Protect Against the Harms of Biotechnology

Current Tools are Blunt and Reactive

The United States relies on a limited set of tools to ensure safety, security, and responsibility in biotechnology.

The first of these is the moratorium—essentially a stop-work order on innovation. Academia, industry, and government alike reach for this tool when research moves beyond existing oversight systems and governance cannot adapt. In the early days of genetic engineering, for example, researchers called for a pause on their own work and spent years collaborating with the government on a set of safety and ethical oversight systems.²⁵⁸

Similar calls followed OpenAI’s release of ChatGPT in the fall of 2022. Many industry leaders raised the alarm and demanded a pause on large AI experiments to mitigate, as an open letter put it, “profound risks to society and humanity.”²⁵⁹ Despite the unprecedented popularity of ChatGPT, it took a year for the government to create the AI Safety Institute, which is part of the NIST.²⁶⁰ Lawmakers are still grappling with the right way to legislate on AI safety. But the U.S. government’s reactive approach lowered confidence in its ability to oversee transformational technology.

Every time innovators have to hit the brakes unexpectedly, they lose time, money, and public trust. Biotechnology has not yet reached its ChatGPT moment. In the face of rapid advancements originating in China, the United States cannot afford for innovation in biosecurity and biosafety governance to happen in stops and starts. 

Another oversight tool the United States uses is lists of biological hazards, such as organisms with destructive potential. List-based systems, such as the Federal Select Agent Program (FSAP), are most appropriate when researchers and innovators know how concerned they should be about a particular organism or type of experiment. List-based systems work less well for emerging or poorly understood risks.²⁶¹

While these tools are good starting points, the government fails to routinely evaluate their effectiveness.²⁶² The United States, therefore, does not know how much innovation is lost or how much safety and security is gained through these approaches.

Government Leadership is Fragmented

Despite the United States’ historic leadership in biosecurity and biosafety, existing government policies are fragmented across federal agencies, leading to redundancies, gaps, and inefficiencies. These policies include the FSAP, Biosafety Levels (BSL) designation and laboratory biosecurity and biosafety guidance, and gene synthesis screening guidance.

For example, a multitude of agencies and offices conduct inspections and require reporting for laboratory oversight. Inspections look at the same things and ask the same questions, but operate on different timelines, imposing a frustrating compliance burden on laboratory staff.

Another example of fragmentation concerns the security of gene synthesis. The process of creating physical genes based on digital sequence data, called gene synthesis, is critical for the growth of the biotechnology industry. While industry is united in calling for a measured, enforceable, and standardized approach, the U.S. government is unable to respond to such requests with the needed agility. Policies regarding gene synthesis security are distributed across multiple federal agencies and offices, including the Department of Health and Human Services (HHS), the Federal Bureau of Investigation (FBI), and the Executive Office of the President (EOP) or Office of Science and Technology Policy (OSTP). As of February 2025, these are voluntary standards, not mandatory ones.

Furthermore, the Commission found that many of the agencies designated to address different aspects of biosecurity and biosafety see this work as peripheral to their core missions and mandates and lack the incentive to tackle these issues.

Policies are Quickly Outdated as Technology Advances

Biosecurity practices and policies have traditionally revolved around preventing the misuse of biological pathogens, primarily through controlling access to them. However, as researchers develop novel biodesign capabilities, such as gene editors, gene synthesis capabilities, and AI-powered protein design, these practices and policies must evolve.

The U.S. government is not modernizing policies quickly enough to keep up with biotechnology development. It took 13 years to update guidance on gene synthesis screening, and the resulting frameworks remain limited to federal research.²⁶³ It took 10 years to modernize oversight of Dual Use Research of Concern (DURC) and research involving Pathogens with Enhanced Pandemic Potential (PEPP).²⁶⁴ Calls for a foundational reassessment of the FSAP have still not resulted in the necessary changes.²⁶⁵ List-based policies are particularly likely to lag behind the leading edge of biotechnology.²⁶⁶

Going Forward

The United States needs a sharper set of tools. The government body that develops those tools must itself be at the leading edge of technology, not just in biotechnology innovation but also in developing the science of biosecurity, biosafety, and responsibility.

