Safety/Final Safety Form

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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 yourselves, your colleagues, 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.

June 29th

An initial version of this form, with as much information as possible, is to be provided by the team by June 29th. The form should NOT be signed off by the PI.

September 7th

A final version of this form must be signed off by the PI by September 7th.
(Please note, that you will need to plan ahead - your PI being unavailable or on vacation is not an acceptable excuse for late submission of this form)

Approach

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

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

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.

Safety Form

Team Selection

Please choose a team

Overview

Contact Information

Name

Email

1. Please upload a photo or two of your lab to the iGEM 2018 server (include your team name in the file name), preferably showing the relevant safety features and paste the link here:

(Instructions on how to upload an image to our servers can be found here)

2. Describe the goal of your project: what is your engineered organism 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.)

Describe your project
This part of the form is for you to tell us about your primary project idea, what organisms and parts you will use and what your project will do. We know that iGEM teams often change project topics during the competition. When you change your primary project idea, please update this form to tell us about your new idea! If you are still working on multiple project ideas by June 29, you may choose one to describe on this form. If there are major changes to your project after June 29, please contact the Safety and Security Committee by emailing safety AT igem DOT org.

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 gasses high in CO2. We will increase their expression of Photosystem II proteins to make them absorb more CO2 from the gas."

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."

1. Identifying possible risks

iGEM has developed a Risk Assessment Tool to help you identify possible risks to you, your colleagues, communities, or the environment. We encourage you to use this tool before filling in this part of the form. What are you using / planning to use? 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.

3. Which whole organisms, including viruses, 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, or to your community or the environment if they escape the lab?

If you are not using an organism, please note this.

5. Check all species you are using as a chassis in your project.

What is your chassis organism?
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.

Comments:

6. What risks could your chassis pose to you or your colleagues, or to your community or the environment if they escape the lab?

If not using a chassis organism, please note this.

What parts are you making or planning to make?
This part of the 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 an organism or part, you should still include it in this section. You may omit non-protein-coding parts (except if they are known virulence or anti-microbial factors – you should undertake a literature search to determine if they are), and 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. If there are major changes to your project after June 29, please contact the Safety and Security Committee by emailing safety AT igem DOT org.

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

8. Part information is submitted in a spreadsheet.

Please visit this page to download a blank copy of the spreadsheet for this question. (If you need a CSV version instead of XLSX, visit this page.)

Instructions for parts spreadsheet: Remember to change the filename of your spreadsheet! Put your team's name in place of "TeamName".

A. Species name (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.

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.)

C. Risk Group Source: Cite the source from which you obtained the Risk Group information. See Risk Group Guide for recommended sources. If you got the information from the Canadian PSDS, from the NIH Guidelines, or from the DSMZ catalogue, you may simply write "PSDS", "NIH", or "DSMZ". Otherwise, please give a web link or a full citation for your source.

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 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--Safety2018_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.

9. 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.”

10. 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? If you are not conducting any experiments, please note this.

11. 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.)

12. What safety, security or ethical risks would be involved with such a use?

It is possible that software projects could also pose relevant risks.

2. 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 the first part of the form.

13. 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?

14. What rules or guidance cover your work which could help to manage any of the risks you identified in the last section?

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.

15. 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.

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

17. 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.

18. What is the biosafety Level of your lab?

Help about Risk Groups and Safety Levels

Note: 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!!

19. How will the rules, training, containment and other procedures and practices help to manage any of the risks you identified in the last section?

Please give details of any steps you have taken to manage any risks identified. This might 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 activated?

3. Compliance with iGEM’s rules and policies

20. Are you planning / have released 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.

21. Are you planning to make / or have made a gene drives?

For the purposes of iGEM, a gene drive includes Cas9 (and other endonucleases, such as dCas9 and Cpf1) integrated into the genome (including through the use of gRNA) of a sexually reproducing eukaryotic organisms (including organisms that reproduce both sexually and asexually, such as yeast) and/or the use of a drive to impact the progeny.

22. Are you planning / have used resistance factors (or associated sequences) for critically or highly clinically important antimicrobials, as listed by the World Health Organization?

For the current list of these antimicrobials see the table on p10 of this report. You need NOT include any resistance factors included in iGEM’s distribution kit.

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

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

25. Are you planning to use, or using any parts not on the Whitelist?

26. Are you planning to use, or using any parts or organisms obtained from outside the lab or regular suppliers?

27. 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.

The information above will save automatically. Please fill as much information as possible by June 29, 2018

Sign off

Due September 7, 2018

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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