Abstract
This chapter presents potential consequences of the adoption of strict detection, identification or traceability requirements in the EU legislation regarding NGT products featuring single nucleotide variants. The context considered encompasses changes in the biosafety legislations not only in countries which were traditionally accepting of modern biotechnology products, but also in countries which were reluctant to use classic GMOs. Due to shifts in the approach to the regulation of NGT products not featuring stable inserts of foreign DNA, the EU risks becoming an isolated market with provisions not harmonized with those of its various trade partners or falling into a situation where regulated products officially not present on the market will enter due to a lack of efficient detection and identification methods and enforcement systems. Recent changes in the laws of such countries as Nigeria, Kenya or Japan are presented, as well as the recent jurisprudence of the Court of Justice of the EU.
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1 Introduction
Following its study on the legal status of new genomic techniques’ (NGT) products in the EU [1], the European Commission (EC) embarked on a mission to reform the current legislation on GMOs in order to facilitate the development and marketing of NGT products and to introduce an act, in which the level of regulation would be proportional to the risks related to the use of a given NGT product. The study considers NGT products as GMOs including: products of directed mutagenesis techniques, products of cisgenesis and intragenesis, as well as products featuring interventions in the genotype without changing the nucleotide sequence (epigenetic changes). The situation occurred in the aftermath of the C-528/16 judgment [2] of the Court of Justice of the European Union (CJEU), where the court opted for a narrow interpretation of the exemption of mutagenesis products from the GMO legislation, limiting it only to products of such methods, which were widely used at the time of adoption of the 2001/18/EC Directive on the deliberate release of GMOs [3]. After the publication of the study of the EC, the CJEU was tasked with deciding yet another legal problem resulting from the sentence of the former judgment – namely whether the mutagenesis exception in the 2001/18/EC Directive applies to products of random mutagenesis in vitro as well as in vivo. The response of the CJEU states that the exception should be interpreted “as meaning that organisms obtained through the application of a technique/method of mutagenesis which is based on the same processes of modification, by the mutagenic agent, of the genetic material of the organism concerned as a technique/method of mutagenesis which has conventionally been used in a number of applications and has a long safety record, but which differs from that second technique/method of mutagenesis by virtue of other characteristics, shall, in principle, be excluded from the exemption laid down in that provision, provided that it is established that those characteristics are likely to lead to modifications of the genetic material of that organism which differ, by their nature or by the rate at which they occur, from those obtained by the application of that second technique/method of mutagenesis. However, the effects inherent in in vitro cultures do not, as such, justify the exclusion from that exemption of organisms obtained by the in vitro application of a technique/method of mutagenesis which has conventionally been used in a number of in vivo applications and has a long safety record with regard to those applications” [4].
In other words, the CJEU stated that the rule of thumb is that if a mutagenesis technique deviates in terms of efficiency or potential for modification from methods conventionally applied in 2001, then its products shall not be exempted from the GMO legislation. However, the fact that random mutagenesis was performed in vitro does not seem to justify such a notion.
It is not the goal of this study to perform a thorough and rigorous interpretation of the judgment. Rather it serves as another iteration of conceptual problems the EU institutions need to solve, when faced with the matter of the current GMO legislation [5]. The criteria for exemption of certain products of mutagenesis from the legislation seem to be connected with the time of the development of the method that brought about a particular mutation and the efficiency of the method. Given the fuzzy nature of such criteria, it is not surprising that the EC has decided to amend the current legislation. The recently published project of a new regulation on the matter, which envisages a confirmation procedure for products featuring minor changes (NGT type 1 plants) and their exclusion from organic production, as well as the questions regarding traceability and detection of NGT products posed by the EC in a recently closed public opinion poll [6], and also other activities, such as the recently closed Horizon Europe call for the development of new detection methods on products derived from new genomic techniques for traceability, transparency and innovation in the food system [7], suggest that the institution wishes to introduce a system that would at least feature some sort of detection and identification mechanism, possibly also labelling, even if the provisions relating to the introduction of certain NGT product to the market were to be relaxed. While such solutions might be based on a wish to honor consumer choice, and address safety concerns, the technical difficulties connected with the performance of detection and identification of NGT products featuring point mutations, together with the regulatory tendencies in third countries, might lead to some undesired consequences. The success of any reform of the current legislation is also not guaranteed, since the recently leaked internal EC documents show [8] that the Commission is concerned about several issues connected with the reform, such as its influence on organic farming, the public rejection of GMOs in general and other issues, which might become an obstacle to the adoption of any amendment of the current laws.
