Safety/Final Safety Form

Safety Form

The purpose of this form is for everyone, including iGEM, to know you are doing your project safely and securely. This is how we know that everyone in iGEM is assessing and managing any risks to iGEM teams, their colleagues, participants in their research, their broader communities, or the environment. If you don't tell us how you are dealing with these risks, we don't know. Being transparent about any possible risks and how we are managing them is a key component of being a responsible scientist or engineer - so please answer the questions as fully as possible.

Important

Complying with the safety and security requirements is a condition of competing at iGEM - that includes providing all the information in this form by the relevant deadlines. Failure to do so can lead to immediate disqualification from the competition and referral to the Responsible Conduct Committee.

Deadlines

The form should be updated throughout the project whenever there is a change that alters possible risks or the procedures, practices and containment provisions being used to manage them.

Preliminary Due Date: June 25, 23:59 EDT
An initial version of this form, with as much information as possible, is to be provided by the team.

Final Due Date: October 1, 23:59 EDT
A final version of this form must be signed off by the PI.

Approach

In general, we are looking for information in four areas. We want you to explain:

  1. An overview of what you are trying to accomplish (Part 1);
  2. What risks might be connected to your project now or in the future (Part 2);
  3. What procedures, practices and containment provisions you are using to manage the risks you identify (Part 3); and
  4. That you are complying with iGEM’s safety and security rules and policies (Part 4).

Other required safety and security information

Any time you are planning to use an organism or part not on the White List the team needs to submit a Check-in Form before using them.

Any time you are planning to use a vertebrate animal in your project the team needs to submit an Animal Use Form before using them.

Public Information

The content of these safety forms are public information. This keeps the safety program transparent to all interested parties.

Contact information, including Name and Email, was included in the public information until August 10, 2021. Contact information is now only viewable by members of the specified team, iGEM HQ personnel, and the Safety Committee.

Safety Form

Team Selection

Please choose a team

Contact Information

Name

Email

Part 1: Overview

1. Please upload a photo or two of your lab to the iGEM 2021 server (include your team name in the file name), preferably showing the relevant safety features and paste the link to the file here. Instructions on how to upload an image to our servers can be found here. If your project does not involve lab work and thus your team has no plans to access lab space, please note this.

2. Describe the goal of your project: what is your engineered organism (or other synthetic biology product, system, or tool) supposed to do? Please include specific technical details and names of important parts. Even though your project might change, please describe the main project idea you are working on right now. See the example answers for help.

Bad example answers (not enough detail)

  • "We are engineering E. coli to cure liver cancer."
  • "Climate change is a very important problem. Our algae will reduce CO2 emissions and fight climate change."

Good example answers

  • "Our bacteria will be engineered to interact with human cells. They will detect tumor cells that express biomarkers for liver cancer. They will use invasin to enter the tumor cells, and then secrete apoptin to kill the tumor cells."
  • "Our algae will receive gases high in CO2. We will increase their expression of Photosystem II proteins to make them absorb more CO2 from the gas."

Part 2: Identifying possible risks

Some organisms and parts present risks beyond what is ordinary for lab work in synthetic biology. As your project progresses, you should consider the risks presented by each organism and part you plan to use. Even if you’re not working with any organisms or parts, your project may be able to generate risks. For example, theoretical designs could highlight environmental or public health vulnerabilities, while software tools could be misused by people seeking to do harm.

Organisms

3. Which whole organisms, including viruses and cell lines, are you planning to use (or using) in your project?
Please provide as much detail as possible (such as strain information). If you are not using an organism, please note this.

4. What risks could these organisms pose to you or your colleagues in the laboratory, or to your community or the environment if they escape the lab?
If you are not using an organism, please note this.

5. What organisms are you using as chasses in your project?
For the purposes of iGEM, a chassis is the organism in which you are putting your parts, or which you are modifying in your project. Many teams will use a common lab organism as a chassis. Some teams may use a more exotic organism. Some project may not involve a chassis.

