Safety/Working Safely

Introduction

Safety, security and responsible conduct

iGEM's Rules of Conduct require teams to be safe, secure and responsible in their 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.

Working safely and securely is a core element of responsible research and innovation. iGEM teams are expected to consider potential risks to themselves, their colleagues communities and the environment. Teams are also expected to manage any risks, including from accidents (through biosafety procedures and practices) and from deliberate misuse (through dual-use and biosecurity procedures and practices).


Watch the Responsible Conduct in Synthetic Biology video on YouTube. ⇗

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 and security?

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.

What is dual-use?

In iGEM, dual-use covers the procedures, practices or other measures used to manage risks that others may misuse your ideas, information or materials to cause harm.

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. For example, the 2016 Arizona State team won a Safety and Security Commendation for developing a white paper on context specific risks.

You will need to identify what procedures, practices or containment measures are needed to manage those risks. For example, the 2012 Paris Bettencourt team won a Safety and Security Commendation for developing a three-level containment system. Members of our community have reviewed some useful tools, such as biosafety systems constructed, either to prevent survival of bacteria outside the lab or to hinder horizontal or vertical gene transfer.

You might need to redesign your projects to avoid some of those risks. For example, the 2014 Aachen team won a Safety and Security Commendation for designing safety into their project and demonstrating their precautions worked.

You might need to think about how others might misuse your project to cause harm. For example, the 2018 Bielefeld-CeBiTec team won a Safety and Security Commendation for considering how their project to reclaim previous metals from discarded electronics could be misused to damage electronics still in use.

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 MUST follow all of iGEM's safety and security rules. You 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 the activities they plan to undertake. Teams should think about hazards associated with organisms or parts by themselves or in combination. Teams wishing to use any organism or part, or to undertake activities not on the White List, will need to use a Check-In form to get permission from the Safety and Security Committee before starting work. We encourage iGEM teams to pursue ambitious projects and to reduce risks by using safer substitutes for more dangerous organisms/parts.

Simply following national or institutional rules and regulations is a minimal requirement. We expect teams to go above and beyond in demonstrating their commitments to responsible and ethical conduct. For example, for teams that do not have established review committees at their institutions (e.g. some community lab teams), we expect them to consult with the international and national policies and other resources and experts linked on the Safety Hub and Human Practices Hub (see the ‘How to Succeed’ section of the Hub).

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
  • Carcinogens, heavy metals or mutagens
  • Psychoactive chemicals
  • Explosives

Follow your institution's rules about how to work safely with these hazards.

Use of controlled chemicals, including those that are particularly hazardous, explosive or psychoactive, will need approval in advance from the Safety and Security Committee. Permission should be requested using a Check-In Form.

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.

iGEM puts Red Flags on certain parts in the Registry, which present safety and security risks beyond what is normal for the Registry. Any part with a Red Flag requires a Check-In before you acquire or use that part. Be extra careful when handling these parts, and consult with your team instructors to determine if you need any additional safety precautions.

Here is a complete list of all parts that have Red Flags.

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.

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.

Safe and Secure Transfers

Transfers can take different forms. You might be getting organisms, parts, genetic material or other resources from another country. You might be sharing biological resources with another team somewhere else. Alternatively, you will also transfer the results of your work to the iGEM community through your wiki, poster and presentation. Throughout your project you might also be transferring data, information and knowledge on both biological engineering and your project outside the iGEM community. It is important that your think about safety and security whenever transferring materials or information.

Safe and Secure Shipment

iGEM teams 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 Registry.

Packaging and Customs

Do not attempt to disguise the nature of your shipment. It is never acceptable be disguise a shipment of biological samples or parts.

Disguised shipments include:

  • Dishonest or misleading labeling on the outside of the package
  • Dishonest or misleading customs declarations
  • DNA samples hidden inside "non-scientific looking" materials, like books or clothing

Safe and Secure Communication

Thinking about risks from accidental or deliberate harm when communicating about your work helps make you a responsible biological engineer! There is a very close connection between your safety and security work and your human practices work.

Some teams have included details on how they addressed safety and security concerns in their talks, posters and wikis. For example the 2017 Wageningen UR team won a Safety and Security Prize for how they addressed these issues in their presentation and poster.

Other teams have put safety or security at the core of their project. For example, the 2011 IIT Madras team won a Safety and Security Commendation for experimental work to develop markers other than antibiotic resistance.

Some teams have developed specific outreach materials, or tools for the iGEM community, on safety and security issues. For example the 2015 Bielefeld-CeBiTec team won a Safety and Security Commendation for their report on the dual-use nature of advanced biotechnology.