Team:Valencia UPV/Practices/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.
Safety
Expertise
Legal aspects
Solutions to have a safety AladDNA
