BIOSECURE Act of 2025
- Bill Number
- S. 3469
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-12-11: Read twice and referred to the Committee on Homeland Security and Governmental Affairs.
- Last Updated
- 2026-03-31T19:34:55Z
AI-Generated Summary
Purpose of the Legislation
The BIOSECURE Act of 2025 aims to protect U.S. national security by restricting federal government dealings with biotechnology companies that could pose risks, particularly those linked to foreign adversaries like China. It focuses on preventing the use of biotech equipment or services that might allow access to sensitive human biological data (such as genetic information) by hostile entities.
Key Provisions
- Prohibitions on Procurement and Contracting:
- Executive agencies (federal departments like Defense or Health and Human Services) cannot buy, obtain, or contract for biotechnology equipment or services from "biotechnology companies of concern."
- Agencies also cannot contract with any company that uses such equipment or services (acquired after the effective date) to fulfill federal contracts.
- Loan or grant funds cannot be used to procure or contract with these companies or their equipment/services.
- Effective Dates and Rules:
- Bans take effect 60 days (for certain Chinese-linked companies) or 90 days (for others) after updates to the Federal Acquisition Regulation (FAR), a set of rules governing federal purchases.
- For the first five years, existing contracts (including pre-negotiated options) are exempt from some rules.
- "Biotechnology equipment or services" includes tools like genetic sequencers, software for biological research, data storage/transmission, consulting on biotech use, and disease/genealogy testing—plus any other items deemed a security risk.
- Waivers and Exceptions:
- Case-by-case waivers allowed for specific needs (e.g., up to 1 year, extendable by 180 days) with approval from the Office of Management and Budget (OMB) Director and notification to Congress.
- Separate waivers for overseas healthcare contracts supporting U.S. employees or contractors.
- Exceptions include: U.S. intelligence activities; overseas healthcare for federal workers, military, or dependents; publicly available human biological data; and emergency medical supplies during public health crises.
- Identification of Companies of Concern:
- OMB must publish a list within one year of enactment, based on input from agencies like Defense, Justice, Health, Commerce, Intelligence, Homeland Security, State, and the National Cyber Director.
- "Biotechnology companies of concern" include:
- Companies on the Defense Department's list of Chinese military-linked firms involved in biotech.
- Entities controlled by or acting for "foreign adversaries" (e.g., China, as defined in law) that handle biotech and pose risks, such as sharing data with adversary militaries/intelligence or collecting data without consent.
- Subsidiaries, parents, or successors of such entities.
- The list is reviewed annually; companies can challenge designations or request removal, with notices and review processes.
- Additional Requirements:
- Guidance issued within 180 days of the list; FAR updated within one year.
- Director of National Intelligence (DNI) must assess risks from foreign access to U.S. citizens' biological data and report to Congress within 270 days (unclassified with possible classified addendum).
- Annual DNI reports on threats from biotech companies mishandling U.S. biological data.
- No new funding authorized; uses existing budgets.
Significant Changes to Existing Law
- Builds on the 2021 National Defense Authorization Act's list of Chinese military companies but expands it to create a new, broader "biotechnology companies of concern" category with specific biotech focus.
- Introduces mandatory FAR revisions and interagency processes for identifying and listing risky biotech firms, which did not previously exist.
- Adds protections for human "multiomic" data (a term for combined biological data like genes, proteins, and metabolites) against foreign adversaries, extending beyond general procurement bans.
- Includes a "safe harbor" for equipment no longer produced by listed companies and deems certain drug manufacturers compliant with veterans' pricing laws despite the bans.
Potential Impacts
- On Government Agencies: Agencies may face procurement disruptions, higher costs, or delays in biotech research, drug development, and health services as they shift to approved providers. This could strain budgets without new funds and require new compliance training.
- On Citizens: Enhances protection of personal biological data from foreign exploitation, potentially reducing privacy risks in research or healthcare. However, it might limit access to affordable biotech tools or services if alternatives are scarce, indirectly affecting medical innovation or costs.
- On International Relations: Targets entities linked to foreign adversaries (primarily China), which could escalate tensions, prompt retaliatory measures, or affect U.S.-China biotech collaborations. It signals stronger U.S. efforts to secure supply chains amid global competition in biotechnology.
Main Stakeholders Affected
- Federal Agencies: Executive branches like Department of Defense, Health and Human Services, and OMB, which must implement bans, waivers, and reporting.
- Biotechnology Companies: U.S. and foreign firms (especially Chinese-linked) involved in equipment, services, or data handling; listed companies face exclusion from federal contracts, while others may gain opportunities.
- U.S. Citizens and Researchers: Individuals whose biological data could be at risk; scientists and healthcare providers relying on federal funding or contracts may need to adapt tools and processes.
- Congressional Committees: Oversight groups (e.g., Armed Services, Intelligence, Homeland Security) receive notifications, reports, and justifications for enforcement.
- Foreign Governments/Entities: Adversaries like China, whose affiliated companies could lose U.S. market access, impacting their biotech sectors.
Notable Legal, Constitutional, or Political Implications
- Legal: Establishes due process for company designations (e.g., notice, 90-day challenges), reducing risks of lawsuits over arbitrary listings. Aligns with existing national security laws but could face challenges if waivers are denied or lists expand broadly, potentially under due process or commerce clause arguments.
- Constitutional: Supports Congress's spending power to condition federal funds on security criteria; exceptions for intelligence activities uphold executive national security authority without infringing First Amendment or privacy rights directly.
- Political: Bipartisan sponsorship (Senators Peters and Hagerty) reflects consensus on China-related threats. It advances U.S. policy to "de-risk" critical technologies, potentially influencing future trade/tech bills, but may polarize debates on economic vs. security priorities. No impact on private-sector dealings, limiting scope to federal actions.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Recent Actions
- 2025-12-11: Read twice and referred to the Committee on Homeland Security and Governmental Affairs.
- 2025-12-11: Introduced in Senate
Bill Versions
- BIOSECURE Act of 2025 — issued 2025-12-11 — PDF (20 pages)