Difference between revisions of "Team:Valencia UPV/Practices/Safety"

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<p>The safety of a project is always a very important part to take into account, especially if the project involves living organisms*. For that reason in our project we have taken all the safety precautions while working in the lab. Things like working on sterile conditions, using gloves or disposing waste in the corresponding container were the bases of our diary work lab, obviously.</p>
 
  
<p>But with our project, AladDNA, we thought to make a step further and think about the safety of our circuit chassis, our genetically modify plant. We had to make a real effort in this due to that the special characteristics that our plant has:</p>
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<p>The safety of a project is always a very important part to take into account, especially if the project involves living organisms. For that reason in our project we have taken all the safety precautions while working in the lab. Things like working on sterile conditions, using gloves or disposing waste in the corresponding container were the bases of our diary work lab. Moreover transient transgene expression in <i>Nicotiana benthamiana</i> was carried out in laboratory and greenhouse facilities equipped with containment measures compliant with National and EU regulations.</p>
  
<ul><li><a href="https://2015.igem.org/Team:Valencia_UPV/Components#scroll4">Drugs production.</a></li>
 
  
<li>Circuit activation by light at different wavelength.</li>
 
  
<li>Functionality of both things named before in a germinated seed. </li>
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<p>Legal considerations on the release of transgenic plants into the environment</p>
  
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<p>To afford all the questions that appeared during the realization of the project we decided to talk to some experts in the area. Also we make some research in the field of legality of transgenic modify organisms and the regulation of the plant growing and production. To see in more detail click the buttons bellow.</p>
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<p>Although we are in an early phase of our project, it is very important to think about safety considerations when the release of our project will be done. Due to this we search about the general legal aspects that a genetically modify organism will fulfil. </p>
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<p>There are two kinds of part when treating a GMO. The first step is the controlled and intentional liberation into the environment to mere test the GMO and see if it has any environmental repercussion. The second step is done if the GMO is going to be commercialized. Both of them are ruled </p>
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<p>  EN CONSTRUCCION</p>
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<p>Safety considerations and risk assessments</p>
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<p>AladDNA is not designed for environmental release. The production phase takes place under contained conditions (the lamp device) and disposal of biological material under safe conditions does not require special equipment, as a simple tissue disruption mechanism will avoid seed viability after the production phase.</p>
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<p>An important advantage of the plant chassis is the multiplication capacity of the seed biofactory. Seed banks should be produced under contained conditions in centralized locations at large scale, whereas small and medium scale contained facilities can also be easily established in remote locations for local multiplication.</p>
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<p>However it is worth to evaluate the risks associated with the eventual scape of transgenic seeds from contained facilities into the environment and propose additional genetic containment measures for reducing risk associated with this contingency.</p>
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<p>Risk for the population and the environment</p>
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<p>Implementation of strict indoors cultivation conditions for the multiplication phase, and automatic disposal after the production phase should be sufficient measures to ensure that no release into the environment takes place. However, unintended release of medicine-producing seeds could ultimately led to contamination of the food chain, and therefore the risk evaluation of this unlikely event needs to be considered. Unintended exposure with vaccine antigens, antibodies or other drugs at low (occasional, dietary) doses is not expected to led to severe health effects on most healthy individuals. Most seeds are consumed after heat treatment (cooking), at conditions that severely reduce or even abolish the biological activity of the drugs. However in certain circumstances and for certain drugs it cannot be discarded that drug exposure could severely affect immunocompromised or allergic individuals. </p>
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<p>As far as the environment is concerned, failures in containment conditions could lead to cross-pollination with wild species during seed batch production bringing the traits outside the boundaries of the target species. Therefore, although the enforcement of contained production measures should be sufficient to maintain AladDNA contamination risks at acceptable low levels, adoption of additional safety measures is advisable.</p>
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<p>Additional measures to increase safety levels of AladDNA</p>
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<p>Taking into consideration the risks discussed above, here we propose a number of additional measures that could be implemented. The introduction of one or more of the following measures, combined with physical containment measures described above, would bring the risk associated with AladDNA implementation virtually to zero.</p>
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<p>Selection of plant species attending to safety considerations: </p>
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<p>Use of non-food, Generally Accepted As Safe (GRAS) seeds as e.g. Medicago truncatula will bring the risk of food contamination to zero.</p>
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<p>Use of seeds of self-pollinating crops to avoid transgene scape by cross-pollination (e.g. pea, rice)</p>
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 +
<p>Implementation of additional genetic containment measures</p>
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<p>Introduction of an additional genetic module in the genetic design for male sterility.</p>
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<p>Introduction an additional genetic module in the genetic design that activates lethality in the hybrid progeny, avoiding propagation.</p>
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<p>Introduction of identity-preservation traits (e.g. distinctive colour/shape) using metabolic engineering.</p>
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<ul class="actions" style="text-align:center">
 
