Biosecurity & Dual-Use Biotechnology

BIOSECURITY & DUAL-USE BIOTECHNOLOGY

Biosecurity and Dual-Use Biotechnology

Beneficial biotechnology research should continue. Research that could reasonably increase the transmissibility, host range, immune evasion, environmental stability, or lethality of a potential pandemic pathogen requires heightened legal controls before federal funding or laboratory work begins.

  • Covered research requires a federal permit, institutional biosafety approval, and review by an independent multidisciplinary panel that includes biosafety, public-health, national-security, ethics, and laboratory experts without a financial conflict.

  • The applicant must disclose the scientific purpose, safer alternatives considered, containment level, personnel screening, incident plan, expected public benefit, and plausible worst-case consequences.

  • Approval expires after one year unless renewed. Material changes to the organism, method, containment, location, or research objective require new review.

  • DNA-synthesis providers must screen customers and sequence orders against federally maintained risk criteria, protect legitimate customer information, and immediately pause and report a qualifying high-risk order for review.

  • A release, containment failure, unexplained exposure, theft, or material security breach must be reported to the designated federal authority within 24 hours. A public incident summary must be issued within 30 days unless specific security or investigative findings justify temporary redaction.

  • Inspectors must have authority to suspend work presenting an imminent risk. Knowing concealment, falsification, unauthorized transfer, or continued work after suspension may result in loss of funding, permit revocation, civil penalties, and criminal referral under applicable law.

  • Researchers and laboratory workers who report a good-faith safety concern must be protected from retaliation. Ordinary low-risk research and clinical work should not be subjected to the highest-risk process merely because it involves biotechnology.

Related policies: Public Health & Emergency Powers; Healthcare; National Cybersecurity Standards & Trusted Personnel; Military.

Status: Proposed / Draft — not yet formally adopted.

Originally published: August 15, 2026.

Last updated: September 25, 2026.

Version: Draft 0.1.

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