Review of EPA's Updated Problem Formulation and Protocol for the Inorganic Arsenic IRIS Assessment (2019) / Chapter Skim
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COMMITTEE'S FINDINGS
COMMITTEE'S FINDINGS
Pages 3-9
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EPA has implemented systematic review approaches to evaluate the scientific literature; has prioritized the health outcomes for dose-response assessment; has presented an approach to assessing multiple cancer and noncancer end points; has begun to implement several analytical approaches to utilize human data in the low-dose range; and has introduced more advanced statistical approaches in its dose-response evaluations that take into consideration multiple studies. The committee was unable to reach consensus about the adequacy of the dose-response methods; the majority of the committee supported EPA's approach and one member objected to this conclusion (see Appendix A for dissenting statement and committee rebuttal)
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EPA's Systematic Review Methods Overall, the committee commends EPA's integration of systematic review in the IRIS iAs assessment plan to identify evidence and to evaluate evidence for hazard identification and subsequent use in doseresponse analyses. Such methods offer greater transparency, rigor, and better use of the overall evidence base.
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Literature Search and Screening The screening process described in the IRIS iAs assessment plan is generally consistent with standard systematic review methods. The following are recommended to increase clarity in the iAs IRIS assessment: A more complete diagram (consistent with PRISMA [Preferred Reporting Items for Systematic Reviews and Meta-analyses]
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For example, whether EPA considered performing meta-analyses for any of the outcomes to support hazard identification is unclear. Although the term "evidence integration" is used in the IRIS iAs assessment plan, it does not appear that separate lines of evidence (human, animal, and mechanistic)
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The IRIS iAs assessment plan does not indicate whether or how dose-response modeling of early life exposure to iAs and adult health end points will be performed. Mode-of-Action Information to Inform Dose-Response Analyses On the basis of the information presented in the IRIS iAs assessment plan, EPA's posters, and discussions with EPA staff, the committee's understanding is that primarily epidemiological data will be used in dose-response modeling in the iAs IRIS assessment.
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Although the majority of the committee agrees with the IRIS iAs assessment plans for performing dose-response analyses, the following concerns should be addressed in the iAs IRIS assessment: EPA should clarify its methods and terminology. It appeared to the committee that EPA performed a dose-response meta-analysis and not a meta-regression.
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From page 9... ...
. On the basis of the IRIS iAs assessment plan and information provided at the public meeting, the committee understands that EPA plans to use the dose-response meta-analysis approach to generate relative risk estimates that will then be fed into a life table to generate estimates of lifetime extra risk.
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