Scientific & Technical Support: Human Health Risk Assessment
Assessing the potential health risks associated with chemical exposure in air,
food and water to occupational, domestic or recreational environments is an
issue of critical importance to the registration, regulation and safe use of
commercial chemical products. A thorough understanding of potential health risks
is also important in liability determination and in toxic tort litigation.
TSG's team of board-certified
toxicologists is highly skilled in hazard
identification, dose-response determination, exposure assessment and risk
characterization, and fully conversant with applicable regulatory guidelines
and procedures. Our toxicologists specialize in unique, custom-designed
assessments employing alternative methodologies most suited to the proper
resolution of specific problems.
Hazard
Identification
Complete, qualitative understanding of the major types of toxic effects
associated with exposure to a given chemical typically requires the
identification, careful review, interpretation and evaluation of highly
specialized data. TSG’s staff has direct access to a variety of databases
which provide a quick and efficient means of searching peer-reviewed
scientific literature and identifying toxicity studies which will support an
effective regulatory strategy.
TSG's toxicologists have many years of
experience in the
evaluation and interpretation of data from
in vivo, in
vitro, and mechanistic studies, employing a total-weight-of-evidence
approach to develop an overall toxicological profile. While completely
adhering to the appropriate evaluation criteria, our consultants make full
use of newly emerging information from the scientific community to develop
advances in data evaluation and assessment methods.
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 | |
 Gary Burin |
 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.