Team:Victoria Australia/Ethics

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Revision as of 00:30, 21 October 2009

ETHICS:

With the biological lighting system that we are creating, we have considered ethical issues that arise for Synthetic Biology where there are distinct advantages in our project, most notably: The dangers of gene technology (control of the system), the dangers of creating artificial life, intellectual property (IP) and gene patenting.

The Dangers of Creating Artificial Life and The Dangers of Gene Technology (Control of The System):

Major societal concerns with gene technology – including Synthetic Biology where there exists the potential to manipulate or create artificial life – is the occurrence of gene transfer that can potentially lead to contamination and genetic modification of foods, crops, animals and even humans. This involves issues with propagation, multiplication or increase by natural reproduction, of the recombinant organism or genetic circuit. Other concerns are that scientists are removing functions from cells in synthetic biology to build a machine and this cannot be controlled. Our project eliminates the specific risk of propagation, as cell-free systems are non-replicating and non-propagating. Because of the general “safe” view of cell-free systems, they are not currently legislated by the Australian Office of the Gene Technology Regulator. However, it should be stated there will always remain statistical probabilities of gene transfer from the cell-free chassis, and so we would argue cell-free systems should also be regulated in the same manner as other recombinant systems. Our project does not eliminate all risks of gene transfer but reduces the probability of this occurring.

There is a limited circuit life from a cell-free chassis dependent entirely on depletion of the essential components of the system. This creates a new level of control and hence a great reduction in the risks associated with gene technology; there is a greatly reduced probability of successful escape or gene transfer to the environment. Furthermore, for gene production to occur most readily, the gene must go into a vector or cell containing a T7 phage polymerase enzyme to replicate, which in nature is not commonly present. Hence a specific recombination event is most likely to be the risks associated with this chassis and naked DNA plasmids.

A fun application we promote is the use of the fluorescent system in Christmas lights. This would create specific societal concerns about the risks of young children eating the synthetically engineered lights which could look similar to a child to the confectionaries which may also decorate the tree. Using a wheat germ or other plant-based extract provides a non-toxic alternative (ie wheat in many households is consumed on a daily basis). However, using an E.Coli extract in the cell free system can be toxic if consumed due to the endotoxins present, resulting in anaphylactic shock. Gene transfer in such a scenario is a highly unlikely but conceptually feasible event.

IP and Gene Patenting

We have put forward material to advance Synthetic Biology and retained specific IP material that has arisen in the course of our project to develop ourselves. Patent protection varies from case to case. DNA is patentable when it has been isolated, purified, or modified to produce a new form not found in nature. In relation to our project, we had isolated the yellow fluorescent protein, purified it and modified it via Polymerase chain reaction to produce a new recombinant blueberry protein. However this invention is not newly discovered and therefore not patentable and judging from our research on the matter, was not a patent from due to previous disclosures as papers in the scientific literature.

Some patents have been granted for fragments of DNA. This presents a problem for someone trying to patent a larger fragment or gene that contains the already patented sequence. Awareness has been raised as to whether the user will need to obtain a license from the first inventor or whether they can obtain the patent without the first patent holder's permission. This is likely to arise in the near future and will most likely be resolved in courts designated to hear patent actions, but currently has not been ruled upon. Modified bacteria are patentable as they do not occur naturally in nature. Our research involved the use of bacteria being E.Coli, however, this was not modified beyond “as supplied” by scientific companies where they are subject to patents, hence this work is not patentable. The cell-free chassis we tested is likewise subject to patenting laws and we have manufactured our own chassis in-house based on literature which is not covered under patent law, and hence these concerns do not apply and we can disclose the majority of our project for the advancement of science.

