TWN Info Service on Biodiversity and TK, Biosafety
29 September 2021
Third World Network
www.twn.my
Dear Friends and Colleagues
Urgency to Assess and Regulate Gene Drives
Enabled by new genetic engineering techniques such as CRISPR/Cas9, so-called gene drives have been developed in recent years that enable humans to spread new genes throughout the genome of wild animal populations. Gene drives force the inheritance of newly introduced genes to be inherited by all offspring, even if this lowers the survival chances of the affected species. In the most extreme case, gene drive technology could drive an entire species to extinction or replace wild populations with genetically modified organisms.
According to current knowledge, any release of a gene drive carries the risk of irreversibly and uncontrollably altering the genetic material of a natural population. Outcrossing across species boundaries could be inevitable. CRISPR/Cas9 can change the activity of the target gene in unpredictable ways, increase the mutation rate in the genome, lead to unexpected mutations, or be disrupted in its function by emerging resistances.
To date, there is a lack of specific international regulations to regulate the research and release of gene drive organisms. Adequate, scientifically based concepts and methods for the estimation, assessment and management of risks as well as for the monitoring of released gene drive organisms into the environment are still lacking. There is no central registry of all currently conducted research and development projects related to gene drives.
The world community must take sufficient time to build a consensus on how to deal with this technology, and on how to assess the ecological, medical, ethical, cultural, scientific and international legal issues involved. A recent report recommends the following:
- A global moratorium on the release of gene drive organisms
- Requirements for retrievability and controllability of gene drive organisms before release
- A global process for decision-making on the release of gene drive organisms
- An integrated system of assessment, evaluation and management of risks from gene drive organisms to the environment and health
- Concepts for international, participatory technology assessments for gene drive organisms
- Binding and specific global rules for liability and redress for damage caused by gene drive organisms
- Mandatory global reporting of gene drive organism research in contained systems and uniform safety standards for gene drive research
- A ban on the development of gene drive organisms with potential for military use
With best wishes,
Third World Network
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GENE DRIVE ORGANISMS: A NEW DIMENSION OF GENETIC ENGINEERING
Applications, Risks and Regulation
Save Our Seeds / Foundation for Future Farming
May 2021
https://www.stop-genedrives.eu/sgd-2020/wp-content/uploads/2021/05/Gene-Drives_-A-new-dimension-of-genetic-engineering-__210526.pdf
[EXCERPT ONLY, FULL REPORT AVAILABLE AT LINK ABOVE]
POLICY RECOMMENDATIONS
To date, no internationally binding agreement specific to gene drives exists to regulate the research and release of gene drive organisms. Neither do specific national or supranational laws exist. Nevertheless, Target Malaria could conduct the first release trials with gene drive mosquitoes as early as 2024
Apart from the lack of specific international regulations, even adequate, scientifically based concepts and methods for the estimation, assessment and management of risks as well as for the monitoring of released GDO into the environment are missing so far. Neither does a central registry of all currently conducted research and development projects related to gene drives exist. There is also a lack of concepts and foundations for technology assessments that go beyond pure environmental risk assessment.
A societal discussion about the circumstances under which the release of a GDO might be justifiable, maybe even ethically required, or has to be ruled out has not begun in earnest, neither at the national or international level.
Against this backdrop, it seems clear that the world community must take sufficient time to deal with this new global challenge. This is the prerequisite for building a consensus on how to deal with this technology, on how to assess the ecological, medical, ethical, cultural, scientific and international legal issues involved here and to make a decision on how to regulate this technology.
That‘s why SAVE OUR SEEDS recommends:
* A global moratorium on the release of gene drive organisms
At the 15th Conference of the Parties to the UN Convention on Biological Diversity (CBD), the European Union should advocate for a global moratorium on any environmental release of GDO. Even before that, the EU should clarify that such releases are prohibited under current EU legislation. The EU should also signal that it will take action with all available means against any release of GDO which could reach the territory of the EU. In the view of Save Our Seeds, the following requirements are essential prerequisites for reaching an agreement on lifting the global moratorium, which should be considered on a case-by-case basis. Of course, it is in the nature of an open-ended decision-making process involving all stakeholders that such criteria may change in the course of the discussion. Whether this moratorium should be converted into a permanent and general ban, or whether the release of gene drive organisms is justified or even required in individual cases, also depends on the criteria to be developed.
* Requirements for retrievability and controllability of gene drive organisms
The prerequisite for any release of GDO should be a sufficiently verified method for their removal from nature. In addition, a temporal and spatial controllability and thus a possibility to limit their effect and spread in nature should be mandatory before any release can be considered.
* A global process for decision-making on the release of gene drive organisms
Due to the international nature of the potential consequences of the release of GDO, international standards and procedures for decision-making are also required for their approval. Crucial to this is the inclusion and equal participation of all potentially affected parties. This refers first to states, but also specifically to indigenous peoples and local communities as defined in UN Declaration 61/295 on the Rights of Indigenous Peoples and Declaration 73/165 on the Rights of Small Farmers and Other Rural Workers. The basis of such decisions must be their effective participation under the full implementation of the principle of free prior informed consent.
* An integrated system of assessment, evaluation and management of risks from gene drive organisms to the environment and health
Given their invasive nature and inability to control, recall or reverse GDO in nature, risk assessment and modelling cannot be undertaken with existing concepts and methods established for genetically modified organisms. Before any release of GDO can be considered, internationally agreed procedures and guidelines must first be developed for how the environmental risks posed by GDO are to be uniformly recorded and assessed. Guidance on risk assessment should fully operationalize the precautionary principle, must seek to obtain the free, prior and informed consent of potentially affected indigenous peoples and local communities. Furthermore, monitoring and identification procedures would need to be established to document and track the spread and behavior of GDO in different ecosystems. In this context, the international community should commit to developing and maintaining contingency plans.
* Concepts for international, participatory technology assessments for gene drive organisms
A comprehensive, anticipatory technology assessment, ensuring the effective participation of all potentially affected states as well as indigenous peoples and local communities should go beyond the purely scientific investigation of ecological and health aspects. It should lay the foundation for discussing ethical questions, socio-economic and cultural and societal consequences, challenges and appropriate decision-making processes. This exercise should include, among other things, the evaluation of the root causes of the problem this technology aims to address, its goals and an assessment whether these root causes could better be addressed by other means. Additional effort should be put in assessing the costs and benefits for specific groups in society.
* Binding and specific global rules for liability and redress for damage caused by gene drive organisms
Both during a global moratorium on the release of gene drive organisms into nature and in the event of a justified lifting of a moratorium, there should be specific and internationally binding rules for liability and redress. They should be able to address unintentional or illegal releases of gene drive organisms and resulting damage.
* Mandatory global reporting of gene drive organism research in contained systems and uniform safety standards for gene drive research
Because even individual, unintentionally released GDO could spread uncontrollably, both temporally and territorially, high safety standards for handling GDO adapted to the respective organisms are of global importance and urgency. An essential prerequisite for adequate safety measures is a central registry of all gene drive research and related field trials, which should include a precise description of the organisms, the gene drive constructs, and the goals pursued with them.
* A ban on the development of gene drive organisms with potential for military use
In addition to the already existing ban on the use of biological weapons by the UN Biological Weapons Convention, a prerequisite for research on gene drives should be the proof that the GDO developed in the process have no potential to be misused as weapons.