Use of multiple lines of evidence to provide a realistic toxic substances control act ecological risk evaluation based on monitoring data: D4 case study.

D4 (octamethylcyclotetrasiloxane) is a high-production-volume cyclic volatile methyl siloxane with a wide range of industrial and consumer applications. This study conducted a robust ecological risk evaluation for D4 using exposure data collected under a nation-wide environmental monitoring program facilitated under the Toxic Substances Control Act (TSCA). This ecological risk evaluation was conducted consistent with the principles outlined in the U.S. Environmental Protection Agency's (EPA's) Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations under TSCA (U.S. EPA 2017a). The evaluation examined multiple lines of evidence (LoEs) to determine the potential risks from D4 to aquatic receptors in rivers and streams in the United States from municipal wastewater treatment plant (WWTP) discharges and discharges from manufacturing, processing, and/or formulating (MPF) facilities after onsite wastewater treatment. The LoEs consisted of comparing D4 concentrations measured in water and sediment to toxicity thresholds derived from laboratory studies; comparing D4 concentrations measured in biota tissue to critical target lipid body burdens (CTLBBs); comparing fugacity-based chemical activities between toxicity thresholds and measured environmental concentrations; and assessing benthic macroinvertebrate community structure and habitat suitability. The approach taken moves beyond a standard deterministic hazard quotient approach to incorporate more advanced methods for risk prediction, using distributions rather than conservative point estimates of exposure to obtain a realistic view of the probability of harm, consistent with EPA's stated intent to "strive to utilize probabilistic approaches for exposure assessments included in a risk evaluation" (U.S. EPA 2017b). The risk evaluation concluded there is negligible risk to water column and sediment receptors from D4 discharged from MPF facilities after onsite wastewater treatment or from municipal WWTPs that may treat a mix of industrial and consumer wastewater.

Variability in Nontarget Terrestrial Plant Studies Should Inform Endpoint Selection.

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).