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1 Introduction
Pages 13-18

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From page 13...
... The assessments are also used by federal, state and tribal agencies as well as community organizations and agencies in other countries to inform decisions concerning health risk assessment and management.1 Over the years, questions had been raised about the scientific basis of toxicity values reported in some IRIS assessments and the extensive amount of time taken to complete assessments. A 2011 report from the National Academies of Sciences, Engineering, and Medicine that reviewed a draft IRIS assessment of formaldehyde offered recommendations for improving the IRIS process (NRC, 2011)
From page 14...
... . In response, the Committee to Review EPA's IRIS Assessment Handbook was convened to evaluate the operating procedures, as described in the handbook, for hazard identification and dose-response assessment of potential human health effects from exposure to environmental contaminants.
From page 15...
... . In addition, the committee received various written materials, including EPA's written responses to the committee's questions and the public comments on the handbook that were submitted to the EPA docket.2 BOX 1-1 Statement of Task An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will evaluate EPA's ORD Staff Handbook for Developing IRIS Assessments (or IRIS Handbook)
From page 16...
... Chapter 6 focuses on the handbook's treatment of evidence integration across data streams and the judgments used to describe the strength of conclusions regarding hazard identification. Chapter 7 covers the handbook's steps of selecting studies for toxicity derivation and deriving toxicity values based upon dose-response analyses.
From page 17...
... • Are the considerations sufficiently broad to allow for application to the wide range of scenarios that will be encountered when applied to individual assessments? • Are the methods sufficiently clear in describing the intent to synthesize the relevant evidence, incorporating study evaluation conclusions, regardless of the study results?
From page 18...
... Are the basic methods for dose-response modeling and deriving toxicity values consistent with the current state of the science, and presented with sufficient clarity? a Chapter and section numbers listed in the questions refer to those of the ORD Staff Handbook for Developing IRIS Assessments (EPA, 2020a)


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