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Pages 3-7

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From page 3...
... , the committee was to organize a workshop to evaluate critical scientific issues in assessing cancer and noncancer effects of oral exposure to inorganic arsenic and offer recommendations on how the issues could be addressed in EPA's IRIS assessment. The second phase of the study will begin after EPA completes its draft assessment; it will involve a review of the draft assessment to determine whether the committee's recommendations were appropriately addressed and also reflect recommendations for improving IRIS assessments made in other National Research Council reports.
From page 4...
... For dose-response meta-analysis, studies will need to have characterized three or more exposure levels. Chapter 3 provides general guidance for performing systematic reviews and meta-analyses, as well as for developing evidence tables on animal and in vitro data to inform causality determinations and mode-of-action analyses in the low exposure range.
From page 5...
... BOX 2 Hierarchy of Health End Points of Concern for Inorganic Arsenic  Tier 1: Evidence of a causal association determined by other agencies and/or in published systematic reviews o Lung, skin, and bladder cancer o Ischemic heart disease o Skin lesions  Tier 2: Other priority outcomes o Prostate and renal cancer o Diabetes o Nonmalignant respiratory disease o Pregnancy outcomes (infant morbidity) o Neurodevelopmental toxicity o Immune effects  Tier 3: Other end points to consider o Liver and pancreatic cancer o Renal disease o Hypertension o Stroke o Pregnancy outcomes (fetal loss, stillbirth, and neonatal mortality)
From page 6...
... The committee does not assume that those background concentrations are with or without health effects; rather, it assumes that the needs of assessing health risks can be facilitated by characterizing dose–response relationships down to the background concentrations by using observed data. The committee recommends that EPA develop risk estimates across the array of health effects on which there is adequate epidemiologic evidence and then derive risk-specific doses to address the needs
From page 7...
... The preferred approach would be to use data that define the individual and population risks and their associated uncertainty on the basis of analyses of adverse-outcome pathways or mode of action and human variability in susceptibility. That would describe human pharmacokinetics, biomarkers of exposure, tissue doses of relevant arsenic forms, and the multiple toxicodynamic processes that lead to the adverse outcomes.

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