6. What risks could your chassis pose to you or your colleagues in the laboratory, or to your community or the environment if they escape the lab?
If not using a chassis organism, please note this.

Parts

This part of the form is for you to tell us about the parts you are planning to make or have developed during your project. It summarises information that might already have been submitted through Check-in forms. If you submitted a Check-In form for a part, you should still include it in this section. You may omit parts that were already in the Registry if you are using them without significant modifications.

For more information on virulence factors see the Safety Policy page and the White List.

7. As part of your project, are you planning to make / have made new parts or substantively changed existing parts in the Registry?

8. Part information is submitted in a spreadsheet.
Instructions for parts spreadsheet: Remember to change the filename of your spreadsheet! Put your team's name in place of "TeamName". Please visit this page to download a blank copy of the spreadsheet for this question.

A. Species name of parent organism (including strain): For an organism, give the scientific name of the species. Include a strain name or number (such as "K-12" for E. coli K-12) if there is one. For a part, give the name and strain of the organism that the part originally came from. If the part has no natural comparator, note this.

B. Risk Group: Give the Risk Group of the organism in column A. You may use a categorization according to your home country, according to the USA, or according to the WHO. If the organism falls into an 'in-between' or special category such as 2+ or 2-Agricultural, explain this category in the Notes column. If you cannot find any Risk Group categorization for this organism, write "N/A" and explain in the Notes column. (Multicellular organisms generally do not have a Risk Group.)
Help about Risk Groups and Safety Levels

D. Disease risk to humans: Does this organism cause any disease in humans? If yes, what disease does it cause?

E. Disease or other risks to the environment: Does the organism cause plant or animal diseases or would in any other way pose a risk to the environment if accidentally released?

F. Part number/name: For a part: If it has a Registry part number (like BBa_XXXXX), write that number. If it has no Registry part number, give a short name for the part. (For example: "Actin", "Alcohol Dehydrogenase".) For a whole organism, leave this column blank.

G. Natural function of part: For a part: Briefly describe what the part does in its parent organism. (If it is an enzyme, what reaction does it catalyze? If it is a receptor, what molecules does it bind to? Etc.) For a whole organism, leave this column blank.

H. How did you acquire it: Describe how you acquired the organism/part. If you have not acquired it yet, describe how you plan to acquire it. (For example: did you receive the part DNA from another lab? Did you order the part DNA from a synthesis company? Did you use PCR to isolate the part from the genomic DNA of its parent organism? Did you order the cell line from a company?)

I. How will you use it: Describe how you are using the organism/part in the lab. (For example: "This organism is our chassis." "This part senses when the cells are exposed to glucose." "This organism is the source for a part that we are isolating by PCR." "This part produces the toxin which our bio-sensor is designed to detect.")

J. Notes: Use this column to give any additional information that is necessary.

Upload Spreadsheet Please do not change the "Destination Filename"! [File:T--TeamName--Safety2021_Spreadsheet.xls] You may upload multiple versions of your spreadsheet, using the same Destination Filename. The wiki software will keep track of different versions, and list them in chronological order.

Activities

9. Which chemicals are you using in your project that might be hazardous?

If you selected any of the hazards above, please list the chemicals:

10. What experiments will you do with your organisms and parts?
Please explain briefly. We are particularly keen to understand the boundaries or scope of your project. You should include the names of species / cell lines / strains. You should include experiments involving parts taken from other organisms, even if they are being synthesized rather than isolated from nature – you need not include any parts already in the registry.

Example answers

  • "Our bacteria is meant to live on plant leaves, so we will test them on tobacco (Nicotiana benthamiana) in a lab greenhouse."
  • "We want to use a protein from ants, but its sequence is unknown. So we will capture ants (Camponotus spp.) to extract DNA and RNA to find the sequence of the protein we want."
  • "Our bacteria need to interact with human cells for a medical application. We will test them in human cell culture using the HEK293 cell line."
  • “We are interested in a RNA-binding protein expressed in Kluyveromyces lactis. We have found the sequence in a paper and will have it synthesized by a provider.”
  • Our project will not involve experiments with organisms or parts. We will run digital directed evolution experiments to identify a candidate receptor binding protein for our fungicide.

