Biosecurity Modernization and Innovation Act of 2026

Bill Number

S. 3741

Origin Chamber

Senate

Congress

119th Congress, Session 2

Policy Area

Science, Technology, Communications

Status

Introduced

Latest Action

2026-01-29: Read twice and referred to the Committee on Commerce, Science, and Transportation.

Last Updated

2026-06-12T13:18:30Z

AI-Generated Summary

Purpose of the Legislation

The Biosecurity Modernization and Innovation Act of 2026 aims to strengthen U.S. biosecurity by regulating the synthesis and sale of synthetic nucleic acids (DNA or RNA building blocks used in biotechnology) to prevent misuse, such as creating dangerous pathogens. It seeks to modernize federal oversight of biotechnology risks, promote innovation, and address gaps in current policies amid rapid technological advances.

Key Provisions

• Definitions: Establishes terms like "covered provider" (entities that synthesize/sell synthetic nucleic acids or related equipment in the U.S.), "Secretary" (of Commerce), "Under Secretary" (of Commerce for Standards and Technology, leading NIST), and "Director" (of the Office of Science and Technology Policy, or OSTP).
• Sense of Congress: Expresses concerns about biotechnology's rapid growth, risks from foreign adversaries, fragmented federal oversight, and the need for immediate gene synthesis screening as a short-term measure while developing a broader strategy.
• Nucleic Acid Synthesis Security (Section 4):
• Requires the Secretary of Commerce to issue regulations within 1 year, in coordination with other agencies, mandating covered providers to:
• Screen orders for "sequences of concern" (potentially harmful DNA/RNA patterns that could create pathogens) using privacy-protected systems to detect split orders (divided across providers).
• Verify customer identities and legitimacy.
• Maintain and update a list of sequences of concern, informed by experts, with public input via a docket and expedited addition processes (e.g., algorithms scanning literature).
• Undergo conformity assessments, including audits and random "red-teaming" (simulated attacks to test compliance), with penalties for non-compliance (e.g., status revocation after a grace period).
• Implement safeguards like expedited reviews for trusted institutions (e.g., universities) and exemptions for non-hazardous sequences.
• Restrict federal fund recipients to buying from compliant providers.
• Provide technical assistance for ambiguous screenings.
• Directs NIST (via the Under Secretary) to develop best practices, standards, and tools for screening, sequence evaluation, and research on sequence functions.
• Mandates regulation updates at least every 2 years.
• Protects customer data from public disclosure under the Freedom of Information Act (FOIA).
• Replaces prior voluntary federal guidelines with these mandatory rules.
• Authorizes civil enforcement by the Attorney General, including injunctions and statutory damages (up to $500,000 for individuals, $750,000 for entities, adjusted for inflation).
• Requires annual reports to Congress on compliance.
• Biotechnology Governance Sandbox (Section 5): NIST must establish a testing environment within 1 year to securely test biosecurity tools and innovations, involve private sector/academia/civil society, conduct related research, and report annually on promising governance strategies to promote U.S. competitiveness and threat anticipation.
• Streamlining Biosecurity and Biosafety Authorities (Section 6): OSTP Director must assess federal oversight within 90 days (covering authorities, overlaps, gaps in funding/tools, and compliance challenges) and develop an implementation plan for more efficient governance. A report with recommendations (e.g., consolidating authorities, possibly creating a new entity) goes to Congress within 90 days after completion, with implementation starting within another 90 days, incorporating sandbox findings.

Significant Changes to Existing Law

• Introduces mandatory screening and compliance requirements for nucleic acid providers, replacing voluntary federal guidelines (e.g., from prior administrations or agencies) with enforceable regulations.
• Creates new federal mechanisms like a sequences-of-concern list, conformity assessments with red-teaming, and a governance sandbox, which did not exist before.
• Adds civil penalties and Attorney General enforcement powers specifically for violations in this area.
• Exempts certain customer data from FOIA, enhancing privacy protections.
• Mandates consolidation and efficiency in biosecurity authorities across agencies, potentially reducing redundancies identified in past studies (e.g., by GAO or NSCBB).

Potential Impacts

• Government Agencies: Increases workload for the Department of Commerce (Secretary and NIST) in rulemaking, standards development, and technical assistance; OSTP gains assessment and planning duties. Other agencies (e.g., HHS, DHS) may collaborate on consultations, potentially streamlining inter-agency efforts but requiring new resources.
• Citizens and Industry: Biotech firms and researchers face new compliance costs (e.g., screening systems) but gain clarity and safeguards to foster innovation; federal grant recipients must use compliant providers, possibly delaying projects initially. Public health benefits from reduced risks of engineered pathogens.
• International Relations: Aims to maintain U.S. biotechnology leadership against foreign competitors (e.g., adversaries), potentially influencing global standards for biosecurity and export controls on synthesis tech, while encouraging international collaboration on threat detection.

Main Stakeholders Affected

• Biotech Industry and Covered Providers: Primary targets for screening, verification, and auditing requirements; resellers of synthesis equipment also included.
• Researchers and Academia: Impacted by customer verification, exemptions for trusted institutions, and restrictions on federal funding use; benefit from sandbox testing and technical assistance.
• Federal Agencies: Commerce (lead on regulations), NIST (standards/tools), OSTP (oversight planning), and others (e.g., for consultations); enforcement by Justice Department.
• General Public and Civil Society: Indirectly protected from biosecurity risks; involved via public dockets for sequence recommendations.
• Congress: Receives annual reports and implementation plans, influencing future biotech policy.

Notable Legal, Constitutional, or Political Implications

• Legal: Establishes enforceable civil penalties and court powers, shifting from voluntary to regulatory framework, which could face challenges over scope (e.g., defining "sequences of concern") or burdens on commerce (balanced by innovation safeguards). FOIA exemption raises privacy vs. transparency debates but aligns with national security precedents.
• Constitutional: Involves interstate commerce regulation (under Commerce Clause), with potential First Amendment concerns for research speech, mitigated by targeted security focus. No direct privacy rights issues, as protections are added.
• Political: Bipartisan (introduced by Sens. Cotton and Klobuchar), reflects consensus on biotech risks post-COVID and amid U.S.-China tensions; promotes proactive governance without creating a new agency immediately, but plan could recommend one, sparking debates on federal expansion vs. efficiency. Emphasizes U.S. competitiveness, aligning with national security priorities.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Cotton, Tom [R-AR]

Cosponsors (5)

Sen. Klobuchar, Amy [D-MN], Sen. Budd, Ted [R-NC], Sen. Coons, Christopher A. [D-DE], Sen. McCormick, David [R-PA], Sen. Hickenlooper, John W. [D-CO]

Recent Actions

• 2026-01-29: Read twice and referred to the Committee on Commerce, Science, and Transportation.
• 2026-01-29: Introduced in Senate

Bill Versions

• Biosecurity Modernization and Innovation Act of 2026 — issued 2026-01-29 — PDF (16 pages)