KYE AI Bio-Chem Governance Pack™ for AI-designed sequences & molecules.
When an AI agent proposes a biological sequence or a chemical structure and that design starts to move toward synthesis, a wet-lab experiment, or a regulated stage, the consequential moment has arrived. The KYE AI Bio-Chem Governance Pack™ governs that action boundary: it binds every consequential action to a recorded authority, screens the design against dual-use controls, holds it advisory until a named biosafety committee or chemical-safety authority signs off, and seals it into a replay-provable provenance record. KYE Protocol™ governs whether the design may proceed — it does not fold proteins, design molecules, or judge the scientific validity of a design.
AI now designs biology and chemistry — and the design layer is where dual-use risk concentrates.
Protein-design models, generative-chemistry systems, and self-driving labs are producing candidate sequences and molecules that move quickly toward synthesis and the bench. The high-value problem is not the science — it is the action boundary. Three facts converge:
- The consequential moment is synthesis, not generation. A sequence in a model's output is inert; a sequence in a synthesis order is consequential. Dual-use control and biosecurity attach at the moment a design proceeds — exactly where governance is weakest.
- The controls already exist; the enforcement of authority does not. US EO 14110's biosecurity provisions, the IBBIS Common Mechanism and IGSC Harmonized Screening Protocol, Australia Group export lists, and the CWC/BWC schedules define what is of concern. KYE Protocol™ governs whether an AI-generated design may proceed under those controls, under whose authority, with screening recorded.
- Provenance is now a regulated expectation. An AI-derived candidate entering an FDA / EMA pipeline must carry documented provenance, reproducibility, and GxP data integrity. KYE Protocol™ produces a signed, replay-derivable provenance pin at the moment the action commits.
- This is a governance wedge, not a science engine. KYE Protocol™ does not compete with the design models. It governs the action boundary they feed — the AI biosecurity / dual-use control + scientific-provenance layer the design ecosystem currently lacks.
Survives a biosecurity spot check — screened, signed-off, and derivable from public keys alone.
- Dual-use-screened by construction. An AI-generated sequence or molecule that moves toward synthesis must carry a recorded screening result — sequence-of-concern (IBBIS / IGSC) for nucleic-acid designs, and controlled-substance / dual-use-list (Australia Group, CWC Schedules 1/2/3, BWC prohibited agents) for chemical and biological designs. A flagged or unscreened design is refused at the action-admissibility gate.
- Oversight-gated. A design stays advisory until a named institutional biosafety committee (IBC), chemical-safety authority, or designated responsible person records sign-off. Unreviewed AI-driven consequential actions are refused and routed dual-channel.
- Authority-bound. Every consequential action maps to a recorded synthesis-admissibility decision — the agent, the design artefact, the intended action, and the authority under which it proceeds. An AI authorised for one purpose cannot proceed under another.
- Replay-provable provenance. A signed provenance pin binds the model and version, the inputs and pinned reference data, the screening result, and the admissibility outcome — GxP-grade data integrity an FDA / EMA reviewer can verify offline, against published keys alone.
- Framework-anchored. US EO 14110 (biosecurity / synthesis screening / provenance), nucleic-acid synthesis screening (IBBIS / IGSC), Australia Group, CWC/BWC, and FDA/EMA AI-provenance each map to a control row — with a 90-day attestation cadence.
Every consequential bio/chem action — authority-bound at the action boundary.
One coherent spine governs three specializations — protein-design, generative-chemistry, and molecular-biology / self-driving-labs — with no parallel packs. Each AI-designed artefact that moves toward a consequential action flows through the same four rules, on the canonical KYE Protocol™ envelopes.
- 1 — Design proposed. An AI agent produces a biological sequence or chemical structure that begins to move toward synthesis, order placement, a wet-lab experiment, or a regulated stage.
- 2 — Dual-use screen + admissibility check. The Action Admissibility™ Gate verifies a recorded dual-use screening result (sequence-of-concern + dual-use / scheduled lists) and the authority under which the design proceeds, under the §25 Edge Governance Safety Floor. No screen, no authority = no action.
- 3 — Advisory pending oversight. The design is advisory until a named biosafety committee, chemical-safety authority, or responsible person records oversight sign-off. Flagged or unreviewed designs are refused and routed dual-channel.
- 4 — Provenance pin sealed. The runtime emits kye.purpose.request.v1 + kye.purpose.admissibility.v1 + kye.evidence.decision_map.v1 + kye.evidence.pack.v1 in lockstep, binding the model and version, the screening result, the named oversight authority, and the Authority Finality™ outcome — signed and replay-derivable for a biosecurity or regulatory spot check.
Bound to the AI biosecurity + dual-use + provenance perimeter.
The pack binds the canonical KYE™ artefact set to the dual-use control perimeter. Every claim resolves to a control row on the bound framework — the five regulations are consumed by the rule pack, never re-mapped.
| Framework | Control area | Pack coverage |
|---|---|---|
| US EO 14110 | Biosecurity, nucleic-acid synthesis screening, content provenance, human oversight | partial |
| Nucleic-Acid Synthesis Screening (IBBIS / IGSC) | Sequence-of-concern + customer screening before synthesis | partial |
| Australia Group | Dual-use biological agents, toxins, equipment & chemical precursors | partial |
| CWC + BWC | CWC Schedules 1/2/3 chemicals; BWC prohibited bio / toxin agents | partial |
| FDA + EMA AI provenance | Design provenance, reproducibility, GxP data integrity (ALCOA+) | partial |
Honest scope. KYE Protocol™ governs the authority, screening, oversight, and provenance of the AI instruction at the action boundary — whether the design may proceed. It does not fold proteins, design molecules, run the screening pipeline, or judge the scientific validity of a design. Partial coverage means the bound surface satisfies the control area when paired with the organisation’s own screening and attestation.
Qualified bio/chem AI partners — apply through the Foundry.
The KYE AI Bio-Chem Governance Pack™ is a §68 sector product productised through the KYE Sector Pack Foundry™ Build tier; commercial distribution is value-based, qualification-gated, and disclosed under NDA to qualified applicants.