1. Nature of the System

Our detection platform is an in vitro protein biosensor system, which contains no living cells or organisms and lacks any replication capability.

The system components (e.g. enzyme mixtures, purified proteins, substrates) are biochemically inert and cannot autonomously propagate or evolve in the environment.

We include post-reaction inactivation steps (such as adding guanidine hydrochloride) to ensure that no residual enzymatic activity or reactive species remain, preventing unintended reactions outside controlled conditions.

2. “Do Not Release” Commitment & Containment

We fully adhere to the iGEM “Do Not Release” policy: at no point will any transgenic organisms, live cells, or their genetic elements be released into the environment.

During transport, storage, and handling, sensor kits are packaged in leak-proof, tamper-resistant containers, with secondary containment to avoid accidental spillage.

3. Risk Group Considerations

Our system does not employ any pathogenic strains or live Pst or virulent bacteria. All biological inputs are recombinant proteins, enzymes from standard safe strains (e.g. E. coli K-12 and E. coli B).

All experimental work is conducted in a BSL-1 or institutional laboratory setting compliant with standard molecular biology safety practices (biosafety cabinets, lab coats, gloves, etc.).

No part of our design requires handling of BSL-2 / BSL-3 pathogens or high-risk agents.

4. Material & Reagent Safety, Transport & Storage

All reagents and enzymes are sourced from certified suppliers; no materials designated as regulated or restricted biohazard reagents are used.

Enzymes, buffers, and substrates are aliquoted and sealed; storage follows recommended temperature and buffer conditions to avoid degradation or cross-contamination.

During transport, kits are placed in sealed packaging with absorbent materials; dry ice / cold chain will comply with shipping regulations for biological reagents.

Any sharps (e.g. pipette tips), discarded reagents, and consumables are handled as biohazard waste and autoclaved or chemically deactivated prior to disposal.

5.Hardware Safety

In addition, our hardware adhered to a predetermined and standard operating method for the workflow. This not only reduced the likelihood of any potential safety issues occurring, but it also lowered the risk of any system components escaping into the environment. Hardware page has other details pertaining the Protato kit that may be found.

6. Risk of Misuse, False Results & Mitigation

We recognize the possibility of false positives or false negatives. To mitigate this risk:

• Each sensor run includes positive and negative controls.
• Calibration curves and internal standards are built into the assays.
• Readouts require threshold confirmation or duplicate measurements to reduce erroneous interpretation.

Misuse (e.g. using the sensor for pathogens other than Pst or misapplying it) is discouraged; user guides include warnings and instructions for correct interpretation and limitations of the assay.

We will include disclaimers indicating that this biosensor is intended as a screening / early warning device, not a definitive diagnostic in clinical or regulatory contexts.

7.Regulatory, Ethical & Institutional Compliance

All of the team members have to follow multiple introduction sessions given by the lab manager. These introductions elaborately cover safety policies and rules inside the specific labs. Every freshman entering the lab must read the manual on Laboratory Safety and Hazardous Chemicals Safety. Besides, anyone who is permitted to use our lab must pass the laboratory safety and skill exam at 90% correctness or above.

Any sampling from real plants or field environments is done with permits and with consideration to avoid environmental contamination.

8. Environmental Impact & Waste Management

Our lab has equipped many facilities that keep our experimental environment safe. The location of all safety equipment was shown during this introduction. All the specific hazards are locked in a hazardous warehouse which can only be opened by two lab managers, detailed in the Safety Form.

After use, sensor consumables and reaction mixtures are inactivated (e.g. by heating, chemical denaturants) before disposal.

Waste liquids are treated with bleach or other approved disinfectants prior to discharge.

Solid wastes are collected in biohazard bags and autoclaved / incinerated per institutional disposal protocols.

We assess the life cycle of consumables to minimize plastic and chemical footprint; explore biodegradable packaging or minimal waste designs for future versions.