Counter-Terrorism: Preventing Misuse of Pathogens and Toxins
Takeaway: For synbio founders, understanding and complying with regulations on select agents and DNA synthesis screening is a non-negotiable part of national security, requiring rigorous internal controls to prevent your powerful technology from being misused.
The immense power of synthetic biology—the ability to write DNA and program life—carries with it a profound and sobering responsibility. While your work is focused on creating life-saving medicines or sustainable materials, the same tools could, in the wrong hands, be used to create dangerous pathogens or toxins.
As a result, the synthetic biology industry is on the front lines of counter-terrorism efforts. Governments around the world have implemented strict regulations to control access to dangerous biological agents and to monitor the raw materials of genetic engineering. For a founder, compliance with these rules is not optional; it is a fundamental part of your license to operate.
The "Select Agents and Toxins" List
The cornerstone of U.S. bioterrorism regulation is the Federal Select Agent Program (FSAP), which is jointly managed by the Centers for Disease Control and Prevention (CDC) and the USDA's Animal and Plant Health Inspection Service (APHIS).
What it is: The FSAP maintains a list of biological agents and toxins that have the potential to pose a severe threat to public, animal, or plant health. This is known as the "Select Agents and Toxins" list.
The Requirement: Any entity—including a university lab or a private company—that possesses, uses, or transfers any agent or toxin on this list must be registered with the FSAP.
What it Entails: Registration is an onerous and expensive process. It requires a comprehensive security plan for the facility, personnel background checks and security clearances for all individuals with access to the agents, and rigorous record-keeping and safety protocols.
For most startups, the strategic implication is clear: avoid working with select agents unless it is absolutely core to your business model. The compliance burden is so significant that it is generally not feasible for an early-stage company. If your research plan could involve a select agent, you must be prepared to make a major investment in a robust security and compliance infrastructure.
Screening DNA Synthesis Orders: The Industry Standard
The raw material of synthetic biology is synthetic DNA. To prevent nefarious actors from simply ordering the DNA sequences for a dangerous virus like smallpox, the industry has developed a strong norm of self-regulation, guided by recommendations from the U.S. Department of Health and Human Services (HHS).
What it is: All major DNA synthesis providers voluntarily screen their orders. They have developed sophisticated bioinformatics pipelines that check every ordered DNA sequence against databases of select agents and other dangerous pathogens.
How it Works: If an order flags a "sequence of concern," the provider will not synthesize it. They will halt the order and, in many cases, notify federal law enforcement agencies like the FBI.
The Implication for You: While your company is likely not a DNA synthesis provider, you are a customer. You must ensure that your own internal processes for designing and ordering DNA are secure. This includes having strong cybersecurity to prevent your systems from being hijacked and having clear internal policies about what can and cannot be ordered.
The synthetic biology community has a shared responsibility to protect its powerful tools from misuse. By understanding your obligations under the Select Agent Program and supporting the industry standard of DNA synthesis screening, you are playing a vital role in ensuring that this transformative technology continues to be a force for good.
Disclaimer: This post is for general informational purposes only and does not constitute legal, tax, or financial advice. Reading or relying on this content does not create an attorney–client relationship. Every startup’s situation is unique, and you should consult qualified legal or tax professionals before making decisions that may affect your business.