"

From 2011.igem.org

---

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.

---

Legal issues

1. Goal

If our project is ever to be realised, it must be released into the environment. There are several laws and statutes regulating the release of genetically modified organisms that we have to consider when deliberating the release of our bacteria. We found that it was necessary to research the main laws that would affect the operation of our finished product.

2. Action

To help inform our design, we investigated the legal issues surrounding Genetically Modified Organisms (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. In order to do this, we needed to read the relevant legislation governing GM technology, focusing particularly on international laws.

3. Result

There are several laws that directly affect GM release. The most important ones are:

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.

15 - Precautionary principle
This is an important principle that requires that 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's safety after it has been implemented.

This article also contains the following important definition:
"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"

17 - Environmental impact assessments
This principle outlines the need for a thorough assessment of the possible impact that a project might have upon the environment. This is necessary to ensure that all natural, social and economic aspects before reaching a decision.

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

How does this affect our project?
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, 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 shows that we need to make a formal assessment of the impact that our project will have on the environment if it is ever released. Our efforts can be read on the Ecology and Implementation pages in the Human Practices section.

Article 22 is also something that we have tried to take into consideration when we drafted a method to implement the project in a practical way. Again, this can be viewed elsewhere in the Human Practices section of our wiki.

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 Living Modified Organisms (LMOs). The protocol came into effect on September 11 2003. 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 needed most. Read the full text here.

Relevant articles

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 that our system is exported to.

How does this affect our project?
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.