Track 4 Session Details

Engineered Microbes for Environmental Release (EMERs) are an emerging biotechnology sector that is poised to play a significant role in the global bioeconomy through their ability to address challenges related to climate change, environmental remediation and diagnostics, self-regenerating structural infrastructure, and more. In this panel session, we will bring together experts from academia, government, and industry who participated in a workshop sponsored by the Linde Center for Science, Society, and Policy (LCSSP) at Caltech in February 2024. The panel will discuss emerging applications of EMERs, the status of our current scientific understanding on EMERS, and regulatory challenges in deploying EMERs, which do not fit always neatly within existing frameworks, causing potential jurisdictional overlaps and/or regulatory gaps that can increase complexity and costs. Finally, we will highlight some of the recent and upcoming activities that government and industry are taking to help address these challenges.

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David Glass, President, Glass Associates, Prospects for relaxed government regulation of environmental and contained use of genome-edited microorganisms

The advent of new, powerful genome-editing technologies such as CRISPR, while enabling the creation of new microorganisms for a multitude of agricultural, environmental and industrial purposes, has posed challenges to biotechnology regulatory regimes around the world. Although gene-edited plants and microorganisms might generally fall under definitions of “genetically modified organism” in many countries, this flies in the face of broad recognition within the industry that genome-editing allows for quicker, more predictable and efficient means of accomplishing genetic changes that could otherwise have arisen by spontaneous mutation, classical selection or plant breeding. So far, discussions around the world have largely focused on how genome-edited plants are regulated, and this has led to considerable progress in recent years in numerous countries towards deregulation or down-regulation of genome-edited plants, due to their equivalent to traditionally-bred plants.

To date, these discussions have largely not been extended to apply to microorganisms modified by genome-editing either for environmental or contained uses, but that is beginning to change. Certain genome-edited microorganisms are exempt from U.S. EPA biotechnology regulations; the biotechnology regulations in Australia also exempt certain gene-editing techniques; and there has been recent movement, albeit slowly, towards consideration of the status of genome-edited microorganisms in Europe, New Zealand and elsewhere. This presentation will discuss the regulatory status of microorganisms modified by genome editing in jurisdictions around the world, and will consider the prospects for more widespread international eligibility of regulatory exemptions for such microorganisms.