Biologically based models unfit for perchlorate risk assessment

Clewell HH 3rd, Gentry PR, Hack CE, Greene T, Clewell RA. An evaluation of the USEPA Proposed Approaches for applying a biologically based dose-response model in a risk assessment for perchlorate in drinking water. Regulatory toxicology and pharmacology. 2019 Jan 29. pii: S0273-2300(19)30036-4. doi: 10.1016/j.yrtph.2019.01.028.

The United States Environmental Protection Agency’s (USEPA) 2017 report, “Draft Report: Proposed Approaches to Inform the Derivation of a Maximum Contaminant Level Goal for Perchlorate in Drinking Water”, proposes novel approaches for deriving a Maximum Contaminant Level Goal (MCLG) for perchlorate using a biologically-based dose-response (BBDR) model. The USEPA (2017) BBDR model extends previously peer-reviewed perchlorate models to describe the relationship between perchlorate exposure and thyroid hormone levels during early pregnancy. Our evaluation focuses on two key elements of the USEPA (2017) report: the plausibility of BBDR model revisions to describe control of thyroid hormone production in early pregnancy and the basis for linking BBDR model results to neurodevelopmental outcomes. While the USEPA (2017) BBDR model represents a valuable research tool, the lack of supporting data for many of the model assumptions and parameters calls into question the fitness of the extended BBDR model to support quantitative analyses for regulatory decisions on perchlorate in drinking water. Until more data can be developed to address uncertainties in the current BBDR model, USEPA should continue to rely on the RfD recommended by the NAS (USEPA, 2005) when considering further regulatory action.

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