Congress Must Act to Secure U.S. Biotechnology

The stakes for U.S. biotechnology could not be higher. Synthetic biology, AI-driven design, and other frontier technologies hold extraordinary promise for advances in medicine, agriculture, clean energy, and manufacturing. At the same time, these tools introduce vulnerabilities that—if misused, whether accidentally or deliberately—could threaten public safety, economic stability, and national security.

Innovation requires security, and security requires innovation. Congress needs to act decisively to ensure U.S. leadership in biotechnology is paired with governance that keeps its development secure.

The United States has the talent, infrastructure, and resources to lead responsibly. However, oversight remains fragmented and reactive, leaving gaps that adversaries could exploit and innovators find burdensome. Without modernized governance, the world remains vulnerable to catastrophic biological events that could cause mass casualties, inflict trillions in economic losses, and destabilize governments.

Where the Gaps Are 

At a September 10th Capitol Hill discussion on Biosecurity and Innovation in the Age of AI, Senator Todd Young (R-Ind.), Dr. Sam Weiss Evans (National Security Commission on Emerging Biotechnology, NSCEB), Dr. James Diggans (Twist Bioscience), Dr. Sarah R. Carter (Science Policy Consulting), and moderator Dr. Jaime Yassif (NTI | bio) highlighted several vulnerabilities in U.S. biotechnology oversight:

• Fragmented oversight: No single authority coordinates biosafety and biosecurity across the federal government, and current structures lack the capacity to develop new biosecurity solutions. Innovators face a patchwork of requirements, allowing risks to slip through the cracks.
• DNA synthesis vulnerabilities: Companies such as Twist Bioscience screen every order to prevent misuse, serving as a frontline defense where digital code becomes physical biology. But screening remains voluntary and inconsistent. Despite bipartisan and industry support, no enforceable federal standards exist. Some companies use rigorous protocols, others rely on partial measures, and some do not screen at all. This uneven adoption leaves openings for misuse of genetic material and creates biosecurity vulnerabilities.
• AI-enabled biology risks: Large language models lower barriers for unskilled actors to misuse biology, while AI-enabled biodesign tools pose greater risks by designing novel biological constructs that could be used to generate pathogens more dangerous than those found in nature. Cloud laboratories magnify these risks by translating digital designs into physical experiments. By integrating AI models trained on biological data with automated laboratory equipment, cloud lab platforms can accelerate experimentation at a scale and pace that existing safeguards were not designed to address.
• Underprotected intellectual property: Engineered DNA and protein sequences hold substantial economic and strategic value, yet U.S. companies often outsource DNA synthesis overseas with minimal safeguards—putting intellectual property, competitiveness, and national security at risk.

What Congress Should Do

To address these gaps, NTI | bio recommends four practical steps to embed strong biotechnology governance and biosecurity into the U.S. bioeconomy.

1. Establish a national agency for biotechnology governance. 
   Congress should create a dedicated agency to coordinate biotechnology governance and biosecurity policy, consolidating responsibilities currently dispersed across multiple agencies, while building public-private partnerships to address evolving threats. NTI | bio endorses the NSCEB’s recommendation to establish this entity and supports the Commission’s proposed approach to innovative governance.
2. Dedicate funding to biosecurity and biosafety innovation. 
   At least 1-2% of federal biotechnology investment should be dedicated to biosafety and biosecurity implementation and innovation. From the NSCEB’s recommended $15 billion over five years, this would direct $150-300 million toward biosecurity by design approaches.
3. Mandate pre-funding biosecurity reviews and incentivize DNA synthesis screening.
   Congress should require federal funding agencies to evaluate biosecurity risks before awarding grants and ensure consistent pre-funding review practices across government. Federally funded researchers should also be required to purchase nucleic acids only from providers that conduct rigorous sequence and costumer screening. As the White House’s AI Action Plan noted, voluntary measures are insufficient—Congress must establish enforceable standards.
4. Provide annual funding for the Center for AI Standards and Innovation (CAISI).
   Congress should allocate at least $8 million annually to CAISI at the National Institute of Standards and Technology to develop technical safety standards and guardrails for AI-enabled biology, in partnership with experts from industry and the scientific community.

Why This Matters  

Congress has already acted on more than half of the NSCEB’s 49 recommendations, signaling strong bipartisan support for safeguarding U.S. biotechnology innovation. Industry leaders have likewise expressed readiness to partner with policymakers to implement these practices.

The policy next steps are clear: require DNA synthesis screening, invest in safeguards at the nexus of AI and the life sciences, and establish a dedicated authority for biotechnology oversight. These are practical measures Congress can address now. While voluntary measures and executive actions have moved the conversation forward, only legislation can provide the comprehensive, enforceable framework needed to secure biotechnology.

As Senator Young concluded, “Congress owes it to our constituents to do this once and do it right. Biosecurity can accelerate the next century of American innovation. Our national security depends on it.”