Executive Order 14081 · Signed Sep 12, 2022

87 FR 56849 · Published Sep 15, 2022 · Effective on signing

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Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy

biotechnologybiomanufacturingbioeconomyfederal procurementnational security

Signed by President Joseph R. Biden Jr.

Establishes the National Biotechnology and Biomanufacturing Initiative, directing more than a dozen federal agencies to coordinate research investments, expand domestic manufacturing capacity, train a skilled workforce, streamline regulations, and collect bioeconomy data — spanning health, climate, agriculture, energy, and national security.

Requires federal agencies to purchase more biobased products and report their spending annually, while directing intelligence and homeland security agencies to assess and counter foreign threats to U.S. biological data and biotechnology leadership.

What this order does

What it orders

The order establishes the National Biotechnology and Biomanufacturing Initiative, directing more than a dozen federal agencies to coordinate policies and investments across biotech R&D, domestic biomanufacturing capacity, workforce education, regulatory reform, bioeconomy data infrastructure, and biosafety. Within 180 days, five agency heads — HHS, Energy, Agriculture, Commerce, and NSF — must submit sector-specific reports on applying biotech to societal goals; OSTP then has 100 more days to produce a consolidated implementation plan. Separately, federal procuring agencies must establish biobased-product purchasing programs, require staff training within two years, and report biobased spending to OMB annually.

It also directs DHS and the Director of National Intelligence to assess foreign threats to U.S. biological data and biotech leadership, with the APNSA required to develop a risk-mitigation plan. The State Department must submit an international engagement strategy. The order does not itself change any regulation, appropriate any funds, or directly alter procurement rules; all concrete impacts depend on future agency reports, plans, and rulemaking the order sets in motion.

Who it affects

Federal agencies directed to prepare reports and plans, federal procuring agencies required to adopt biobased-product purchasing programs and train their contracting staff, life sciences researchers whose work is funded by the federal government, biotechnology companies and developers navigating federal regulatory processes, and agricultural producers supplying biomass.

Why it matters

Federal contractors selling biobased products gain new mandatory federal procurement programs and annual scoring that could expand their market. Biotech companies get a promise of a clearer, unified regulatory portal. The intelligence community is directed to assess — and help block — foreign acquisition of U.S. biological data, which affects research institutions and genomic data holders.

What must happen and when

How the order is supposed to work

The order runs in cascading stages: five agency heads submit sector reports within 180 days, then OSTP has 100 additional days to synthesize those into a government-wide implementation plan. Parallel tracks cover a bioeconomy data initiative (240 days), a domestic biomanufacturing strategy (180 days), a DNI threat assessment (240 days), a biosafety plan (180 days), and a regulatory streamlining plan (280 days). OMB conducts a budget crosscut at 90 days to inform the plan. The APNSA chairs coordination through the NSM-2 interagency process, and directed agencies must report back on implementation within two years.

Actions and deadlines

  • Director of OMB performs budget crosscut identifying agency spending on biotech and biomanufacturing activitiesWithin 90 days of signing
  • Secretary of Commerce, through NIST, creates and publishes a publicly available lexicon for the bioeconomyWithin 90 days of signing
  • Chief Statistician establishes an Interagency Technical Working Group on bioeconomy statistical measurementWithin 120 days of signing
  • Secretaries of HHS, Energy, Agriculture, Commerce, and NSF Director submit sector-specific biotechnology reports to the PresidentWithin 180 days of signing
  • President's Council of Advisors on Science and Technology submits and publishes bioeconomy competitiveness reportWithin 180 days of signing
  • APNSA and APEP develop a strategy to expand domestic biomanufacturing capacityWithin 180 days of signing
  • Secretary of Homeland Security provides bioeconomy infrastructure vulnerability assessments to the APNSAWithin 180 days of signing
  • Procuring agencies begin reporting prior fiscal year biobased procurement spending to OMB, and annually thereafterWithin 180 days of signing
  • Secretaries of HHS and Homeland Security produce biosafety and biosecurity plan for the bioeconomyWithin 180 days of signing
  • Secretary of State submits international bioeconomy engagement plan to the APNSAWithin 180 days of signing
  • Agencies identify regulatory ambiguities in the biotechnology coordinated framework and engage stakeholdersWithin 180 days of signing
  • Commerce, Labor, Education, OSTP, and NSF produce and publish a biotech workforce education and training planWithin 200 days of signing
  • Director of OSTP issues a Data for the Bioeconomy Initiative report identifying data gaps and a protection planWithin 240 days of signing
  • Director of National Intelligence provides classified threat assessments on foreign adversary bioeconomy threatsWithin 240 days of signing
  • Regulatory agencies provide a regulatory reform implementation plan to OMB and OSTPWithin 280 days of signing
  • OSTP develops government-wide implementation plan based on the five sector reportsWithin 100 days of receiving the sector reports
  • APNSA develops and finalizes a risk-mitigation plan for the U.S. bioeconomy based on DNI threat assessmentsWithin 120 days of receiving DNI assessments
  • Procuring agencies that lack a biobased procurement program establish oneWithin 1 year of signing
  • OSTP reviews national security implications of federal procurement rules and recommends FAR updatesWithin 1 year of signing
  • ITWG recommends bioeconomy-related NAICS and NAPCS classification revisions to the Economic Classification Policy CommitteeWithin 1 year of signing
  • All appropriate procuring agency staff complete biobased product purchasing trainingWithin 2 years of signing
  • Agencies directed in the implementation plan report to OMB and OSTP on measures taken to advance biotech and biomanufacturingWithin 2 years of signing

Agencies directed to act

Department of Health and Human ServicesDepartment of EnergyDepartment of AgricultureDepartment of CommerceNational Science FoundationOffice of Science and Technology PolicyOffice of Management and BudgetDepartment of Homeland SecurityDepartment of DefenseEnvironmental Protection AgencyDepartment of StateDepartment of LaborDepartment of EducationOffice of the Director of National IntelligenceNational Aeronautics and Space AdministrationGeneral Services AdministrationPresident's Council of Advisors on Science and Technology

Authority and reach

Authorities cited

Article II

Constitutional grant of executive power to the President.

7 U.S.C. 8102

Federal statute requiring agencies to give purchasing preference to biobased products.

Competition in Contracting Act of 1984

Federal law requiring full and open competition in government contracting.

Executive Order

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Executive Order 14081: Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy | EO Reporter