By Madeline Roty
The symposium “International Collaboration without Complications and Confusion” at the ASM Biothreats Conference emphasized the complexity of promoting and protecting biological research and innovation in today’s society. The four speakers featured on the panel discussed what exists now and what still needs to be done to strike a balance between promoting and protecting biotechnology, with attention given specifically to export controls, synthetic biology, the select agent program, and biosecurity.
Kimberly Orr, from the Bureau of Industry and Security in the Department of Commerce opened the symposium with a discussion on “Deemed Exports: Sharing Technology or Material with Foreign Collaborators.” When it comes to biotechnology, how do you know if the Department of Commerce needs to be involved? The 2018 Export Control Reform Act (ECRA), codified by the Export Administration Regulations (EAR) establishes regulations on the export, reexport, or transfer of emerging and foundational technologies, including to foreign nationals located in the United States. Orr defined terms and briefly discussed the provisions of the ECRA. The key takeaway from all of this information was that laboratories and companies need to know the classification and licensing requirements, be aware of their personnel, and establish an export control program. In today’s world of interconnectedness, export control systems are essential for national and global security.
The next panelist, Diane DiEullis from the National Defense University, explored “Synthetic Biology: Industry/Government.” DiEullis has conducted research regarding industry practices in synthetic biology in order to identify opportunities for biosecurity. When it comes to biotechnology, there is always the risk for accidental or intentional misuse, but controlling the bioeconomy, comprised of consumer products, pharma, fuel, agriculture, food, material, and digital sectors, is complicated. It is even appropriate to ask if we should be controlling things that have every day purposes in laboratories. The issue does not just concern the United States because industry is becoming increasingly international.
Clearly the bioeconomy is complex and has yet to be fully defined and measured, but it still needs to be promoted and protected. As technology rapidly advances, political and scientific communities are increasing discussion about this issue. There was a Bioeconomy Summit at the White House in 2019, and January was declared National Biotechnology Month. The emergence of the new coronavirus has contributed to the conversation by demonstrating the need to engage all of the sectors of the bioeconomy not just public health.
Sam Edwin, the director of the Center for Disease Control and Prevention (CDC) Division of Select Agents and Toxins, followed DiEullis’ discussion with “Overview of the U.S. Federal Select Agent Program.” The Select Agents and Toxins Program is managed jointly by the CDC, Health and Human Services, the Agriculture Select Agent Services, the Animal and Plant Health Inspection Service, and the United States Department of Agriculture. The three domains under the program are plants and plant products, animals and animal products, and public health. Public health is the CDC’s domain. The program regulates and provides access to select agents, receives reports of loss and theft, enforces compliance with the regulations, and makes reports to Congress. Edwin then briefly discussed how the regulations are enforced. Security risk assessments, conduct with the Criminal Justice Information System (CJIS) of the Federal Bureau of Investigation (FBI), are required for individuals who want access to select agents. In summary, the program is essential for safe-guarding national and health security. Since the program began in 2003, there have been no thefts, deaths, or public health incidents related to select agents.
Edward You, from the FBI Weapons of Mass Destruction Directorate, concluded the symposium with his thoughts on “Biosecurity: Safeguarding Science: Dual-Use, Cybersecurity, and Insider Threat (Including Foreign Threat).” You emphasized the need for cooperative threat reduction – the FBI collaborates with public health. It also engages foreign partners in training and education. You was passionate about finding ways to safeguard biosecurity in future generations. The FBI sponsors a program called the International Genetically Engineered Machine (IGEM), which teaches students that “with great power comes great responsibility.” For example, students who developed a genetically modified bacteria that could eat garbage acknowledged the dual-use capabilities of their technology. The students then modified their innovation to reduce the risk associated with it. Education about responsible research needs to be integrated into curriculum and shared internationally. Export controls and select agent lists are important, but “Biosecurity transcends regulations.” There must be a culture of accountability and awareness.
The main takeaway from the panel was that there are many efforts to ensure security without restricting science. But without collaboration and cooperation between national and international partners and engagement with the future scientific community, no balance may ever be found.