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From 2011.igem.org

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Informing Design

We consulted numerous experts in various fields to ensure that the design of the AuxIn system respects all relevant social, ethical and legal issues. One module of our system, Gene Guard, is a direct result of brainstorming around the issues involved in the release of genetically modified organisms (GMOs). Although we have only reached the proof of concept stage, we have put a lot of thought into how AuxIn may be implemented as a product and the legal issues that would be involved.

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Legal issues

1. Goal

In order to implement our project in the field, we are going to have to release genetically modified organisms (GMOs) into the dryland environment. Aside from the scientific issues surrounding the release of GMOs, we also need to take into account the legal issues. We need to incorporate these ideas into our design so that our project can become a viable product that could one day be used in the field. The legal issues will not only affect the design of the bacteria themselves, but also the method of implementation and the nature of the trials we carry out to verify our project.

2. Action

We looked into the main laws that would affect the operation of our finished product. To help inform our design, we investigated the legal issues surrounding GMOs and living modified organisms (LMOs), in particular, the issues relating to their release. This will allow us to include the legal limitations into our specification as we design our system, meaning that our system will be designed with every intention to release the bacteria safely and legally.

From our Human Practices panel, we found that there were two important documents that we should study. The first is the Rio Declaration on Environment and Development, which is an international agreement for sustainable development that contains some very important principles. The second document is the Cartagena Protocol on Biosafety, an international agreement that seeks to establish guidelines for the safe release of GMOs without harming biodiversity.

The articles that are relevant to our project are summarised below together with our approaches to make sure we comply with these rules.

The Rio declaration on environment and development

This is a document that was produced at the 1992 UN Earth Summit and it consists of 27 principles for sustainable development.

Article 15 - Precautionary principle
Those who wish to implement a technology are the ones who are required to prove that it is safe. In other words, the burden of proof rests with those who wish to use the new technology, and should not rely on others to test the product safety after it has been implemented.

"In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation"

While it is important that we follow the precautionary approach when it comes to releasing our bacteria, article 15 shows that we may be able, in cases of extreme risk of desertification, to release our bacteria for a field trial without necessarily needing to show full scientific certainty of the system's safety. It can also be seen that this applies more to non-biological technologies than to GMO's. However, the argument is still valid, and could be seen to apply to our project as it seeks to help to prevent desertification, a serious and irreversible change.

Article 17 - Environmental impact assessments
There is a need for a thorough assessment of the possible impact that a project might have upon the environment in terms of all natural, social and economic aspects.

We need to make a formal assessment of the impact that our project will have on the environment if implemented. Our efforts can be read in Ecology and Implementation.

Article 22 - Indigenous peoples have a vital role
The cultural practices of the indigenous populace need to be taken into account when implementing a project.

We have tried to take this into consideration when we drafted a method to implement the project. For many cultures, certain plants can hold a religious or cultural significance, and we would likely cause offense if we began to plant them as a barrier to desertification.

Since many dryland areas are in less economically developed countries, and the indigenous populace are often poor farmers, it is very important that we find an effective method of educating the people about what our project seeks to accomplish and how it does so.

The Cartagena protocol on biosafety

This is an international agreement on biosafety that seeks to protect biodiversity from the potential risks from released GMOs, specifically LMOs. The Cartagena Protocol is especially relevant to our project as it includes guidelines for the transboundary transport of LMOs, which we will require to take our system to where it is most needed.

Article 7 - Advance informed agreement

This is a procedure that applies to the first time that an organism is imported into an environment. As the name suggests, the agreement is to be reached in advance of the specified organism being transported. This is to give both the exporting party and the importing party the opportunity to independently evaluate the scientific information before reaching an agreement. The importing party may, at any time, change its decision in the event that new scientific evidence comes to light. The import of the LMO is still subject to the domestic legislation however, so we would need to research the regulations for each particular nation to which our system is exported.

Article 17 - Unintentional transboundary movements and emergency measures

This article states that, in the event of an unintentional transboundary movement that may cause adverse affects upon the environment, the Biosafety Clearing House and all affected States must be notified as soon as the issue is known.

In making affected States aware of the unintentional movements, it is necessary to give details of any effects that the organism may have upon human health.

This means that we must find a method by which we are able to track our bacteria, since, even though the Gene Guard module should prevent the spread of our engineered genes, the unauthorised movement of our organisms cannot be allowed.

This specifies that we have to have some significant scientific evidence for our system's safety before we can consider exporting it to a country that is affected by desertification. This means that we will need to carry out rigorous field tests here in the UK and make all of our data available to the importing government, so that they can reach an agreement independently of us.

The same article requires us to disclose any and all information on the organism in the event of such an uncontrolled spread, including any possible effects on human health. This means that we must also carry out extensive trials in order to categorise any adverse effects on human health.

3. Result

Looking at the legal aspects of preparing a GMO for release has given us an understanding of the issues that we need to take into account as we design our project. The precautionary principle outlined the need to prove that our technology is safe before we are able to release it, and this led us to the research that we did on the ecological aspects of our project. This was necessary in order to investigate the safety of our bacteria towards the soil environment. Further work would include a small scale soil test to attempt to realise any factors that we previously overlooked.