Access and benefit‐sharing DNA Componentry for plant synthetic biology: Bioparts expressed in plant chassis

Societal Impact Statement The “Parts Agenda” is an approach to synthetic biology that fragments genetic resources into functional bioparts to help design and build biological devices and systems. Access and benefit‐sharing (ABS), and the issue of how to regulate digital sequence information (DSI) within the current ABS regime, poses a problem for synthetic biology because it assumes fragmented and abstracted bioparts can be traced to their country of origin for the purposes of benefit‐sharing, and that contributions to information and knowledge can be quantified and appropriately valued. Any DSI regulatory solutions should account for genetic resource fragmentation and other complexities of modern scientific practice. Summary The inclusion of digital sequence information (DSI, including genetic sequence data) in the existing access and benefit‐sharing (ABS) regime will alter the practice of synthetic biology. The potential impediments could be magnified for the “Parts Agenda”: the approach to synthetic biology that fragments genetic resources into their smallest functional units to create standardized, interchangeable “bioparts”, the building blocks for assembling synthetic biological devices. These biological devices are themselves interchangeable and can be used to engineer higher order synthetic biological systems. This article examines how the extension of ABS laws to include DSI could foreseeably apply to the creation and use of plant‐derived and other bioparts in engineered biological devices expressed in plant chassis. The article demonstrates that ABS issues will be similar for all approaches to synthetic biology, but that the Parts Agenda is uniquely exposed to the potential regulatory burden of bilateral ABS transactions between users and providers of genetic resources. The original vision for bioparts was one of openness and sharing, with access and use unencumbered by intellectual property. This article shows that open access to bioparts will not last long if DSI is enclosed within the current ABS regime, destabilizing the values of openness and sharing in synthetic biology that are ostensibly foundational to this still developing field.