The Executive Order that Brings Private Bioresearch Under Federal Oversight

Earlier this month, the White House issued an Executive Order (EO), “Improving the Safety and Security of Biological Research,” to tighten biosafety and biosecurity across the life-sciences landscape. Section 5 of the order ‘Managing Risks Associated with Non-federally Funded Research”, could fundamentally reshape how privately financed sponsors, contract research organizations, and university labs operate. By extending federal oversight far beyond projects that rely on U.S. government grants, it may require any work involving genetic engineering of human, animal, or plant pathogens, i.e. gain-of-function techniques, to undergo Institutional Biosafety Committee (IBC) review. An IBC review is a rigorous risk assessment, ensuring that experiments are properly contained, workers are shielded from exposure, and the surrounding community and environment remain safe.

The government hasn’t defined precisely which pathogens the new rules will cover. Previously, federal oversight applied to only 15 named agents or toxins, among them plague (Yersinia pestis), anthrax (Bacillus anthracis), the smallpox virus, and botulinum toxin. That 15-agent limit has been rescinded by the EO.

As stated in the Executive Order, the federal government seeks to implement measures that balance the needs of identifying gaps in the oversight of generic-manipulation research with the United States’ imperative to be a leader in the field of biotechnology. Those gaps are not limited to viruses. Take tuberculosis, with today’s genetic engineering techniques, Mycobacterium tuberculosis could be manipulated into a strain that is both more contagious and antibiotic-resistant. Much of that work could potentially slip past meaningful government scrutiny as the bacteria is not covered under many current rules. Clearly, the oversight system needs rapid and substantial reinforcement.

Within six months, the Director of the Office of Science and Technology Policy must deliver a national plan that tracks, limits, and governs gain-of-function research conducted with or without federal funding and rolls out a robust, verifiable screening system for genetic engineering in the private sector. The plan must also recommend new laws to plug any remaining regulatory gaps, strong evidence that full-scale biosafety oversight of research on pathogens is coming to privately financed labs for the first time.

In the current landscape, an IBC review is compulsory only for research supported by the NIH. That means privately funded trials and overseas labs that are funded by the U.S. often move forward without outside oversight. Section 5 aims to change the equation. Any study that boosts a pathogen’s virulence, transmissibility, or susceptibility to therapeutics (e.g. antibiotics), no matter where funding comes from, could soon come under direct federal scrutiny and enforcement.

For five decades the NIH Guidelines have been the de-facto rulebook governing genetic engineering, yet they are voluntary whenever federal funds or scientific collaboration are absent. Section 5 could invite regulators to convert IBC oversight from best practice to legal requirement, closing the “private funding” loophole highlighted in pandemic-origin debates. The government must submit its plan within 90 and 180 days of the EO. Organizations that establish or outsource a robust IBC now will be well-positioned if the new baseline becomes law.

The speed at which emerging tools are lowering technical barriers makes expanded oversight more pressing. Just this month, TIME reported that frontier AI models (including OpenAI’s o3 and Google’s Gemini 2.5 Pro) outperformed PhD-level virologists on a demanding wet-lab troubleshooting test, highlighting AI’s growing potential to accelerate vaccine and antiviral development. Yet the author cautions that the same step-by-step know-how could be weaponized, urging AI companies to gate dangerous capabilities and calling for stronger government safeguards against AI-enabled biothreats. Recent scientific advancements involving genetic engineering, such as synthetic nucleic acids (2013), gene editing (2024), and gene drives (2024) were included under the jurisdiction of IBC oversight. It stands to reason that utilizing AI to genetically engineer pathogens will similarly fall under IBC scrutiny.

The Director of the Office of Science and Technology Policy’s 180-day clock expires in early November 2025. We expect draft guidance before year-end. If that schedule holds, IBC reviews may be fast-tracked to keep genetic-engineering projects moving. Advarra’s regulatory team is following each milestone closely and is available to provide guidance on the implications of changes to forming and managing an IBC. For questions, please reach out to Ask the Experts on our Contact Us page.