Difference between revisions of "Safety/Risk Groups"

 
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<h2>Risk Groups</h2>
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<h1> Risk Groups</h1>
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<p>iGEM teams often do projects that have an immediate practical application. But <em>within the context of the iGEM competition</em>, wet-lab projects should remain at an experimental stage. iGEM teams should not release or deploy any genetically modified organisms, or the products of genetically modified organisms, outside the lab.</p>
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<h4> iGEM teams are not permitted to use Risk Group 3 or 4 organisms, or to work in Safety Level 3 or 4 laboratories.</h4>
  
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<p>Any teams that release their genetically modified organisms, or products of their genetically modified organisms, will be referred to the <a href="https://2017.igem.org/Competition/Responsible_Conduct">Responsible Conduct Committee</a>.</p>
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<p>Microorganisms are classified into four <b>Risk Groups</b>, and biological laboratories are classified into four corresponding <b>Safety Levels</b>. 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. </p>
  
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<p>Instead of aiming toward release, we encourage you to focus on producing the best laboratory results.</p>
 
  
 
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<h2>Why?</h2>  
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<p><strong>Keep Your Activities Legal:</strong> In most countries, it is illegal to release GMOs or their products into the natural environment without extensive government permits and approvals. Obtaining these permits and approvals would probably take longer than the entire iGEM competition. Instead, you should focus your efforts on producing the best laboratory results. (And, of course, you should not release your GMOs illegally!)</p>
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<tr>
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<td>&nbsp;</td>
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<th>Risk Group 1</th>
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<th>Risk Group 2</th>
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<th>Risk Group 3</th>
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<th>Risk Group 4</th>
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</tr>
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<tr>
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<th>Examples</th>
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<td><i>E.&nbsp;coli</i>&nbsp;K-12, <i>S.&nbsp;cerevisiae</i> (yeast), <i>Lactobacillus</i>, <i>B.&nbsp;subtilis</i></td>
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<td><i>Streptococcus</i>, Herpes virus, most mammalian cell lines</td>
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<td><i>Yersinia&nbsp;pestis</i> (black plague), HIV, SARS virus</td>
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<td>Ebola virus, Marburg virus, Lassa virus</td>
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</tr>
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<tr>
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<th>Description</th>
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<td>Risk Group 1 organisms do not cause disease in healthy adult humans.</td>
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<td>Risk Group 2 organisms can cause disease in humans, but the disease is treatable or preventable.</td>
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<td>Risk Group 3 organisms cause serious disease in humans. Treatments and vaccines for these diseases may exist.</td>
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<td>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.</td>
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</tr>
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<tr>
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<th>Lab Safety Level</th>
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<td>Safety Level 1</td>
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<td>Safety Level 2</td>
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<td>Safety Level 3</td>
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<td>Safety Level 4</td>
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</tr>
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<tr>
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<th>Typical Lab Photo</th>
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<td><a href="https://2015.igem.org/File:BioSafetyLevel1.JPG"><img src="https://static.igem.org/mediawiki/2015/8/8a/BioSafetyLevel1.JPG" width="150px"></a></td>
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<td><a href="https://2015.igem.org/File:Sea-turtle-bsl2.jpg"><img src="https://static.igem.org/mediawiki/2015/4/47/Sea-turtle-bsl2.jpg" width="150px"></a></td>
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<td><a href="https://2015.igem.org/File:Phac-aspc-class3bsc.jpg"><img src="https://static.igem.org/mediawiki/2015/f/f5/Phac-aspc-class3bsc.jpg" width="150px"></a></td>
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<td><a href="https://2015.igem.org/File:Cdc-bsl4.jpg"><img src="https://static.igem.org/mediawiki/2015/c/c9/Cdc-bsl4.jpg" width="100px"></a></td>
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</tr>
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<th>Typical Work Area</th>
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<td>Open bench</td>
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<td>Biosafety cabinet</td>
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<td>Class 3 biosafety cabinet</td>
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<td>Full isolation suits</td>
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</tr>
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<tr>
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<td>&nbsp;</td>
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<td colspan="2">Permitted in iGEM</td>
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<td colspan="2">Not permitted in iGEM</td>
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<h3>What if we want to use a Risk Group 3 or 4 organism?</h3>
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<p>Don't do it. Find a substitute.</p>
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<p>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.</p>
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<p>Using safer substitutes for dangerous organisms is entirely appropriate for iGEM. For example, the 2013 Paris Bettencourt team studied tuberculosis. <i>Mycobacterium tuberculosis</i> is a Risk Group 3 organism, so for safety reasons, <a href="https://2013.igem.org/Team:Paris_Bettencourt/Human_Practice/Safety">they substituted a related Risk Group 2 organism (<i>Mycobacterium smegmatis</i>) in their experiments</a>. These experiments were a proof of principle for their project ideas.</p>
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<h3>Animals and plants have no Risk Group</h3>
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<p><strong>Be a Responsible Scientist:</strong> There are many extremely complicated risks involved in releasing a genetically modified organism (GMO) outside the lab. Without extensive testing, you cannot know if your GMO is safe for humans and the environment. It would be dangerous, even reckless, to release a GMO without the proper risk assessment and testing.</p>
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<p>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.</p>
 +
 
 +
<p>If you are using a part from an animal or plant, you should consider the <strong>function</strong> 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 <i>Aequorea victoria</i>, 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 <i>A. victoria</i>, 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!</p>
  
