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
• Contained Use
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

The two EU directives concerning our plans are the directive 2009/41/EC on contained use and the 2001/18/EC directive on deliberate release of GMOs. Of these, the contained use directive is probably most appropriate, though it is possible that the deliberate release directive may be relevant too. The 2009/41/EC directive defines contained use as: “any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment”, in Article 2(c).

By contrast, the 2001/18/EC directive defines deliberate release as: “any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment”, in Article 2(3).

By comparing these, and reviewing the proposed implementation of our idea (link), we can see that we would most likely fall under the contained use directive because of our suggested containment measures. Our technology will use all of the activities specified by contained use, and implement appropriate safety measures. Based on this, we shall chiefly address contained use regulations, but mention rules on environmental release that are significant.

EU: Contained Use

In summary, class 1 contained use requires:

We shall explore each of these points in further detail.

Article 4 defines one of the main requirements for contained use: for a risk assessment to be carried out (Article 4(2)), in accordance with the guidelines in Annex III, with the aim of classifying the GMM. The criteria include assessing the potential to cause disease, effect on the environment (Annex III (A1)), and harmful effects of the genetic material, recipient, donor, vector and final GMM (Annex III (A2)). The severity of these issues and the chance of them happening must also be analysed. As a non-pathogenic organism, capability of causing disease is not relevant to our organism. The most germaine section is in Annex III (A1), which lists considering “deleterious effects due to establishment or dissemination in the environment” and “deleterious effects due to the natural transfer of inserted genetic material to other organisms.” Annex III (B7) goes on to require that the proposed use of the microorganism be combined with the above assessment in assigning it to a class. “Non-standard operations” is mentioned as affecting classification (Annex III (B7 iii)); this term is ambiguous, but may encompass our suggestion of having GMMs on roofs of private properties. Our drip-in/drip-out system (link), with the filter needing autoclaving upon replacement, may also fall under non-standard use. This would need to be taken into consideration if attempting to use our technology commercially. From this, it is clear that our GMM belongs in class 1 (as defined in Article 4(3)), so requires level 1 containment measures, though any doubt raised from our “non-standard operations” might cause a more strict classification (Article 4(4)). For those wishing to classify their organism, Directive 2000/54/EC can be referred to, or classification systems of the specific country.

The risk assessment has a particular focus on waste disposal (Article 4(5)), making our drip-out waste disposal system very important (link). As removing the filter from the panel might be a source of accidental release, careful planning of waste management should be high on our priority list. The final risk assessment must be given to the competent authority (Article 4(6)) - HSE in the case of the UK. Containment measures are defined in Annex IV.

Article 6 poses a potential issue. It requires notifying authorities upon contained use at each new property. While this is reasonable for single use at the university, our idea of having installations on separate houses would mean giving the information listed in Annex V for each site, including the risk assessment, which individuals are responsible for supervising, and a description of the premises. This would mean that the risk assessment must be sufficiently comprehensive to envision all potential environments where an installation may be set up, and would mean extra administration work for our organisation. It may be that, in the future, EU directives would need to be altered in order to make GMM technologies like ours more easily available for public benefit. Deliberate release regulations already contain a separate section for commercial use, and contained use may be separated this way in the future too.

For class 1 organisms, no further notification is needed before commencing with contained use (Article 7). For higher risk classes more information is needed; as our organism is only class 1 we will not consider this, but rules can be found in Articles 8 and 9.

Further thought should be given to the minimum containment measures stipulated in Annex IV, and whether our system meets these conditions. There are different requirements given for different potential situations. Our proposition would most likely fall under “Containment and other protective measures for other activities” for the panel itself, but other containment procedures would need to be reviewed for labs where genetic modification is done and areas where GMMs are cultured. Almost all containment options for class 1 organisms in this category are optional according the Annex IV. It is likely that the level of containment assumed for this category is more severe than in our proposition (i.e. the EC has assumed all contained use will occur inside a building). As such, we should expect to see some or all of the containment measures to be required, rather than optional, for our project.

Beyond the obvious physical containment, there are several possible containment measures we could be required to enforce. This includes control of aerosols during “addition of material to a closed system or transfer of material to another system”. This would include transferring cyanobacteria to the fuel cell, which would be done in a separate contained facility, and during the removal of waste or the waste filter (see design section), which would have to be done on site. The latter is one of the biggest issues our project could face.

Inactivation of waste containing GMMs is also listed as optional, but could potentially be required. Furthermore, the air leaving the system, assuming filter-sterilised air is bubbled through our panel, could have to be filtered to prevent or minimise release. The only point already required for class 1 work is that personnel wear protective clothing.

According to Article 13, an emergency plan is required. This must be made available to the public, relevant bodies and authorities, and other concerned EU member states. The plan is required in case containment measures fail, leading to “serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment”. No information is given on how extensive this plan should be, and no minimum requirements are given. Member state legislation must therefore be consulted for any rules on how the plan must be structured.

Finally, it should be noted that member states may consult the public on the proposition if they decide it is relevant (Article 12).

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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