Preventing Illegal Laboratories and Protecting Public Health Act of 2025
This bill would require the Secretary of Health and Human Services, through the Assistant Secretary for Preparedness and Response (ASPR), to run a program that obligates each “covered distributor” of highly pathogenic agents to keep an electronic logbook of all sales, leases, loans, and other transfers. The bill defines which agents are considered highly pathogenic, requires the Secretary to create and maintain an initial list (with annual updates) and to consult with multiple federal agencies and established biosafety guidance in doing so. For each transfer, distributors must record detailed information about the agent, the purchaser, the intended use, where the agent will be housed, transfer timing, and purchaser verification, and purchasers must provide identification and signatures. Sales to purchasers must meet identity-verification standards, and logbooks must retain entries for at least three years. The bill also creates rules governing disclosure of logbook information, establishes penalties for false logbook statements under 18 U.S.C. 1001, and clarifies that the logbook and data are exempt from certain FOIA disclosures. Beyond the logbook program, the bill directs a separate strategic effort: a National Security Advisor-led, periodic evaluation of high-containment laboratories (BSL-3 or higher) to assess capacity, security, risks, and oversight, along with a newly created Public Health Biosafety and Biosecurity Team to serve as a single federal point of contact for state/local/Tribal/territorial officials. It also requires a feasibility study to design a centralized database of high-containment labs with ownership, licensing, compliance history, and related biosafety/biosecurity information, with a report to Congress. The overall aim is to improve biosafety, biosecurity, and public health preparedness, though it would impose new regulatory duties on distributors and researchers.
Key Points
- 1Establishes a program requiring covered distributors of highly pathogenic agents to maintain an electronic logbook of all transfers, with detailed data for each transaction and purchaser verification.
- 2Creates a process to identify and update which agents count as “highly pathogenic,” including initial listing within 6 months and annual updates, with interagency and biosafety guidance (BMBL and NIH guidelines) informing the list.
- 3Sets stringent logbook contents and sale-transfer requirements, including purchaser identification, description of use and housing, transfer timing, purchaser signatures, and validation by the distributor.
- 4Requires safeguards around disclosure of logbook data, including restricted access for law enforcement and health officials and FOIA exemptions to protect sensitive information.
- 5Adds penalties for false statements by purchasers and imposes retention obligations (at least 3 years) with successor entities taking on logbook responsibilities; clarifies that the program does not supersede the Federal Select Agent Program.
- 6Section 3 creates a National Security Advisor–led process to evaluate high-containment laboratories, including capacity, security, risks, oversight needs, and national standards for design and operation.
- 7Establishes a Public Health Biosafety and Biosecurity Team as a single federal contact point for State/local/Tribal/territorial entities on laboratory biosafety and biosecurity matters, with a defined timeline for establishment.
- 8Requires a feasibility study for a centralized database of high-containment laboratories (ownership, location, licensing, violations, etc.) and a congressional report detailing findings and recommendations.