US Biosecurity Oversight Faces Its Biggest Overhaul in Decades as Congress and the White House Move on Parallel Tracks
A bipartisan Senate bill, a sweeping executive order on gain-of-function research, and a GAO report exposing transparency gaps converge to reshape how the United States governs biological risk.
Overview
The United States is in the midst of its most significant rethinking of biosecurity and biosafety oversight in more than two decades. Three parallel policy efforts—a bipartisan Senate bill targeting gene synthesis screening, an executive order that froze federally funded gain-of-function research, and a Government Accountability Office report calling for greater public transparency around high-risk pathogen studies—are converging to reshape how the country governs biological risk in an era of rapidly advancing biotechnology.
Taken together, these developments signal a shift away from the voluntary, self-governance model that has characterized US life-sciences oversight since the 2001 anthrax attacks and toward a framework with enforceable rules, centralized authority, and mandatory disclosure.
The Biosecurity Modernization and Innovation Act of 2026
In late January, Senators Tom Cotton (R-AR) and Amy Klobuchar (D-MN) introduced S.3741, the Biosecurity Modernization and Innovation Act of 2026, a bill that targets three structural weaknesses in the current biosecurity regime.
First, the bill directs the Secretary of Commerce to require gene synthesis providers to screen orders and customers for dangerous pathogen sequences. Unlike the existing voluntary guidelines, violations of the new screening requirements would carry civil penalties of up to $500,000 for individuals and $750,000 for organizations. The legislation includes provisions for expedited review for accredited institutions and exemptions for clearly non-hazardous sequences.
Second, the bill establishes a biotechnology governance sandbox at the National Institute of Standards and Technology (NIST), designed to provide a controlled environment for testing biosecurity tools and evaluating new regulatory approaches as the field evolves.
Third, and perhaps most consequentially, the legislation gives the White House 90 days to conduct a comprehensive assessment of federal biosecurity oversight—clarifying roles and responsibilities across agencies, measuring the effectiveness of existing systems, and identifying gaps in resources and capability. The assessment is intended to drive both executive and legislative action to create what supporters describe as a centralized oversight hub for biorisk matters.
The bill has drawn endorsements from the National Security Commission on Emerging Biotechnology, Ginkgo Bioworks, Twist Bioscience, and Integrated DNA Technologies, among others, according to the bill text and supporting materials filed with Congress.
The Gain-of-Function Research Freeze
The legislative effort arrives against the backdrop of a sweeping executive order issued by President Trump on May 5, 2025. Executive Order 14292 halted all federal funding for what the administration defined as “dangerous gain-of-function research”—work that enhances the transmissibility, virulence, or immune evasion of pathogens—and rescinded the 2024 Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential policy that had been finalized under the previous OSTP framework.
The order imposed several deadlines. Within 120 days, the Office of Science and Technology Policy was directed to develop replacement oversight guidance. Within 180 days, OSTP was to deliver a strategy for governing gain-of-function research that occurs without federal funding, including measures to achieve “comprehensive, scalable, and verifiable nucleic acid synthesis screening” in non-federally funded settings. The order also permanently ended federal funding for such research conducted by foreign entities in countries deemed to have insufficient oversight, including China and Iran.
The NIH responded by suspending funding for affected projects and requiring all awardees to complete portfolio reviews identifying any gain-of-function work by June 30, 2025. Institutions that failed to comply faced automatic funding suspension or termination, with no exemptions granted.
However, the order’s broad terminology—particularly the phrase “dangerous gain-of-function” and “significant societal consequences”—created confusion across research institutions. A July 2025 analysis in PMC described a “serious operational crisis” in which laboratories working on influenza, antimicrobial resistance, synthetic biology, and vaccine platforms considered pausing research because it was unclear which activities fell under the new restrictions. The ambiguity about which prior frameworks (the 2014 moratorium guidelines, the 2017 HHS review framework) remained active left researchers without clear guardrails.
GAO Finds Transparency Gaps in HHS Risk Oversight
Adding to the pressure for reform, the Government Accountability Office published GAO-26-107348 in January 2026, a report examining how the Department of Health and Human Services assesses and communicates risks associated with high-risk pathogen research.
The GAO found that while HHS agencies have established procedures for reviewing pathogen research risks—including evaluating pathogen characteristics, assessing mitigation strategies, determining appropriate biosafety containment levels, and weighing risks against benefits—the department “does not always share key information on these risk reviews with the public.” Internally, HHS collects and reports this data to federal stakeholders, but the information does not reach the broader public.
The report recommended that HHS publicly share outcomes of risk assessments, steps taken to mitigate identified risks, and total numbers of higher-risk pathogen research projects it supports. HHS neither agreed nor disagreed with the recommendations, committing only to ensuring transparency “upon policy finalization.”
The report also noted that sources continue to conflict on whether gain-of-function research directly contributed to COVID-19 vaccines and therapeutics, though there is broad consensus that the research poses biosafety and biosecurity hazards.
What We Don’t Know
Several critical questions remain unanswered. The 120-day deadline for OSTP to deliver replacement gain-of-function oversight guidance passed in September 2025, and it remains unclear whether a finalized policy has been issued or whether the research pause has been formally lifted for domestic investigators. The Congressional Research Service has noted that there is currently no overarching federal law providing oversight of laboratory biosafety and biosecurity with enforceable legal penalties—a gap that neither the executive order nor the Senate bill fully addresses on its own.
The fate of S.3741 in committee also remains uncertain. While it has bipartisan sponsorship and broad industry support, biosecurity legislation has historically faced slow progress—the BIOSECURE Act, which addressed Chinese biotech companies, took years of legislative wrangling before being signed into law in December 2025.
It is also not yet clear how the gene synthesis screening mandates in S.3741 would interact with the executive order’s own directive to achieve synthesis screening in non-federally funded settings. Coordination between the legislative and executive tracks will be essential to avoid creating overlapping or conflicting requirements.
Analysis
The convergence of these three policy efforts reflects a broader recognition that the United States’ existing biosecurity infrastructure—built largely in response to the 2001 anthrax attacks and patched incrementally over two decades—is no longer adequate for the pace of modern biotechnology. The rise of accessible gene synthesis tools, AI-assisted biological design, and a growing number of actors capable of engineering pathogens has made the old model of voluntary compliance and fragmented federal oversight untenable.
The shift toward mandatory screening with civil penalties, centralized risk assessment, and public transparency represents a meaningful departure from the status quo. Whether these parallel efforts can be coordinated into a coherent national framework—rather than adding yet another layer of patchwork regulation—will determine whether the overhaul delivers on its promise.