11. What risks could arise from these experiments?
For example, could they produce aerosols making it more likely that you could inhale something? Or are you using needles and could accidentally stick yourself? Could you produce something that is not inactivated using standard lab protocols? Could your in silico experiments produce insights that someone might be able to harmfully misuse?

12. Are you collecting any data about people, such as their opinions, quotations, health information, gender, behavior, attitudes, or concerns?
This includes surveys and interviews carried out as part of human practices work, whether anonymous or not.

Anticipating Risks

13. Imagine that your project was fully developed into a real product that real people could use. How would people use it?
Check all appropriate boxes and expand in the comments section. (Note: iGEM teams should not release modified organisms into the natural environment but you could imagine such a release if your project was fully developed.)

14. What safety, security or ethical risks would be involved with such a use? Virtually all modern life science and biotechnology carries with it some risks. These can be identified and managed helping to ensure your work makes a positive impact on the world. As you think about how your project might enter the real world, being a responsible biological engineer will require you to think about and manage these risks yourselves. You can find some great resources on the Safety and Security and Human Practices hubs on our wiki.

Examples of hazards you might consider

  • Harm to human, animal or environmental health (e.g. from pathogens, antimicrobial resistance, altered immune function)
  • Harm to important crops or materials (e.g. conferring the ability to damage important materials)
  • Unintentional environmental spread (e.g. from horizontal gene transfer, biased inheritance frequency, or out-competing non-engineered organisms)
  • Reducing global, national or health security (e.g. disabling medical countermeasures or making it easier for bad actors to do harm with biology)
  • Creating or reinforcing of social inequities (e.g. engineering a technology that benefits only an already-advantaged group)
  • Convergence with other technologies (e.g. generic delivery mechanisms that could be combined with other scientific advances to do harm)

15. If you were permitted, would the continued development of your project require environmental release (as described in our Do Not Release policy)?

  • Yes
    Please briefly describe what experiments or tests you would need to do outside of laboratory containment. Include any institutional approval processes or national regulations that you are aware you would need to comply with.

16. If your project were fully developed, could any of your engineered organisms or parts spread autonomously in the environment?
Organisms might enter the environment intentionally (e.g. in field trials) or accidentally. If you have incorporated biocontainment strategies (such as kill switches or auxotrophy) into your project to prevent environmental spread, please make a note of those strategies and why you chose them. If your project does not involve organisms or parts (e.g. a software tool) please note this.

Part 3: Managing the risks you have identified

It is impossible to remove all risk from any biological activity. Instead, we attempt to manage these risks - to reduce them to an acceptable level. In this section, you should outline what steps have been taken (or you are planning to take) to reduce any risks you identified in Part 2 of the form, in particular Question 11.

17. How will experts overseeing your project help to manage any of the risks you identified in this form?
For example, who is responsible for the safety and security of biology labs at your institution? What role has any institutional biosafety officer played in reviewing your work? What skills do these experts have that might help? For example, do they have a long history of working with an organism or part that might pose a risk? How familiar are they with the experimental procedures and practices you will be, or are, using?

18. What rules or guidance cover your work which could help to manage any of the risks you identified in Part 2 of this form (in particular Question 11)?
For example: In your country / region, what are the laws and regulations that govern biosafety or biosecurity in research laboratories? Please give a link to these regulations, or briefly describe them if you cannot give a link.What are the guidelines for laboratory biosafety and biosecurity? Please give a link to these guidelines, or briefly describe them if you cannot give a link.

