S. 4363 — Engineering Biology Readiness Act

This section extends the requirement for annual briefings on the National Biodefense Strategy to the date that is five years after the date of the enactment of the National Defense Authorization Act for Fiscal Year 2027 (from March 1, 2025).

This section requires the first biennial update of the biodefense threat assessment—provided to congressional committees pursuant to section 364(d)(1)(D) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (6 U.S.C. 106(d)(1)(D)) after enactment—to include an analysis of engineering biology risks (i.e., risks to national security or public safety from misuse, abuse, or accidental release of engineering biology materials, methods, tools, or information) and recommendations to enhance readiness of the U.S. national security and life sciences research enterprises against such risks. The analysis must include (1) an assessment of threats to national security and public safety from current and anticipated engineering biology risks; (2) a description of current research and development in covered departments and agencies (i.e., those listed in 6 U.S.C. 106(a), such as DHS and DOD) on biodefense against such risks, covering prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation; (3) an analysis of relevant U.S. authorities, regulations, and programs on biosafety, biosecurity, and biodefense; (4) an evaluation of gaps, deficiencies, redundancies, and ambiguities in those authorities and regulations; and (5) other relevant matters. The recommendations must include (1) alignment of research and development across covered departments and agencies to reduce redundancies and promote biosafety, biosecurity, and biodefense; (2) modernization of relevant authorities, regulations, and programs to mitigate risks while enabling benefits from engineering biology innovations under an enduring governance framework; (3) establishment or modernization of programs to enforce safeguards, identify best practices, promulgate voluntary guidance, and provide consultation on biosecurity and biosafety; (4) detailed legislative proposals and funding estimates for items (2) and (3); and (5) other relevant matters. Recommendations must be developed in consultation with industry, academia, and civil society representatives—including life sciences researchers without federal grants or contracts in the prior five years—and other stakeholders. The analysis and recommendations must be submitted unclassified, with a possible classified annex.