Safety/What is Safety
Safety, security and responsible conduct
iGEM teams follow a high standard of safe, secure and responsible biological engineering. Because you are members of the synthetic biology community, you are responsible for living up to the trust placed in you to design, build, and share biological devices safely.
iGEM teams are expected to consider potential risks to themselves, their colleagues communities and the environment. Teams are also expected to take step to manage any risks they identity, including from accidents (through biosafety procedures and practices) and from deliberate misuse (through biosecurity procedures and practices).
iGEM believes in addressing safety and security issues throughout the competition lifecycle. iGEM teams are expected to update and revise their risk assessments as their projects evolve and to review and revise the risk management measures they are using. iGEM's safety and security programme is based around safe and secure Project Design, Laboratory Work, and Transfer Practices.
What is safety
In iGEM, safety, or biosafety, covers the procedures, practices or other measures used to manage risks from accidental exposure or release. They protect people from bad bugs.
What is security
In iGEM, security, or biosecurity, covers the procedures, practices or other measures used to manage risks from deliberate exposure or release. They protect bugs from bad people
Safe and Secure Project Design
Be a responsible engineer! As part of the process of designing your project you need to think about any potential risks to you, your colleagues, communities, or the environment. You then need to identify what procedures, practices or containment measures are needed to manage those risks. You might need to redesign your projects to avoid some of those risks. To support you, we provide guidance and tools on risk assessment. You can find links to external resources and we are working with experts around the world to create our own risk assessment tool.
You need to record the risks you identify and the measures you are using to manage them in your Safety and Security Form. As your project evolves, the possible risks connected to it can also change. You will need to review and update your Safety and Security Form regularly. This is why is the form is considered a work in progress until it is submitted by your PI prior to the Jamboree.
You will also need to think carefully about what would happen if you completely "finished" your project, and turned it into a product that real people use. What effects might it have in the real world? Here are some questions to get you started:
- Who will use your product? What opinions do these people have about your project?
- Where will your product be used? On a farm, in a factory, inside human bodies, in the ocean?
- If your product is successful, who will receive benefits and who will be harmed?
- What happens when it's all used up? Will it be sterilized, discarded, or recycled?
- Is it safer, cheaper, or better than other technologies that do the same thing?
- Could others use your project in ways other than you plan to cause accidental or deliberate harm?
Consider these questions, and consider how you might modify your project design in response to these real-world issues. Even if you cannot think of a good modification, you can discuss the problem with others, and propose future experiments to find a good solution.
>Safe and Secure Lab Work
All biological lab work, even simple experiments, carries some risk to the experimenter. To reduce these risks, iGEM teams should work in properly equipped facilities and use standard lab safety techniques. Teams should also consider the organisms and parts they will work with, and what hazards are associated with these organisms/parts by themselves or in combination. We encourage iGEM teams to pursue ambitious projects and to reduce risks by using safer substitutes for more dangerous organisms/parts.
iGEM's Lab Safety and Security Rules
- Teams must use the Safety and Security Form, to provide information on any safety and security risks from their project and steps taken to manage them.
- Teams must complete a Check-In Form before using parts and organisms not on the White List , and submit an animal use request form before using vertebrates.
- The Instructor or Primary Contact must sign off the Safety and Security Form and any animal use request form before using vertebrates.
- All deadlines for providing safety and security information must be met.
- Teams must be in full compliance with iGEM's safety and security policies.
- Teams must work in the biosafety level appropriate for their project. If your project involves organisms and parts that can be used safely in a BSL1 lab, you should not work at higher containment levels. If this is not possible an explanation must be provided in the Safety and Security Form
- Teams must follow iGEM shipment requirements when submitting samples
- Teams must follow all biosafety and biosecurity rules of their institution and all biosafety and biosecurity laws of their country
- Teams cannot conduct work with Risk Group 3 or 4 organisms
- Teams cannot conduct research in a Safety Level 3 or 4 laboratory
- Teams cannot conduct work with parts from a Risk Group 4 organism
- Teams cannot release or deploy their project outside of the laboratory (including putting them in people) at any time during the competition or at the Giant Jamboree
- If you conduct any experiment with human subjects (including non-invasive experiments, such as surveys), you must comply with all rules of your institution/country that govern experiments with human subjects.
