1. Would the materials used in your project and/or your final product pose:

  • a. Risks to the safety and health of team members or others in the lab?
  • The only risks are those usually associated with any other molecular biology lab. The potentially dangerous materials, i.e. ethidium bromide and UV radiations, are used only in the authorized areas of the lab with the necessary precautions (lab coat, lab glasses, gloves), according to the procedures approved by the Internal Safety Board. These spaces are attended only by authorized personnel, under the supervision of expert people.

  • b. Risks to the safety and health of the general public if released by design or accident?
  • No, all the DNA parts used as well as the final product are all intrinsically safe. They do not represent any danger, nor does their transcripts or compounds they produce in vivo. The only risks are those normally involved in E. coli manipulation.

  • c. Risks to environmental quality if released by design or accident?
  • None of the parts used poses any additional risks to the common ones demanded by E. coli use to environmental quality if released intentionally or not.

  • d. Risks to security through malicious misuse by individuals, groups or states?
  • The project does not involve design or production of potentially dangerous parts, not even in case of misuse by anyone with sinister intents, since our project does not require production of any toxic products or any other hazardous compounds.

Specifically, are any parts or devices in your project associated with (or known to cause):
  • - pathogenicity, infectivity, or toxicity?
  • No, there are no parts used or produced nor devices associated with toxicity, infectivity or pathogenicity. The genes used are implicated in the mechanism of bioluminescence; all of them have already been utilized by other teams in older iGEM competitions and they do not present risks linked to their cloning or expression in E.coli.

  • - threats to environmental quality?
  • There are no threats to environmental quality of any kind, since we are exploiting Quorum Sensing (QS), which is a mechanism already present in nature.

  • - security concerns?
  • No, as already stated, the only dangerous materials are the ones routinely used in molecular biology labs, like UV radiations and ethidium bromide.

2. Under what biosafety provisions will / do you operate?
We work in a level 1 biosafety lab since we only work with non-pathogenic strains of E. coli.

  • a. Does your institution have its own biosafety rules and if so what are they?
  • Yes, our institution provides us with biosafety regulations

  • b. Does your institution have an Institutional Biosafety Committee or equivalent group? If yes, have you discussed your project with them? Describe any concerns or changes that were made based on this review.
  • There is a biosafety board in our department (C.I.T. – Centro interidpartimentale di Ingegneria Tissutale). Since standard safety routine were enough for our work, the biosafety board approved our project without any particular restriction. It took care to train students in using devices and instruments following all safety prescriptions. In particular, we have managed ethidium bromide, hydrochloric acid 37%, and IPTG following all safety prescriptions. No changes were made based on this review nor any concerns were raised.

  • c. Will / did you receive any biosafety and/or lab training before beginning your project? If so, describe this training.
  • Yes, all the students received biosafety and lab training before the beginning of the project to learn how to correctly handle chemicals and living materials and how to properly dispose of them. Moreover, all the students have always worked under the supervision of experienced advisors.

  • d. Does your country have national biosafety regulations or guidelines? If so, provide a link to them online if possible.
  • Yes, for what concerns the use of genetically modified micro-organisms there is the D.M.25.09.2011.
    ISS (Istituto Superiore di Sanità) is the Italian public institution that provides guidelines for biosafety in scientific research.

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