A few weeks ago the Environmental Protection Agency (EPA) organised a broad ranging conference on biotechnology issues, particularly GMOs. It looked at the use of GMO technologies in the industrial, medical and agricultural sectors. There appeared to be general agreement that the use of these tools in industry and medicine operated well under the current controls and appeared to be non-contentious.
However, EU agriculture has effectively been denied access to GMO crop technology through the combination of controls governing release into the environment and the virtual prevention and rejection of sound independent research to verify food and environment safety issues. While the precautionary principle was reasonable initially, the scientists present stated that there have been no valid food safety or environmental issues identified and that there is a need to modernise the relevant control legislation.
The major public challenge to gene transfer and engineering technologies has been in the EU, and mainly in agriculture, or at least the field production of agricultural crops. But genetically engineered or modified substances have been in use in Europe for over 40 years now.
Insulin for the control of diabetes has been produced using genetic modification since 1982 and is now the major source internationally. GM rennet, used for the manufacture of cheese, has been on the market since 1990 and Prof David McConnell, TCD, stated that 90% of all cheese manufactured in the US and Britain uses GM rennet.
While all processes used in the research, development and manufacture of genetically engineered solutions for industry and medicine are heavily controlled, and rightly so, the legislative framework appears to allow progress in these areas. The ever-increasing knowledge and technology base is facilitating increasing application and uses in both areas.
||PIC2||
A range of biotechnology-based tools have been developed to produce control or containment drugs for diabetes, AIDS and a vaccination against Papilloma virus. Speakers stated that GM technologies are now being used in the fight against multiple sclerosis, autism and rheumatoid arthritis with genetic engineering used to produce the proteins to make drugs and DNA-based diagnostic procedures.
The legislation
The main problem stated with regard to GM legislation in the EU is that it controls the process of making the change, rather than the product that is changed. In the US the legislation controls the product that is changed.
European legislators and consumers were right to be concerned about any new technology of this nature, especially when it comes to market in the absence of clear independent evaluation. But the design of a regulatory system which inadvertently prevents any such independent verification research being conducted represents the failure of both the regulatory and the political systems themselves.
||PIC3||
The European regulatory system has paralysed progress in the EU and resulted in a regime that appears incapable of being advised by science or adjusted by the regulators themselves. It was described as slow, complex, conservative, highly politicised and unreliable.
This can be seen in the fact that the EU, so far, has only given 67 GM crop approvals. The vast majority of these were for food or feed uses and there have only been two approvals for crop cultivation – Mon 810 insect tolerant maize and a high starch potato, BPS-25271-9. And the latter has since been withdrawn. There were also two separate approvals for carnations.
While regulation is essential, virtually all the speakers and attendees, including the EPA who are our competent authority, felt that the GM regulations have prevented technological development in crops in the EU. And the even bigger fear is that they will continue to do so if they are not modernised.
Nobody wants unsafe food and nobody wants to introduce plants that provide a known risk to the environment but the feeling was that approval decisions need to be more balanced. Nature changes all the time, that is how evolution happens and this will continue in the absence of GM crops.
The regulatory system is just not operating. What was supposed to take months, according to our laws, has taken years.
The regulations are not just hitting crop cultivation, but they are also threatening feed importation. This is because the new types that continue to be developed and grown in the Americas are not being approved fast enough to facilitate importation.
But apart from this it is increasingly evident that exporting countries are becoming less concerned about the EU market where consumption is falling. It seems likely that exporters may, in time, decide to bypass the inconveniences associated with the EU market in favour of the expanding Asian markets.
‘The GM regulations assume danger – why is this?’ some asked. ‘They are just not fit for purpose,’ another speaker stated. We now have non-GM herbicide tolerance in crops and there is no issue with this. We have been using GM technology in its different guises for over 30 years with no verifiable ill effects to man or environment. But real change at EU level will be difficult to achieve.
