Toxicology Excellence for Risk Assessment (TERA)

2300 Montana Avenue, Suite 409, Cincinnati OH 45211
Phone: 513-542-7475
Fax: 513-542-7487

Email: TERA@TERA.org

TERA Research 


TERA scientists bring together a practitioner’s knowledge of the issues and pitfalls involved in the day-to-day application of methods for developing risk values, along with expertise in cutting-edge risk assessment methods.  Our staff has led efforts in the development of the reference dose (RfD), categorical regression, and use of mechanistic data in risk assessment.  We continue to research and publish in these areas, as well as on other methods for improving the practice of risk assessment.  TERA can provide training for others in many of these areas.

TERA conducts risk-assessment related research and applications in the following areas:

Use of Dose-Response Data for in vivo Mutagenicity to Inform Cancer Risk Assessment  Toxicology Excellence for Risk Assessment (www.tera.org ), NCTR (http://www.fda.gov/nctr/index.html), and Environ (http://www.environcorp.com/) have established a collaborative relationship to enhance the use of mutagenicity data for informing the mode of action analysis for cancer risk assessment, by investigating a new approach to quantitatively compare mutation data with tumor data.  The essence of the approach involves comparing the in vivo mutagenicity dose-response (using the Big Blue® rat, mouse, or other transgenic in vivo shuttle vector model) in the tumor target tissue with the tumor dose response in the same rodent strain.  More information

For further information, contact:

Lynne Haber                            Annette Shipp                           Martha Moore
Haber@tera.org                       AShipp@environcorp.com       martha.moore@fda.hhs.gov
513-542-7475 x17                  318-255-2277                         870-543-7050
TERA                                       ENVIRON                              NCTR

Quantitative Risk Assessment  TERA staff have extensive experience with the use of tools for quantitative risk analysis and in evaluating issues and refinements related to their application.  These tools can be used to improve risk estimates and conduct statistical analyses of experimental data.  TERA’s expertise includes biological systems modeling using physiologically-based pharmacokinetic (PBPK) and biologically-based dose response (BBDR) modeling, Bayesian uncertainty analysis (including Markov chain Monte Carlo – MCMC) methods, and advanced statistical methods.

Use of Mode of Action Data in Risk Assessment  Today’s risk assessors face many challenges in using state-of-the-science data and methods:

  • How much data is enough to meet EPA’s criteria for identifying a mode of action?  What studies are needed to address EPA’s framework?
  • How can data be used to move away from default approaches, and what are the implications for risk assessment?

  •  What is the impact of genetic polymorphisms on total human variability?

TERA scientists have frequently addressed these questions, along with determining the human relevance of tumors and whether to use linear or nonlinear low-dose extrapolation for cancer assessment.

Dose Response Modeling  TERA scientists are adept at dose-response methods, and can provide hands-on instruction in use of modeling software and applications to risk assessment for:  

  • Benchmark dose modeling – How does one interpret the data?  What are the current issues to be aware of?  How does one apply the results in risk assessment?

  • Categorical regression modeling – What is it and how can it be used? 

Children’s Risk  Children’s risk is attracting increasing interest on the national and international level.

  •  How should risk assessors consider risk to children in developing risk values and   considering environmental and consumer product exposure?

  • Are children more sensitive than adults?  Under what conditions?

Risk Characterization and New Risk Issues  Chemical exposures are rarely uniform for an entire lifetime, and exposure to multiple chemicals in varying quantities is common.  

  • How should risk assessors consider exposures to mixtures, including cumulative risk (risk from multiple stressors in aggregate)?

  • How should risk from short-term exposures be considered, given that sensitivity varies with age?

  • How should one evaluate risk in the occupational setting, given the difference in exposure scenarios, and difference between the exposed population and general populations?  

Exposure Assessment  Guidelines exist for many aspects of exposure assessment, but many issues remain:

  • How does one evaluate dermal exposure?

  • What exposure factors should one use for consumer product exposures?  For exposure in environmental media?

  • How can one extrapolate from available data to estimate exposure from incomplete data?

For more information, please contact Dr. Lynne Haber at 513-542-7475, x17 or email Haber@tera.org.

Projects

 

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Last updated:  01/03/2007

 

© 2008 Toxicology Excellence for Risk Assessment