§702.37. Evaluation requirements. — Inbound Citations

(4) In determining whether there is sufficient information to support a manufacturer-requested risk evaluation, EPA expects to apply the same standard as it would for EPA-initiated risk evaluations, including but not limited to the considerations and requirements in § 702.37.

(3) Consistent with § 702.37(b), information evaluated may include, but would not be limited to: Human epidemiological studies, in vivo and/or in vitro laboratory studies, biomonitoring and/or human clinical studies, ecological field data, read across, mechanistic and/or kinetic studies in a variety of test systems. These may include but are not limited to: toxicokinetics and toxicodynamics (e.g., physiological-based pharmacokinetic modeling), and computational toxicology (e.g., high-throughput assays, genomic response assays, data from structure-activity relationships, in silico approaches, and other health effects modeling).