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 21st 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.
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.
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.
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.
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.
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.
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.
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.
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