title: The acquisition and application of absorption, distribution, metabolism, and excretion (ADME) data in agricultural chemical safety assessments.
abstract: A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studies are scientifically appropriate and necessary without being redundant, and that tests emphasize toxicological endpoints and exposure durations that are relevant for risk assessment. Incorporation of pharmacokinetic studies describing absorption, distribution, metabolism, and excretion is an essential tool for improving the design and interpretation of toxicity studies and their application for safety assessment. A tiered approach is described in which basic pharmacokinetic studies, similar to those for pharmaceuticals, are conducted for regulatory submission. Subsequent tiers provide additional information in an iterative manner, depending on pharmacokinetic properties, toxicity study results, and the intended uses of the compound.
authors.affiliation: U.S. Environmental Protection Agency, National Centerfor Computational Toxicology, Research Triangle Park, North Carolina, USA.
authors.forename: Hugh A
authors.initials: HA
authors.lastname: Barton
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Pastoor
authors.forename: Karl
authors.initials: K
authors.lastname: Baetcke
authors.forename: Janice E
authors.initials: JE
authors.lastname: Chambers
authors.forename: Janet
authors.initials: J
authors.lastname: Diliberto
authors.forename: Nancy G
authors.initials: NG
authors.lastname: Doerrer
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Driver
authors.forename: Charles E
authors.initials: CE
authors.lastname: Hastings
authors.forename: Seshadri
authors.initials: S
authors.lastname: Iyengar
authors.forename: Robert
authors.initials: R
authors.lastname: Krieger
authors.forename: Bernhard
authors.initials: B
authors.lastname: Stahl
authors.forename: Charles
authors.initials: C
authors.lastname: Timchalk
mesh_terms: D016573:Agrochemicals / Q000493:pharmacokinetics* / Q000633:toxicity; D000818:Animals; D006801:Humans; D018570:Risk Assessment; D017751:Safety Management
chemical_list: D016573:Agrochemicals