Safety

From 2014.igem.org

Revision as of 22:46, 27 January 2014

iGEM treats the safety of participants and the public and protection of the environment as top priorities. To this end, iGEM has adopted a three level review process that challenges participants to address the safety, security and environmental implications of their work.

Deadline

TBA

INSTRUCTIONS:

Forms must be completed and emailed to the correct mailing list below for your region by 30 August 2014

• ALL iGEM 2014 teams must complete the GEM 2013 Basic Safety Form (coming soon!)
• Teams working with parts or organisms that are greater than Risk Group 1, or mammalian, must complete the iGEM 2014 Biosafety Form Part 2 for each part or organism listed in the Basic Safety Form.
• All iGEM 2014 Software Teams must complete the iGEM 2014 Software Safety Form: iGEM 2014 Software Coding Practices Questionnaire

SUBMISSION:

Email your COMPLETED and SIGNED forms to the appropriate email address for your region:

Note

Please complete these forms using Adobe Reader.

Your advisor will need to sign the forms and Adobe Reader has an option to do so electronically.

Safety Form Resource

In order to complete these forms and submit them to the iGEM Safety Committee, you will need to know a few things about the organisms you are working with. More specifically, you will need to know the Risk Group (and corresponding Biological Safety Level) for the organisms and some of the parts you are working with. Here are some sites that should help you find out the Risk Group for your organisms and parts.

We have created a Risk Group and Biological Safety Level quick reference table. Use this table to help determine which BSL you should be using for an organism with a certain RG.

Organism Risk Group classification:

• American Biological Safety Association The ABSA has a searchable database of organisms that give the risk group for many different regions.
• National Institutes of Health Risk Group Definitions. This appendix of the NIH guidelines lists the Risk Group classification for organisms and gives examples of RG2, RG3 and RG4.
• The Australia Group List of Biological Agents for Export Control. This page lists many organisms that can't be used in iGEM. They are dangerous pathogens. Heavy restrictions apply to the international shipment of these organisms, as well as to the international shipment of their DNA. You should avoid using organisms on this list, because they are dangerous to handle in the lab. You should also avoid creating or using genetic parts from these organisms, because you won't be able to send the DNA to the Registry.

Lab Biosafety:

World Health Organization Laboratory biosafety manual. The WHO biosafety manual will help you determine the BSL (biosafety level) classification of your lab, if you don't know it already.

Additional Information

For help in completing safety requirements, please watch these two videos:





Made available through SynBERC. Video by Terry D. Johnson, based on slides by J. Christopher Anderson, both of UC Berkeley Bioengineering.

Stage 1

First, all teams must fulfill local requirements for review and approval of projects by university institutional biosafety committees, where available. iGEM will defer to approvals and waivers granted by local biosafety committees when documentation is provided. All teams should seek guidance and information from their university's biosafety committees or other appropriate local groups.

Note: Standards for review vary from nation to nation and university to university. You will need to check local university documents and websites for requirements.

Stage 2

Due August 30th, 2013: Second, all teams must complete the Basic Safety Page by August 30, 2013. The Safety Page is your team’s primary location for discussing potential safety, security and environmental implications of your project and for describing your team’s plans for addressing risks. If you are only using parts from the official iGEM Distribution Kit and/or parts derived from Risk Group 1 organisms, this completes your safety requirements. The Safety Resources List contains links to resources that will help you assess and address risks.

Stage 3

• Due August 30th, 2014: Third, is your team is planning to use an organism, or a part from an organism, that is rated above Risk Group 1 (RG1)? Are you planning to use any mammalian cells or parts? If YES to either of these questions, then you must complete a Beyond the Basics Form. If you decide to work with an above-RG1 or mammalian organism later, please complete the Beyond the Basics Form at that time. Some teams working on projects raising the most serious potential safety issues may be asked to complete an in-depth biosafety assessment form.
• Some organisms and parts are exempt from this requirement. Exemptions are listed at the beginning of the iGEM Biosafety Part 2.
• Are you unsure if this requirement applies to you? To learn more about what risk groups and biosafety levels (BSL) are assigned to organisms you are working with, start by consulting the Safety Resources List. For further help, please speak with your team's faculty advisor, consult the WHO Biosafety Manual (PDF), contact the Safety Committee at safety@igem.org, or consult your own national or institutional standards.
• The Risk Group and BioSafety Level system is used in many countries, but other classification schemes exist. In particular, some countries have Risk Group 4 as the least dangerous organisms. The Beyond the Basics form is for anything more dangerous than the least-dangerous category. You may use your own national standards or World Health Organization (WHO) standards to determine whether you must complete the Beyond the Basics Form.

Safety Policies

• The Safety Committee must be able to communicate with your team's faculty advisor about any safety concerns for your project. If your advisor cannot be reached, you may be subject to restrictions at the Jamboree.
• No organism rated Risk Group 3 or 4 may be used as a chassis.
• Genetic parts from Risk Group 3 or 4 organisms may only be used if you submit a Beyond the Basics Form and receive approval from the Safety Committee. We STRONGLY encourage you to find substitutes for these parts from RG1 or RG2 organisms.
• Any project that is ''intended'' to cause harm to the environment, or to human health, will be disqualified.
• If there are significant discrepancies between your safety forms and your Jamboree presentation, you may be subject to restrictions at the Jamboree.

If you have any questions regarding issues of safety, security, and iGEM, please do not hesitate to contact the Safety Committee at safety [AT] igem [DOT] org.

Downloads

• iGEM 2013 Basic Safety Form
• iGEM 2013 Biosafety Form Part 2
• iGEM 2013 Software Coding Practices Questionnaire
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