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healthcare · Federal Select Agent Program · NIH Guidelines · DURC Policy

Synthetic Biology / Biosecurity

Screening AI failure = criminal liability under Select Agent regulations

—Federal Select Agent Program + DURC

Regulatory exposure — commonly overlooked:
Cloud lab orders sequence — lab owns biosecurity violation, screening vendor owns API uptime SLA. · Multinationals built for one jurisdiction fail exams in another — one receipt architecture, many filing packs.

TAM / Exposure

Synthetic biology market $80B+ · DNA synthesis screening mandatory

Insurance lines

Biotech E&O · Product liability

Exhibit authority

Global External Validation — Biosecurity AI Screening Pack

Global leaders

CDC · Ginkgo Bioworks · Twist Bioscience · NIH · WHO · ISO · NIST · OECD

DURC policy

Dual use research of concern — AI screening decision must be documented for IBC review.

Sequence orders

Every synthesis order needs screening receipt — HHS 2010 framework now AI-accelerated.

Insurance exclusion

Biotech policies excluding unscreened AI sequence design.

[Global / Multi-jurisdiction] Jurisdiction shopping ends

Regulators share examination findings via IAIS, IOSCO, Basel — governance gap in one market triggers another.

[Global / Multi-jurisdiction] Vendor contract forum

AI vendor chooses Delaware law — deployer owns EU, UK, and US state fines simultaneously.

[Text / Chat] Modality hook

Baseline — all frameworks apply to text decisions.

7 mandate layers (live)

Regulatory Clock Countdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition. Open →

Domain Classifier Industry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping. Open →

Exhibit / Filing Pack Regulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11. Open →

Mandate Registry Enroll deployers/insureds under vertical-specific governance mandate. Open →

Bind / Action Gate ALLOW/BLOCK before consequential action — bind policy, sell loan, deactivate worker. Open →

Compliance Certificate Deployer-facing downloadable cert — forward to counsel, auditor, regulator. Open →

Actuarial / Risk Feed Anonymized asymmetry signals for pricing, reserving, reinsurance correlation. Open →

Run synthetic_biology demo Regulatory calendar Download exhibit pack Verify independently