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.

Edinburgh University iGEM Team 2009