Difference between revisions of "Team:Reading/Practices"

Human Practices

Synthetic Biology is becoming an increasingly important field. It is offering a new source of innovation and progress for some of the 21^st century’s most difficult problems, such as providing reliable electricity to some of the most inaccessible and poverty stricken areas without causing extensive and irreversible damage to the environment. The use of synthetic biology is ushering in a new era of sustainable development by improving access to power without harming our environment in the process. However, like all novel technologies, these are mainly untested and untried and so require new regulatory legislation as well as presenting new ethical issues which need to be considered.

Regulation

The aim of our project was to build a photovoltaic cell which could provide cheap and reliable electricity to provide power to a larger number of people, who would normally not have access to this, without compromising the environment. As a result of intended use of the design and the use of biological matter there are significant regulatory measures in place to consider. Regulation can vary from an international, such as EU regulation and other international framework to a national government level. These are then implemented by the university, or organisation, which the research is being undertaken. The University of Reading itself has its own control and regulatory methods which follow that of UK and EU guidance and control genetic modification research within the university itself.

Genetically Modified Organisms

International Regulation

This is regulation which applies to multiple countries. The main international regulation at its highest level is the Cartagena Protocol on Biosafety¹. This agreement controls the movement of genetically modified organisms across borders in an attempt to minimise risk of environmental damage as a result of contamination and to prevent damage to human health.

1. EU Regulation

   The use of genetically modified organisms is controlled by legislation set out by the European Commission which all member states of the European Union have to follow. The main regulatory legislation that applies to genetically modified organisms is Directive 2001/18/EC which controls the deliberate release of genetically modified organisms and Directive 2009/41/EC which controls the contained use of genetically modified microorganisms as well as Regulation (EC) No 1946/2003 which controls the movement of genetically modified across borders. The legislation on genetically modified organisms provides a framework to ensure that the development of biotechnology is developed in safe conditions, minimising the impact on human health and the environment².

2. Directive 2001/18/EC

   This legislation controls the release of genetically modified organisms into the environment to minimise the damage to the environment and without disruption to biodiversity and of that of human health³. The legislation requires a risk assessment to be carried out prior to release to determine if there are any potential impacts on human health and on that of the environment. The assessment is carried out on a case by case basis to ensure that each case has the proper attention to ensure no damaging materials are released into the environment. This then requires the member state to then set up authorities which must enforce this directive and ensure compliance with this legislation, such as a further regulatory body which controls how this directive is enforced to review the risk assessments, safety and has the power to alter the conditions or even to terminate the process. In the UK this is the Health and Safety Executive. As well as this, all Genetically Modified Products which are released must be traceable to the owner if an investigation is required.

   Within this directive, there are slight variations depending on if this is released for market use or non-market release. For example, in non-market release, this requires a greater level of monitoring as unlike market products, there is a much limited existing monitoring already in place. For example, these must have a risk assessment in place to determine some of the risks, that wouldn’t be associated with non-market release. This should be risk assessed per case and along with this, regular reports should be passed to the European Commission. If this were released for market use on the other hand, as we would need to consider with our project, there are a number of other steps For example, the organisation releasing the product must gain consent from the relevant authority in the relevant member state as well as review by the European commission. There must be a risk assessment as well as monitoring plan for the products before and during release. The products must also be labelled indicating the presence of GMOs as well as special handling to ensure proper controls.

3. Directive 2009/41/EC

   This directive controls the contained use of genetically modified micro-organisms. This states that all necessary precautions should be taken to avoid adverse effect on the environment and on human health. The microbes which are being modified should be classified based upon the microorganism safety classification, which will dictate the control mechanisms which should be used and the level of restriction. The member state has the responsibility to set up regulatory bodies which control the use of these microbes and ensure they are being properly used. The relevant authorities have the authority limit the time of which the organisation are able to use the microorganism and of which they are allowed to study or use or if need be to completely terminate the project or restrict the usage. They also have the power to change the circumstances and safety measures of which the microorganisms are used. As well as this, the relevant authorities are required to regularly inspect the organisation but to also have an emergency plan in place⁴.

4. Regulation (EC) No 1830/2003

   This regulation ensures that all genetically modified products or products which use genetically modified organism must be traceable and labelled so consumers are aware of the genetic nature of the product in question. Consumers are therefore able to make informed decisions about the product. These products must therefore be traceable to the original producers of the product with the use of unique labels, specific to the product so it can therefore be traced to the producer. The member state has the responsibility to provide inspectors to test products for GMOs and to ensure that the products adhere by these rules⁵. In the case of our project, if it were to be placed on the market for retail we would need to ensure that we state that the products are genetically modified and ensure that they are traceable to us, the producers of the product.

National Control

In the UK legislation is directed by legislation put in place by the European Commission⁶. For example, as the UK is a member state of the EU, all laws set by the European Commission will apply to the UK. These include EU Directive 2001/18/EC, controlling the release of genetically modified organisms into the environment and EU Directive 1830/2003. These feature very heavily therefore in UK regulation. Legislation related to genetically modified organisms are controlled and enforced by the Health and Safety Executive (HSE)⁷. The HSE enforce the legislation by regular inspections of locations working with genetically modified organisms and working with institutions to ensure that they follow the legislation and are informed.

1. Environmental Protection Act 1990

   This legislation sets out methods to control the release of genetically modified organisms into the environment and keeping of genetically modified organisms under the umbrella of the environmental protection act which covers a large number of environmental hazards.

