Team:Newcastle/HP/Law
From 2013.igem.org
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=Law= | =Law= | ||
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+ | ==UK and EU Law== | ||
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+ | Synthetic biology has potential to help solve diverse problems and make the world a better place. This has been reflected by the eagerness of governments across the world to support and fund synthetic biology projects and initiatives. | ||
+ | However, the effects of genetic engineering are complex and currently difficult to predict. There is a risk that modified genes pass from our engineered organisms into wild strains, and out of our control; in plants through interbreeding, in bacteria through horizontal gene transfer. It has been mooted that genetically modified organisms may outcompete native species, reducing biodiversity, or that eating genetically modified crops may have long term adverse health effects, although there is currently little evidence for this. | ||
+ | The above concerns, coupled with worries from the public ranging from the ‘unnaturalness’ of genetic engineering to valid ethical and economic worries (as covered in our ethics section) have led to stringent regulations on the cultivation and release, whether controlled or into the environment, of genetically modified organisms. | ||
+ | In most countries, research groups/universities have committees for the approval of experiments using or producing genetically modified organisms. Higher risk experiments usually have to be ratified by a national regulatory body. In the UK, this is DEFRA, and in the U.S. the Coordinated Framework for the Regulation of Biotechnology. European assessments for approval are solely concerned with safety, whilst U.S. also considers the potential economic impact of the proposed experiments. The 6 steps in environmental risk assessment that must be followed before experimentation can take place in Europe are: | ||
+ | 1: Identification of characteristics which may cause adverse effects | ||
+ | 2: Evaluation of the potential consequences of each adverse effect, if it occurs | ||
+ | 3: Evaluation of the likelihood of the occurrence of each identified potential adverse effect | ||
+ | 4: Estimation of the risk posed by each identified characteristic of the GMO(s) | ||
+ | 5: Application of management strategies for risks from the deliberate release or marketing of GMO(s) | ||
+ | 6: Determination of the overall risk of the GMO(s) | ||
+ | It should be noted that there are various exempt dealings for laboratory based experiments on highly studied genetically modified organisms. The vast majority of iGEM projects will fit within this category- our project for one did not need to be certified by DEFRA. | ||
+ | As can be seen in the flowchart below, experiments with the aim of releasing the modified organisms are treated differently to those which merely aim to use the organism within a contained system. Note that this need not necessarily be in a research lab, but could be in a sealed vial. | ||
+ | European laws regarding the release of genetically modified organisms are notably stringent, with all organisms subject to extensive case by case evaluations by the European Food Safety Authority, and then passed through a number of other EU committees before being authorized for use. | ||
+ | |||
+ | |||
+ | ==Our Project== | ||
+ | |||
+ | References== |
Revision as of 12:41, 29 August 2013
Law
UK and EU Law
Synthetic biology has potential to help solve diverse problems and make the world a better place. This has been reflected by the eagerness of governments across the world to support and fund synthetic biology projects and initiatives. However, the effects of genetic engineering are complex and currently difficult to predict. There is a risk that modified genes pass from our engineered organisms into wild strains, and out of our control; in plants through interbreeding, in bacteria through horizontal gene transfer. It has been mooted that genetically modified organisms may outcompete native species, reducing biodiversity, or that eating genetically modified crops may have long term adverse health effects, although there is currently little evidence for this. The above concerns, coupled with worries from the public ranging from the ‘unnaturalness’ of genetic engineering to valid ethical and economic worries (as covered in our ethics section) have led to stringent regulations on the cultivation and release, whether controlled or into the environment, of genetically modified organisms. In most countries, research groups/universities have committees for the approval of experiments using or producing genetically modified organisms. Higher risk experiments usually have to be ratified by a national regulatory body. In the UK, this is DEFRA, and in the U.S. the Coordinated Framework for the Regulation of Biotechnology. European assessments for approval are solely concerned with safety, whilst U.S. also considers the potential economic impact of the proposed experiments. The 6 steps in environmental risk assessment that must be followed before experimentation can take place in Europe are: 1: Identification of characteristics which may cause adverse effects 2: Evaluation of the potential consequences of each adverse effect, if it occurs 3: Evaluation of the likelihood of the occurrence of each identified potential adverse effect 4: Estimation of the risk posed by each identified characteristic of the GMO(s) 5: Application of management strategies for risks from the deliberate release or marketing of GMO(s) 6: Determination of the overall risk of the GMO(s) It should be noted that there are various exempt dealings for laboratory based experiments on highly studied genetically modified organisms. The vast majority of iGEM projects will fit within this category- our project for one did not need to be certified by DEFRA. As can be seen in the flowchart below, experiments with the aim of releasing the modified organisms are treated differently to those which merely aim to use the organism within a contained system. Note that this need not necessarily be in a research lab, but could be in a sealed vial. European laws regarding the release of genetically modified organisms are notably stringent, with all organisms subject to extensive case by case evaluations by the European Food Safety Authority, and then passed through a number of other EU committees before being authorized for use.
Our Project
References==