title: Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Document: are they sufficiently protective for insecticides?
abstract: BACKGROUND
  The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides. The tier-1 and tier-2 RACs were compared with RACs based on threshold concentrations from micro/mesocosm studies (ETO-RAC). A lower-tier RAC was considered as sufficiently protective, if less than the corresponding ETO-RAC.
  
  
  RESULTS
  ETO-RACs were calculated for repeated (n = 13) and/or single pulsed applications (n = 17) of 26 insecticides to micro/mesocosms, giving a maximum of 30 insecticide × application combinations (i.e. cases) for comparison. Acute tier-1 RACs (for 24 insecticides) were lower than the corresponding ETO-RACs in 27 out of 29 cases, while tier-2 Geom-RACs (for 23 insecticides) were lower in 24 out of 26 cases. The tier-2 SSD-RAC (for 21 insecticides) using HC5 /3 was lower than the ETO-RAC in 23 out of 27 cases, whereas the tier-2 SSD-RAC using HC5 /6 was protective in 25 out of 27 cases.
  
  
  CONCLUSIONS
  The tier-1 and tier-2 approaches proposed by EFSA for acute effect assessment are sufficiently protective for the majority of insecticides evaluated. Further evaluation may be needed for insecticides with more novel chemistries (neonicotinoids, biopesticides) and compounds that show delayed effects (insect growth regulators).
authors.affiliation: Alterra, Ecological Risk Assessment, Wageningen UR, Wageningen, The Netherlands.
authors.forename: René P A
authors.initials: RP
authors.lastname: van Wijngaarden
authors.affiliation: Department of Animal and Plant Sciences, University of Sheffield, Sheffield, UK.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Maltby
authors.affiliation: Alterra, Ecological Risk Assessment, Wageningen UR, Wageningen, The Netherlands.
authors.forename: Theo C M
authors.initials: TC
authors.lastname: Brock
mesh_terms: D000818:Animals; D059001:Aquatic Organisms / Q000187:drug effects*; D007306:Insecticides / Q000633:toxicity*; D007448:Invertebrates / Q000187:drug effects*; D023382:Toxicity Tests, Acute / Q000379:methods*; D014874:Water Pollutants, Chemical / Q000633:toxicity*
chemical_list: D007306:Insecticides; D014874:Water Pollutants, Chemical
keywords: aquatic invertebrates; effect assessment; evaluation; insecticides; micro/mesocosms; tiered approach