Governance must keep pace with innovation. To do so, the government must streamline policies and develop a proactive culture, cultivate dedicated expertise, and secure a resource stream for advancing governance capabilities. Policies should not stifle innovation. Rather, they should ensure risk awareness and mitigation while maximizing benefit.

The United States should lead by example in building biosecurity and biosafety into research and innovation processes. International collaboration will be essential to realizing the full benefits of advances in biosecurity, biosafety, and responsible innovation.

Fixing the U.S. government’s outdated approach in these areas would secure America’s technological lead by giving the nation’s industry and academia the confidence to do what they do best: out-innovate the world.

The U.S. government could continue to have each agency with a hand in biotechnology innovation perform its own biosecurity and biosafety measures. For example, in December 2024, the HHS and the Department of Homeland Security (DHS) announced the Biosafety and Biosecurity Innovation Initiative Plan for the Bioeconomy, a suite of recommendations for each biotechnology agency to implement on their own.²⁶⁷ But this approach does not adequately address the problems described above.

Instead, the United States could take a new approach: create a consolidated, dedicated capability to protect against harms from biotechnology in a way that integrates leading-edge science and evidence-based policymaking into enforcement and regulation, allowing policies and enforcement to continuously adapt.

Congress must direct the executive branch to advance safe, secure, and responsible biotechnology research and innovation.

After 20 years of trying and failing to protect against harms without stifling innovation, Congress must pursue a different approach. One solution is for Congress to create a new entity that both serves as a resource to innovators at the forefront of technology development and modernizes legacy safety and security policymaking and enforcement.²⁶⁸

The Department of Commerce (DOC) is the logical place to house such an entity: it has a culture of promoting innovation and economic development across the country, experience with metrology and standards-setting through the NIST, and a focus on security. It could work closely with the NBCO (see recommendation 1.1a), the Centers for Biotechnology (see recommendation 4.3a), and implementers of the proposed grand research challenges for biotechnology (see recommendations 4.3b and 4.3c).

This entity would have five main responsibilities:

1. Identify emerging risks and vulnerabilities with biotechnology and existing oversight. To do so, it would:

• perform continual evaluation and assessment of vulnerabilities, weaknesses, and threats, including lab testing of equipment and advanced tools;
• analyze inputs from regular disclosures (which already exist) and a no-fault reporting system (which should be developed) from industry and academia on potential concerns; and
• run a whistleblower mechanism and host regular forums for industry and academia to identify gaps in technical capabilities and concerns with existing oversight.

2. Fund basic and applied biosecurity, biosafety, and responsibility innovation and tool development. Taking an ARPA-style approach to solving hard problems quickly, the entity could fund projects addressing:

• technical advances on biosecurity and biosafety by design capabilities;
• the use of machine learning to assess the level of concern of novel sequences or organisms;
• methodologies for biosafety officers to handle concerns about specific research projects that do not fit neatly into existing policies;
• methods and organizational designs for safe, secure, and responsible biotechnology; and
• systematic and streamlined risk assessments to inform biotechnology innovation pathways.²⁶⁹
  The entity could also pilot, test, and refine new technological and organizational abilities in a controlled sandbox with key stakeholders.

3. Develop and incentivize the adoption of best practices. This would include:

• standardizing best practices for biosecurity, biosafety, and responsibility across funding agencies;
• promoting the adoption of innovations that arise from the entity’s research; and
• collaborating with industry and academia to train and develop the workforce for biosecurity, biosafety, and responsibility.

4. Consolidate and oversee biosecurity, biosafety, and responsibility policies. This would entail:

• immediately modernizing and overseeing the FSAP and enforcing gene synthesis screening procedures;
• over time, updating and adapting other biosecurity and biosafety policies;
• helping other agencies adapt policies affecting biotechnology where it converges with other technology areas (for example, working with the DHS and the Cybersecurity and Infrastructure Security Agency (CISA) on cybersecurity policies that involve biological algorithms and data);
• establishing a comprehensive licensing system for BSL-3/4 facilities and accreditation for relevant biosecurity and biosafety personnel; and
• maintaining strong connections with law enforcement agencies, including the FBI and the DHS, to enable effective enforcement of relevant criminal statutes.

5. Work with the international community. This would include improving best practices and standards and sharing information and technical advances to prevent misuse and encourage trust in emerging biotechnology.