THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Genome Edited Plants Need Stringent Regulation
The United States Department of Agriculture (USDA) has reportedly given non-regulated status to 22 plants genetically engineered with genome editing techniques. The plant species include pennycress, green foxtail, potatoes, camelina, alfalfa, maize (corn), rice, soybeans, tobacco, tomatoes and wheat and one mushroom. The crucial question is how the risks of organisms resulting from these methods should be assessed.
A recent Testbiotech report shows that there are significant differences in methods of production, traits and risks of the non-regulated genome edited plants in comparison to those derived from conventional breeding. ‘Gene-scissors’ such as CRISPR/Cas can delete whole families of gene variants all at once which is impossible or barely possible with current conventional breeding methods. Additionally, older genetic engineering methods such as the ‘gene gun’ or gene transfer via Agrobacterium tumefaciens are commonly used as a first step in the process.
Genetic engineering interventions bypass natural biological mechanisms governed by evolution, inheritance and gene regulation, and the resulting plants and animals can be very different to those from conventional breeding. In the EU, all genetically engineered organisms must undergo a mandatory risk assessment. In the USA, on the other hand, individual cases are registered at the USDA’s APHIS division (Animal and Plant Health Inspection Service) to assess whether they need to be regulated.
The report however deems APHIS’ system unsuitable to sufficiently assess the risks of organisms developed with new methods of genetic engineering, as it ignores the differences between conventional breeding and genetic engineering; it only takes into account intended effects but not unintended changes; and it treats too much relevant information as confidential business information, preventing informed public debate and making in-depth risk assessment by independent scientists practically impossible.
Specific gaps in risk assessment are cited as: unintended changes in plant metabolism, interaction between the genome and the environment, and effects on subsequent generations. The report underscores that there is no scientific justification to assume the overall safety of genetically engineered organisms developed with new methods of genetic engineering simply on the basis that no additional genes are inserted. The extent of the actual risks involved needs to be assessed in each case, and the report proposes specific criteria by which to do so.
With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang
Malaysia
Email: twn@twnetwork.org
Websites: http://www.twn.my/and http://www.biosafety-info.net/
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Item 1
Media release
THE US EXAMPLE SHOWS WHY NEW METHODS OF GENETICALLY ENGINEERING CROP PLANTS NEED TO BE REGULATED
https://www.testbiotech.org/node/2348
14 March 2019
According to research carried out by Testbiotech, the United States Department of Agriculture (USDA) has already given non-regulated status to more than 20 plants genetically engineered with so-called genome editing techniques. None of the applications registered at USDA were referred for further more detailed assessment. The Testbiotech report published today shows that there are however significant differences in methods of production, traits and risks of the non-regulated plants in comparison to those derived from conventional breeding.
These differences are not caused by the newly introduced gene sequences but by e.g. the patterns of genetic changes. ‘Gene-scissors’ such as CRISPR/Cas can delete whole families of gene variants all at once – this is either impossible or barely possible with current conventional breeding methods. A further specific difference: in a first step, older methods such as the ‘gene gun’ (biolistic method) or gene transfer via agrobacterium tumefaciens are commonly used. However, USDA completely ignores these differences to conventional breeding.
The plant species listed include pennycress, green foxtail, potatoes, camelina, alfalfa, maize (corn), rice, soybeans, tobacco, tomatoes and wheat and one mushroom. The exact intended traits of the plants cannot always be precisely determined. In many of the registered documents no information is provided because the precise description of the targeted genes is categorised as confidential business information (CBI). It is also sometimes difficult to find information on the progress of developments – it does however appear that applications are filed at early stage. Generally, it has to be assumed that by no means will all of the plants registered come on to the market. On the other hand, some companies have announced to investors that some specific plants will be on the market very soon.
Essentially, conventional breeding is always based on a wide range of genetic and biological diversity found in natural populations, as well as in all previously bred plant and animal varieties and breeds. In addition, new mutations happen continually and specific triggers can speed up the occurrence of mutations. Not all of these mutations are considered beneficial. In order to achieve the desired results, breeders screen natural populations and previously bred varieties for specific traits. Subsequently, plants are chosen and then grown and crossed to achieve an optimal combination of genetic information. The natural mechanisms of inheritance and gene regulation cannot be bypassed with this method.
Genetic engineering on the other hand uses direct technical and targeted intervention to establish new traits. These technical interventions bypass natural biological mechanisms governed by evolution, inheritance and gene regulation, and can therefore be much faster than conventional breeding. Since genetic engineering intervenes directly in the genome, the resulting plants and animals can be very different to those from conventional breeding. Therefore, it is necessary to treat these organisms with caution before any environmental releases take place or they are approved for use in food production.
