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Revision as of 11:57, 14 October 2010

Campaign Devleopment

Legislative hurdles, extensive testing and patentability are amongst the issues that we would have to consider before production and sale of our nutrient indicator beads. For our campaign, we have designed a hypothetical product and features based on wet lab work and computational modelling to inform the design of a public information leaflet. We acknowledge that there are many further stages of development from lab to commercial use – some of which have also been investigated in detail by previous iGEM teams. To give our public information leaflet more credibility, and to increase our understanding of legislation in the UK and EU, we have investigated some of the main stages of development that would be considered on the way to producing a marketable bead system.

Challenges for releasing our product for real There would be many challenges facing us if we were to want to pursue the option of releasing our product for sale.

These include:

• Patentability: investigating whether our beads, or our idea, can be protected in any way, especially now that we have released it into the public domain via the iGEM competition
• Regulations: in the EU, GMOs have to undergo extensive testing, trials, and approval process involving all member states.
• Economics: producing a viable product for sale that is cheaper to buy than the cost of the fertiliser that could be potentially saved

Legislation

There is a centralised approval process for GMOs in the EU. National agencies also play a role, as well as overseeing laboratory regulations and practices.

UK Agency Roles

Advisory Committee on Novel Foods and Practices, ACNFP: advises Food Standards Agency on GM foods, for example by contributing to the EFSA’s risk assessments or advising the Agency on other GM issues. [http://www.acnfp.gov.uk]

Advisory Committee on Releases to the Environment, ACRE: advise relevant Ministers and other bodies on environmental and human health aspects of activities involving GMOs [http://www.defra.gov.uk/environment/quality/gm/regulation/process/index.htm] ACRE is a committee of independent scientific experts that assess GMOs for safety and advise Defra (guidance note, check address [http://www.defra.gov.uk/environment/gm/regulation/guide.htm])

Food Standards Agency: leads on controlling the assessment of GM food or feed [http://www.defra.gov.uk/environment/quality/gm/regulation/process/index.htm]

DEFRA: [http://www.defra.gov.uk/environment/quality/gm/intro/index.htm] control the deliberate release of GMOs in England. Responsible for

• developing national GM policy and turning EU directives into national law,
• representing UK and EU in international negotiations on the environmental safety of GMOs,
• commissioning and disseminating scientific research on environmental aspects of GM
• assessing the environmental risk of the contained use of GMOs

decides whether or not proposed [R&D] [non-commercial] GMO releases in England meet the safety criteria of the Regulations, and issues or refuses a Part B consent accordingly (guidance note, check address [http://www.defra.gov.uk/environment/gm/regulation/guide.htm])

Health and Safety Executive, HSE: directly regulate GMOs in contained use (e.g. laboratory). Risk assessment guidelines at [http://www.hse.gov.uk/biosafety/gmo/acgm/acgm31/paper6.pdf], or [http://www.hse.gov.uk/biosafety/gmo/acgm/ecrisk.htm]. [http://www.defra.gov.uk/environment/quality/gm/intro/ index.htm]

EU approval process

The European Commission GMO authorisation is based on an independent risk assessment (guidance [http://www.efsa.europa.eu/en/scdocs/doc/99.pdf]) completed by the European Food Standards Authority, and is summarised below from their online guide . It is specifically intended for GMOs in food and feed. Our product is not intended to enter the food chain, however the regulations summarised here will hopefully represent the harshest approval that it should have to undergo. (non-food [http://ec.europa.eu/food/food/biotechnology/qanda/c4_en.htm#c])

-a summarised EU process-