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From 2010.igem.org

Campaign Development

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.

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. The majority of the following information has been compiled using the EFSA website [http://www.efsa.europa.eu]. It is presented as our interpretation of the process, and complete information compiled by the agencies can be found at the reference websites.

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: [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: [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], [http://www.hse.gov.uk/biosafety/gmo/acgm/ecrisk.htm] or [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])

• application for authorisation for placing GM food or feed on the market sent to national authority

• national authority acknowledges receipt, informs EFSA

• EFSA publishes summary on website. It has 6 weeks to check for completeness of the application dossier and, if complete, the application is declared valid. [http://www.efsa.europa.eu/en/faqs/faqgmo.htm]

• Application sent to European Commission and to member states – 3 month consultation period

(for GMO seeds, national authority carries out appropriate environmental risk assessment)

• EFSA opinion given within 6 months of receipt of application (extended if additional data requested during scientific assessment) the total time period taken to carry out the risk assessment is variable and can range from 4 up to 24 months depending on the time requested by the applicant to submit the additional information. [http://www.efsa.europa.eu/en/faqs/faqgmo.htm]

• The EC opens a consultation online, and general public may make comments on the overall EFSA opinion within 30 days of its publication.

• The European Commission submits a draft Decision to the Standing Committee of Food Chain and Animal Health (SCoFCAH) within 3 months of receiving the overall EFSA opinion. (The rules for the adoption of a Decision are at [http://ec.europa.eu/transparency/regcomitology/faq_en.htm].)

• An authorisation for a certain GMO product and its intended uses is given for a limited time of 10 years, after which period the applicant must apply for a renewal of Authorisation to continue to place the GM product on the EU market. This renewal is dependent on EFSA’s GMO Panel carrying out a risk assessment of the GMO after 10 years of being on the market. [http://www.efsa.europa.eu/en/faqs/faqgmo.htm]

The Experts

This information is summarised from [http://www.efsa.europa.eu/en/faqs/faqgmo.htm]. The GMO panel (making the assessments) is made up of scientific experts and supported by scientific workgroups. The following are involved in the process:

• EFSA's GMO Panel is made up of 21 scientific experts who are responsible for evaluating the scientific information, discussing its content and deciding on the final risk assessment opinion.

• More than 40 external experts in fields such as biochemistry, food and environmental food microbiology, soil microbiology, molecular biology, genetics, toxicology, animal pathology, immunology, biotechnology, food sciences, ecology, plant biology, agronomy, entomology and statistics. The Declarations of Interests (DoIs) of these experts are also published on the EFSA website. [http://www.efsa.europa.eu/en/gmotopics/topic/gmo.htm?wtrl=01]

• An EFSA scientific secretariat presently consisting of 11 scientists and 4 support staff.

• EFSA’s Scientific Co-operation and Assistance Directorate provides support to all Panels on specific scientific aspects, such as statistics and data collection.

• EFSA’s Scientific Committee which includes the chairpersons of EFSA’s 10 Panels, including the Chair of the GMO Panel, provides guidance and opinions on horizontal risk assessment issues, for example on risk/benefit analysis and transparency.

• When necessary, EFSA’s Advisory Forum which brings together national food safety authorities of all EU Member States is consulted on specific issues.

The considerations

For every application, the following aspects are considered:

• Molecular characterisation of the GM product, taking into account the characteristics of the donor and recipient organism.

• Compositional, nutritional, and agronomic characteristics of the GM product.

• Potential toxicity and allergenicity of the GM product.

