chemical exposures. These recommendations included specific recommendations to incorporate population variability, vulnerability, cumulative exposures, and uncertainty into risk assessments in a more quantitative and transparent way. The IRIS program has begun to grapple with how to incorporate these changes while continuing to make progress on assessments already underway. The 1996 NRC report, Understanding Risk: Informing Decisions in a Democratic Society is also very relevant in its recommendations that impacted communities be engaged in a meaningful way in risk assessment. New technologies have transformed and radically democratized our ability to collect exposure data, including fence-line “bucket brigades” and body burden biomonitoring. Communities and other NGOs are advocating for policies that require chemical manufacturers to identify chemicals that are in their production or supply line and require that the database on that chemical is complete and available to regulators and the public. Professional societies like SRA should help to promote these recommendations within current and future IRIS assessments, without delaying risk assessments already in progress.

W4-B.5  16:50  EPA’s Path Forward for the Integrated Risk Information System Program . Clark B, Deener K, Cogliano V*, Kadry A; National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC, USA

Abstract: EPA’s Integrated Risk Information System (IRIS) is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to chemical substances found in the environment. In 2009, EPA implemented a new IRIS process. In 2011, the National Research Council (NRC) provided recommendations for improving the development of draft IRIS assessments. Since that time, EPA has made changes to further strengthen and streamline the IRIS Program. The Program has created a new document structure that substantially reduces the volume of text and addresses redundancies and inconsistencies in assessments. EPA has replaced Chapter 1 of IRIS assessments with a Preamble that describes the application of existing EPA guidance and the methods and criteria used to develop the assessments. The new document structure includes a detailed description of the literature search strategy and study evaluation process used to develop IRIS assessments. EPA is also working to develop a formal framework to establish conclusions about the weight of evidence for health effects other than cancer. In addition to the public listening session and public comment period that is already part developing IRIS assessments, EPA will increase the use of public peer consultation workshops to enhance the input of the scientific community early in the process as certain assessments are designed. EPA has also established a dedicated Chemical Assessment Advisory Committee, under the auspices of EPA’s Science Advisory Board (SAB), to provide advice to EPA on draft IRIS Toxicological Reviews and the IRIS Program. Finally, EPA has developed and is using the web-based Health and Environmental Research Online database (, which promotes transparency by capturing and making available to the public the references and abstracts to scientific studies used in Agency assessments. A strong IRIS Program is critical not only to EPA, but to state and local governments, industry, international organizations, and other stakeholders.

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