2 Problems with Detection and Identification of NGT Products
If the EC fails to introduce a reform of the legislation, which would somehow exempt NGT products from authorization procedures, or if the reform will contain a relaxation of the current provisions but with the maintenance of detection, identification, traceability or labelling requirements, the compliance with such requirements might be technically challenging. Some researchers advocate a rather strict approach to the use of such techniques, including case-by-case risk assessment and inter alia whole genome sequencing for the detection of potential unintended consequences of editing [9]. Others seem much more skeptical as to the feasibility of such postulates, particularly, when it comes to detection or identification of products featuring single nucleotide variants, as well as the ability to prove that a given mutation (even if detected) was caused by a regulated technique rather than by an exempted one (e.g. random mutagenesis) or was spontaneous.
Detection of single nucleotide mutations in plant material, using PCR methods, depending on the method used, might require previous knowledge about the edit or might require data about the sequence surrounding the edit [10, 11]. It is also pointed out that even whole genome sequencing supported by bioinformatics and database access might be prone to errors especially for heterogenous samples, and that the efficiency of such detection methods also depends on the size of the genome that is being sequenced, making detection of potential contaminations in samples of such species as wheat or maize, less feasible [12].
These problems will gain practical significance with a broader adoption of NGT products featuring single nucleotide variants or even lacking changes in the nucleotide sequence, worldwide. The lack of applicability of existing laboratory methods for enforcement has already been stressed by the ENGL. It needs to be noted that, should EU legislation not change, unauthorized NGT products in the EU will be treated as unauthorized GMOs and essentially banned from the market. Should some requirements regarding detection, identification, labelling, coexistence with conventional varieties remain, these will need to be enforced somehow, in a situation of lack of easily accessible, efficient and economic detection methods. Such outcomes, in the context of trade exchange with the currently biggest producers of GMO products imported to the EU have already been described [13]. It seems however that the problems might also apply to exchange in agricultural goods with other countries, which were hitherto reluctant to introduce classic GMOs, but have decided to relax the legislation or even exempt products featuring single nucleotide variants or not featuring stable foreign DNA inserts.
3 Situation in Third Countries
Countries, which are already well known for excluding certain NGT products from their GMO legislations, such as the USA, Canada, Argentina or Brazil [14, 15] have introduced changes in their legislations that will be difficult to harmonize with an EU solution that will require the authorization of such products and more importantly their identification through molecular methods. Also, several countries, which were so far reluctant to adopt products of genetic engineering, are changing their policies in such a way that they allow products featuring single nucleotide variants to be less regulated than classic GMOs.
Some African nations have been reluctant to adopt the GMO technology [16], partially due to the restrictive policies of the EU, a major trading partner in agricultural goods. However when it comes to NGT products, some African countries are adopting policies, which are more permissive for plants featuring single nucleotide variants or more generally: mutations akin to those achievable through random mutagenesis or conventional breeding. For instance Nigeria issued new guidelines regarding the procedures for administrative handling of certain NGT products in December 2020 [17], according to which the applicant shall receive a biosafety approval if the method used for obtaining a product does not involve recombinant DNA or if such DNA is not present in the final product [see also 18].
Kenya issued an interpretation of its existing legislation [18, 19],: “modifications by inserting genes from sexually compatible species and where regulatory elements (promoters and terminators) are also from the same species; deletions/knock outs provided that there is no insertion of foreign genetic material in the end-product; processed products whose inserted foreign genetic material cannot be detected; – do not fall under the Biosafety Act, which would otherwise require them to undergo an authorization procedure. The applicant is expected to submit an Early Consultation Form to the competent authority, in order to determine whether their product will fall under the biosafety legislation or not.”
Japan is another example of a country introducing a leeway for products of directed mutagenesis without stable inserts of foreign DNA [20]. Relatively recent amendments to the biosafety policies provide that food products derived through a gene editing technology that do not contain remnants of foreign DNA fragments (e.g. SDN-1 products) fall under a notification rather than authorization procedure, hence do not require to go through a safety assessment procedure. Conventional crosses with such plants do not require to be notified anymore. This solution, based on a preemptive confirmation of status, results in a release of certain products of gene editing and their progeny, to the market, without a requirement for traceability or any sort of identity preservation. Hence their products can freely circulate on the market, once they were initially notified to the competent authority. This step means that SDN-1 products would not fall under the legislation [21, 22]. In Japan classic GMOs can be authorized for cultivation, but their use would subsequently be thwarted through the decisions of regional governments, who had the last voice in the matter [23]. The currently adopted solution allows developers to avoid the administrative burdens to a large extent and some gene editing products were actually already accepted according to the new provisions, most notably fish [24] and tomatoes [25], which were already placed on the market [26].
