Molecular profiling — a tool for addressing emerging gaps in the comparative risk assessment of GMOs

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. ► Molecular profiling is based on well-established and reliable ‘omics’ techniques. ► Profiling can help to screen out potentially hazardous products early in development. ► Emerging types of GMOs and new uses of GMOs require more tools for adequate pre-market risk assessment. ►Advice on applying profiling has been vague or lacking in guidance documents. ► We provide a framework for how to apply profiling on a case-by-case basis.