The Use of “Omics” in Human Health Risk Assessment
Goal
To convene an expert working group to address issues relative to the regulatory acceptance and use of “omics” in human health risk assessments.
Project Rationale
The emerging “omic” technologies of genomics, proteomics and metabolomics provide an unprecedented amount of information about the functioning of living organisms, allowing researchers to sequence and measure tens of thousands of genes, messenger RNAs, and proteins and to assess metabolic function.
Approach
An expert working group will assess the kinds of data that are (or likely will be) available from toxicogenomics and their importance to human health risk assessments, assess the criteria for use of the data, and address issues related to information exchange and communication between researchers and the risk assessment and regulatory community. The Expert Working Group may also address the use of “omic” data in evaluation of the “weight-of-evidence” approach and with regard to risk management decision making.
Status
ILSI Research Foundation staff is exploring the specific issues relative to the use of “omics” in human health risk assessment to select topics that the expert working group will address. Staff has also begun to identify potential working group members. It is expected that the expert working group will meet in late 2006.
This project is supported financially by Health Canada, Existing Substances Division.
Introduction to the Use of “Omics” in Human Health Risk Assessment
Goal
To educate risk assessors, risk assessment reviewers, science policy or regulatory affairs professionals, as well as laboratory scientists that design studies and/or generate “omics” data on the use of “Omics” in human health risk assessment.
Project Rationale
The emerging “omic” technologies of genomics, proteomics and metabolomics provide an unprecedented amount of information about the functioning of living organisms, allowing researchers to sequence and measure tens of thousands of genes, messenger RNAs, and proteins and to assess metabolic function.
Approach
This one-day course introduced participants to the techniques that generate “omic” data and described the types of information resulting from “omic” investigations. Issues in statistical analysis and experimental design for “omic” evaluations were presented in relation to risk assessment. Also, the promise of this technology, as well as potential pitfalls, was illustrated through case examples that integrate “omic” data with mechanistic and mode-of-action data in risk assessment.
Status
This course was presented to 120 scientists by Elaine M. Faustman, Ph.D., William Griffith, Ph.D., and Xiaozhong Yu, MD, Ph.D, from the University of Washington, Seattle in May and June 2005.
This project was supported financially through a cooperative agreement with the US Environmental Protection Agency, Office of Pollution Prevention and Toxics.