In the EU, all genetically engineered organisms must undergo a mandatory risk assessment. In the USA, on the other hand, there are no such legal requirements. There are nevertheless also stakeholders in the EU who want to market their products as quickly as possible. Their goal: plants and animals and related products developed with new genetic engineering techniques should be released without undergoing an approval process and sold without labelling. If however the new plants are marketed without regulation or approval process, then neither farmers nor gardeners would know what he/she is actually cultivating. The plants could also be crossed and combined with others, without combinatorial effects being investigated in detail. Consumers would lose their freedom of choice since they would no longer be able to distinguish whether the products were genetically modified or not. Even the authorities would not know which plants were imported from which countries, and what they would have to look for if there was in fact harm to people or the environment.
Christoph Then summarises the Testbiotech findings: “The risks of genetically engineered organisms have to be assessed in each and every case. Moreover, if organisms are known to show potential for environmental spread or might develop such characteristics, efficient measures and restrictions have to be put in place to prevent gene flow.”
Contact:
Christoph Then, Tel 0049 15154638040, info@testbiotech.org
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Item 2
AM I REGULATED? THE US EXAMPLE: WHY NEW METHODS OF GENETICALLY ENGINEERING CROP PLANTS NEED TO BE REGULATED
Christoph Then, Testbiotech
https://www.testbiotech.org/en/content/am-i-regulated-en
March 2019
Summary
New methods of genetic engineering, also known as genome editing, are increasingly at the centre of controversial public debate. One crucial question is, how the risks of organisms resulting from this methods should be assessed. In the EU, all genetically engineered organisms must undergo a mandatory risk assessment. In the USA, on the other hand, there are no such legal requirements, instead individual cases are registered at the US Department of Agriculture resp. the APHIS division (Animal and Plant Health Inspection Service) to assess whether they need to be regulated. For the purposes of this report, we have chosen organisms already registered with the APHIS division of the US Department of Agriculture (USDA), which offers a program titled “Am I Regulated?”. The applications filed at APHIS are especially relevant because some of the organisms (mostly plants) are intended for cultivation in the near future, and for use in food and feed production. The following questions were included:
› Which organisms and technical methods were considered?
› What was examined and what was the outcome?
› What were the conclusions in general for risk assessment and what are the consequences for EU regulation?
Up until end of 2018, APHIS received more than 70 applications from large companies, research institutions and universities. 22 applications were specifically for new genetic engineering techniques (also known as ‘genome editing’). The applications all involved the use of nucleases such as CRISPR/Cas and TALEN to change the genomes of 21 plants and 1 mushroom. In particular, the use of the nuclease CRISPR/Cas has increased substantially in the past few years. With this method, no new genes were inserted in the genome, instead natural genes were knocked out or changed in their structure. The plant species listed in APHIS are pennycress, green foxtail, potatoes, camelina, alfalfa, maize (corn), rice, soybeans, tobacco, tomatoes and wheat. The intended traits can be categorised as follows: changes in oil composition (5 examples); other changes in plant composition (5 examples); food production criteria such as harvest, transport and processing (4 examples); improved resistance to plants diseases (3 examples); environmental stress (1 example) and higher yield (1 example). APHIS gave all applications non-regulated status. None of the applications were referred for further more detailed assessment. APHIS only has very little leeway in its decision-making. In its notifications the authority states that genetically regulated organisms can only be regulated, i.e. undergo more detailed assessment resp. not be released if the plants are classified as a pest resp. pathogen for plant diseases (plant pest), or have the potential to become noxious weeds. As shown in the filed documents, in most cases the process of genetically engineering the plants is carried out in several steps and includes pre-existing genetic engineering methods: in a first step, older methods such as the ‘gene gun’ (biolistic method) or gene transfer via agrobacterium tumefaciens are commonly used. These methods do not allow the targeted insertion of additional genes, only random insertion. This first step is necessary to introduce the DNA sequence for the nuclease into the plant genome to establish the preconditions for the nuclease to be activated in the cells. The outcome of this first step are transgenic plants with DNA sequences originating from microorganisms and other organisms – the genes have been inserted randomly into the genome often with several and flawed copies. It is only in a second step that the nucleases intended to target specific locations in the genome are formed in the cells and ultimately lead to the desired changes; the previously inserted gene constructs provide the necessary preconditions for this process.
