By Eva Gelinsky and Lena Hüttmann
Without GMO-free seeds, a GMO-free agricultural and food industry is not possible. Yet there has been little discussion of the potential impact on GMO-free seed production of the European Commission’s planned deregulation of new genomic techniques (NGTs). Op-ed by Eva Gelinsky and Lena Hüttmann of IG Saatgut.
In July 2023, the European Commission (COM) presented a lex specialis to regulate certain plants produced using new genomic techniques (NGTs) separately. The planned deregulation for Category 1 NGT plants is particularly far-reaching. According to the plans, in future, these plants will not be subject to labelling, an authorisation procedure with risk assessment, a location register, mandatory submission of detection methods or monitoring.
Below is a summary of our position paper which lists the challenges that the GMO-free seed production sector could face.
Detection methods
Under the EU’s current legislative framework on GMOs, those applying for authorisation for a product containing GMOs must also provide the information necessary to develop a detection method. Under the planned deregulation of Category 1 NGT plants, the mandatory submission of the relevant genomic data and the development of detection methods will no longer be required. Nor would companies be required to provide reference material. Without detection methods at the genetic level, it would not be possible to check for contamination in seeds. However, it is particularly important in the seed sector that contamination is detected immediately, as seeds are reproduced on a large scale. Detection methods are essential to ensure that seeds remain GMO-free. If companies no longer provide these, another player will have to step in to conduct research and development into detection methods and cover the costs incurred.
Zero tolerance
The current zero tolerance policy for seeds is based on two articles of the EU Deliberate Release Directive. These stipulate that unauthorised GMOs must not be released, meaning that they must not be present in seeds (intended for sowing). With regard to authorised GMOs, the following applies: Since no threshold values have been set for seeds, contamination with authorised GM constructs must be labelled. We currently assume that the zero tolerance policy for seeds will remain in place for unauthorised or unregistered NGT constructs. However, without comprehensive transparency – which NGT plants are grown where – and without detection methods that can reliably detect or distinguish between NGT1 and NGT2 modifications, verification is not possible. Added to this is the problem that NGT plants are already being grown in the USA, for example, without labelling or traceability.
Cultivation register and other ‘coexistence’ measures
Current EU genetic engineering legislation stipulates that both GMO-free and GM cultivation should exist in parallel. The deregulation plans for NGT1 do not yet include any coexistence rules. This means that the existing location register will not be used for this purpose. As a result, it will no longer be transparent whether and, if so, where NGT1 plants are being cultivated in one’s own neighbourhood. These uncertainties not only hinder the exchange of breeding material, which affects breeding progress. It would also no longer be possible to take appropriate precautionary measures, such as protecting one’s own crops or not growing crops affected by potential cross-pollination.
Polluter pays principle and collective liability
Current genetic engineering legislation does not stipulate that those who develop and patent GMOs are also liable for contamination. Instead, farmers who grow GMOs are “collectively liable”. The draft deregulation bill does not anticipate any cases of damage. However, organic farming will suffer damage. The bill stipulates that the cultivation of NGT plants (NGT1 and NGT2) will remain prohibited in organic farming. This is consistent, as NGTs are genetic engineering techniques, as the European Court of Justice clarified in July 2018. However, it remains unclear how the organic sector is to implement this legal ban in practice. It is also unclear how GMO-free agriculture is to protect itself from unwanted cross-breeding and who will bear the costs in the event of contamination.
Labelling
Existing EU legislation on genetic engineering requires GMOs to be labelled throughout the entire value chain. Processed food and feed produced from GMOs must also be labelled. If the Commission and Council prevail in the trilogue and propose labelling only for NGT seeds, it would no longer be possible to tell whether a product contains genetically modified organisms or not anywhere in the value chain from the field onwards.
Patent law and the real scandal
Regardless of the fact that the draft regulation is based on the scientifically untenable equivalence of NGT1 plants with conventionally bred plants, companies using NGT are advocating and applying for patents. The planned deregulation of new genetic engineering will therefore lead to a sharp increase in patents in Europe in general. These will affect the contamination problem: in future, breeders, propagators and farmers must expect that, in the event of NGT contamination, they will unwittingly also be subject to patent claims. The real scandal, however, is that NGT patents are already affecting conventional breeding even before deregulation: processes such as CRISPR/Cas are being cited by companies in patent applications in order to circumvent the prohibition in Article 53(b). While the problems with patents in the field of NGT cannot be solved in the foreseeable future, solutions exist for (actually unlawfully granted) patents on conventionally bred plants and, in principle, for the extension of GMO and NGT patents to conventional plant breeding, which could be implemented within the existing legal framework.
How to address these challenges?
A series of specific demands have been derived from the challenges mentioned above.
- All old and new genetic engineering techniques must be legally defined and regulated as genetic engineering. This means that NGT plants must continue to be subject to comprehensive risk assessment and approval procedures in the future.
- Labelling and traceability must be ensured throughout the entire value chain.
- Zero tolerance for NGT events in seeds must be maintained (for both approved/registered and unregistered NGTs).
- Before plants in categories 1 and 2 are placed on the market, binding and strict coexistence rules must be established to help prevent contamination. Possible changes in the fitness of NGT plants (increased seed and pollen production, etc.) must be taken into account.
- Establishment of a location register for NGT1 plants and continuous monitoring of released plants.
- Mandatory disclosure of all relevant genomic data and submission of reliable and practical detection methods by companies using NGT.
- Promotion of risk research projects (with regard to the threat to GMO-free seed production) and research and development in the field of detection methods (specific to certain modifications and methods).
- Compliance with freedom of choice and the precautionary principle. Clear labelling throughout the value chain.
- Liability: Patent holders of NGTs must be liable for contamination and the consequences of the release of NGTs and finance the precautionary measures.
- Effective protection mechanisms against the negative effects of patents to preserve breeding freedom and access to genetic diversity.
Conclusion
A decisive factor for the quality of varieties is their diversity. The security of our food supply depends on the adaptability of plants to and within a rapidly changing environment. In breeding, it is therefore common practice to cross different varieties and origins in order to diversify the gene pool.
Without fundamental control mechanisms such as mandatory detection procedures and the maintenance of zero tolerance in seeds, the purchase of seeds could become an increasing risk factor for the GMO-free seed sector in the future. The availability and quality assurance of GMO-free seeds is therefore at risk.
The decoupling of NGT products from genetic engineering legislation undermines fundamental principles of freedom of choice, precaution and transparency. This would have far-reaching consequences for GMO-free seed production and GMO-free organic and conventional agriculture: they would be unable to identify or exclude genetically modified organisms and would therefore no longer be structurally capable of maintaining their quality standards.
Whether we protect GMO-free seed production has an impact on the organisation of our plant breeding, seed production and agriculture. IG Saatgut is convinced that without GMO-free seeds, there can be no independent seed production and breeding by farmers, nor the urgently needed restructuring and reorganisation of agriculture. Ultimately, it is about securing our food and seed sovereignty.
This article is a summary of a position paper by IG Saatgut. Click here to read the full position paper.
Available here in German.
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