The new sciences
The regulations must evolve to accommodate new developments in biotechnology. Assessment of these technologies should consider the benefits that individual traits may bring, as well as looking at the potential risks. We cannot force things to remain as they are. Genetic engineering happens all the time in nature and so the controls governing GM must be proportionate.
Delegates suggested that better regulation of GMO technology in the EU should:
be product-based regulation, in line with rest of worldbe proportionate to the risksassess risks versus benefitshave an economic benefit assessment done to help keep biotech jobs in the EU. Technology continues to progress and much has been learned through the use of GMO technology elsewhere. As a result we now have many new biotechnological techniques which are being prevented by current GM regulations.
A number of these new technologies are currently being considered by an EU working group to evaluate whether or not these new sciences should come under the control of GM legislation. These include:
Oligonucleotide Directed Mutagenesis (ODM)
Zinc Finger Nuclease Technology (ZFN)
Cisgenesis, comprising Intragenesis
Grafting
Agro-infiltration
RNA-dependent DNA methylation (RdDM)
Reverse breeding
Synthetic genomics.
Many of these techniques do not result in any new gene-associated proteins being present in the end product, hence questioning the justification of having them controlled by GM legislation.
An example would be a non-GM apple scion grafted onto a GM root stock – the apple would be non-GM. The genetic changes generated by many of these sciences are similar to conventional breeding.
Safety
No one wants unsafe food or risk to the environment. That said, risk is ubiquitous and generally provided by nature itself within the context of modern food safety. Pests and diseases threaten the availability of the very food that is helping to sustain the planet, at both production and storage levels.
The loss of many pesticides in the EU leaves production systems increasingly vulnerable to an evolving army of natures aggressors. Biotechnology tools provide our best defence options for the moment and they need to be employed.
No difference
Food production is an intervention in nature and nature will always win this battle unless man fights back. To not fight back would be to condemn a portion of humanity to death by starvation. Scientists argue that GM crops should be governed by the same rules as classical plant breeding. But classical breeding generates a very uncontrollable mix, making new commercial varieties difficult and costly to create.
In contract, molecular techniques are described as precise engineering with only a very small number of gene alterations to add a specific trait.
Examples to date would be the addition of a bacterial gene to degrade glyphosate to produce Roundup-tolerant plants. A different bacteria gene was inserted into plants to kill insects. In the latter case, only insects that eat the plants would be affected so it is highly targeted. There have been no adverse affects associated with 13 years of GMO BT maize production in Spain.
Indeed, the point was made many times during the meeting that there is no significant difference between GM and non-GM food or feed. But the EU has already spent over €300 million in biosafety research. The big question is: ‘how much independent research does it take to influence public opinion?’
Research has being conducted on food and environmental safety and we constantly hear challenges as to its impact on biodiversity. The point was well made that the switch from making hay to silage 40 years ago had a far greater impact on biodiversity than any single GM crop. And, more recently, ecosystems are being destroyed by invasive species like Gunnera and Japanese knotweed but there is very little heed being paid to these at EU level. Evolution has not ceased!
Even doing good evaluative independent research has been difficult and groups frequently prevented or destroyed such trials. How can independent evaluative research be generated if trials are destroyed? This is the type of work being conducted by Teagasc currently on ‘GM’ potatoes. This is independent work (part of a larger EU-funded project) to help guide political and consumer opinion by identifying the facts as they are found.
GM traits
Over 80% of global soyabean production is now GM and we import big quantities of this for feed. On top of this, 64% of the cotton, 29% of the maize and 23% of the oilseed rape is now of GM origin globally.
During the past 30 years the bulk of GM trait progress was confined to two traits (herbicide and insect tolerance) and four crops (maize, soyabean, cotton and oilseed rape). But this list is expanding and now there are many more traits being developed, which include:
pest resistancedrought tolerancenitrogen assimilationsalt tolerancenutritional valueallergen reductionshelf lifechemical quality (starch)bioplastic production.Many of these characteristics help steer the GM sector towards traits that are more for the good of humanity, either through increased production potential or increased nutritional value. All of these need to be evaluated independently from a food and environmental perspective.