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-Propagation is multiplication or increase by natural reproduction. There is concern as to the consequences that would occur if the E.coli was incidentally transferred into the environment and propagated. People fear it would replicate and become mutagenic resulting in problems such as disease, contamination and resistance. However,our project eliminates the risks of propagation – cell-free systems are non-replicating  and non-propagating; i.e. it's principally just the genetic circuit and ancillary nucleotides, amino acids, supporting enzymes and energy exchange systems. Therefore there is a limited circuit life dependent entirely on depletion of the system, creating a level of control, hence a great reduction in the risk of making ‘life’ or introducing a replicating system into the environment. For these reasons cell-free systems are not currently legislated by the Australian Office of the Gene Technology Regulator, though technically they can be using plasmids which themselves are capable of transfer and hence may pose an actual risk.
+Major societal concerns with gene technology – including Synthetic Biology where there exists the potential to manipulate or create artificial life – is the occurrence of gene transfer that can potentially lead to contamination and genetic modification of foods, crops, animals and even humans. This involves issues with propagation, multiplication or increase by natural reproduction, of the recombinant organism or genetic circuit. Other concerns are that scientists are removing functions from cells in synthetic biology to build a machine and this cannot be controlled. Our project eliminates the specific risk of propagation, as cell-free systems are non-replicating and non-propagating. Because of the general “safe” view of cell-free systems, they are not currently legislated by the Australian Office of the Gene Technology Regulator. However, it should be stated there will always remain statistical probabilities of gene transfer from the cell-free chassis, and so we would argue cell-free systems should also be regulated in the same manner as other recombinant systems. Our project does not eliminate all risks of gene transfer but reduces the probability of this occurring.
+There is a limited circuit life from a cell-free chassis dependent entirely on depletion of the essential components of the system. This creates a new level of control and hence a great reduction in the risks associated with gene technology; there is a greatly reduced probability of successful escape or gene transfer to the environment. Furthermore, for gene production to occur most readily, the gene must go into a vector or cell containing a T7 phage polymerase enzyme to replicate, which in nature is  not commonly present. Hence a specific recombination event is most likely to be the risks associated with this chassis and naked DNA plasmids.
-In our system our plasmids are dependent on a phage polymerase for transcription, so only infected prokaryotes pose a suitable threat of zoonotic transfer in terms of viable recombinant protein being produced. As a result there is less of a concern with unintentional release as not only can the system not survive and replicate, but there is reduced risk of the plasmid creating viable recombinant protein production in the environment without a specific recombination event.
+A fun application we promote is the use of the fluorescent system in Christmas lights. This would create specific societal concerns about the risks of young children eating the synthetically engineered lights which could look similar to a child to the confectionaries which may also decorate the tree. Using a wheat germ or other plant-based extract provides a non-toxic alternative (ie wheat in many households is consumed on a daily basis). However, using an E.Coli extract in the cell free system can be toxic if consumed due to the endotoxins present, resulting in anaphylactic shock. Gene transfer in such a scenario is a highly unlikely but conceptually feasible event.
-The system we have chosen is based on waste products from everyday use such as a lysate from grass clippings to control the production and switching on and off of the proteins. Aside from positive environmental aspects, this system can be regarded as GRAS (Generally Regarded As Safe). Indeed, a preferred test system was to use a non-toxic wheat germ extract.
-Importantly, gene transfer is far less likely if we decouple the system, whereby transcription occurs in one reaction, and the actual machine is a genetic circuit comprising only translation and using RNA in the feed stock. In this system there is less selective processes due to the requirement of integration by reverse transcription. Furthermore, RNases are endemically present in all areas of our environment, including transfer in the air and dust particles, and so RNA encoding a recombinant protein of interest technically is not a protein and is even less likely to survive, get into the cell intact, and/or integrate into a genome. Lastly, GFPs are known to be non-toxic as seen in fluorescent dogs, cats, mice, rats and frogs from scientific investigations.
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-We have put forward material to advance Synthetic Biology and retained IP material in hand to develop ourselves.
+We have put forward material to advance Synthetic Biology and retained specific IP material that has arisen in the course of our project to develop ourselves. Patent protection varies from case to case. DNA is patentable when it has been isolated, purified, or modified to produce a new form not found in nature. In relation to our project, we had isolated the yellow fluorescent protein, purified it and modified it via Polymerase chain reaction to produce a new recombinant blueberry protein. However this invention is not newly discovered and therefore not patentable and judging from our research on the matter, was not a patent from due to previous disclosures as papers in the scientific literature.
-Patent protection varies from case to case.
-DNA is patentable when it has been isolated, purified, or modified to produce a new form not found in nature. In relation to our project, we had isolated the yellow fluorescent protein, purified it and modified it via Polymerase chain reaction to produce a new recombinant blueberry protein. However this invention is not newly discovered and therefore not patentable and judging from our research on the matter, was not a patent form previous papers.
-Some patents have been granted for fragments of DNA. That presents the problem of someone trying to patent a larger fragment or gene that contains the already patented sequence. Awareness has been raised as to whether the user will need to obtain a license from the first inventor or whether they can obtain the patent without the first patent holder's permission. This is likely to arise in the near future and will most likely be resolved in courts designated to hear patent actions.
+Some patents have been granted for fragments of DNA. This presents a problem for someone trying to patent a larger fragment or gene that contains the already patented sequence. Awareness has been raised as to whether the user will need to obtain a license from the first inventor or whether they can obtain the patent without the first patent holder's permission. This is likely to arise in the near future and will most likely be resolved in courts designated to hear patent actions, but currently has not been ruled upon. Modified bacteria are patentable as they do not occur naturally in nature. Our research involved the use of bacteria being E.Coli, however, this was not modified beyond “as supplied” by scientific companies where they are subject to patents, hence this work is not patentable. The cell-free chassis we tested is likewise subject to patenting laws and we have manufactured our own chassis in-house based on literature which is not covered under patent law, and hence these concerns do not apply and we can disclose the majority of our project for the advancement of science.
-Modified bacteria are patentable as they do not occur naturally in nature. Our research involved the use of bacteria being E.Coli, however, not modified, hence these patenting laws do not apply.