--- title: "KYE™ Genomics-Biosecurity Authority Pack™ — AI genomic-sequence biosecurity & clinical-genomic authority · KYE™ Sector Pack Foundry™ · KYE Protocol™" description: "The Genomics-Biosecurity Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack governing AI-generated and AI-assisted genomic sequences at the action boundary. Every sequence moving toward synthesis, order, or a regulated wet-lab / clinical stage maps to a recorded admissibility decision, a sequence-of-concern screen, a CLIA / ISO 15189 provenance pin, a GDPR / PHIPA genomic-data authority basis, and named biosafety oversight. Bound to the Genetic Sequencing Authority Agent™." url: https://kyeprotocol.com/foundry/genomics-biosecurity-authority-pack/ lang: en source: "KYE Protocol" --- > The Genomics-Biosecurity Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack governing AI-generated and AI-assisted genomic sequences at the action boundary. Every sequence moving toward synthesis, order, or a regulated wet-lab / clinical stage maps to a recorded admissibility decision, a sequence-of-concern screen, a CLIA / ISO 15189 provenance pin, a GDPR / PHIPA genomic-data authority basis, and named biosafety oversight. Bound to the Genetic Sequencing Authority Agent™. KYE™ Sector Pack Foundry™ # Genomics-Biosecurity Authority Pack™ for AI-generated genomic sequences. When an AI-generated or AI-assisted genomic sequence moves toward synthesis, an order, or a regulated wet-lab or clinical stage, KYE Protocol™ governs **whether it may proceed** — and proves the basis. The Genomics-Biosecurity Authority Pack™ binds each consequential action to a recorded admissibility decision, a sequence-of-concern screen, a laboratory-grade provenance pin, a genomic-data authority basis, and named biosafety oversight — sealed at the moment it happens and verifiable offline. It is bound to the Genetic Sequencing Authority Agent™. [Apply via the Foundry](https://kyeprotocol.com/sector-pack-foundry/apply/) See the pipeline Why this Pack exists The wedge ## AI genome design meets biosecurity screening — the action boundary is where authority is decided. AI models now generate and optimise nucleic-acid sequences at scale. The same capability that accelerates therapeutics raises a dual-use concern that regulators and synthesis providers are moving to close. Several facts converge: - **Synthesis screening is becoming mandatory.** US EO 14110 §4.4 and the IBBIS Common Mechanism / IGSC Harmonized Screening Protocol push sequence-of-concern screening to the point of order. An AI design heading toward synthesis needs a recorded screening result, not an after-the-fact log. - **Dual-use overlap is real.** Genomic designs can intersect Australia Group control lists and CWC / BWC prohibited-agent scope. The cross-check belongs at the action boundary, before the order commits. - **Clinical genomics is regulated laboratory work.** When AI assists interpretation in a CLIA / ISO 15189 laboratory, the provenance of the model, inputs, and reference data must carry laboratory-grade and GxP-grade data integrity — verifiable, not asserted. - **Genomic data is special-category personal data.** GDPR Article 9 (genetic and health data) and PHIPA Ontario custodianship govern its use. The authority basis must bind to the consequential action, not sit in a separate consent ledger. Why a lab or platform buys this ## Recorded authority on every consequential action — derivable from public keys alone. - **Admissibility at the moment, not after.** Each sequence heading toward synthesis, order, or a regulated stage carries a recorded admissibility decision binding the Genetic Sequencing Authority Agent™, the design artefact, the intended action, and the authority under which it proceeds. - **Sequence-of-concern screening native.** A recorded screen (IBBIS Common Mechanism / IGSC protocol) cross-checked against Australia Group and CWC / BWC scope. A flagged or unscreened sequence is refused and routed dual-channel. - **Laboratory-grade provenance pin.** A signed, replay-derivable provenance record binds the generating model and version, the inputs and pinned reference data, the screening result, and the admissibility outcome — CLIA / ISO 15189 and GxP-grade, verifiable offline. - **Genomic-data authority bound to the action.** GDPR Article 9 special-category basis and PHIPA Ontario custodian basis recorded against each use of identifiable genomic data, at the action boundary. - **Named human oversight.