The exact intended characteristics cannot always be precisely determined. In many of the documents no information is provided because the precise description of the targeted genes is categorised as confidential business information (CBI). As a rule, it is also difficult to find information on the progress of development – it does however appear that applications are filed at early stage. Generally, it has to be assumed that by no means will all of the plants registered at APHIS come on to the market. On the other hand, DowDuPont (Corteva) and Calyxt have announced to investors that some specific plants will be on the market very soon. In order to examine the usefulness and reliability of the US system, the report provides a description of the characteristics of the new methods of genetic engineering; in addition, we include an overview of the differences between conventional breeding and pre-existing methods of genetic engineering. Essentially, conventional breeding is always based on a wide range of genetic and biological diversity found in natural populations, as well as in all previously bred plant and animal varieties and breeds. In addition, new mutations happen continually and specific triggers can speed up the occurrence of mutations. Not all of these mutations are considered beneficial. In order to achieve the desired results, breeders screen natural populations and previously bred varieties for specific traits. Subsequently, plants are chosen and then grown and crossed to achieve an optimal combination of genetic information. The natural mechanisms of inheritance and gene regulation cannot be bypassed with this method. Genetic engineering on the other hand uses direct technical and targeted intervention to establish new traits; whereby additional genetic changes are not desired but regarded as unintended effects. These technical interventions bypass natural biological mechanisms governed by evolution, inheritance and gene regulation, and can therefore be much faster than conventional breeding. Since genetic engineering intervenes directly in the genome, the resulting plants and animals can be very different to those from conventional breeding. Therefore, it is necessary to treat these organisms with caution before any environmental releases take place or they are approved for use in food production. The differences to conventional breeding are very clear despite the reduced amount of information provided by APHIS applicants.
The following examples illustrate the differences:
- simultaneous manipulation of several genes,
- simultaneous manipulation of several gene copies,
- separation of genes that are naturally only transferred together.
In the context of this evaluation, it is clearly evident that the APHIS system is unsuitable to sufficiently assess the risks of organisms developed with new methods of genetic engineering and changes in their genome.
Three categories can be identified: 1. APHIS ignores the differences between conventional breeding and genetic engineering. In general, the risks associated with genetically engineered organisms by no means solely depend on whether or which new genes are inserted. The removal of gene copies and specific patterns of genetic or epigenetic changes can alter the biological characteristics of plants in other ways than might be expected from conventional breeding. As a result, plants and other organisms can emerge that are not only changed in their gene structure but which, due to their unexpected biological traits and associated risks, are clearly different to plants from conventional breeding. APHIS completely ignores this aspect in its opinion.
- APHIS only takes into account the intended effects. By doing so, APHIS overlooks that plants engineered with a combination of ‘gene gun’ and CRISPR can show many undesirable changes in their genome, even if no more transgenes can be found in the genome. Moreover, APHIS does not take into account unintended changes in the genome that are often caused by incorrect use of the gene scissors. The authority further overlooks that unexpected effects might only become apparent in interaction with the environment or after several generations.
- The APHIS system treats too much relevant information as confidential business information (CBI). This prevents informed public debate and makes in-depth risk assessment by independent scientists either very difficult or practically impossible. Specific gaps in risk assessment are, in particular: › unintended changes in plant metabolism, › interaction between the genome and the environment, › effects on following generations. There is no scientific justification for general assumptions that conclude on the overall safety of genetically engineered organisms simply on the basis that no additional genes are inserted. The extent of the actual risks needs to be assessed in each case. Preventative measures must therefore be implemented or prohibitions imposed for plants that either have, or could develop, the potential to spread.
Therefore, the risk assessment of organisms developed with the new methods of genetic engineering should take the following criteria into account:
- the whole pattern of genetic changes and their effects need to be considered, including the impact on cells and organisms;
- if, in specific cases, it is assumed that the results of genome editing cannot be distinguished from those of conventional breeding, then comparative data must be requested, including whole genome sequencing data;
- data from so-called omics techniques must also be provided to assess unintended changes in the genome that, for instance, might have been caused by ‘gene-gun’ methods (biolistic methods) or by the nucleases themselves;
- omics data are also necessary to assess changes in the transcriptome, the proteome and the metabolome in order to assess the effects of gene changes in the organism;
- the genetically engineered organisms should be exposed to wide range of defined environmental stress conditions to, in particular, test their response to climate change or pathogens;
- effects on the associated microbiome (in particular soil organisms) must be taken into consideration;
- the assessment of risks from consumption of respective products should also focus on the microbiome in the gastrointestinal tract;
- if plants are cultivated, then effects on the food web have to be taken into account;
- likewise potential adverse effects on pollinators, beneficial and protected species;
- effective measures need to be implemented and prohibitions imposed to prevent the uncontrolled spread of genetically engineered organisms into the environment.
In addition:
- all relevant genomic data that provide information on the exact genetic changes should be made publically available in data bases;
- labelling should be mandatory and measures should be taken to protect conventional production in order to protect freedom of choice for breeders, farmers and consumers;
- state run programs should be initiated with the participation of civil society (especially nature protection-, environmental- and consumers’ rights groups) to agree on goals in research and development as well as concomitant research in risk assessment.