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</br> | </br> | ||
<h3 class="text-left" style="font-family: Rubik; margin-top: 1%; clear: both">Legislation</h3> | <h3 class="text-left" style="font-family: Rubik; margin-top: 1%; clear: both">Legislation</h3> | ||
− | <p> | + | <p> |
+ | As well as tackling legislative issues affecting biosensors, brought up by Dr Chris French, in the lab by the creation of an optimised cell free system, we also looked at the process of getting authorisation for the use of GMO in the environment, here in the UK. We contacted the Advisory Committee for Release into the Environment (ACRE), as all GMO approvals go through his committee, to inquire the process we would need to take to get a GMO-based biosensor approved for use. We spoke to Ivy Wellman, who works for the committee as part of Department of Environment, Food and Rural Affairs (DEFRA), and she was able to shed light on the situation with the following email: | ||
+ | </br></br> | ||
+ | “Hi Declan | ||
+ | </br> | ||
+ | No worries, and thanks for confirming your position. I thought that it might be useful to pen something to you for your future reference so here’s what’s required for an application to deliberately release (DR) a (non-plant) GMO into the environment. | ||
+ | </br> | ||
+ | The relevant legislation governing DRs is EU Directive 2001/18 and domestic legislation as follows: Environmental Protection Act 1990, Section 111 and 112 and the Genetically Modified Organisms (Deliberate Release) Regulations 2002. | ||
+ | </br> | ||
+ | In general, the introduction of GMOs into the environment should be carried out according to the “step by step” principle. This means that work with the GMO should begin under containment first (i.e., under laboratory conditions) in order for the researchers to demonstrate that the organism behaves as expected. The containment measures can then be reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken. It is the HSE who regulate the contained use of GMOs. | ||
+ | </br> | ||
+ | An application for the deliberate release of a GMO would come to Defra. All documentation submitted should be as a ‘word’ document and should not contain any confidential information as we are required to publish the information on Gov.uk. You may want to look at previous applications (for plants and non-plants) here: https://www.gov.uk/government/collections/genetically-modified-organisms-applications-and-consents | ||
+ | </br> | ||
+ | All potential trial sites should be included in the application; it is better to include a site that is not used rather than issue a variation to include a site that was omitted. If citing references, the applicant should provide either a copy of the paper, or a link to it, and be mindful of copyright as it forms part of the application form which is published on the internet. The public are always invited to make representation on any risks of damage being caused to the environment by the release. The independent Advisory Committee on Releases to the Environment (ACRE) is an independent panel of experts providing advice to Government. ACRE will consider the application and also any scientific evidence from the representation. Defra is responsible for notifying the European Commission and placing information on a (statutory) UK public register. | ||
+ | </br> | ||
+ | An applicant must inform various Authorities of a trial application and is required to place an advertisement in a national newspaper within 10 days of the application being acknowledged. Defra is grateful to know whether there might be any additional pro-active media around a trial application a few weeks before it takes place. There is a fee of £5,000 per application. | ||
+ | </br> | ||
+ | The Minister will issue a letter with his decision within 90 days of the application being acknowledged and this will also be published on Gov.UK. The 90 days may be extended if we need to ask the applicant for additional data. If that happens we will ‘stop the clock’ while you gather the additional evidence, and re-start the clock when the information is submitted. The day on which the application is acknowledged by Defra counts as day 1 for the application. | ||
+ | </br> | ||
+ | The DR of GMOs for trial purposes is already a national competence, with the UK making its own decisions independent of the EU. Further, decisions to DR GMO are a devolved matter so if an applicant wanted to conduct a trial in England, the application would be made to Defra. However, if the trial is to take place in Scotland, Wales or Northern Ireland, it would those Governments who would make the decision, with applications having been made directly to them. ACRE advises the whole of the UK. | ||
+ | </br> | ||
+ | I hope that you find this information helpful, Ivy” | ||
+ | </br> | ||
+ | </p> | ||
</br> | </br> | ||
<h3 class="text-left" style="font-family: Rubik; margin-top: 1%; clear: both">Safety</h3> | <h3 class="text-left" style="font-family: Rubik; margin-top: 1%; clear: both">Safety</h3> |
Revision as of 19:21, 31 October 2017
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Human Practices (Silver)
“The limits of my language mean the limits of my world.”
Summary of our Silver Human Practises Outputs
- Attending North East Big Bang Fair to talk to students and teachers about synthetic biology
- A report of our investigation into science communication:A Corpus Based Investigation Into Science Communication
- A set of guidelines for communicating synthetic biology:Breaking down the barriers: How should we communicate SynBio to the public?
