Consideration of new approach data and fit for purpose analyses in the ORD toxicity assessment portfolio
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Invited presentation to 2024 Winter ToxForum meeting.
EPA’s Office of Research and Development (ORD) is advancing their portfolio of human health toxicity assessment products to draw on the range of available toxicity data to inform the myriad public health decisions confronting the Agency and communities. Many environmental chemicals are data poor and lack toxicological data that are traditionally used in the derivation of toxicity values. As alternative approaches to human health toxicity assessment are developed and implemented, scoping and problem formulation steps are critical to appropriately tailor the assessment product to the decisions being made. Examples, such as the recent ORD Human Health Toxicity Value assessments for Perfluoropropanoic acid (PFPrA) and lithium bis[(trifluoromethyl)sulfonyl]azanide (HQ-115), showcase the importance of integrating considerations of decision context and data availability and quality objectives when selecting an assessment product. Another example, such as Provisional Peer-Reviewed Toxicity Value assessments of data-poor chemicals, that rely on expert driven read-across approaches, showcase the importance of an evolving portfolio of assessment approaches in circumstances of limited data.