** An AI design stays advisory until an institutional biosafety committee, a CLIA / ISO 15189 laboratory director, or a designated responsible person records sign-off. The accountability is personal and named, and does not transfer to the AI. How productisation works ## A governed pipeline — from AI sequence to oversight-signed action. Every consequential action flows through the same governed steps. The pipeline is bound to canonical KYE Protocol™ envelopes — no parallel surfaces, no one-off shapes per lab. 1. **1 — AI sequence proposed.** A model generates or optimises a nucleic-acid sequence that the lab intends to move toward synthesis, an order, or a regulated stage. 2. **2 — KYE™ admissibility check.** The Action Admissibility™ Gate verifies the recorded admissibility decision via the Genetic Sequencing Authority Agent™. No decision = no action. 3. **3 — Sequence-of-concern screen.** The recorded screen (IBBIS / IGSC) plus Australia Group and CWC / BWC cross-checks. A flag refuses the action and routes dual-channel. 4. **4 — Provenance pin emitted.** The runtime emits kye.evidence.tool\_call.v1 + kye.replay.context\_seal.v1 + kye.evidence.pack.v1 binding model, inputs, reference data, and screening result. 5. **5 — Genomic-data authority recorded.** The GDPR Article 9 / PHIPA Ontario authority basis for any identifiable genomic data is bound to the action envelope. 6. **6 — Oversight sign-off.** A named biosafety committee, laboratory director, or responsible person records sign-off. Unreviewed AI-driven actions are refused. 7. **7 — Evidence sealed.** The signed Evidence Pack™ is sealed and made replay-derivable from published JWKS, available to the lab, the oversight body, and a regulator on demand. 8. **8 — Register surfaced.** The consequential-action register surfaces in the compliance and oversight view, reviewed and co-signed on the Pack’s attestation cadence. Framework binding ## Bound to the canonical genomics-biosecurity regulatory perimeter. The Pack binds the canonical KYE™ artefact set — the bio-chem-governance sector pack, rule pack, and dictionary — to the genomics-biosecurity regulatory perimeter. Every claim resolves to a control row on a deep-mapped framework. | Framework | Control area | Pack coverage | | --- | --- | --- | | Nucleic-acid synthesis screening (IBBIS / IGSC) | Sequence-of-concern screening at the point of order | full | | Australia Group | Dual-use biological control-list cross-check | partial | | CWC / BWC | Prohibited-agent / schedule scope cross-check | partial | | US EO 14110 | §4.4 synthesis screening + §4.5 content provenance + human oversight | partial | | CLIA / ISO 15189 | Medical-laboratory provenance & laboratory-director responsibility | partial | | GDPR Article 9 / PHIPA Ontario | Special-category genomic-data authority basis | full | Full coverage means every requirement in the control area is bound to a canonical KYE™ rule, dictionary term, or evidence-pack contract. Partial coverage means the bound surface satisfies the control area when paired with the deploying lab’s own attestation envelope. Honest scope ## KYE Protocol™ governs whether a sequence may proceed — and proves it. KYE Protocol™ governs WHETHER an AI-generated genomic sequence may proceed to a consequential action and PROVES the basis. KYE Protocol™ does not design sequences, fold proteins, run the screening pipeline, interpret clinical genomic results, or judge the scientific validity of a design. The screening science stays with the lab and the established screening providers; KYE Protocol™ binds the authority decision and the evidence around it. Apply via the Foundry ## Qualified genomics partners — apply through the Foundry. The Genomics-Biosecurity Authority Pack™ is a canonical reference expert-pack under constitution §54 §13. Productisation is via the KYE™ Sector Pack Foundry™ Build tier; commercial distribution is value-based, qualification-gated, and disclosed under NDA to qualified applicants. [Apply via the Foundry](https://kyeprotocol.com/sector-pack-foundry/apply/) [See the three Foundry tiers](https://kyeprotocol.com/sector-pack-foundry/) [Bound regulatory frameworks](https://kyeprotocol.com/frameworks/) Canonical KYE™ surfaces referenced on this page: [Evidence Pack™](https://kyeprotocol.com/evidence-pack/) · [KYE Protocol™](https://kyeprotocol.com/).