title: Does GLP enhance the quality of toxicological evidence for regulatory decisions?
abstract: There is debate over whether the requirements of GLP are appropriate standards for evaluating the quality of toxicological data used to formulate regulations. A group promoting the importance of non-monotonic dose responses for endocrine disruptors contend that scoring systems giving primacy to GLP are biased against non-GLP studies from the literature and are merely record-keeping exercises to prevent fraudulent reporting of data from non-published guideline toxicology studies. They argue that guideline studies often employ insensitive species and outdated methods, and ignore the perspectives of subject-matter experts in endocrine disruption, who should be the sole arbiters of data quality. We believe regulatory agencies should use both non-GLP and GLP studies, that GLP requirements assure fundamental tenets of study integrity not typically addressed by journal peer-review, and that use of standardized test guidelines and GLP promotes consistency, reliability, comparability, and harmonization of various types of studies used by regulatory agencies worldwide. This debate suffers two impediments to progress: a conflation of different phases of study interpretation and levels of data validity, and a misleading characterization of many essential components of GLP and regulatory toxicology. Herein we provide clarifications critical for removing those impediments.
authors.affiliation: Dept. Physiol. Sciences, Univ. FL College of Veterinary Medicine, Applied Pharmacology and Toxicology, Inc, and C.E.H.T, Gainesville, Florida 32605; Cjborgert@apt-Pharmatox.Com.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Borgert
authors.affiliation: American Chemistry Council, Washington, District of Columbia 20002;
authors.forename: Richard A
authors.initials: RA
authors.lastname: Becker
authors.affiliation: Bluestar Silicones USA Corp 10520 Whitestone Rd., Raleigh, North Carolina 27615.
authors.forename: Betsy D
authors.initials: BD
authors.lastname: Carlton
authors.affiliation: Department of Environment and Geography, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Mark
authors.initials: M
authors.lastname: Hanson
authors.affiliation: Bayer CropScience, Research Triangle Park, North Carolina 27709.
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Kwiatkowski
authors.affiliation: Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan 48674.
authors.forename: Mary
authors.initials: M
authors.lastname: Sue Marty
authors.affiliation: Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan 48674.
authors.forename: Lynn S
authors.initials: LS
authors.lastname: McCarty
authors.affiliation: Quill Law Group, LLC, Washington, District of Columbia 20006;
authors.forename: Terry F
authors.initials: TF
authors.lastname: Quill
authors.affiliation: University of Guelph, Centre for Toxicology, School of Environmental Science, Guelph, Ontario N1G 2W1, Canada;
authors.forename: Keith
authors.initials: K
authors.lastname: Solomon
authors.affiliation: Department of Integrative Biology, University of Guelph, Guelph, Ontario N1G 2W1, Canada.
authors.forename: Glen
authors.initials: G
authors.lastname: Van Der Kraak
authors.affiliation: Department of Physiology & Biophysics, School of Medicine, Virginia Commonwealth University, Richmond, Virginia 23298-0551;
authors.forename: Raphael J
authors.initials: RJ
authors.lastname: Witorsch
authors.affiliation: Syngenta Crop Protection, Inc, Greensboro, North Carolina 27419-8300.
authors.forename: Kun Don
authors.initials: KD
authors.lastname: Yi
mesh_terms: D000818:Animals; D032921:Consensus; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D052244:Endocrine Disruptors / Q000633:toxicity*; D017408:Guidelines as Topic; D006801:Humans; D011050:Policy Making; D011786:Quality Control; D015203:Reproducibility of Results; D018570:Risk Assessment; D014116:Toxicology / Q000331:legislation & jurisprudence* / Q000592:standards
chemical_list: D052244:Endocrine Disruptors
keywords: data quality; endocrine toxicology; evaluation; good laboratory practice; risk assessment; safety evaluation