§ Biosecurity
Biosecurity Policy
TuringDNA is a directed-evolution design tool with an optional DNA-synthesis marketplace (not yet live). This policy describes our biosecurity posture, what we expect from users, and what authorities can expect from us. Cross-referenced from Terms §4 and §7.3, and Privacy Policy.
Purpose
TuringDNA does not manufacture DNA. When the synthesis marketplace launches, manufacturing and primary biosecurity screening will be performed by our Vendors (initially Twist Bioscience, IDT, and GenScript). This policy describes how we relate to that screening pipeline and what we require from users.
The goal is straightforward: prevent misuse of the Service for the design or production of dangerous biological agents, while keeping the tool usable for legitimate protein-engineering research.
Standards and frameworks we follow
We design our practices around the following frameworks. We do not claim certification under any of them; we use them as the reference for "what good looks like":
- International Gene Synthesis Consortium (IGSC) Harmonized Screening Protocol — the industry standard for double-screening of synthesis orders (sequence screening + customer screening).
- U.S. HHS Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids (2023).
- Select Agent Regulations: 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73.
- Australia Group control lists for biological agents, toxins, and equipment.
- EU Dual-Use Regulation (EU) 2021/821 and analogous national export controls.
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules — for downstream-use guidance.
- WHO Laboratory Biosafety Manual (4th edition) — for downstream-use guidance.
Roles
| Party | Responsibility |
|---|---|
| User | Comply with all applicable biosecurity, export, and safety laws. Only design and order sequences for legitimate research use. Provide accurate organization/affiliation information at order. Comply with each Vendor's biosecurity flow-down terms. |
| Vendor | Perform IGSC-aligned sequence screening and customer screening for every order. Report flagged orders to TuringDNA and, where required, to authorities. Determine, in its discretion, whether to manufacture an order. |
| TuringDNA | Pass user-attestation and order data to Vendors. Refuse or hold any order at our discretion, including based on Vendor flags, our own review, or risk signals. Cooperate with Vendor and authority inquiries. Maintain account, order, and audit records per the Privacy Policy. |
What the Service does and does not do at the screening layer
Does:
- Surfaces a research-use-only banner in the engine UI at every step (paste, edit, synthesize, download).
- Requires the user to acknowledge the Acceptable Use list in Terms §4 before ordering.
- Forwards Vendor flag responses to the user and allows the user to revise or withdraw an order.
- Maintains an audit trail of orders, including the requesting account, the Sequence as submitted, the Vendor selected, the flag/clear response, and the disposition.
Does not:
- Perform our own primary biosecurity screening. The Vendor's screening is authoritative. We may add a lightweight pre-filter in the future (see Forward-looking commitments below); we do not represent that the current Service catches risky sequences before reaching the Vendor.
- Verify user identity beyond email confirmation. Customer screening (the IGSC's "Know Your Customer" component) is the Vendor's.
- Guarantee that a sequence cleared by a Vendor is safe to manufacture or to use — that is the user's responsibility.
Prohibited sequences and uses
You may not use the Service to design, order, request, or facilitate synthesis of:
- Any sequence encoding (in whole or substantially in part) a select agent or toxin listed under 7 CFR Part 331, 9 CFR Part 121, or 42 CFR Part 73, except where you hold the registrations required to possess such agents and you have notified us in writing prior to the order.
- Any pathogen of pandemic potential, including any sequence on the relevant national or international consensus lists.
- Gain-of-function modifications of pathogens that increase transmissibility, virulence, host range, or evasion of countermeasures.
- Any sequence listed on the Australia Group dual-use biological control lists, or any sequence controlled under the U.S. EAR, ITAR, or your national export-control regime, except under valid licenses.
- Gene drives, horizontal-transfer systems, or sequences for environmental release, unless you hold all required regulatory authorizations and provide proof on request.
- Sequences for clinical, diagnostic, therapeutic, prophylactic, food, feed, or cosmetic use (see Terms §12 — Research Use Only).
- Sequences intended for biological-weapon use, as defined under the Biological and Toxin Weapons Convention and U.S. 18 U.S.C. § 175.
We may refuse or cancel any order at our discretion, including based on Vendor flags or our own review, without liability.
Reporting and disclosure
To Vendors. We share order details (account, Sequence, attestation) with the Vendor you select. The Vendor performs IGSC-aligned screening and may decline or hold your order under its own policy.
To authorities. Where required by law, by Vendor agreement, or where we reasonably believe disclosure is necessary to prevent imminent harm, we may share order details (account information, the Sequence, the disposition) with biosecurity authorities (e.g., U.S. CDC Division of Select Agents and Toxins, USDA APHIS, FBI WMD Coordinators) or your national equivalent. We may do so without notice to you where notice would be unlawful, infeasible, or would risk harm.
To the public. We do not currently publish aggregate or per-order screening statistics. We may publish aggregated, anonymized statistics in the future if it serves the biosecurity community.
Refusal authority
We may, without liability:
- Refuse to accept any order.
- Hold any order pending review.
- Cancel any order at any stage before shipment.
- Suspend or terminate the account responsible for any order that, in our judgment, violates this policy or §4 of the Terms.
Refusals based on Vendor flags pass through Vendor remedies under Terms §7.6. Refusals based on our own review are at our sole discretion.
Forward-looking commitments
The following are stated intentions, not current commitments, and may change:
- Add a lightweight in-app sequence-class warning for obvious red flags before the order is submitted to the Vendor (e.g., similarity to known select-agent toxins). This is not a substitute for Vendor screening.
- Publish an annual transparency note describing aggregate refusal rates and categories.
- Join or align with the IGSC as a non-manufacturer member if eligibility permits.
Reporting concerns
If you believe an order, account, or use of the Service raises a biosecurity concern, contact info@turingdna.com with the subject line "Biosecurity". Reports may be made anonymously; we will protect the identity of good-faith reporters to the extent permitted by law.
For urgent threats, contact appropriate authorities directly:
- U.S. FBI WMD Coordinator in your local field office (locations at fbi.gov).
- U.S. CDC Division of Select Agents and Toxins — selectagents@cdc.gov.
- Your national biosecurity authority outside the U.S.
Contact
TuringDNA
Tbilisi, Georgia
info@turingdna.com