A few weeks ago the Environmental Protection Agency (EPA) organised a broad ranging conference on biotechnology issues, particularly GMOs. It looked at the use of GMO technologies in the industrial, medical and agricultural sectors. There appeared to be general agreement that the use of these tools in industry and medicine operated well under the current controls and appeared to be non-contentious.
However, EU agriculture has effectively been denied access to GMO crop technology through the combination of controls governing release into the environment and the virtual prevention and rejection of sound independent research to verify food and environment safety issues. While the precautionary principle was reasonable initially, the scientists present stated that there have been no valid food safety or environmental issues identified and that there is a need to modernise the relevant control legislation.
The major public challenge to gene transfer and engineering technologies has been in the EU, and mainly in agriculture, or at least the field production of agricultural crops. But genetically engineered or modified substances have been in use in Europe for over 40 years now.
Insulin for the control of diabetes has been produced using genetic modification since 1982 and is now the major source internationally. GM rennet, used for the manufacture of cheese, has been on the market since 1990 and Prof David McConnell, TCD, stated that 90% of all cheese manufactured in the US and Britain uses GM rennet.
While all processes used in the research, development and manufacture of genetically engineered solutions for industry and medicine are heavily controlled, and rightly so, the legislative framework appears to allow progress in these areas. The ever-increasing knowledge and technology base is facilitating increasing application and uses in both areas.
||PIC2||
A range of biotechnology-based tools have been developed to produce control or containment drugs for diabetes, AIDS and a vaccination against Papilloma virus. Speakers stated that GM technologies are now being used in the fight against multiple sclerosis, autism and rheumatoid arthritis with genetic engineering used to produce the proteins to make drugs and DNA-based diagnostic procedures.
The legislation
The main problem stated with regard to GM legislation in the EU is that it controls the process of making the change, rather than the product that is changed. In the US the legislation controls the product that is changed.
European legislators and consumers were right to be concerned about any new technology of this nature, especially when it comes to market in the absence of clear independent evaluation. But the design of a regulatory system which inadvertently prevents any such independent verification research being conducted represents the failure of both the regulatory and the political systems themselves.
||PIC3||
The European regulatory system has paralysed progress in the EU and resulted in a regime that appears incapable of being advised by science or adjusted by the regulators themselves. It was described as slow, complex, conservative, highly politicised and unreliable.
This can be seen in the fact that the EU, so far, has only given 67 GM crop approvals. The vast majority of these were for food or feed uses and there have only been two approvals for crop cultivation – Mon 810 insect tolerant maize and a high starch potato, BPS-25271-9. And the latter has since been withdrawn. There were also two separate approvals for carnations.
While regulation is essential, virtually all the speakers and attendees, including the EPA who are our competent authority, felt that the GM regulations have prevented technological development in crops in the EU. And the even bigger fear is that they will continue to do so if they are not modernised.
Nobody wants unsafe food and nobody wants to introduce plants that provide a known risk to the environment but the feeling was that approval decisions need to be more balanced. Nature changes all the time, that is how evolution happens and this will continue in the absence of GM crops.
The regulatory system is just not operating. What was supposed to take months, according to our laws, has taken years.
The regulations are not just hitting crop cultivation, but they are also threatening feed importation. This is because the new types that continue to be developed and grown in the Americas are not being approved fast enough to facilitate importation.
But apart from this it is increasingly evident that exporting countries are becoming less concerned about the EU market where consumption is falling. It seems likely that exporters may, in time, decide to bypass the inconveniences associated with the EU market in favour of the expanding Asian markets.
‘The GM regulations assume danger – why is this?’ some asked. ‘They are just not fit for purpose,’ another speaker stated. We now have non-GM herbicide tolerance in crops and there is no issue with this. We have been using GM technology in its different guises for over 30 years with no verifiable ill effects to man or environment. But real change at EU level will be difficult to achieve.
