Team:Reading/Human Practices

Biosafety and regulatory challenges of rooftop installations

Contents

An important part of iGEM is thinking about the wider impact of your project. We considered whether it would be possible to set up our cyanobacterial solar panels on roofs at Reading or on people’s houses. This meant coming up with a design for a larger photovoltaic cell, considering the biosafety issues involved, and what regulatory challenges we would face.

1. Summary
2. Introduction
3. Levels of Regulation
4. EU Regulations
• Introduction
5. Regulations
• Example
6. Commercialisation
7. Acknowledgements
8. References

Introduction

Creating a cyanobacterial photovoltaic cell and getting it installed on a roof at a university presents a number of challenges. The design of the system is the first aspect to consider. We look into design and cost of the parts on the Fuel Cell page. Then there are European Union (EU) and government regulations and, in the case of Reading, several boards and internal committees through which applications would have to pass. We consider these in this section. Each of these raises questions about biosafety, such as potential effects of the escape of our organism into surrounding environments. We answer these in the safety section. In addition to using our technology at our own university, we also considered commercialising the technology and installing it on people’s houses. This opens up a new realm of issues, such as getting our energy source classed as renewable according to the EU’s Renewable Energy Directive (RED), and getting permission for having GMOs on many distinct properties. These wider problems are also reviewed here.

Many sections of our report will be applicable to other teams considering contained use of GMOs, and we hope future teams will benefit from our research. The EU section will be particularly relevant to other EU member states, as the EU regulations form the common minimum requirements for each country. In general, this page and the safety page should guide teams considering biosafety issues associated with cyanobacteria; there are currently no reviews of biosafety in synthetic biology of cyanobacteria that we are aware of. We finish with a roadmap for those thinking about whether they could commercialise a genetically modified microorganism (GMM)-containing system, especially as a renewable fuel source.

It should be noted that the report mainly refers to contained use of GMMs. Though our system is contained, parts of it could be considered to overlap with deliberate release (discussed below). We have therefore focussed on regulations pertaining to contained use, but have referred to those on deliberate release where our system could potentially fall under its purview. Due to this relevance, and partly time due to time constraints, we have not exhaustively considered deliberate release or contained use categorised as class 2 or above.

The Different Levels of Regulations

At the highest level, the Cartagena Protocol on Biosafety covers living modified organisms (LMOs) and their transport across borders. This is an international United Nations agreement that has been in place since 2003, and is implemented in the EU by Regulation EC 1946/2003. Below that, the EU issues “directives” on genetically modified organisms (GMOs) that must be implemented by all EU member states. For contained use, only the state’s regulations need to be considered; there is no involvement at the EU level. For deliberate release, rules are much more complicated, involving notification of the European Commision (EC). There are also other EU regulations governing GM food that will not be covered here. In the UK, the EU directives are implemented by the Department for Environment, Food and Rural Affairs (DEFRA) and the Health and Safety Executive (HSE). Finally, at Reading we would have to pass at least 3 committees - including the sub-committee for biological safety, the project committee, and the environmental committee - in addition to getting approval from the building manager.

EU Regulations

Introduction to EU Regulations

Regulations

Regulations

Sample Subsection Number One

This is how an example subsection could be formatted.

Other challenges in bringing our product to market

More info.

Acknowledgements

Everyone we need to thank for help with regulations and biosafety information.

References

Here are the references.

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