THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Non-regulation of New GE Can Wreak Havoc with Natural and Agricultural Ecosystems
One of the most important tools in ‘New Genetic Engineering’ or ‘new genomic techniques’ or ‘genome editing’ is CRISPR/Cas gene scissors (nuclease). Gene scissors can be synthesized in the laboratory, programmed to specific sites of the target genome and introduced into the cells of plants and animals by various technical processes.
Over the course of evolution, mechanisms called ‘flexible safety barriers’ emerged to protect specific genomic regions against too frequent mutations. New GE is designed to circumvent these mechanisms. CRISPR/Cas for the first time makes the whole genome available for technical interventions and alterations. New GE can make changes in the biological characteristics of plants without introducing any additional DNA sequences. These changes can exceed the range of characteristics developed gradually through evolution or previous breeding methods, as pointed out in a recent briefing by Testbiotech.
A wide range of specific unintended effects have been observed when New GE is applied, arising, for example, from the multi-step process of the genetic intervention, and the lack of precision in the CRISPR/Cas system. There have been reports of rearrangements of the genome, including the unintended insertion of additional genes, and the genome being cut by mistake.
Therefore, the briefing calls for mandatory detailed examination of all organisms derived from New GE that starts with the specific process that was used. The need for detailed risk assessment cannot be limited to organisms with additionally inserted gene sequences. The briefing warns that without strict regulation, the uncontrolled release of large numbers of organisms with characteristics not gradually developed through evolution can be expected. This would result in the substantial likelihood of damage to ecosystems, agriculture, forestry and food production.
We reproduce below the summary of the briefing.
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Third World Network
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WHY ‘NEW GE’ NEEDS TO BE REGULATED
Frequently Asked Questions on ‘New Genetic Engineering’ and technical backgrounds for CRISPR & Co
Testbiotech
October 2020
https://www.testbiotech.org/sites/default/files/Frequently_asked_questions_about_CRISPR_and_Co.pdf
Summary
This briefing gives a condensed overview of scientific information decisive for the regulation of ‘New Genetic Engineering’ (New GE) techniques.
New GE – or ‘new genomic techniques’, or ‘genome editing’ – opens up new possibilities which go beyond conventional breeding and previous methods of genetic engineering. One of the most important tools in this scenario are CRISPR/Cas gene scissors (nuclease). Gene scissors can be synthesized in the laboratory, programmed to specific sites of the target genome and introduced into the cells of plants and animals by various technical processes.
In contrast to chemical or physical mutagens, e.g. radiation, tools such as CRISPR/Cas can directly interfere with biological mechanisms in the cells. During evolution, mechanisms emerged which, for example, can protect specific genomic regions against too frequent mutations. They are, as it were, the flexible safety barriers of evolution. These mechanisms seem to be mostly relevant to genes that are of special importance to the survival of a species. New GE is designed to circumvent these mechanisms. In particular, the nuclease CRISPR/Cas for the first time makes the whole genome available for technical interventions and alterations. Genomic conditions, which until now could hardly be influenced via breeding, can now be accessed. Organisms generated with New GE may contain profound changes in their genomes and show new biological characteristics, even if no additional genes are inserted.
The technical potential of New GE can be used to make changes in the biological characteristics of plants without introducing any additional DNA sequences. These changes can exceed the range of characteristics developed gradually through evolution or previous breeding methods. Therefore, risks associated with the release or usage of the genetically engineered organisms for food production need to be thoroughly examined. There are plans to introduce into agriculture and forestry many plants and animals edited with new GE and showing new biological characteristics within short periods of time. Examples include plants with changes in their composition, which often also impact their interactions with the environment (such as pollinators, wild species and soil organisms). Other organisms show enhanced fitness, and can therefore become invasive and replace natural species. Further examples are pesticide resistant honeybees displaying behavioural changes during pollination. Another goal of New GE is to enhance the profits from forestry. In addition, there are ongoing projects to genetically engineer wild (non-domesticated) species such as corals, rodents, flies and wild plant species. However, if a large number of these New GE organisms are released within short periods of time, they may become disruptive to ecosystems and severely endanger biodiversity.
Besides the intended new biological characteristics, there are further risks linked to the introduction of New GE organisms into the ecosystems and agriculture: a wide range of specific unintended effects have been observed when New GE is applied. These effects arise for example from the multi-step process of the genetic intervention, which in many cases also implies the use of Old GE methods. Further causes of unintended effects include the lack of precision in the CRISPR/Cas gene scissors. There have also been reports of rearrangements of the genome, including the unintended insertion of additional genes. In many cases, the genome is unintentionally cut in regions which are similar to the target DNA, i.e. the gene scissors can cut these by mistake. These unintended effects can be significantly different to those caused by conventional breeding. Therefore, risk assessment has to take all effects arising from the multi-step process of New GE into account.
If the regulation of New GE is insufficient, problems similar to those known in the US are likely to emerge: by October 2020, around 80 New GE organisms were already exempt from regulation. At the same time, there is no access to detailed data and information on the process and target of the genetic intervention used in those cases.
Therefore, the necessary information for monitoring, control and independent risk assessment are not available. Without sufficient regulation of New GE
· severe damage to biological diversity is likely;
· risks to food production may be introduced and accumulate unnoticed;
· access to data needed for risk assessment by independent experts is not made available;
· no measures can be taken against the uncontrolled spread of the organisms in the environment;
· no data are available to track and trace the New GE organisms and products derived thereof;
· agriculture and food production relying on GE free sources can no longer be protected.
Therefore, a detailed examination of all organisms derived from New GE has to be mandatory and must start with the specific process that was used. The need for detailed risk assessment cannot be limited to organisms with additionally inserted gene sequences. Without strict regulation of New GE, the un-controlled release of large numbers of organisms with characteristics not gradually developed through evolution can be expected. This would result in the substantial likelihood of damage to ecosystems, agriculture, forestry and food production.