- Considering the safety of our work
- Investigating legislative issues associated with our project
Introduction
When considering reasons for the lack of uptake of biosensors, we chose to investigate one of the most fundamental aspects for the success of any project: communication. Communication also affects how synthetic biology and the many projects emerging from the field are received. Because of this, many of our human practices, education, and public engagement activities are centred around sharing the research and activities we have completed in relation to science communication. Our human practices work has focused on addressing technology uptake, which is one of the challenges that we identified to biosensor development and deployment. This took place in three main stages. First, we determined the current state of dialogue by consulting previous dialogue studies and reviewing how language is used in the media. We then generated our own guidelines to help future researchers to develop dialogue in a constructive way. Finally, we put this into practise by creating activities and sharing our work in a way that established a dialogue and encouraged discussion. Attending the N8 conference made us aware of the barriers which must be overcome to increase uptake of biosensors. Alongside other factors which we have identified and tackled through experimental and design adaptation, communication between scientists and the public is an aspect which we have considered in our aim of increasing uptake of biosensors and synthetic biology. In our work, we used different perspectives and methods to investigate science communication. By gaining advice from academics working in the humanities and social sciences, and completing our own engagement and research, we have taken a journey through science communication and considered how this can help the success of our project!
Synthetic Biology Communication Guidelines
![](https://static.igem.org/mediawiki/2017/e/ed/T--newcastle--zw-guidelines_front_page.png)
As a culmination of our research into science communication, we have complied a set of guidelines for communicating synthetic biology to the public. These guidelines can be used for different purposes, including: to advise scientists when communicating about their work to the press; to guide in how to present to the public; and to help iGEM teams writing up their work! The guidelines start with some more general points to consider when you start to communicate synthetic biology. They also make use of the information we gained during the corpus linguistics research to suggest some more specific linguistic features to consider when communicating synthetic biology. Read the guidlines here: Breaking down the barriers: How should we communicate SynBio to the public?
Legislation
As well as tackling legislative issues affecting biosensors, brought up by Dr Chris French, in the lab by the creation of an optimised cell free system, we also looked at the process of getting authorisation for the use of GMO in the environment, here in the UK. We contacted the Advisory Committee for Release into the Environment (ACRE), as all GMO approvals go through his committee, to inquire the process we would need to take to get a GMO-based biosensor approved for use. We spoke to Ivy Wellman, who works for the committee as part of Department of Environment, Food and Rural Affairs (DEFRA), and she was able to shed light on the situation with the following email: “Hi Declan No worries, and thanks for confirming your position. I thought that it might be useful to pen something to you for your future reference so here’s what’s required for an application to deliberately release (DR) a (non-plant) GMO into the environment. The relevant legislation governing DRs is EU Directive 2001/18 and domestic legislation as follows: Environmental Protection Act 1990, Section 111 and 112 and the Genetically Modified Organisms (Deliberate Release) Regulations 2002. In general, the introduction of GMOs into the environment should be carried out according to the “step by step” principle. This means that work with the GMO should begin under containment first (i.e., under laboratory conditions) in order for the researchers to demonstrate that the organism behaves as expected. The containment measures can then be reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken. It is the HSE who regulate the contained use of GMOs. An application for the deliberate release of a GMO would come to Defra. All documentation submitted should be as a ‘word’ document and should not contain any confidential information as we are required to publish the information on Gov.uk. You may want to look at previous applications (for plants and non-plants) here: https://www.gov.uk/government/collections/genetically-modified-organisms-applications-and-consents All potential trial sites should be included in the application; it is better to include a site that is not used rather than issue a variation to include a site that was omitted. If citing references, the applicant should provide either a copy of the paper, or a link to it, and be mindful of copyright as it forms part of the application form which is published on the internet. The public are always invited to make representation on any risks of damage being caused to the environment by the release. The independent Advisory Committee on Releases to the Environment (ACRE) is an independent panel of experts providing advice to Government. ACRE will consider the application and also any scientific evidence from the representation. Defra is responsible for notifying the European Commission and placing information on a (statutory) UK public register. An applicant must inform various Authorities of a trial application and is required to place an advertisement in a national newspaper within 10 days of the application being acknowledged. Defra is grateful to know whether there might be any additional pro-active media around a trial application a few weeks before it takes place. There is a fee of £5,000 per application. The Minister will issue a letter with his decision within 90 days of the application being acknowledged and this will also be published on Gov.UK. The 90 days may be extended if we need to ask the applicant for additional data. If that happens we will ‘stop the clock’ while you gather the additional evidence, and re-start the clock when the information is submitted. The day on which the application is acknowledged by Defra counts as day 1 for the application. The DR of GMOs for trial purposes is already a national competence, with the UK making its own decisions independent of the EU. Further, decisions to DR GMO are a devolved matter so if an applicant wanted to conduct a trial in England, the application would be made to Defra. However, if the trial is to take place in Scotland, Wales or Northern Ireland, it would those Governments who would make the decision, with applications having been made directly to them. ACRE advises the whole of the UK. I hope that you find this information helpful, Ivy”
Safety
To ensure that our design was safe and good for the world we considered the following safety aspects:
Chassis
The chassis, which we chose, are all non-pathogenic and were selected within the design stage to minimise the risk, these were all strains of E. coli.
