Editing Nature: Reconceptualizing Biotechnology Governance

Abstract

CRISPR-Cas9 (CRISPR) and other advances in gene editing techniques are fostering a rapid evolution within the field of biotechnology. Scientists can now modify the DNA of living organisms with precision by removing undesirable traits or inserting desirable traits. The edits may impact a single organism or result in genetic alterations that are designed to pass on to offspring (referred to as “gene drives”), potentially altering or eradicating an entire species. Prior to the discovery of the CRISPR gene editing process, the state of the technology presented barriers to widespread and precise genetic engineering. CRISPR changes the equation. With fewer technological limits and the technical and economic accessibility of new gene editing techniques, society now must grapple with fundamental questions regarding the proper use of technologies that can reengineer organisms, species, and ecosystems. The existing approach to biotechnology governance is unprepared to address these new capabilities, in part because the technology has quickly surpassed the bounds once thought possible, and in part because the regulatory system is premised on a narrow set of considerations designed to foster advances in the field of biotechnology. This Article examines early regulatory oversight of advanced gene editing techniques and identifies important gaps in legal oversight of genetic engineering: a failure of existing laws to cover some CRISPR-edited organisms; narrow consideration of ecological impacts; regulators’ inability to consider alternatives; and a failure to assess and respond to competing ideologies. This Article then argues for addressing those gaps by incorporating a natural resource management perspective into biotechnology governance. The article concludes by arguing that biotechnology governance should incorporate a natural resource management perspective. The scientific advances are new, but the challenges with balancing competing considerations regarding the use and alteration of natural resources are not. Although existing natural resource laws do not contemplate the ability to reorder ecosystems via gene editing, there is an established regulatory system designed to address risks of extinction, accommodate competing ideologies regarding resource use, and incorporate interests of future generations when considering irreversible decisions regarding natural resources—issues that are all implicated by gene editing.