NOTE
Failure to meet any of these requirements can lead to immediate disqualification from the competition and referral to the Responsible Conduct Committee.
Working Safely and Securely with Organisms
Microorganisms are generally classified into four Risk Groups, according to how dangerous they are to humans. The majority of iGEM teams use Risk Group 1 organisms, such as yeast or E. coli K-12. A few teams use Risk Group 2 organisms, such as human cell lines. iGEM teams are not permitted to use Risk Group 3 or 4 organisms, or to work in Safety Level 3 or 4 laboratories.
Appropriate safety precautions depend on the Risk Group of the organisms you work with. Choose an appropriate lab facility and use the correct protective equipment for the organisms you use in your project.
Read the page about Risk Groups and Safety Levels for more detail, including how to find out which Risk Group an organism is in.
Working Safely and Securely with Parts
When you work with biological parts, you must consider the function of each part to determine whether and how you can handle it safely. We encourage iGEM teams to avoid the use of dangerous parts and to seek safer alternatives.
If you are unsure about a part, consult your team instructors or your institutional biosafety officers. You can also email safety AT igem DOT org for advice!
Parts in Combination and Context
Even if the individual parts in your project are safe, they may have a dangerous function when combined. You must think about how your parts will work together. Could they imitate the function of a virulence factor? Could they be harmful to humans or the environment in some other way? A white paper on the issue was put together by the 2016 Arizona State team.
Safety Flag
The iGEM Safety Committee puts Safety Red Flags on certain parts in the Registry, which present safety risks beyond what is normal for the Registry. Be extra careful when handling these parts, and consult with your team instructors to determine if you need any additional safety precautions. Any part with a Red Flag requires a Check-In before you acquire or use that part.
Toxins
Is your part toxic to humans? It could encode a protein that is toxic by itself (like Botulinum toxin, a.k.a. Botox), or perhaps it is an enzyme that synthesizes a toxic small molecule.
Virulence Factors
Virulence factors are genes that give microbes certain capabilities to infect or sicken people. Although these capabilities can be useful in synthetic biology, they also make microbes more dangerous.
Visit Virulence Factors of Pathogenic Bacteria to learn more.
General Lab Safety Manuals
- Synthetic Biology: A Lab Manual by Liljeruhm, Gullberg, and Forster: general guide to laboratory work in synthetic biology, with a chapter on basic safety practices. Purchase on Amazon
- WHO Biosafety Manual: PDF format, in several languages (English, Français, Español, Português, 中文, Русский, Italiano, 日本語, Српски / srpski, Tiếng Việt)
- Biosafety in Microbial and Biomedical Laboratories (BMBL): a comprehensive guide to laboratory safety, published by the US Centers for Disease Control and Prevention.
Non-Biological Hazards
Laboratories also have physical and chemical hazards, such as:
- Fire
- Sharp objects & broken glass
- Extreme cold temperatures (e.g. liquid nitrogen)
- Acids and corrosive chemicals
- Toxins (e.g. acrylamide)
Follow your institution's rules about how to work safely with these hazards.
>Safe and Secure Transfers
Protect your part submissions from delays and blockages!
iGEM teams and the Registry frequently exchange samples of DNA through the mail. Although these shipments are generally not dangerous, they are still governed by national and international laws. iGEM teams should learn how to ship DNA samples safely and legally, and learn which samples should not be shipped.
Why are there laws about shipping DNA?
Countries regulate the shipment of DNA across their national borders in order to keep dangerous genetic material under control. This is both to prevent people accidentally being harmed (by a spill or lab accident), and to prevent malicious actors from obtaining dangerous materials.
The vast majority of DNA that is sent and received by iGEM teams poses no risks and is perfectly safe for shipment. However, it is worthwhile to understand the rules and best practices around shipping DNA, both so that your routine safe shipments are less likely to be delayed by customs, and so that you can respond appropriately if you ever do want to ship something potentially dangerous.
Genes to Avoid Shipping
Different countries have different laws about what DNA cannot be shipped across national/state borders. If you are unsure, you should consult the biosafety office of your institution.
As a starting point, you can consult the Australia Group List and the U.S. Select Agents and Toxins List. If any of your parts come from organisms on the Australia Group List or the Select Agents and Toxins list, please contact iGEM (email safety AT igem DOT org) to discuss whether you should refrain from submitting these parts to the Reg