E. coli
The strains of E. coli we used are DH5-α and BL21-DE3, these strains are within safety group 1, like most E. coli strains these present the lowest level of risk to humans. Research commissioned by HSE (Chart et al. (2000)) showed that these lack the pathogenic mechanisms usually present within hazardous E. coli strains.
Cell-Free
From the perspective of safety aspect of our project were advantageous due to their cell free factor. Within cell-free systems random mutations and dissemination are not as likely. This utilizes cell extract for transcription and translation. Sonification and centrifugation steps remove the cell membrane. This makes them suitable for use outside of the lab, however in line with Newcastle and iGEM’s ‘Do Not Release’ policy’s this was not carried out.
Arsenic
As we produced an arsenic biosensor to characterise this arsenic is needed. In order to use this sepecific safety forms needed to be filled out within the lab, these COSHH forms detailed the use and possible hazards involved. For this we had to assess the health risks and procautions, provide the appropriate protection with reduced exposire. The lab has appropriate ventelation and fume cupboards that can be used. The use of arsenic on the small scale that we needed was allowed witin our labs. It is a groundwater contaminant of major significance to public health. Arsenic can get into the body via ingestion and absorption, for this reason it is not used as a fine dust as it can be breathed in which can cause serious health hazards. The health hazards related to arsenic range from irritation to internal bleeding for short term exposure. As arsenic is only used for characterisation longer term effects do not need to be considered. The risk team members working with this in the lab is set to as low as 'reasonably practicable' as it is with every hazardous compound.
Formaldehyde
Sarcosine Oxidase was used to transform glyphosate into formaldehyde so that existing biosensors can be used to sense formaldehyde and therefore this glyphosate.The concentrations produced when characterising K2205003 were detected at a minimum concentration of 10 mg/L. The testing strips used could detect a maximum value of 200 mg/L, two samples indicated this value and so greater concentrations could be present. These were 20mL cultures tested at 5mL a time. The volumes used were low, sealed tubes were used, the formaldehyde was within solution when testing the part and all experiments were carried out underneath fume hoods, hence there was no real risk to team members.
North-East Big Bang Fair
![](https://static.igem.org/mediawiki/2017/b/b8/Newcastle-big-bang-jack-1b.png)
![](https://static.igem.org/mediawiki/2017/f/f6/Newcastle-big-bang-jack-2.png)
In July, we attended the North East Big Bang Fair- a large and exciting science fair. Over 2000 students and teachers attended, and we got the opportunity to talk to everyone about synthetic biology, iGEM, and our project! We had a few different activities to get the students and teachers involved with synthetic biology… ‘Build your own Biosensor’ is an interactive activity we developed to get the students thinking about synthetic biology independently. Many of the students did not know what a biosensor was, so this was also a good way to introduce the function and purpose of biosensors in an understandable and relatable way. We asked the students to think about what they would like to sense (an input), and how this would be detected (an output). There were lots of fun and creative responses!
![](https://static.igem.org/mediawiki/2017/b/b9/T--newcastle--zw-big_bang_board.png)
![](https://static.igem.org/mediawiki/2017/b/b0/T--newcastle--build_own_biosensor.png)
We also had many great conversations with both school pupils and teachers, based around 4 main questions that we posed:
- What is synthetic biology?
- What do you think synthetic biology can achieve?
- How does the current curriculum tackle synthetic biology, and how would you change science teaching if you could?
- How do you engage with science outside of the classroom?
![](https://static.igem.org/mediawiki/2017/1/1c/Newcastle-big-bang-jack-3d.png)
![](https://static.igem.org/mediawiki/2017/2/26/Newcastle-big-bang-jack-3c.png)
![](https://static.igem.org/mediawiki/2017/8/87/Newcastle-big-bang-jack-3b.png)
![](https://static.igem.org/mediawiki/2017/3/3d/Newcastle-big-bang-jack-3a.png)
It was great to spread awareness of synthetic biology among the next generation of scientists, and even give teachers ideas for how they could introduce synthetic biology teaching into their lessons!