The new sciences
The regulations must evolve to accommodate new developments in biotechnology. Assessment of these technologies should consider the benefits that individual traits may bring, as well as looking at the potential risks. We cannot force things to remain as they are. Genetic engineering happens all the time in nature and so the controls governing GM must be proportionate.
Delegates suggested that better regulation of GMO technology in the EU should:
be product-based regulation, in line with rest of worldbe proportionate to the risksassess risks versus benefitshave an economic benefit assessment done to help keep biotech jobs in the EU. Technology continues to progress and much has been learned through the use of GMO technology elsewhere. As a result we now have many new biotechnological techniques which are being prevented by current GM regulations.
A number of these new technologies are currently being considered by an EU working group to evaluate whether or not these new sciences should come under the control of GM legislation. These include:
Oligonucleotide Directed Mutagenesis (ODM)
Zinc Finger Nuclease Technology (ZFN)
Cisgenesis, comprising Intragenesis
Grafting
Agro-infiltration
RNA-dependent DNA methylation (RdDM)
Reverse breeding
Synthetic genomics.
Many of these techniques do not result in any new gene-associated proteins being present in the end product, hence questioning the justification of having them controlled by GM legislation.
An example would be a non-GM apple scion grafted onto a GM root stock – the apple would be non-GM. The genetic changes generated by many of these sciences are similar to conventional breeding.
Safety
No one wants unsafe food or risk to the environment. That said, risk is ubiquitous and generally provided by nature itself within the context of modern food safety. Pests and diseases threaten the availability of the very food that is helping to sustain the planet, at both production and storage levels.
The loss of many pesticides in the EU leaves production systems increasingly vulnerable to an evolving army of natures aggressors. Biotechnology tools provide our best defence options for the moment and they need to be employed.
No difference
Food production is an intervention in nature and nature will always win this battle unless man fights back. To not fight back would be to condemn a portion of humanity to death by starvation. Scientists argue that GM crops should be governed by the same rules as classical plant breeding. But classical breeding generates a very uncontrollable mix, making new commercial varieties difficult and costly to create.
In contract, molecular techniques are described as precise engineering with only a very small number of gene alterations to add a specific trait.
Examples to date would be the addition of a bacterial gene to degrade glyphosate to produce Roundup-tolerant plants. A different bacteria gene was inserted into plants to kill insects. In the latter case, only insects that eat the plants would be affected so it is highly targeted. There have been no adverse affects associated with 13 years of GMO BT maize production in Spain.
Indeed, the point was made many times during the meeting that there is no significant difference between GM and non-GM food or feed. But the EU has already spent over €300 million in biosafety research. The big question is: ‘how much independent research does it take to influence public opinion?’
Research has being conducted on food and environmental safety and we constantly hear challenges as to its impact on biodiversity. The point was well made that the switch from making hay to silage 40 years ago had a far greater impact on biodiversity than any single GM crop. And, more recently, ecosystems are being destroyed by invasive species like Gunnera and Japanese knotweed but there is very little heed being paid to these at EU level. Evolution has not ceased!
Even doing good evaluative independent research has been difficult and groups frequently prevented or destroyed such trials. How can independent evaluative research be generated if trials are destroyed? This is the type of work being conducted by Teagasc currently on ‘GM’ potatoes. This is independent work (part of a larger EU-funded project) to help guide political and consumer opinion by identifying the facts as they are found.
GM traits
Over 80% of global soyabean production is now GM and we import big quantities of this for feed. On top of this, 64% of the cotton, 29% of the maize and 23% of the oilseed rape is now of GM origin globally.
During the past 30 years the bulk of GM trait progress was confined to two traits (herbicide and insect tolerance) and four crops (maize, soyabean, cotton and oilseed rape). But this list is expanding and now there are many more traits being developed, which include:
pest resistancedrought tolerancenitrogen assimilationsalt tolerancenutritional valueallergen reductionshelf lifechemical quality (starch)bioplastic production.Many of these characteristics help steer the GM sector towards traits that are more for the good of humanity, either through increased production potential or increased nutritional value. All of these need to be evaluated independently from a food and environmental perspective.
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