19. Have your team members received any safety training?
For the purposes of iGEM, biosafety and biosecurity training covers the procedures and practices used to manage risks from accidents or deliberate misuse of your projects to your team, colleagues, communities and the environment. All team members are expected to be aware of these risks and to work to manage them

20. Please select the topics that you learned about (or will learn about) in your safety training.

21. Which work areas do you use / are you using to handle biological materials?
Please check all the containment provisions you are using. If you are using more than one space please check all that apply and note this in the other work area box.

22. What is the biosafety level of your work space?
Help about Risk Groups and Safety Levels
If you are working in a biosafety cabinet it may be a biosafety level 2 space (then select Level 2), but biosafety cabinets are sometimes also used in a biosafety level 1 laboratory to provide a sterile work space (then select Level 1). If in any doubt, please discuss this with a biosafety professional or your instructors, supervisors or lab techs to make sure you understand how the equipment you use helps to manage risks.

Alert

iGEM teams should not use Risk Group 3 or 4 organisms, and they should not work in Safety Level 3 or 4 labs. If you are planning to work at Safety Level 3 or 4, contact safety [AT] igem [DOT] org right away!

23. What other risk management tools will cover your work?
Please select as many as are relevant, including those that happen automatically at your institution and are not specifically connected to your project. If in any doubt, please discuss this with a biosafety professional or your instructors, supervisors or lab techs to make sure you understand how the equipment you use helps to manage risks.

24. How will the rules, training, containment and other procedures and practices help to manage any of the risks you identified in Part 2 of this form (in particular Question 10)?
Please give details of any steps you have taken to manage any risks identified. This might include how any of the following have helped manage risks: the rules you identified, the training you have had, the equipment you have used, the spaces you have worked in, and the procedures and protocols you have followed. It might also include things you deliberately didn't do. For example, if you are not conducting any experiments, especially on grounds of safety, security or as a responsible scientist / engineer, please note this. Examples might include, making sure you only use non-pathogenic strains of an organism, deciding that animal use experiments are not yet warranted, or avoiding plant infection experiments because the affected plant is found in your country. Please also consider waste treatment – how will you know that any waste produced in your project will be successfully inactivated?

Part 4: Compliance with iGEM’s rules and policies

25. Are you planning to release any organism or product derived from your project?
For the purposes of iGEM, release includes putting any engineered organism or product from one into the environment, yourselves or volunteers (including by eating or drinking), or into a device that will be placed in the environment.

26. Are you planning to use (or using) any animals (including insects and invertebrates) not on the Whitelist?

27. Are you planning to use (or using) any vertebrates (e.g. rats, mice, guinea pigs, hamsters) or higher order invertebrates (e.g. cuttlefish, octopus, squid, lobster)?

28. Are you planning to use (or using) any parts not on the Whitelist?

29. Are you planning to do (or doing) any of the activities not on the Whitelist?
These include experiments likely to bias the inheritance frequency of a genetic marker in an organism’s progeny, such as through the creation of a gene drive, experiments likely to confer resistance to the World Health Organization's list of Critically Important Antimicrobials, and experiments likely to increase the hazard posed by your project.

30. Are you planning to use (or using) any parts or organisms obtained from anywhere other than a trusted commercial or institutional supplier?

31. Are you planning to use or test any part of your project, or products produced from it, on humans (including members of the team)?

32. What else can you tell us about any risks associated with your project, how you are managing them, or your compliance with iGEM’s safety and security rules and policies?
This can include any improvements you would like to see to our safety and security efforts, or anything that has not been sufficiently clear, or where additional guidance would be useful, or where you see important uncertainties.

Note

The information above will save automatically. Please fill as much information as possible by June 25, 2021.

Sign off

Due October TBD, 2021

Only a team Instructor or PI may submit the Safety and Security Form. Instructors/PIs, please read the form you are submitting, and confirm that all its information is correct. By checking the "I Agree" box and clicking the "Submit" button, you are agreeing that the Safety and Security Form accurately describes the activities of your team and that they have complied with all relevant institutional, national or regional laws, rules and regulations.
We are using the "I Agree" box in lieu of a signature with paper and pen.


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