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<p>Also, releasing GMOs is a huge international controversy. Because of this controversy, when synthetic biologists seem to act recklessly, they can damage the reputation of the whole field of synthetic biology. As iGEM team members, you are ambassadors between scientists and the public, so it is important that you be excellent scientific citizens!</p>
 
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<h2>What actions count as "release"?</h2>
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<h3>Parts from higher risk groups </h3>
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<p> 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. </p>
  
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<p>If you genetically modify an organism in the lab, you may not deliberately release it outside the lab, even inside a "containing" device. You also may not release any chemicals synthesized by a genetically modified organism, even if you purify the chemicals so that no living organisms remain.</p>
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<p>Some parts from risk group 2 and 3 organisms are permitted and more information can be found on the <a href="https://2017.igem.org/Safety/White_List">White List</a>.</p>
  
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<p>The following examples should clarify what counts as "release" or "not release":</p>
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<h2>How can I find out the Risk Group of my organism?</h2>
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<h3> 1. Common iGEM organisms </h3>
  
 
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<th>Release</th>
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<th>Species</th>
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<th>Not Release</th>
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<th>Risk Group</th>
 
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<td>E. coli K-12 and derivatives (DH5alpha, TOP10, etc.)</td>
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<ul>
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<td>1</td>
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<li>Putting your GMOs into the natural environment (soil, lakes, oceans, forests, etc.)</li>
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<li>Putting your GMOs into a human body</li>
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<li>Putting the <strong>products</strong> of your GMOs into the natural environment, or a human body. "Products" includes any chemicals that your GMOs might synthesize, even if you purify them.</li>
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<li>Putting your GMOs (or their products) into a containing device, and then putting that containing device into the natural environment</li>
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<li>Eating food made using your GMOs (bread, beer, etc.)</li>
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<li><span style="color: red; font-weight: bold">Bringing your GMOs or their products to the Jamboree. This includes any biological material, including synthetic DNA.</span></li>
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</ul>
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<td>
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<ul>
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<li>Submitting part samples to the Registry, according to the <a href="http://parts.igem.org/Help:Submission">submission guidelines</a>.</li>
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<li>Transporting cells or DNA between two labs, in proper packaging, for research or teaching purposes</li>
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<li>Releasing software or hardware</li>
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<li>Performing a field experiment using a wild-type organism <a href="https://2013.igem.org/Team:TU-Munich/Results/Implementation">(see TU-Munich 2013 for an example)</a></li>
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<li>Disposing of sterilized lab waste</li>
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</ul>
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<td>S. cerevisiae</td>
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<td>1</td>
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<td>Most human and mammal cell lines</td>
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<td>2</td>
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<td>Lactobacillus spp.</td>
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<td>1</td>
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<td>Bacillus subtilis</td>
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<td>1</td>
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<h3>2. Other Reliable Sources</h3>
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<p>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.</p>
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<p>For help finding a reliable source, you can consult your advisor, or speak to the biosafety authorities of your university. You can also contact <span class="email">&lt;safety AT igem DOT org&gt;</span> for help.</p>
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<h3>Are you unsure?</h3>
 
  
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<p>Email <i>safety AT igem DOT org</i>. We can advise you about whether your experiment counts as "release", and help you think of alternate experiments that are more appropriate for iGEM.</p>
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<h3>3. Recommended Sources</h3>
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<p>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. iGEM recommends three sources for Risk Group information: <strong>Canadian PSDS, NIH Guidelines, and DSMZ.</strong></p>
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<h5>Canadian Pathogen Safety Data Sheets (PSDS)</h5>
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<p>The Public Health Agency of Canada has published safety data sheets for a wide variety of microorganisms.</p>
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 +
<ul>
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<li><a href="http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php">In English</a></li>
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<li><a href="http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-fra.php">En Français</a></li>
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</ul>
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<p>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".</p>
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<h5>NIH Guidelines, Appendix B</h5>
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<p>The <a href="http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines">NIH Guidelines</a> 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.</p>
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<p><a href="http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html#_Toc351276291">Click here to go directly to Appendix B.</a></p>
  
 
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<h5>DSMZ</h5>
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<p>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.</p>
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<li><a href="http://www.dsmz.de/catalogues/catalogue-microorganisms.html">Catalogue Microorganisms</a> -- 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.</li>
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<li><a href="http://www.dsmz.de/catalogues/catalogue-human-and-animal-cell-lines.html">Catalogue Human and Animal Cell Lines</a> -- search this catalogue by the same method as for Catalogue Microorganisms.</li>
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<li><a href="http://www.dsmz.de/bacterial-diversity/prokaryotic-nomenclature-up-to-date/prokariotic-nomenclature-up-to-date.html">Prokaryotic Nomenclature Up to Date</a> is an alphabetical list of <i>all</i> 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.) <br /><i>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.</i></li>
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Latest revision as of 15:25, 27 January 2017

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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.

  Risk Group 1 Risk Group 2 Risk Group 3 Risk Group 4
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
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.
Lab Safety Level Safety Level 1 Safety Level 2 Safety Level 3 Safety Level 4
Typical Lab Photo
Typical Work Area Open bench Biosafety cabinet Class 3 biosafety cabinet Full isolation suits
  Permitted in iGEM Not permitted in iGEM

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 contact 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. iGEM recommends three sources for Risk Group information: Canadian PSDS, NIH Guidelines, and DSMZ.

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".

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.

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.