Team:Edinburgh/ethics(legislationissues)

Personal note

Since our system requires genetically modified bacteria to be released into the environment there are certain legal issues that must be reviewed before we can do this. In the UK the release of genetically modified organism, GMO’s is covered under “The Genetically Modified Organisms (Deliberate Release) Regulations 2002”. This legislation covers all releases that are not subject to higher, more stringent legislation for example GM medicines. In the USA there is less clearly defined legislation for the release of GMO’s, which is still covered by the laws which were first adopted in 1986 to regulate against the products of biotechnology. This is done using federal agencies in the “Coordinated Framework for Regulation of Biotechnology”¹

As previously stated the UK legislation on release of GMO’s is covered by “The Genetically Modified Organisms (Deliberate Release) Regulations 2002”. This legislation sets out all the steps which must be taken before any permission will be granted for the release of GMO’s. The legislation is split into 2 types of release, either a Part B or Part C release. A Part B release is one where the GMO is released for a non commercial application including for research purposes and a Part C release is for a commercial application. The decision making processes for these releases are slightly different with Part B applications being dealt with by the member EU state, in this case the UK, while Part C releases are dealt with at EU level, while also ensuring that local regulations are met. This means that all the countries in the EU have a say in any commercial release of GMO’s.

Before any GMO can be released to the environment it must go through the following stages of regulation :

• An application must be submitted to the Secretary of State.
• The application will then be scrutinised by independent scientific experts to ensure the safety standards of directive 2001/18 are met
• A public consultation is held
• A decision is taken by the regulators based on the expert advice and the public representations. If consent is granted, a list of conditions for the release will be included stating how the GMO may/may not be used.
• If the GMO is released, it will be monitored and if any new risks are discovered then the regulators have the right to amend of revoke the consent.

There are slight differences in the way that Part B and Part C releases are dealt with and these are shown in the following Gantt charts shown in Figure 1 and Figure 2.

Figure 1: Gantt chart showing the different stages required before a Part B release will be approved.

Figure 2: Gantt chart showing the different stages required before a Part C release will be approved.

Since one of the steps in this both Part B and Part C releases require a public consultaion to be held before any approval would be made we decided that it would be interesting to conduct our own survey to find out the public perception on both our system and on synthetic biology in general. The survey results can be found here.

From the information given on the “Department for Environment, Food and Rural Affairs”, DEFRA, website , no release of GMO bacteria for a similar purpose to ours had been approved however there was no information to indicate if any attempt had been made. This is to say that we are unsure about how the UK authorities would react to our system.

The legislation covering the release of GMO’s in the USA is much less clearly defined with the main source of legislation being the 1986 “Coordinated Framework for Regulation of Biotechnology”. These laws were set up based on the assumption that biotechnology did not have any special or unique risks associated with it and hence it was covered by any previous laws which would govern similarly designed products but were produced by a more traditional approach. This has led to any release of GMO’s been looked at on a case by case basis.

Since our system would essentially be an environmental release, in the US it would be covered under the “Toxic Substances Control Act, (TSCA)” which is enforced by the US Environmental Protection Agency’s Office of Pollution Prevention and Toxics⁴. Further to this is would be subject to other legislation covering for example food and health as there is a possibility if the bacteria were released the could end up in the food chain and hence there could be a health implication. It is unclear as to which party would make the final decision on if a GMO would be approved for release.

In the US some research has been carried out with releasing GMO’s in field; however this has only been done in galvanised steel silos with covered lids which were placed 3 m under the soil surface. This experiment was conducted this was as the scientist had to ensure that none of the GMO’s could be released to the environment for safety and environmental reasons. Since it was conducted in enclosed containers it does not give us a true representation of how the system would operate in practise but it is more realistic than carrying out the experiments in a lab based environment.

At the moment it is unclear as to whether our bacteria would be allowed to be released for use in landmine detection systems in either the UK or the US as there have been no preceding cases to judge this on. If permission was to be granted it is likely that bacteria would require some form of kill mechanism were it would only survive as long as necessary. For our system this is likely to be the length of time required for it to be seen and the location of the landmines marked, either physically or using some form of graphical representation.

¹Pew Initiative of Food and Biotechnology, “Guide of U.S Regulation of Genetically Modified Food and Agricultural Biotechnology Products” 2001

²DEFRA, Department for environment, food and rural affairs, “Draft: Deliberate release of genetically modified organisms: a guide” 2002

³http://www.defra.gov.uk/

⁴Sayler, G, Ripp, S, “Field applications of genetically engineered microorganisms for bioremediation processes”, Current opinion in Biotechnology, vol 11, 2000, p286-289.

Edinburgh University iGEM Team 2009