• Potential environmental impact following a deliberate release of the GM product and taking into account its intended uses either for import, processing or cultivation. [http://www.efsa.europa.eu/en/faqs/faqgmo.htm]

In around 95% of cases the panel asks applicants for further scientific information, study results or clarifications before processing their applications if it is not satisfied with the original dossier. [http://www.efsa.europa.eu/en/faqs/faqgmo.htm]

Public relations plan for next year

We could take our campaign further with the aim to raise the profile of synthetic biology research and its potentials. For future teams, there is a chance for collaboration amongst iGEM participants to create a brochure of leaflets detailing products that could be made possible by our projects. These varied ideas can be used to promote the field in a varied way to the general public – designed to encourage debate and get people talking with materials designed by those scientists involved in the research themselves. By presenting many practical uses, diversity and the motivation of scientific understanding rather than economic gain, we would hope to gain trust for synthetic biology as a potential solution to many problems, not as another new technology that is misunderstood and dangerous.

Collaborating organisations should be investigated: sympathetic organisations that encourage public knowledge in the area of synthetic biology. There may be educational collaborations, or even potential cooperation with activist groups to disseminate accurate and positive literature. There are events around the country promoting science, which could also be approached as a platform from which to contact the public.

Our role as students partaking in a competition gives us credibility as our motives are informative. Teams have been well received into schools, as with our own visit to Clevedon Community School, and likewise welcomed to radio interviews. There is a call for more information, and framing these projects as an advertising campaign gives the research the feeling of being closer to daily life and having a purpose that can be related to, rather than abstracted.

References

[1] [http://www.efsa.europa.eu/ EFSA, accessed September 2010]
[2] [http://www.acnfp.gov.uk/ ACNFP, accessed September 2010]
[3] [http://www.defra.gov.uk/environment/quality/gm/regulation/process/index.htm DEFRA Regulatory process for genetically modified organisms, accessed September 2010]
[4] [http://www.defra.gov.uk/environment/quality/gm/regulation/ DEFRA accessed September 2010]
[5] [http://www.defra.gov.uk/environment/quality/gm/regulation/process/index.htm DEFRA Regulatory process for genetically modified organisms, accessed September 2010]
[6] [http://www.defra.gov.uk/environment/quality/gm/intro/index.htm DEFRA Introduction to genetically modified organisms (GMOs), accessed September 2010]
[7] [http://www.defra.gov.uk/environment/quality/gm/regulation/ DEFRA accessed September 2010]
[8] [http://www.hse.gov.uk/biosafety/gmo/acgm/acgm31/paper6.pdf Risk Assessment of GMMs, accessed September 2010]
[9] [http://www.hse.gov.uk/biosafety/gmo/acgm/acgm31/paper6.pdf EC guidance notes for RA GMMs, accessed September 2010]
[10] [http://www.defra.gov.uk/environment/quality/gm/intro/index.htm Introduction to genetically modified organisms (GMOs), accessed September 2010]
[11] [http://www.efsa.europa.eu/en/scdocs/doc/99.pdf EFSA Guidance Document for RA GMMs, accessed September 2010]
[12] [http://www.efsa.europa.eu/en/scdocs/doc/99.pdf EC GMOs in a nutshell, accessed September 2010]
[13] [http://www.efsa.europa.eu/en/faqs/faqgmo.htm EFSA FAQ on GMOs, accessed September 2010]
[14] [http://www.efsa.europa.eu/en/faqs/faqgmo.htm EFSA FAQ on GMOs, accessed September 2010]
[15] [http://ec.europa.eu/transparency/regcomitology/faq_en.htm EC, accessed September 2010]
[16] [http://www.efsa.europa.eu/en/faqs/faqgmo.htm EFSA FAQ on GMOs, accessed September 2010]
[17] [http://www.efsa.europa.eu/en/faqs/faqgmo.htm EFSA FAQ on GMOs, accessed September 2010]
[18] [http://www.efsa.europa.eu/en/gmotopics/topic/gmo.htm?wtrl=01 EFSA GMOs, accessed September 2010]
[19] [http://www.efsa.europa.eu/en/faqs/faqgmo.htm EFSA FAQ on GMOs , accessed September 2010]
[20] [http://www.efsa.europa.eu/en/faqs/faqgmo.htm EFSA FAQ on GMOs, accessed September 2010]

• Motivation • Product Specification • Public Perception • Materials • Future Work •