Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
Executive Order 14081, issued by President Biden and signed on September 11, 2022, establishes a government-wide initiative—the National Biotechnology and Biomanufacturing Initiative—to accelerate the United States’ leadership in biotechnology and biomanufacturing while prioritizing safety, security, ethics, and equity. The order directs interagency coordination, data architecture, and strategic investment to advance health, climate and energy goals, food security, supply chain resilience, and national security. It also emphasizes a stronger domestic biomanufacturing ecosystem, improved regulatory clarity, a robust biosafety/biosecurity framework, workforce development, and international engagement. Across these areas, the order seeks to balance rapid innovation with risk reduction and public accountability, including protecting sensitive data and infrastructure from foreign threats. Overall, the executive order creates time-bound reporting, planning, and implementation milestones, assigns leadership to multiple agencies, and links research, data, procurement, regulation, and workforce efforts into a unified national strategy intended to grow the bioeconomy responsibly and securely.
Key Points
- 1National Biotech and Biomanufacturing Initiative and coordinated action
- 2- Establishes a whole-of-government effort to coordinate R&D, data, manufacturing, biosafety, workforce, and international engagement in biotechnology and biomanufacturing; uses the NSC’s NSM-2 process for interagency coordination; requires stakeholder input from industry, academia, labor, and state/local governments.
- 3Data for the Bioeconomy Initiative and measurement
- 4- Creates a data initiative to identify critical bioeconomy data types (including genomic/multiomics data), ensure data are findable and reusable, assess security/privacy risks, and outline the federal actions and timelines needed; establishes cybersecurity guidance for bio data stored on federal systems.
- 5Building a vibrant domestic biomanufacturing ecosystem
- 6- Requires a strategy within 180 days to expand domestic biomanufacturing across health, energy, agriculture, and industrial sectors; directs agency actions (e.g., NSF’s Regional Innovation Engines, DoD, DOE, DOC) to grow capacity, strengthen supply chains, and mitigate foreign-adversary risks; includes a plan for biomass resilience and energy/bioeconomy research.
- 7Biobased products procurement and workforce development
- 8- Sets a 1-year deadline for agencies to establish biobased procurement programs (per 7 U.S.C. 8102) and mandates staff training within 2 years; requires regular reporting on procurement activity and progress toward increasing biobased purchasing, plus a workforce plan with emphasis on equity and underserved communities, including HBCUs and Tribal Colleges.
- 9Regulation clarity, biosafety, and threat assessment
- 10- Tasks agencies to identify regulatory gaps in the Coordinated Framework for Biotechnology, produce plain-language regulatory information for developers, and develop a plan to streamline or update rules within specified timeframes; establishes a Biosafety and Biosecurity Innovation Initiative within 180 days to reduce risks along the R&D and manufacturing lifecycles; calls for national threat assessments led by the DNI and a mitigation plan coordinated across agencies; includes a focus on cyberbiosecurity and safeguarding critical infrastructure.