Regulation of Synthetically Engineered Organisms as Sources of Bio-Hacking and Bio-Terrorism

The emerging science of synthetic biology provides the ability to create and program synthetically engineered organisms (SEOs) using genetic building blocks. This technology allows researchers to create new organisms with potential benefits such as clean energy, smarter medicine, and increased food production. The applicant proposes to develop software models to validate SEOs safety. This research is expected to lay the foundational arguments for a regulatory framework for SEOs. "Note: This project contains a research and/or development component, as defined in applicable law," and complies with Part 200 Uniform Requirements - 2 CFR 200.210(a)(14). NCA/NCF

The emerging science of synthetic biology provides the ability to create and program synthetically engineered organisms (SEOs) using genetic building blocks. This technology allows researchers to create new organisms with potential benefits such as clean energy, smarter medicine, and increased food production. However, the technology is also becoming inexpensive and accessible to the layperson. This leads to worries that the science will be "deskilled" and anyone will be able to create their own SEOs in the future. A primary concern is that SEOs can be created by malicious actors such as bio-hackers or bio-terrorists, creating a "dual use" for the new technology. Currently there is a lack of research on validating and verifying that these organisms will work as expected, and on assuring that they will not exhibit malicious behavior. Furthermore, it is unclear what sort of federal regulatory framework should be in place concerning SEOs, and what activities should be allowed or prohibited by criminal statues. Without a scientific foundation, this void will remain. This dissertation proposes to conduct research that will provide the technicial foundations and evidence that can lead to an appropriate regulatory framework concerning the creation and use of SEOs. We propose to apply software engineering and molecular communication principles to SEOs in order to validate their safe and secure operation. We will leverage years of research on software testing and assurance techniques and nano-communication. We will customize them to work in this new discipline. This includes making SEOs resistant to malicious attacks, as well as developing methods to detect and stop SEOs created by malicious actors. The research will be organized as follows: 1) we plan to apply software testing techniques such as combinatorial internation testing, utilizing modles of nano-communcation, to understand the intricate interactions that might be exploited; 2) use that technical knowledge to build assurances cases for SEOs; and 3) develop foundational arguments for a new federal regulatory framework for SEOs. The products of this research will include new algorithms, software tools, data sets, and assurance cases for verifying and validating SEOs. The research will be presented at scientific conferences on software engineering, nano-communications and legal technology. Ideally this work will also lead to an internship with a relevant federal agency in order to collaborate more directly with government representatives.

"Note: This project contains a research and/or development component, as defined in applicable law," and complies with Part 200 Uniform Requirements - 2 CFR 200.210(a)(14). NCA/NCF