Scientific & Technical Support: Environmental Risk Assessment (ERA)
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.
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