   The legislation states that a risk assessment must be undertaken prior to release of the genetically modified organism into the environment. Those then wishing to release the organism into the environment much gain approval from the relevant authority, the secretary of state decided by the Advisory Committee on the Releases to the Environment⁸. They have the authority to appoint inspectors to test the organisms to determine if they are allowed to be used as well as to determine if the person is legally allowed to release the or to use the organism. The user of the genetically modified organism is required to disclose all relevant information to the relevant authority. If the organism is considered to be a risk to the environment then the inspector has the power to remove and destroy the organism to prevent significant damage to the environment.

   There are variation depending on the use of the genetically modified organism as to what the party is required to follow. For example, if the person intends to keep the organism then the organism must be identified by reference to the nature of organism and the manner in which they intend to keep them. They must then have suitable methods in place to ensure that the organism does not escape and therefore reduces the risk of environmental damage. The person must complete a risk assessment if they wish to keep the organism, to determine the environmental risk associated with keeping the organism. The organism must be destroyed if there is considerable risk associated with maintaining the organism. If the person wishes to release the organism then the party involved must be informed, by reference to the nature of the organisms and the extent and manner of the release as well as the risks of damage to the environment as a result of release of the organism into the environment. However, if there is a considerable risk of damage despite the precautions taken then the organism must be destroyed to prevent damage to the environment.

2. Genetically Modified Organisms (Contained Use) Regulation 2014

   These regulations build upon the EU directive 2009/41/EC in how organisms are used. These state that all work must be risk assessed for impacts on environmental and human health. The organisms must be classified based on safety rating and the HSE should be notified on the use of these organisms. The institution must have a public register which should be maintained, detailing the work undertaken by the institution⁹.

3. Genetically Modified (Deliberate Release) Regulations 2002

   This piece of legislation builds upon the EU directive 2001/18/EC which controls the release of organisms into the environment, setting out the implementation of EU directive 2001/18/EC in the UK¹⁰.

University Control

At university level, all research involving genetic modification are controlled by a number of bodies within the university. The main body is the Sub Committee for Biological Safety (SCBS)¹¹. This committee controls the use of genetically engineered material. The SCBS has a number of functions:

• To ensure compliance with legislation on biological safety.
• To advise on risk assessments.
• To approve health and safety aspects and improve upon where needed.
• To receive reports on activities involving genetically modified material, including their usage and accidents involving genetically modified material.
• Higher risk projects, above class 2 biological safety hazard must be reported to the SCBS which will then inform the HSE.
• To ensure that all workers which are trained and qualified to work with genetically manipulated organisms especially pathogens of class 2 or higher.

The committee has the power to make changes to the experiment if they do not follow legislation or are unsafe and can terminate the project entirely¹².

Environmental Impact/Safety

With the project, the overall environmental impact is particularly limited as of the fact that the system itself produces electricity without use of polluting fossil fuels, and even removes carbon dioxide from the atmosphere, so is therefore in that sense beneficial to the environment. However there are a number of environmental issues associated with this project. For example, the main environmental hazard is the accidental release of the bacteria from the fuel cell. This may potentially occur when changing of the bacteria or chemical components of the cell. This can occur when poor microbial practice is not properly applied such as using an insufficient amount of cleaning agent is used. There is limited risk from this for our mutants as these would be less able to compete with local species due to slower growth rate as a result of the mutation.The main risk however is horizontal gene transfer of our modifications to other bacteria in water such as that from waterborne pathogens - fecal oral route pathogens often cause disease by adhering to the mucosal surface of the GI tract via pili/fimbriae, so if it say picked up the hyperpilation modification from our bacteria, this could make the pathogen more virulent.

Scale Up and Deployment Issues

There are a number of issues associated with the deployment of our photovoltaic cell. For example, there are a number of regulatory issues associated with selling the products abroad. The Cartagena Protocol on Biosafety ensures that we would have to get full authorisation from the state to therefore allow us to export to the country in question. If we were to then export to the EU, we would need to then conform to regulation 1946/2003, which controls the movement of genetically modified products across borders. With scaling up, there are a number of issues with growing the bacteria. For example, Synechocystis sp PCC 6803 can take over fourteen days to grow to optimum population numbers. This presents issues with supply as it will mean that if a fuel cell is ordered, this may take a significant amount of time to therefore reach the customer. For example, growing the bacteria alone will take over two weeks until are of an optimum population for use in the cell. As well as that the fuel cell needs to be set up and then exported. There are a number of solutions. For example, use of technology such as a bioreactor can be used to significantly increase the rate of growth. For example, Synechocystis sp. PCC 6803 when grown in a flat-bottomed bioreactor achieved a doubling time of 5.13 per hour¹², considerably greater than our recorded growth rate using standard cell culturing techniques. Our techniques used a basic set up of 100ml of BG-11 in a 500ml flask. This would considerably increase the growth of bacteria to around an average of 1.7 per day¹³ by using a bioreactor. Another issue is that of exporting the bacteria. These will need to be frozen to ensure that they remain alive while being transported. This presents an issue of transport where the fuel cell will need to be kept in constant light to prevent degradation of the bacteria. This can be resolved by storing the cells when in transport in cold storage to inhibit growth. When the cells are delivered, they can then be allowed to thaw naturally in sunlight. This option is much cheaper in terms of having a constant light and nutrient supply. It also means that the bacteria have a longer effective life when in the cell as they will not be consuming nutrients while in storage or transit, therefore being more cost effective to the consumer. Another issue associated with the deployment is the fact that the bacterial population will eventually begin to decline and the cell will therefore become unusable. The solution is within the design of the cell. It is of a modular construction which allows individual modules to be replaced independent of each other. Therefore the customer can then replace a module which has a declining population. The customer can be advised on the average effective life of a module and so would know when it requires replacing without needing to conduct complex testing.

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