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Variability in Nontarget Terrestrial Plant Studies Should Inform Endpoint Selection.

Authors
  • Staveley, Jane P1
  • Green, John W2
  • Nusz, Josie1
  • Edwards, Dan3
  • Henry, Kevin4
  • Kern, Matt5
  • Deines, Andrew M1
  • Brain, Richard6
  • Glenn, Brad7
  • Ehresman, Nathan8, 9
  • Kung, Tiffany10
  • Ralston-Hooper, Kimberly11
  • Kee, Faith10
  • McMaster, Steve12
  • 1 Exponent, Chapel Hill, North Carolina, USA.
  • 2 DuPont, Wilmington, Delaware, USA.
  • 3 BASF, Research Triangle Park, North Carolina, USA.
  • 4 NovaSource/Tessenderlo Kerley, Phoenix, Arizona, USA.
  • 5 Waterborne Environmental, Leesburg, Virginia, USA.
  • 6 Syngenta, Greensboro, North Carolina, USA.
  • 7 Bayer CropScience, Research Triangle Park, NC, USA.
  • 8 Nufarm, Morrisville, North Carolina, USA.
  • 9 Metalaxyl Task Force, Morrisville, North Carolina, USA.
  • 10 FMC Corporation, Ewing, New Jersey, USA. , (Jersey)
  • 11 Dow AgroSciences, Indianapolis, Indiana, USA. , (India)
  • 12 Industry Task Force II on 2,4-D Research Data, Zionsville, Indiana, USA. , (India)
Type
Published Article
Journal
Integrated Environmental Assessment and Management
Publisher
Wiley (John Wiley & Sons)
Publication Date
Sep 01, 2018
Volume
14
Issue
5
Pages
639–648
Identifiers
DOI: 10.1002/ieam.4055
PMID: 29729081
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Inherent variability in nontarget terrestrial plant (NTTP) testing of pesticides creates challenges for using and interpreting these data for risk assessment. Standardized NTTP testing protocols were initially designed to calculate the application rate causing a 25% effect (ER25, used in the United States) or a 50% effect (ER50, used in Europe) for various measures based on the observed dose-response. More recently, the requirement to generate a no-observed-effect rate (NOER), or, in the absence of an NOER, the rate causing a 5% effect (ER05), has raised questions about the inherent variability in, and statistical detectability of, these tests. Statistically significant differences observed between test and control groups may be a product of this inherent variability and may not represent biological relevance. Attempting to derive an ER05 and the associated risk-assessment conclusions drawn from these values can overestimate risk. To address these concerns, we evaluated historical data from approximately 100 seedling emergence and vegetative vigor guideline studies on pesticides to assess the variability of control results across studies for each plant species, examined potential causes for the variation in control results, and defined the minimum percent effect that can be reliably detected. The results indicate that with current test design and implementation, the ER05 cannot be reliably estimated. Integr Environ Assess Manag 2018;14:639-648. © 2018 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC). © 2018 The Authors. Integrated Environmental Assessment and Management Published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

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