Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde (2011) / Chapter Skim
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7 A Roadmap for Revision
7 A Roadmap for Revision
Pages 151-167
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From page 151... ...
The committee is focused on the development of the draft IRIS assessment. CRITICAL REVISIONS OF THE CURRENT DRAFT IRIS ASSESSMENT OF FORMALDEHYDE The formaldehyde draft IRIS assessment has been under development for more than a decade (see Chapter 1, Figure 1-3)
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From page 152... ...
FUTURE ASSESSMENTS AND THE IRIS PROCESS 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.
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From page 153... ...
Science and Decisions: Advancing Risk Assessment made several recommendations directly relevant to developing IRIS assessments, including the draft formaldehyde assessment. First, it called for the development of guidance related to the handling of uncertainty and variability, that is, clear definitions and methods.
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From page 154... ...
Revise Assessment Address peer review and public Complete Draft IRIS comments; prepare response to Post Final Assessment on IRIS comments document. Assessment Includes IRIS summary, Toxicological Review and response to comments.
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From page 155... ...
For hazard identification, the general guidance is also found in Chapter 1 of the draft IRIS assessment. The approach to conducting hazard identification is critical for the integrity of the IRIS process.
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From page 156... ...
The committee recognizes that some of the concepts and approaches discussed below are elementary and are addressed in some of EPA's guidelines. However, the current state of the formaldehyde draft IRIS assessment suggests that there might be a problem with the practical implementation of the guidelines in completing the IRIS assessments.
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From page 157... ...
; the report offers relevant coverage of the practice of causal inference. This brief and necessarily selective coverage of evidence reviews and evaluations shows that models are available that have proved successful in practice.
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From page 158... ...
If prepared correctly, the tables eliminate the need for long descriptions of studies and result in shorter text. Some draft IRIS assessments have begun to use a tabular format for systematic and concise presentation of evidence, and the committee encourages EPA to refine and expand that format as it revises the formaldehyde draft IRIS assessment and begins work on others.
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From page 159... ...
Current Approaches to Hazard Identification Hazard identification involves answering the question, Does the agent cause the adverse effect?
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From page 160... ...
The present committee supports those recommendations but offers additional suggestions on the complementary coverage of the use of meta-analysis and pooled analysis in dose-response assessment. IRIS assessments should address the following critical questions: Which studies should be included for derivation of reference values for noncancer outcomes and unit risks for cancer outcomes?
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From page 161... ...
Their proposal includes a table with a proposed check list that has broad categories for reporting, including background (such as problem definition and study population) , search strategy (such as searchers, databases, and registries used)
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From page 162... ...
The new process replaces the criteria document with an integrated science assessment and a staff paper that includes a policy assessment. For the one pollutant, PM, that has nearly completed the full sequence, a risk and exposure analysis was also included.
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From page 163... ...
The policy assessment develops policy options on the basis of the findings of the integrated science assessment and the risk and exposure analysis. The policy assessment for the PM NAAQS is framed around a series of policyrelevant questions, such as, Does the available scientific evidence, as reflected in the integrated science assessment, support or call into question the adequacy of the protection afforded by the current 24-hr PM10 standard against effects associated with exposures to thoracic coarse particles?
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Thus, EPA may be able to make changes in the assessment process relatively quickly by drawing on appropriate experts and selecting and adapting existing approaches. One major, overarching issue is the use of weight of evidence in hazard identification.
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o Determine whether combining estimates among studies is warranted. Calculation of Reference Values and Unit Risks Describe and justify assumptions and models used.
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Provide adequate documentation for conclusions and estimation of reference values and unit risks. As noted by the committee throughout the present report, sufficient support for conclusions in the formaldehyde draft IRIS assessment is often lacking.
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From page 167... ...
2010b. Policy Assessment for the Review of the Particulate Matter National Ambient Air Quality Standards (Second External Review Draft)
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