<li><a href="#scrollsect1" class="button alt">Expertise</a></li>
 
<li><a href="#scrollsect1" class="button alt">Expertise</a></li>
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<p><p>Having other people opinion is always a good thing so we talk with two different experts, Carmelo López that guides us in the general legislation of a GMO and Jose Miguel Mullet (pendiente)…</p>
 
  
<p>First we talk to Carmelo López del Rincón, titular professor of the Biotechnology Department at the UPV. He imparts courses related to plants production and genetically modified food as well as courses of the GMO legislation.</p>
 
 
<p>He showed us the general legislation that a transgenic plant has to accomplish in Spain, Europe and internationally to be accepted and commercialized.</p>
 
 
<p>As it is said before, there are three levels of legislation that our transgenic plant will have to accomplish.  The first one is the estate level, the second one is the EU although both are closely related and finally the international level that is ruled by the Cartagena treaty (enlace al doc). In the legal aspect part this is widely explain.</p>
 
 
<p>Also we talked about possible measures that will improve and facilitate the introduction into the environment of our plant. The most highlight option was to locate our circuit into the chloroplasts. Chloroplasts will avoid that the production go out the cell and so secrete it into the environment. But main problems were found, for example the insertion of the DNA will have to be in a 100% effectiveness. Other issue that we found is that in seeds the chloroplasts are immature because they do not receive light and so they will not be working normally.</p>
 
 
<p>Finally we discard this option.  </p>
 
 
<p>(Lo que se haya hablado con mullet)</p></p>
 
 
 
 
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<p><p>In this submenu we are going to amplify the information obtained by the interview with Carmelo. So, we are going to talk with more detail about the specific laws in Spain, Europe and internationally. (gift de Obama “it’s the law”)</p>
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<p>Something to point out is that after researching and reading some documents we can observed that the main idea is the same. The law wants to protect people and the environment avoiding any incident cause by a GMO. We as a group human beings and citizens, want that anyone or anything can be injure so for that we decided invest time to know how to prevent any kind of problem that may or may not occur with our genetically modify plant.</p>
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<p>Let’s begin with the Spanish law about GMO. It is controlled by the Ministerio de Agricultura, Alimentación y Medio Ambiente. It is in charge of controlling the commercialization and voluntary liberation of the GMO in the environment in case that this organism produce medicines for human and veterinary use, as it is in our case (Chapter2, article3 from law 9/2003, de 25 April). Also the ministry collaborate and exchange information with the European Union that have an important role making the decisions.</p>
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<p>One thing to keep in mind is that our project will be evaluated step by step so is very important to fill correctly all the attaches needed. This are the general data asked in the  </p>
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<p>The competency of the EU is</p>
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<p>The protocol of Cartagena is…</p></p>
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<p><p>After researching about all the conditions to handle and distribute our plant finally we come up with some conclusions to make AladDNA a very very safety project.</p>
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<p>First of all, our seedlings will germinate into a recipient, “the magic lamp” (enlace a magic lamp), a handling device that has been designed exclusively to put up with the growing seeds. The lamp will give to the seedlings the right light pulses controlling the optimal conditions to make a regular production of the drugs. </p>
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<p>It is made taking into account all the details for instance the electronic part is isolated form the growing section. The system to close the device is hermetic so the seeds can go out until their need to be consumed. More info here.</p>
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<p>(foto de la lamapara por la mitad y con un germinado)</p>
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<p>Furthermore, we thought about the idea of growing our plant in a greenhouse to produce more drugs doses to supply a small village in a remote place in the world, for instance. This is also possible! With the respective bureaucracy and a close and hermetic greenhouse authorized for that kind of activity (quiza alguna palabra mas tecnica), it just will be necessary the seeds, the leds, a bit of water and… magic! The production made by a live organism avoids the big expenses on money that will suppose create in a difficult access place an industry to produce unlimited drugs.</p>
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<p>The information is reduced to its minimal expression and the infrastructure is just a small seed!</p>
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<p>If our chassis stay inside a controlled device and there is no intentionally liberation into the environment, there will be no problem at all. But, what happened if someone accidentally drop a seed into the wild… DISASTER! </p>
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<p><div style="text-align: center;"><img width=600em src="https://static.igem.org/mediawiki/2015/a/a4/Valencia_upv_carasorpresa.png" ></div> </p>
 
<p><div style="text-align: center;"><img width=600em src="https://static.igem.org/mediawiki/2015/a/a4/Valencia_upv_carasorpresa.png" ></div> </p>
  
