THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Increasing Number of Patents Filed on Gene-Editing and Synthetic Gene Technology
In the past few years, new methods of genetic engineering have been developed that can also be used in plants and animals for food production. These techniques can be collectively called gene-editing or synthetic gene technologies. A report by Testbiotech gives an overview of patents filed by large corporations for the use of gene-editing and synthetic gene technology in food plants and farms animals such as cows and pigs. DuPont and Dow Agrosciences have filed the highest number of patent applications for plants derived from the new methods, followed by Bayer.
Although such technologies might not always give rise to a transgenic organism (a result of the insertion of genes from a different organism), according to Testbiotech, they must still be regarded as methods that result in a genetically engineered (GE) organism because they directly interfere with the plant and animal characteristics at the level of the genome by inserting material that was produced outside the cells. The report warns that these techniques could have major negative impacts on humans, animals, the environment and our food supply.
Industry and other interested stakeholders are actively lobbying to exempt these techniques from the EU regulation currently applied to GE organisms. They want these organisms to be treated in the same way as plants and animals derived from conventional breeding. However, if this were the case, the result would be that these organisms would be introduced to the market without prior risk assessment or labelling.
The report also highlights how gene editing can lead to wide-ranging off-target effects and call for case-specific risk assessment. Testbiotech recommends that the products derived from these new technologies be subject to risk assessment and labelling regulation, and that patents on plants and animals used in agriculture be prohibited. It further calls for a general ban on GE organisms that cannot be controlled in their spatio-temporal dimension.
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Item 1
SYNTHETIC GENE TECHNOLOGIES APPLIED IN PLANTS AND ANIMALS USED FOR FOOD PRODUCTION
Overview on patent applications on new techniques for genetic engineering and risks associated with these methods
Testbiotech
www.testbiotech.org/node/1568
Summary
In the past few years, new methods of genetic engineering have been developed that can also be used in plants and animals for food production. These techniques can be collectively called gene-editing or synthetic gene technologies.
This report provides an overview of patents already filed, and of companies active in this field. Further, it gives examples of such plants and animals and the risks associated with their release into the environment or their imminent introduction to the markets. Finally, it discusses some legal and technical aspects based on this overview.
Most of the relevant technological tools are tailored nucleases that allow DNA to be cut at a targeted location and synthetic nucleotides (DNA and RNA) that can be produced in the laboratory (with and without a natural template) and then introduced into the cells and genome of plants and animals. These technologies can be used to:
* insert transgenes
* recombine DNA without inserting DNA from other species (originating from same species or without a natural template)
* replace native DNA by re-synthesised DNA
* remove or silence DNA
* change gene regulation without changing the DNA by manipulating epigenetic mechanisms.
Such technologies might not always give rise to a transgenic organism (because no DNA gets transferred across borders of species), but must, nevertheless, be regarded as methods that result in a genetically engineered organism. To summarise, all these techniques directly interfere with the plant and animal characteristics on the level of the genome by inserting material that was produced outside the cells.
Thus, EU regulation (Directive 2001/18) requires these techniques to be regulated. This is made evident in detailed legal analysis. Regardless, industry and other interested stakeholders are actively lobbying to exempt these techniques from EU regulation (Directive 2001/18) currently applied to genetically engineered organisms. They want these organisms be treated in the same way as plants and animals derived from conventional breeding.
The proponents argue that:
* current regulation could become an obstacle for the introduction of the products to the market and therefore negatively impact smaller and medium sized companies.
* the products should be regarded as safe if only minor changes are introduced into plants and animals not giving rise to transgenic plants or animals.
The result could be that products are introduced to the market without previous risk assessment or labelling. As shown in this overview, current developments in the application of gene editing in plants and animals used for food production are largely driven by patents. Future developments will be massively influenced by the interests of the so-called seed giants, and the introduction of such plants and animals into agriculture will foster market concentration in plant and animal production.
There is no doubt that the bigger companies are the ones that will dominate the markets as well as the strategies for research, innovation and product development. This will in turn impact traditional breeders, farmers, food producers and also consumers. In comparison, other factors such as differences in the requirements for market authorisation and labelling cannot be assumed to have a similar major impact on the structure of the seeds market.
In regard to risk regulation, it is shown that gene-editing can lead to wide-ranging off-target effects. These unintended effects might in some cases be the cause of risks and hazards. Therefore, there has to be case-specific risk assessment. In this context, it is not decisive whether new DNA is inserted or parts of the original DNA are removed or the activity of the natural genes is changed by epigenetic effects without changing the structure of the genome.
To assess the actual risks it is necessary to know which techniques were applied for which purposes. The relevant data have to be collected systematically and assessed independently. If these techniques are exempted from regulation, the relevant data will be kept as confidential business information. In this case, neither independent scientists nor authorities will be able to access the data in a way that will enable them to obtain a sufficient overview of the specific techniques, the relevant traits and the associated risks.
Further, with regard to regulatory aspects, it also has to be taken into account that the single steps meant to induce small changes can be applied several times in same organism. This can lead to much more extensive changes in the genome. Moreover, plants and animals showing single or several genetic changes can be crossed with each other. In addition, all the different techniques could possibly be used in combination. All these plants and animals might completely escape the scrutiny of the regulatory bodies if Directive 2011/18 is not applied in a coherent manner.
Therefore, we recommend:
* exemption from patentability of plants and animals used in agriculture and food production
* that plants and animals derived from gene-editing be made subject to EU regulations in Directive 2001/18
* agreement on an international framework for a general ban on genetically engineered organisms that cannot be controlled in their spatio-temporal dimension
Item 2
Media Release
SEED GIANTS ACTIVE AROUND NEW METHODS OF GENETIC ENGINEERING
http://www.testbiotech.org/en/node/1570
Testbiotech has published a report which for the first time gives an overview of patents filed by large corporations for the use of gene-editing and synthetic gene technology in food plants. According to the research presented in the report, DuPont and Dow Agrosciences are the corporates that have filed the highest number of patent applications for plants derived from the new methods. They are closely followed by German company, Bayer. In addition, there is an increasing number of patents being filed for the use of these methods in farm animals. The report provides examples of plants and animals derived from these new methods of genetic engineering, and points to the associated side-effects and risks.
Companies such as DuPont are demanding that the plants and animals derived from these new methods be allowed to be marketed and released into the environment without risk assessment or labelling. However, existing publications about recent applications already show the new methods cause many unintended effects and are not as precise as often claimed by industry.
"A closer look shows that these new techniques for genetic engineering show a similar range of unintended effects and risks as previous methods. It looks like some companies are trying to create a new image for their products to ease marketing and increase acceptance", Christoph Then says for Testbiotech. “At the same time, more and more farm animals such as cows and pigs are being genetically engineered. Overall, this development could have major negative impacts on humans, animals, the environment and our food supply.”
Most of the relevant technological tools are tailored DNA-scissors developed to cut DNA at a targeted location. Synthetic DNA that can now be produced with and without a natural template is of further major relevance. These technologies might not always give rise to transgenic organisms incorporating DNA from other species, but must, nevertheless, always be regarded as methods of genetic engineering which need to be regulated. This is also made evident in the legal dossiers.
Testbiotech is demanding that the products derived from these new technologies are subjected to risk assessment and labelling regulation. Further we recommended that patents on plants and animals used in agriculture are prohibited.