Environmental Risk Assessment (ERA)

The industry faces increased requirements for environmental testing to support chemical registrations, determine clean-up levels and define acceptable chemical concentrations in the environment.  Risk assessment is critical to incorporating complex information into the regulatory process, and for conducting risk/benefit analyses.

Environmental Risk Assessment (ERA) integrates
ecotoxicological, environmental fate and physicochemical characteristics with existing or expected use-patterns to assess potential adverse impact on non-human, environmental end-points, such as wildlife and the surrounding environment. ERA is an evolving scientific discipline increasingly used by regulators. TSG is committed to the application of state-of-the-art ERA procedures across a range of regulatory arenas.

Four basic Environmental Risk Assessment components have been identified:

Problem formulation
Problem formulation involves the preliminary characterization of exposures and effects and evaluates the adequacy of available data. Relevant policy and regulatory issues are also defined. TSG's staff gathers data necessary for defining the issues and questions important to the regulatory agencies, while maintaining a balance to meet industry objectives and obligations.

Exposure characterization
Exposure characterization includes an assessment of the magnitude, duration and frequency of ecological exposures to potentially damaging chemicals, based mainly on use rates, disposal patterns, and the environmental fate characteristics of the compound(s). TSG’s ecotoxicologists and environmental chemists are familiar with types, sources and interpretation of data used to assess exposure. Environmental fate models are employed to predict environmental residues and identify key chemical characteristics or fate processes for further analysis.

Environmental effects characterization
Environmental effects characterization constitutes an in-depth evaluation of the total spectrum and effects of a chemical based on available laboratory and field data. This 
data includes environmental monitoring studies, model ecosystems, terrestrial field studies, sediment bioassays, and site-specific environmental assessments. TSG’s consultants conduct, monitor and interpret ecotoxicology studies, including those conducted on aquatic and terrestrial organisms.

Risk characterization
Risk characterization integrates exposure, fate and potential impact estimates to describe and quantify adverse ecological effects. An ERA ideally provides quantitative risk estimate and an accompanying estimate of uncertainty. Due to their complexity, however, ERAs often are strictly qualitative. Because this field is evolving, there are many opportunities for innovation in evaluation and interpretation.

TSG’s interdisciplinary team of toxicologists, environmental fate chemists and regulatory experts address the concerns and policies of regulatory agencies. Our staff provides expertise in
designing, monitoring and interpreting compound-, issue- and site-specific studies under laboratory and field settings. This enables TSG’s consultant to propose scientifically sound solutions to complex regulatory problems that meet agency requirements while supporting client business objectives.