proach. The following recommendations are viewed as critical overall changes needed to complete the draft IRIS assessment:

  • To enhance the clarity of the document, the draft IRIS assessment needs rigorous editing to reduce the volume of text substantially and address redundancy and inconsistency. Long descriptions of particular studies, for example, should be replaced with informative evidence tables. When study details are appropriate, they could be provided in appendixes.

  • Chapter 1 needs to be expanded to describe more fully the methods of the assessment, including a description of search strategies used to identify studies with the exclusion and inclusion criteria clearly articulated and a better description of the outcomes of the searches (a model for displaying the results of literature searches is provided later in this chapter) and clear descriptions of the weight-of-evidence approaches used for the various noncancer outcomes. The committee emphasizes that it is not recommending the addition of long descriptions of EPA guidelines to the introduction, but rather clear concise statements of criteria used to exclude, include, and advance studies for derivation of the RfCs and unit risk estimates.

  • Standardized evidence tables for all health outcomes need to be developed. If there were appropriate tables, long text descriptions of studies could be moved to an appendix or deleted.

  • All critical studies need to be thoroughly evaluated with standardized approaches that are clearly formulated and based on the type of research, for example, observational epidemiologic or animal bioassays. The findings of the reviews might be presented in tables to ensure transparency. The present chapter provides general guidance on approaches to reviewing the critical types of evidence.

  • The rationales for the selection of the studies that are advanced for consideration in calculating the RfCs and unit risks need to be expanded. All candidate RfCs should be evaluated together with the aid of graphic displays that incorporate selected information on attributes relevant to the database.

  • Strengthened, more integrative, and more transparent discussions of weight of evidence are needed. The discussions would benefit from more rigorous and systematic coverage of the various determinants of weight of evidence, such as consistency.


This committee’s review of the draft IRIS assessment of formaldehyde identified both specific and general limitations of the document that need to be addressed through revision. The persistence of limitations of the IRIS assessment methods and reports is of concern, particularly in light of the continued evolution of risk-assessment methods and the growing societal and legislative pressure to evaluate many more chemicals in an expedient manner. Multiple

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