<p>No, it is just a joke! AladDNA will pass for sure the controls of a transgenic plant. Moreover we think in a method of regulation in case that something happen. We can make our seed WHAT? (necesito un metodo que 1.evite que la semilla germine y por tanto que no se produzcca ningun medicamento O 2.que apenas germine se muera)(creo que acabaría de rematar toda la idea del safety)</p>
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<p>
 
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<p>The especial “what ever” regulator allow AladDNA to be also safe in case accidentally liberation.</p>
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<p>Ok, now after reading all this restrictions that we make to our plant you might think, why all this restrictions to their plant? Well that is a good question.</p>
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<p>AladDNA was thought as a perfect way to reduce to the minimum all the information needed for the production of drugs or any other substance but with a social propose: provide an easy, self-made, and cheap way to get closer the products need in specific situations.</p>
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<p>Our aim is that no matter where you are, in a lost mountain, in a catastrophic area, in the middle of the desert or in the middle of the city in rush hour or even far away in the space, you can cover in a short period of time your necessity.</p>
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<p>The characteristic that AladDNA is for all users leads to the following point. As our project is think as a biopharmaceutical resource, pointing out that the circuit can have any final biological production, we will need to study in a future al the drugs produced. This is even more complicated, it is easy to explain, just watch the graphic and the numbers in it… Xmillion dollars!?</p>
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Revision as of 21:18, 18 September 2015

Valencia UPV iGEM 2015

Safety


The safety of a project is always a very important part to take into account, especially if the project involves living organisms. For that reason in our project we have taken all the safety precautions while working in the lab. Things like working on sterile conditions, using gloves or disposing waste in the corresponding container were the bases of our diary work lab. Moreover transient transgene expression in Nicotiana benthamiana was carried out in laboratory and greenhouse facilities equipped with containment measures compliant with National and EU regulations.

Legal considerations on the release of transgenic plants into the environment

Although we are in an early phase of our project, it is very important to think about safety considerations when the release of our project will be done. Due to this we search about the general legal aspects that a genetically modify organism will fulfil.

There are two kinds of part when treating a GMO. The first step is the controlled and intentional liberation into the environment to mere test the GMO and see if it has any environmental repercussion. The second step is done if the GMO is going to be commercialized. Both of them are ruled

EN CONSTRUCCION

Safety considerations and risk assessments

AladDNA is not designed for environmental release. The production phase takes place under contained conditions (the lamp device) and disposal of biological material under safe conditions does not require special equipment, as a simple tissue disruption mechanism will avoid seed viability after the production phase.

An important advantage of the plant chassis is the multiplication capacity of the seed biofactory. Seed banks should be produced under contained conditions in centralized locations at large scale, whereas small and medium scale contained facilities can also be easily established in remote locations for local multiplication.

However it is worth to evaluate the risks associated with the eventual scape of transgenic seeds from contained facilities into the environment and propose additional genetic containment measures for reducing risk associated with this contingency.

Risk for the population and the environment

Implementation of strict indoors cultivation conditions for the multiplication phase, and automatic disposal after the production phase should be sufficient measures to ensure that no release into the environment takes place. However, unintended release of medicine-producing seeds could ultimately led to contamination of the food chain, and therefore the risk evaluation of this unlikely event needs to be considered. Unintended exposure with vaccine antigens, antibodies or other drugs at low (occasional, dietary) doses is not expected to led to severe health effects on most healthy individuals. Most seeds are consumed after heat treatment (cooking), at conditions that severely reduce or even abolish the biological activity of the drugs. However in certain circumstances and for certain drugs it cannot be discarded that drug exposure could severely affect immunocompromised or allergic individuals.

As far as the environment is concerned, failures in containment conditions could lead to cross-pollination with wild species during seed batch production bringing the traits outside the boundaries of the target species. Therefore, although the enforcement of contained production measures should be sufficient to maintain AladDNA contamination risks at acceptable low levels, adoption of additional safety measures is advisable.

Additional measures to increase safety levels of AladDNA

Taking into consideration the risks discussed above, here we propose a number of additional measures that could be implemented. The introduction of one or more of the following measures, combined with physical containment measures described above, would bring the risk associated with AladDNA implementation virtually to zero.

Selection of plant species attending to safety considerations:

Use of non-food, Generally Accepted As Safe (GRAS) seeds as e.g. Medicago truncatula will bring the risk of food contamination to zero.

Use of seeds of self-pollinating crops to avoid transgene scape by cross-pollination (e.g. pea, rice)

Implementation of additional genetic containment measures

Introduction of an additional genetic module in the genetic design for male sterility.

Introduction an additional genetic module in the genetic design that activates lethality in the hybrid progeny, avoiding propagation.

Introduction of identity-preservation traits (e.g. distinctive colour/shape) using metabolic engineering.


Expertise


Legal aspects

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Solutions to have a safety AladDNA