"

From 2012.igem.org

Before answering these questions on your team Safety page, be sure to read the Safety in iGEM page. and the FAQ section below.

Key questions

For iGEM 2012, teams are asked to detail how they approached any issues of biological safety associated with their projects. Specifically, teams should consider the following questions:

Would any of your project ideas raise safety issues in terms of: researcher safety, public safety, or environmental safety? Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues? If yes, did you document these issues in the Registry? how did you manage to handle the safety issue? How could other teams learn from your experience? Is there a local biosafety group, committee, or review board at your institution? If yes, what does your local biosafety group think about your project? If no, which specific biosafety rules or guidelines do you have to consider in your country? Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?

Teams, please document any answers to these safety questions on your wiki safety page. Judges will be asked to evaluate your project, in part, on the basis of if and how you considered and addressed issues of biological safety. If any questions arise regarding iGEM and biological safety please send an email to safety AT igem.org.

Contents 1 FAQ 1.1 Question 1: Why does iGEM ask teams to address safety questions and screen projects? 1.2 Question 2: How does this work? Does anyone actually read answers to safety questions and review project wikis? 1.3 Question 3: We need clarification on the safety questions. Would you please provide guidance on each iGEM safety question? 1.3.1 1. Would any of your project ideas raise safety issues in terms of: 1.3.1.1 Guidance: 1.3.2 2. Do any of the new BioBrick parts (or devices) that you made this year raise safety issues? If yes, 1.3.2.1 Guidance: 1.3.3 3. Is there a local biosafety group, committee, or review board at your institution? 1.3.3.1 Guidance: 1.3.4 4. Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering? 1.3.4.1 Guidance:

FAQ

Question 1: Why does iGEM ask teams to address safety questions and screen projects?

iGEM safety questions and screening procedures are designed:

• To protect team members as they work in their labs, iGEM institutions, the general public and the environment
• To encourage team members to consider safety, health, security, and environmental implications of their projects, both within and beyond the scope of iGEM competition.

Question 2: How does this work? Does anyone actually read answers to safety questions and review project wikis?

Members of the iGEM Safety Committee and Graduate Safety Screeners review all safety pages and project wikis for consistency, identify potential safety issues and contact iGEM teams and external advisors if additional information is needed. Teams may be disqualified if they do not demonstrate that their projects are safe.

iGEM Safety Committee:

• Todd Kuiken, Synthetic Biology Project, Woodrow Wilson Center, Smithsonian Institution;
• Piers Millett, UN Biological Weapons Convention, Implementation Support Unit, Geneva;
• Kenneth Oye, Engineering Systems and Political Science, Massachusetts Institute of Technology;
• Megan Palmer, Deputy Director, Practices, NSF Synthetic Biology ERC, Stanford University;
• Sam Yu, Biosafety Officer, Hong Kong University of Technology, Clearwater Bay, Hong Kong

Graduate Safety Screeners:

• Shlomiya Bar-Yam, MIT,
• Julie MacNamara, MIT,
• Ralph Donald Turlington, MIT

External Consultants:

• Rocco Casagrande, Gryphon, former Director UNMOVIC Biological Lab;
• George Church, Harvard Medical;
• Chan-Wha Kim, President Asia-Pacific Biosafety Association and Korea University;
• Michael Imperiale, U Michigan Medical and NSABB; Allen Lin, Cambridge University;
• Scott Mohr, Chemistry, Boston University;
• Pamela Silver, Harvard Medical

Question 3: We need clarification on the safety questions. Would you please provide guidance on each iGEM safety question?

1. Would any of your project ideas raise safety issues in terms of:

• researcher safety,
• public safety, or
• environmental safety

Guidance:

There are three recommended steps in addressing this question.

1. To start, please list organisms you are using and organisms from which your parts are derived, indicating the risk group or biosafety level for each. For help, see Table 1 and 2 of the [http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf World Health Organization (WHO) Laboratory Biosafety Manual]. You are welcome to use your national standards if you prefer. If national standards do not use the WHO 1-4 scale, please provide a link to an explanation of your standards.
2. Then consider risks to team members, publics and environment if the project goes according to plan. Please describe risks posed by lab equipment and chemicals as well as biological parts and organisms. How are you addressing these issues in project design and lab work? Have you received biosafety training and other laboratory safety training? If so, please briefly describe the training.
3. Then consider risks to team members, publics and environment if the project does not go according to plan. What are risks if safety measures such as containment procedures go wrong and organisms or parts are released? What are risks to security from malicious misuse? How are you addressing such risks?

---

2. Do any of the new BioBrick parts (or devices) that you made this year raise safety issues? If yes,

• Did you document these issues in the Registry?
• How did you manage to handle the safety issue?
• How could other teams learn from your experience?

Guidance:

Please reference the biosafety level of parts. If you are working with anything other than a BSL1 organism, take extra care with this question. Your nation regulates handling and transfer of pathogens and parts associated with pathogenicity. For a list of regulated organisms, see the [http://www.australiagroup.net/en/biological_agents.html Australia Group website].

---

3. Is there a local biosafety group, committee, or review board at your institution?

• If yes, what does your local biosafety group think about your project?
• If no, which specific biosafety rules or guidelines do you have to consider in your country?

Guidance:

The iGEM Safety Committee is not a substitute for national and local university institional biosafety committees

1. Does your university have a Biosafety Committee or equivalent? Please provide a link to regulations and local requirements.
2. Is your project in compliance with national regulations and university requirements?
3. If you are working with any organisms or parts requiring containment arrangements above BSL 1 or equivalent, have you consulted with your Institutional Biosafety Committee regarding your project?

---

4. Do you have any other ideas how to deal with safety issues that could be useful for future iGEM competitions? How could parts, devices and systems be made even safer through biosafety engineering?

Guidance:

This is an open-ended space for you to consider and suggest ways of improving safety or safety awareness at iGEM and beyond. Some iGEM teams have offered ideas (and sometimes full projects) to limit gene flow, to create software for screening pathogens, and to reduce reliance on antibiotic resistant markers. Other iGEM projects have discussed concerns that might arise if the project succeeded and became widely used, as commercial product or other means of distribution. Some iGEM projects have discussed risks that might materialize if the knowledge generated or methods developed were to become more widely available.