Review of EPA's 2022 Draft Formaldehyde Assessment (2023) / Chapter Skim
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These reports encouraged the IRIS Program to adopt systematic review methods, to develop a staff handbook with general guidance on the methods used in IRIS assessments, and to develop an a priori protocol for each major IRIS assessment. In line with its statement of task, the committee considered that any Tier 1 recommendations would be important to address to improve critical scientific concepts, issues, or narrative in the 2022 Draft Assessment.
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FIGURE S-1 Timeline of development of EPA's formaldehyde Draft Assessment.
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Transparency in EPA's systematic review methods implies that the committee should be able to replicate each step based on the information included in the assessment documents or in publicly available supplemental materials. Accordingly, the committee used a case study approach to provide a detailed evaluation of the transparency and replicability of the 2022 Draft Assessment methods, relying on the documentation provided by EPA in the 2022 Draft Assessment and in the written responses to the committee's queries.
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This aspect of the committee's review addressed each step of EPA's assessment methods for each outcome as used to develop evidence integration judgments and derive risk estimates for formaldehyde. In line with its overall charge, the committee focused its review on whether the 2022 Draft Assessment adequately and transparently evaluated the available studies and data, and used appropriate methods in reaching hazard identification conclusions and dose-response analyses that are supported by the scientific evidence.
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. The committee concluded that prepublished protocols are essential for future IRIS assessments to ensure transparency for systematic reviews in risk assessment.
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Such inconsistency was broadly evident in the committee's review of EPA's evaluation of human and animal studies across noncancer outcomes (including for sensory irritation, pulmonary function, respiratory pathology, allergy and asthma, reproductive and developmental toxicity, and neurotoxicity)
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Transparency could be enhanced by explicitly identifying the models used to derive flux values in the summary tables, and by improving documentation of the dosimetry approaches in the tables and text. For noncancer outcomes comprising effects on pulmonary function, respiratory pathology, allergy and asthma, reproductive and developmental toxicity, and neurotoxicity and sensory irritation, EPA presents hazard identification conclusions supported by the available scientific evidence from humans, experimental animals, and mechanistic studies.
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: EPA should carefully address the following points re garding the derivation of the RfC: • Fully disclose data extracted from original study reports using HERO or other means. • Cite relevant guidance documents regarding the use of a mean versus median and arithmetic mean versus geometric mean to estimate a lowest observed ad verse effect level or no observed adverse effect level.
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: EPA should discuss the extent to which the inhalation unit risk estimates based on animal squamous cell carcinoma data and mechanistic data provide supporting evidence for the inhalation unit risk based on the human na sopharyngeal carcinoma data.
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The three estimates in Table 2-35 should be presented as alternative, low-confidence inhalation unit risk estimates for myeloid leukemia without selection of a preferred estimate. EPA should not characterize the combining of other/unspecified leukemia with myeloid leukemia as "the best approach." THE PATH FORWARD EPA's 2022 Draft Assessment has been revised over a period spanning more than a decade and has been improved substantially.
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This report provides a number of specific Tier 1, 2, and 3 recommendations to guide the assessment's finalization, and the committee encourages EPA to implement all of the needed changes. A confined set of revisions will enhance clarity and transparency.
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