New Evaluation Tool for GM Biocontrol Products Proposed

Seasoned regulatory experts from around the world have come up with a protocol that developers of genetically modified (GM) biocontrol products will find useful in understanding the required safety data and information when generating a regulatory dossier to be used for the evaluation and decision making. Regulators will also likely benefit from the tool as it will help support their systematic and rigorous evaluation towards the product.

GM biocontrol products are novel in nature and involve the release of GM organisms into the environment, sometimes intentional, to prevent the transmission of vector-borne parasitic and viral diseases and the spread of invasive plant and animal species. These interventions are often not completely covered by existing biosafety regulations and this poses new challenges and opportunities for regulatory overview and decision-making. Thus, a group of experts have come up with the tool for technology developers to organize and plan their information gathering on a case-by-case basis when developing a regulatory dossier in order to gain approval to conduct laboratory research, confined field testing, and controlled release of the GM control products into the environment. The recommendations resulting from the new protocol may also be informative for other types of genetic biocontrol products.

The new tool takes into account that information on the receiving environment and intended use of the GM biocontrol product will be significantly different in each situation. Hence, the plans for risk assessment and risk management are expected to also be different for each situation as it will be dependent on the potential spread of the product. It also considers that containment may encompass physical confinement in indoor and outdoor facilities, and environmental release may be conducted in phases starting with isolated small-scale testing that will work into a larger scale testing in different conditions with a separate biosafety approval to be obtained for each of the different phases of release.

Read the full paper in Transgenic Research for the complete details.