title: Predicted no effect concentration derivation as a significant source of variability in environmental hazard assessments of chemicals in aquatic systems: an international analysis.
abstract: Environmental hazard assessments for chemicals are carried out to define an environmentally "safe" level at which, theoretically, the chemical will not negatively affect any exposed biota. Despite this common goal, the methodologies in use are very diverse across different countries and jurisdictions. This becomes particularly obvious when international scientists work together on documents with global scope, e.g., in the World Health Organization (WHO) International Program on Chemical Safety. In this article, we present a study that describes the extent of such variability and analyze the reasons that lead to different outcomes in deriving a "safe level" (termed the predicted no effect concentration [PNEC] throughout this article). For this purpose, we chose 5 chemicals to represent well-known substances for which sufficient high-quality aquatic effects data were available: ethylene glycol, trichloroethylene, nonylphenol, hexachlorobenzene, and copper (Cu). From these data, 2 data sets for each chemical were compiled: the full data set, that contained all information from selected peer-review sources, and the base data set, a subsample of the full set simulating limited data. Scientists from the European Union (EU), United States, Canada, Japan, and Australia independently carried out hazard assessments for each of these chemicals using the same data sets. Their reasoning for key study selection, use of assessment factors, or use of probabilistic methods was comprehensively documented. The observed variation in the PNECs for all chemicals was up to 3 orders of magnitude, and this was not simply due to obvious factors such as the size of the data set or the methodology used. Rather, this was due to individual decisions of the assessors within the scope of the methodology used, especially key study selection, acute versus chronic definitions, and size of assessment factors. Awareness of these factors, together with transparency of the decision-making process, would be necessary to minimize confusion and uncertainty related to different hazard assessment outcomes, particularly in international documents. The development of a "guideline on transparency in decision-making" ensuring the decision-making process is science-based, understandable, and transparent, may therefore be a promising way forward.
authors.affiliation: Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Hahn
authors.forename: Jerry
authors.initials: J
authors.lastname: Diamond
authors.forename: Stuart
authors.initials: S
authors.lastname: Dobson
authors.forename: Paul
authors.initials: P
authors.lastname: Howe
authors.forename: Janet
authors.initials: J
authors.lastname: Kielhorn
authors.forename: Gustav
authors.initials: G
authors.lastname: Koennecker
authors.forename: Chris
authors.initials: C
authors.lastname: Lee-Steere
authors.forename: Inge
authors.initials: I
authors.lastname: Mangelsdorf
authors.forename: Uwe
authors.initials: U
authors.lastname: Schneider
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Sugaya
authors.forename: Ken
authors.initials: K
authors.lastname: Taylor
authors.forename: Rick Van
authors.initials: RV
authors.lastname: Dam
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Stauber
mesh_terms: D000818:Animals; D001315:Australia; D002170:Canada; D016208:Databases, Factual; D005062:European Union; D005104:Expert Testimony; D015386:Hazardous Substances / Q000032:analysis*; D007564:Japan; D019055:No-Observed-Adverse-Effect Level; D010636:Phenols / Q000633:toxicity; D011336:Probability; D018570:Risk Assessment / Q000379:methods*; D023382:Toxicity Tests, Acute; D036401:Toxicity Tests, Chronic; D014481:United States; D014874:Water Pollutants, Chemical / Q000032:analysis* / Q000633:toxicity*
chemical_list: D015386:Hazardous Substances; D010636:Phenols; D014874:Water Pollutants, Chemical; C025256:nonylphenol
keywords: Chemicals; Hazard assessment; PNEC; Risk; Variability