Abstract
Assessing the risks of genetically modified organisms (GMOs) is required by both international agreement
and domestic legislation. Many view the use of the “omics” tools for profiling classes of molecules as useful in
risk assessment, but no consensus has formed on the need or value of these techniques for assessing the risks
of all GMOs. In this and many other cases, experts support case-by-case use of molecular profiling techniques
for risk assessment.
We review the latest research on the applicability and usefulness of molecular profiling techniques for GMO
risk assessment. As more and more kinds of GMOs and traits are developed, broader use of molecular profiling
in a risk assessment may be required to supplement the comparative approach to risk assessment. The
literature-based discussions on the use of profiling appear to have settled on two findings: 1. profiling
techniques are reliable and relevant, at least no less so than other techniques used in risk assessment; and 2.
although not required routinely, regulators should be aware of when they are needed. The dismissal of routine
molecular profiling may be confusing to regulators who then lack guidance on when molecular profiling
might be worthwhile. Molecular profiling is an important way to increase confidence in risk assessments if the
profiles are properly designed to address relevant risks and are applied at the correct stage of the assessment.