12 - Finding a Regulatory Balance for Genetic Biohacking

Summary

The rise and ease of genome-editing technologies, like CRISPR, has ushered in communities of “biohackers,” do-it-yourself enthusiasts for molecular genetics who perform experiments outside traditional institutional laboratory settings. Conventional wisdom posits that such research is beyond traditional modes of regulation or legal enforcement and that new biohacking laws are needed. This view, however, is incorrect; both public and private regulators currently possess–and in other contexts, use–many of the tools needed to regulate the safety and ethics of biohacking. The U.S. Food and Drug Administration, for example, has expansive authority over “biologics,” which includes many of the biohacking kits currently in use. Patent holders and community laboratories similarly have the power to impose ethical and safety restrictions on biohacking activities. Rather than new laws or stiffer enforcement, regulators should do what they do for other industries: actively engage with the community to educate and promote the advancement of technology.