About the Study

Statement of Task

The National Academy of Sciences, Engineering, and Medicine will convene an ad hoc committee to:

  • Review the state of the science of gene drive research that relies on genome editing techniques, such as CRISPR/Cas9 and other endonucleases, or other genetic modification approaches. The focus should be on identifying the key scientific techniques for reducing ecological and other risks that should be considered prior to field releases of organisms carrying gene drives. This will require characterizing and assessing environmental and other hazards to target and non-target organisms, and will also include consideration of developing appropriate mitigation strategies, such as reversal drives
  • Using appropriate case studies that are based on likely applications of gene drive technologies to animals, plants, insect vectors, etc., examine the oversight mechanisms, including guidelines and regulations for:
    • Organisms containing gene drives in the laboratory or other contained, or semi-contained environments;
    • Organisms containing gene drives for use in field releases within the U.S.; and
    • Organisms containing gene drives for use in field releases in low and middle income countries.

This should include examination of the roles of institutional biosafety committees, national or local regulatory authorities, and international frameworks and instruments such as the Cartagena Protocol. An extensive review of international country specific regulations is not requested, except to the extent that such regulations are illustrative of the general context of oversight or exemplify unique approaches.

The committee will also:

  • Determine the adequacy of the existing oversight mechanisms and risk assessment guidance to identify the immediate and long term potential environmental and public health implications raised by individual applications of gene drive technology. This should include safeguarding against accidental or intended misuse spanning the full developmental spectrum from laboratory to release. This may also include identification of gaps that regulators may need to address, although the committee should not attempt to develop specific proposals for new regulations;
  • Discuss relevant legal, social or ethical considerations in selecting sites for field releases and engaging those living in or near potential release sites; and
  • Provide general principles that will guide responsible practices in gene drive research for the laboratory setting through to field releases for use by investigators, their institutions, the research funders, and regulators.