Review of EPA's Integrated Risk Information System (IRIS) Process (2014) / Chapter Skim
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2 General Process Issues
2 General Process Issues
Pages 17-29
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From page 17... ...
EPA has recently adopted a new document structure for IRIS assessments, drafted a preamble to be included with all IRIS assessments, and instituted several changes to enhance quality-control processes within the IRIS program. Those changes are reviewed in the following sections.
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Specifically, in the formaldehyde IRIS assessment, the basis of the conclusions on health outcomes was not clear and transparent, and the rationales for selecting studies for deriving quantitative toxicity values for cancer and noncancer outcomes were not well developed or consistent. Consequently, the NRC committee that reviewed the formaldehyde assessment offered a number of general suggestions to enhance document clarity, including reducing document length, editing rigorously, eliminating redundancies and inconsistencies, and using evidence tables rather than long narrative descriptions of individual studies.
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. It discusses the general scope and elements of the IRIS program; the peer-review process for the IRIS assessments; the identification, selection, and evaluation of studies; integration of evidence; and derivation of toxicity values.
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For example, CAAC members could provide specific expertise for a chemical being assessed by periodically reviewing activities at critical stages of each IRIS assessment and interacting with the chemical-assessment team and the CAST assigned to the assessment. The need for increased expert judgment in the IRIS process is discussed further in the section "Using Expert Judgment in the IRIS Process." Development of Information-Management Tools In its status report to the committee, EPA described several information-management tools that should promote quality control in the IRIS process (EPA 2013a, Appendix D)
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Stakeholder involvement needs to be an integral part of the risk-based decision-making framework, beginning with problem formulation and scoping." The present committee agrees that early and continuing stakeholder involvement not only will increase the likelihood that EPA will address the concerns of diverse stakeholders but should strengthen the quality of IRIS assessments. In considering initiatives to expand stakeholder involvement, the various stakeholder groups should be recognized.
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Stakeholder involvement today begins with the nomination of substances for review, but not all potential stakeholders are likely to be aware of this opportunity. The IRIS program lists planned reviews in the Federal Register (78 Fed.
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Most public comments on draft IRIS assessments have come from industry or parties representing the interests of entities that produce, use, and release possibly toxic substances. Indeed, almost all the public input -- written and oral -- received by the present committee has come from trade organizations.
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Develop explicit timelines for the various components of IRIS assessments. The committee recognizes that IRISTrack on the EPA Web site provides some information, but the information is often too general or incomplete (for example, "TBD" [to be determined]
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Promote within EPA a research program that studies the best way to use and incorporate data that are being generated from new in vitro, in silico, and high-throughput toxicity testing into the IRIS process. USING EXPERT JUDGMENT IN THE IRIS PROCESS The name Integrated Risk Information System might suggest to some a rather mechanical and automated system of assessing the health consequences of chemical exposure.
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Recommendation: EPA needs to complete the changes in the IRIS process that are in response to the recommendations in the NRC formaldehyde report and specifically complete documents, such as the draft handbook, that provide detailed guidance for developing IRIS assessments. When those changes and the detailed guidance, such as the draft handbook, have been completed, there should be an independent and comprehensive review that evaluates how well EPA has implemented all the new guidance.
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Recommendation: Regarding promotion of efficiencies, EPA should continue to expand its efforts to develop computer systems that facilitate storage and annotation of information relevant to the IRIS mission and to develop automated literature and screening procedures, sometimes referred to as text-mining. Finding: The draft handbook and other materials are useful but lack explicit guidance as to the methods and nature of the use of expert judgment throughout the full scope of the assessmentdevelopment process, from literature searching and screening through integrating evidence to analyzing the dose-response relationship and deriving final toxicity values.
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2013f. Integrated Risk Information System Program: Summary Report from November 2012 Public Stakeholder Meeting [online]
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2011. Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde.
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