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Risk Groups

iGEM teams are not permitted to use Risk Group 3 or 4 organisms, or to work in Safety Level 3 or 4 laboratories.

Microorganisms are classified into four Risk Groups, and biological laboratories are classified into four corresponding Safety Levels. Risk Group 1 contains non-pathogenic organisms like yeast and E. coli K-12. The majority of iGEM teams use only Risk Group 1 organisms. Some teams use Risk Group 2 organisms.

	Permitted in iGEM		Not permitted in iGEM
	Risk Group 1	Risk Group 2	Risk Group 3	Risk Group 4
Lab Safety Level	Safety Level 1	Safety Level 2	Safety Level 3	Safety Level 4
Typical Lab Photo
Description	Risk Group 1 organisms do not cause disease in healthy adult humans.	Risk Group 2 organisms can cause disease in humans, but the disease is treatable or preventable.	Risk Group 3 organisms cause serious disease in humans. Treatments and vaccines for these diseases may exist.	Risk Group 4 organisms cause deadly disease in humans, and they can easily travel from one person to another. No treatments or vaccines exist for these diseases.
Typical Work Area	Open bench	Biosafety cabinet	Class 3 biosafety cabinet	Full isolation suits
Examples	E. coli K-12, S. cerevisiae (yeast), Lactobacillus, B. subtilis	Streptococcus, Herpes virus, most mammalian cell lines	Yersinia pestis (black plague), HIV, SARS virus	Ebola virus, Marburg virus, Lassa virus

What if we want to use a Risk Group 3 or 4 organism?

Don't do it. Find a substitute.

Risk Groups 3 and 4 include the most serious and deadly pathogens in the world. They require extremely stringent safety precautions and specialized lab facilities. There is no compelling reason for any iGEM team to choose to work with Risk Group 3 or 4 organisms, when instead you could choose from the vast array of interesting project topics that use only Risk Group 1 or 2 organisms.

Using safer substitutes for dangerous organisms is entirely appropriate for iGEM. For example, the 2013 Paris Bettencourt team studied tuberculosis. Mycobacterium tuberculosis is a Risk Group 3 organism, so for safety reasons, they substituted a related Risk Group 2 organism (Mycobacterium smegmatis) in their experiments. These experiments were a proof of principle for their project ideas.

Animals and plants have no Risk Group

The four Risk Groups only apply to microorganisms (bacteria, fungi, and viruses). For animals, plants, and other multicellular organisms, there are different safety guidelines. Please consult with your advisor or university authorities if you plan to do experiments with animals and plants.

If you are using a part from an animal or plant, you should consider the function of the part, and consider whether it might be dangerous to humans. For example, the gene for Green Fluorescent Protein (GFP) comes from the jellyfish Aequorea victoria, which does not have a Risk Group. GFP is only a fluorescent protein, absorbing and emitting light, so it is safe for humans and you can use it in a Safety Level 1 lab. But if you consider a different gene from A. victoria, such as the gene for the toxin in its stinging tentacles, you might conclude that you should only use that gene under strict safety conditions!

Parts from higher risk groups

In many parts of the world, the highest risk group of any organism or part being used will determine the type of biosafety precautions needed for the work. This means if you are using a part or sequence (or synthesised genetic material with the same sequence) from an organism that needs a BSL4 laboratory, the work should only be undertaken in such a facility. As a result, iGEM teams are not allowed to use ANY part from a Risk Group 4 organism.

Some parts from risk group 2 and 3 organisms are permitted and more information can be found on the White List.

How can I find out the Risk Group of my organism?

1. Common iGEM organisms

Species	Risk Group
E. coli K-12 and derivatives (DH5alpha, TOP10, etc.)	1
S. cerevisiae	1
Most human and mammal cell lines	2
Lactobacillus spp.	1
Bacillus subtilis	1

2. Other Reliable Sources

If you cannot find your species in any of the recommended sources, you must find another reliable source. There may be a paper in the peer-reviewed scientific literature that describes your species. Your country's government might have its own list of microorganisms and their Risk Groups.

For help finding a reliable source, you can consult your advisor, or speak to the biosafety authorities of your university. You can also email safety AT igem DOT org for help.

3. Recommended Sources

To determine the Risk Group of an organism, we must consult reliable sources. There is no world-wide standard list of microorganisms and their Risk Groups. Some countries and some cell culture vendors have provided lists, but no single list includes all species, so you might need to check several sources. Some useful starting points include:.

List of pathogenic microorganisms transmitted from humans, China CDC

China CDC has published a list detailing the risk groups and biosafety levels of a wide variety of microorganisms.

In Chinese ⇗

NIH Guidelines, Appendix B

The NIH Guidelines ⇗ are a set of rules that govern research on recombinant/synthetic DNA in the United States. Appendix B of the guidelines gives a list of pathogens in Risk Groups 2, 3, and 4. It does not list Risk Group 1 organisms.

Click here to go directly to Appendix B ⇗

ABSA Risk Group Database

The American Biological Safety Association maintains a Database ⇗ of the risk groups of many different bacteria, viruses, fungi, and parasites.

Canadian Pathogen Safety Data Sheets (PSDS)

The Public Health Agency of Canada has published safety data sheets for a wide variety of microorganisms.

To use the PSDS, find your species in the list. Click on the species name to open extensive safety information about that species. Scroll down to "SECTION VII" and look for "RISK GROUP CLASSIFICATION" or "CONTAINMENT REQUIREMENTS".

American Type Culture Collection (ATCC) product sheets

The ATCC product sheets ⇗ include a recommended biosafety level for working with the microbes and cell cultures they provide. This is largely based in current rules and regulations in the United States.

Simply search for the specific strain, organism or culture you are interested in and examine the relevant product sheet. The recommended biosafety level is indicated in a black box on the top left of the document.

DSMZ

DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen / German Collection of Microorganisms and Cell Cultures) is a large collection that includes Risk Group information for thousands of different species, strains, and cell lines. It is more difficult to use, but it includes the most species of any source that iGEM recommends.

Catalogue Microorganisms ⇗ -- search bacteria. Enter your genus, species, and/or strain information in the "Search term" box, and click Search. You will receive a long list of results, which may include many different strains and species. Examine the list to find the correct strain, and click on its DSM number to view its catalogue page. The Risk Group is listed in the table.
Catalogue Human and Animal Cell Lines ⇗ -- search this catalogue by the same method as for Catalogue Microorganisms.
Prokaryotic Nomenclature Up to Date ⇗ is an alphabetical list of all bacterial and archaeal species names in the scientific literature. Find your species in the list, and click on its name to view details. In the table row "Type strain", look for a blue DSM link. If one is present, it will bring you to a DSMZ catalogue page where you can find details about that species. The Risk Group is listed in the table. (If there is no blue DSM link, it means that the DSMZ does not offer that species.)
Note: "Prokaryotic Nomenclature Up to Date" has information about wild strains of microorganisms, not lab strains. Wild strains of E. coli can cause disease in humans (so they are Risk Group 2), but lab strain E. coli is Risk Group 1 and is safe to handle.

Safety/Risk Groups