Question 1

How will the specific requirements for post-release monitoring be determined?

Stephanie James · Accepted Answer

National regulators will determine monitoring requirements as part of the approval process for release of gene drive-modified mosquitoes, according to relevant laws, implementing regulations, and policies. In general, potential harms associated with the proposed activities will be characterized during case-specific pre-release risk assessment. Pertinent information, such as prior experience with gene drive-modified and other related genetically modified mosquitoes as well as knowledge of the biology and behavior or the mosquito species, of the modified trait(s), and of the receiving environment (geography, weather, land use, built environment, etc.) will be considered in the risk characterization. Regulatory authorities will provide a recommendation of acceptable risks and those that need to be managed or mitigated, as well as any strategies to provide such management or mitigation. These recommendations will form the basis for the terms of reference for use of an approved gene drive-modified mosquito product. Once approved and released, it will be necessary to monitor the effectiveness and sufficiency of the risk management measures. Thus, requirements of post-approval monitoring are expected to focus largely on those issues where there is ongoing uncertainty about safety and efficacy that was not resolved during risk assessment. Monitoring endpoints, frequency, and duration can be altered based on post-approval data resolving the remaining uncertainty.

Question 2

How will the specific requirements for post-release monitoring be determined?

Stephanie James · Accepted Answer

National regulators will determine monitoring requirements as part of the approval process for release of gene drive-modified mosquitoes, according to relevant laws, implementing regulations, and policies. In general, potential harms associated with the proposed activities will be characterized during case-specific pre-release risk assessment. Pertinent information, such as prior experience with gene drive-modified and other related genetically modified mosquitoes as well as knowledge of the biology and behavior or the mosquito species, of the modified trait(s), and of the receiving environment (geography, weather, land use, built environment, etc.) will be considered in the risk characterization. Regulatory authorities will provide a recommendation of acceptable risks and those that need to be managed or mitigated, as well as any strategies to provide such management or mitigation. These recommendations will form the basis for the terms of reference for use of an approved gene drive-modified mosquito product. Once approved and released, it will be necessary to monitor the effectiveness and sufficiency of the risk management measures. Thus, requirements of post-approval monitoring are expected to focus largely on those issues where there is ongoing uncertainty about safety and efficacy that was not resolved during risk assessment. Monitoring endpoints, frequency, and duration can be altered based on post-approval data resolving the remaining uncertainty.

Question 3

How will the specific requirements for post-release monitoring be determined?

Stephanie James · Accepted Answer

National regulators will determine monitoring requirements as part of the approval process for release of gene drive-modified mosquitoes, according to relevant laws, implementing regulations, and policies. In general, potential harms associated with the proposed activities will be characterized during case-specific pre-release risk assessment. Pertinent information, such as prior experience with gene drive-modified and other related genetically modified mosquitoes as well as knowledge of the biology and behavior or the mosquito species, of the modified trait(s), and of the receiving environment (geography, weather, land use, built environment, etc.) will be considered in the risk characterization. Regulatory authorities will provide a recommendation of acceptable risks and those that need to be managed or mitigated, as well as any strategies to provide such management or mitigation. These recommendations will form the basis for the terms of reference for use of an approved gene drive-modified mosquito product. Once approved and released, it will be necessary to monitor the effectiveness and sufficiency of the risk management measures. Thus, requirements of post-approval monitoring are expected to focus largely on those issues where there is ongoing uncertainty about safety and efficacy that was not resolved during risk assessment. Monitoring endpoints, frequency, and duration can be altered based on post-approval data resolving the remaining uncertainty.