1. Our Commitment
Scoville Splice is committed to the responsible development and use of synthetic biology tools. We design our constructs with safety-by-design principles, provide transparent documentation of biosafety classifications, and require users to operate within established biosafety frameworks. We believe that the plant synthetic biology community can and must maintain high ethical standards while advancing science.
2. Biosafety Level Requirements
Construct files are classified by biosafety level requirements, as indicated in each construct's datasheet:
- BSL-1: Standard Capsicum constructs involving only native plant pathway genes with no mammalian activity. No special containment required beyond standard good laboratory practice (GLP).
- BSL-1 Enhanced: Constructs involving high-capsaicinoid accumulation or novel regulatory sequences. Requires standard IBC notification and eye/skin protection protocols.
- BSL-2: Any construct involving sequences with documented mammalian activity, potential aerosolization of concentrated capsaicinoids, or co-expression with pathogen-associated sequences. Requires IBC approval and appropriate containment.
Users are responsible for verifying the BSL classification of each construct with their institutional biosafety officer (BSO) before beginning physical work.
3. Institutional Biosafety Committee Requirements
All users conducting physical laboratory work with Scoville Splice constructs must have an active IBC protocol registration (or local equivalent, e.g., OGTR registration in Australia, SACGM review in the UK) covering the specific constructs and activities to be performed. Industrial or commercial users without institutional affiliation must have a biosafety management plan reviewed by a qualified biosafety professional. Users certify their IBC compliance by accepting these terms at the time of account creation.
4. NIH Guidelines Compliance
All users conducting research with Scoville Splice constructs must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. This includes: registration of all experiments with a properly constituted IBC; adherence to containment requirements; prohibition on deliberate release; compliance with DURC policies for any research meeting the definition of Dual-Use Research of Concern under Section II-A of the NIH Guidelines.
5. Ethical Limits on Construct Design
The Capsaicin Design Platform includes safeguards to prevent the design of constructs that exceed ethical limits. These include automated screening against: sequences known to confer mammalian toxicity at low doses; pathogen-associated sequences; gene drive elements; human germline-applicable sequences. Users who attempt to design constructs that trigger these safeguards will be notified, and flagged designs may be reviewed by Scoville Splice before processing. We reserve the right to decline to provide designs that we determine, in our sole discretion, pose unacceptable biosafety or ethical risks.
6. Dual-Use Research of Concern (DURC)
Scoville Splice is committed to the responsible communication and oversight of DURC as defined by U.S. federal policy. Users conducting research with Scoville Splice constructs that might constitute DURC must: identify the research as DURC to their IBC; submit to institutional DURC review; notify Scoville Splice at scovillesplice@gmail.com if they identify potential DURC applicability. Scoville Splice will cooperate with institutional and federal DURC oversight processes.
7. Incident Reporting
Licensees must report to scovillesplice@gmail.com within 24 hours any: accidental spill, release, or exposure involving Scoville Splice construct materials; unauthorized access to or theft of construct files or physical materials; discovery that construct materials have been used for purposes prohibited by the AUP or applicable licenses; safety incidents, near-misses, or potential biosafety breaches in connection with construct use. Scoville Splice will treat all reports with confidentiality to the extent permitted by law and will cooperate with institutional safety investigations.
8. International Compliance
Users outside the United States must comply with the biosafety laws and regulations applicable in their jurisdiction, including but not limited to: the Cartagena Protocol on Biosafety (for cross-border movements of living modified organisms); the Nagoya Protocol on access and benefit-sharing; applicable national biosafety laws and GMO regulations. It is the user's responsibility to determine the regulatory status of Scoville Splice constructs in their jurisdiction before use. Scoville Splice makes no representation that constructs are approved for use in any particular jurisdiction.
9. Destruction of Materials
When laboratory work is complete or a license expires, Licensee must destroy all physical constructs, transformed cells, and derived materials by autoclaving (minimum 121°C, 15 psi, 20 minutes), incineration, or chemical treatment validated for the materials involved. Digital files should be deleted and their deletion certified to Scoville Splice upon request.
10. Biosafety Questions
Questions about biosafety compliance, construct classification, or incident reporting: scovillesplice@gmail.com