Scientific & Technical Support: Environmental Risk Assessment
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 staff conducts, monitors and interprets
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 Canadian
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.
Dose-Response
Assessment
TSG's scientists have outstanding experience in determining dose-response
relationships from animal studies and in extrapolating such data to humans.
Our staff determines NOEL and Benchmark Dose-based reference doses and uses
a number of models to develop cancer potency factors from oncogenicity data.
In conducting dose-response assessment, TSG employs scientifically rigorous
approaches and state-of-the-art methodologies, including:
▲Incorporating mechanistic information
▲Pharmacokinetic modeling
▲Meta
analysis
Exposure
Assessment
TSG’s consultants provide multimedia exposure assessment to
pesticides and
other chemicals and utilizes the most advanced software, databases and
methodologies available. The range of programs offered allows selection of
the model best suited to the client's needs. This helps increase the
accuracy while decreasing the uncertainty in the exposure assessment
process.
Risk
Characterization
TSG’s scientists have extensive experience in all facets of human risk
characterization. Our staff has conducted numerous risk assessments for
federal and state requirements, and continuously seeks to develop and use
new techniques that improve the level of confidence in the risk assessment
by defining and quantifying uncertainty. These techniques include
application of route-specific pharmacokinetics, less-than-lifetime exposure
and risk estimations, and distributional-based approaches for exposure/risk
analysis.
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| Key Contacts | |
 Saadia Eltayeb |
 Beth Mileson |
 Greg Gorder |
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TSG’s consultants are highly knowledgeable of the registration requirements for disinfectants regulated by both PMRA and TPD. TSG provides comprehensive product registration services, from determining data obligations and developing compliant labels, to compiling and submitting the registration application.
The goals of EPA's TSCA IUR program are to collect quality screening-level, exposure-related information on chemical substances in commerce in the United States and to make that information available for use by EPA and the public. The IUR data are used to support risk screening, assessment, priority setting and management activities at EPA and constitute the most comprehensive source of basic information on chemicals in commerce available to EPA.
TSG has offices throughout North America and Europe, including Sacramento, CA, Washington, DC, Canada, United Kingdom, Spain and Slovenia. Through these locations and our affiliates, TSG works with companies in 36 countries worldwide including China, Japan, Australia, New Zealand and Latin America.
REACH (Registration, Evaluation, Authorization and restriction of Chemicals) is an EU Regulation that came into effect on June 1st, 2007, imposing strict guidelines on the manufacture or import of chemicals, preparations and articles in or to the EU.
Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, was approved by voters to address the growing concerns about exposure to toxic chemicals. Proposition 65 requires California to publish a list of chemicals, updated at least once a year, known to cause cancer, birth defects or other reproductive harm. Proposition 65 also requires California businesses to post notification about significant amounts of chemicals in the products they sell, in their homes or workplaces, or that are released into the environment.