Gene Drive-Modified Organisms: Developing Practical Risk Assessment Guidance

Potential use of gene drive modified insects against disease vectors, agricultural pests and invasive species poses new challenges for risk assessment

“…Once in place, regular review must be continued to establish overall guidance utility and applicability, and assess where any refinements are necessary. This may ensure that guidance is realistic and proportionate, and remains consistent with the weight of scientific evidence and familiarity that will be gained with future GDMI releases [95].…”

“…Some international/ regional entities have suggested that the risk assessment of GDMIs can build on existing risk assessment frameworks for GMIs that do not contain engineered GDs, and be informed by the experience gained releasing insects for genetic and biological disease vector/ pest control. Moreover, the problem formulation approach has been acknowledged to provide a compelling framework to organize existing knowledge and identify relevant new knowledge and uncertainties on engineered GDs to support case-specific risk assessments and decision-making [15,95,98]. It is also recognized that there are specific areas where further guidance may be needed for the risk assessment of GDMIs [15,86].…”

“…Developers and potential applicants need useful and practical guidance to ensure that GD products meet the regulatory standards of safety for human and animal health and the environment, and receive public acceptance. The development of new or additional guidance for the risk assessment of GDMO releases is a challenge, especially at an international level [95]. Due to different, often contrasting, opinions toward GDMOs, and on the adequacy of current risk assessment frameworks for such organisms [91,96], defining the scope of guidance and topics to prioritize may be contentious, and so may be the procedure to develop such guidance (i.e.…”

“…For guidance to be proportionate, practical and current, we recommend tailoring it to the most likely cases moving to practical applications for release (i.e. disease-transmitting mosquitoes whose control is a long-standing public health goal), requiring prioritization of its scope and regular updates as application priorities change [95]. We also consider that guidance should differentiate between diverse GD systems and refrain from taking single cases to make broader, more general statements that may not be applicable for all GDMOs [95].…”

“…disease-transmitting mosquitoes whose control is a long-standing public health goal), requiring prioritization of its scope and regular updates as application priorities change [95]. We also consider that guidance should differentiate between diverse GD systems and refrain from taking single cases to make broader, more general statements that may not be applicable for all GDMOs [95]. Ideally, guidance should offer an overarching framework that is flexible and outlines general principles and methodology for risk assessment instead of being overly prescriptive [95].…”