Similar provisions were also adopted in high volume GMO trading countries. In Argentina and Brazil, it is the introduction of a stable construct of foreign DNA, which determines the regulatory status of the product [13, 14]. In the USA exemptions are inter alia:
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products featuring changes resulting from the cellular repair of a targeted DNA break in the absence of an externally provided repair template;
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single-base-pair substitutions or the introduction of a gene known to occur in the plant’s gene pool
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a change in the targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool.
The consultation or notification of the authorities is not mandatory [27, 28].
England and Wales have also introduced relaxed provisions regarding field trials and marketing of “precision bred organisms”, which could have been obtained from traditional processes [29].
Such solutions, as the ones presented above will likely result in products derived through e.g. SDN-1 techniques to fall out of the legislation, and are not required to meet the provisions associated with classic GMOs, such as traceability or development of detection or identification methods.
4 A Global Conceptual Shift
The situation presented above – where not only countries that were liberal towards cultivation and other use of traditional GMOs relax their legislation, but also countries, which used to oppose the use of such products for various reasons – constitutes a conceptual shift, where the need for regulation is altered significantly.
The EU is a trendsetter in the case of many technological standards, in that entrepreneurs from third countries tend to comply with the EU-set standards, due to the size of the common market and the purchasing power of EU citizens. Complying with such standards seems economically more viable than being effectively locked out of such a market, due to lack of compliance. A recent example of this phenomenon was observed with the introduction of the USB-C port as the common charger port for all phones and tablets [30], which resulted in a decision to install such ports in iPhones, a step hitherto resisted by the manufacturer. In the case of “classic” GMOs the EU was also a de facto trendsetter for many third countries, which would prohibit the cultivation and often other uses of such products in order to prevent accidental influx of such products to the EU and so as to not to endanger their exports to the Union [16]. This seems not to be the case anymore, at least when it comes to NGT products featuring single nucleotide variants or lacking stable inserts of foreign DNA. In this sense the EU instead of being a standard setter is at risk of becoming an isolated island surrounded by regions with a fundamentally different approach to NGT products, namely a permissive rather than a precautionary one. This scenario is more likely to be realized if no changes are made in the current legislation or if the changed legislation will still require detection, identification, labelling or coexistence measures for such products. In the latter 2 cases, two not mutually exclusive scenarios can be presented for the behavior of foreign exporters, local importers or operators of those products. Firstly, they might attempt to adhere to the restrictive provisions, which might result in increased costs as well as lowering the competitive position of their products on the market. The development of a rigorous documentation system for all the steps of the production chain, capable of creating a reliable paper trail for each imported product would probably be required to support compliance with such provisions. Secondly, some entrepreneurs might choose to ignore such requirements, counting on the lack of rapid detection methods and a general lack of efficiency of the enforcement authorities in the detection of NGT products. The latter scenario might result not only in formally “unauthorized GMOs” circulating in the common market, or even authorized products not being properly labelled, but might cause damage further down production chains, if unauthorized products get eventually detected at the later stages of processing or marketing of processed products. A situation, where such plant material is used in breeding activities and is only later detected as a component of registered “conventional” or organic varieties needs also to be considered.
5 Conclusions
While the final shape of the new EU legislation regarding the development and use of NGT products is unknown and its fate also remains uncertain, the latest CJEU jurisprudence did not bring about any significant change to the existing status quo and the proposed legislative changes still feature authorisation procedures and labelling of some products, such as reproductive material of NGT type 1 plants. Concurrently a conceptual shift in the approach to NGT products featuring single nucleotide variants takes place in third countries, in that such products are no longer considered to be GMOs requiring strong regulation. This phenomenon becomes characteristic not only for nations, which were traditionally accepting of modern biotechnology products, but also in countries, which were reluctant when it came to the adoption of classic GMOs. This shift might result in serious practical problems for EU entrepreneurs and enforcement authorities alike, due to practical problems with the development of efficient detection methods and also might lead to a situation of legal fiction, where certain products, although officially regulated, will circulate on the market due to the aforementioned deficiencies in cost- and technically-efficient detection and identification methods.
This work was financed from a National Science Centre Grant no: UMO-2020/39/D/HS5/03144, Transformation of biosafety legislation in agriculture in the EU law and the laws of its selected trade partners, with respect to the scientific development.
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Zimny, T. (2024). NGT Plant Products in the EU. The Postulates, The Outlooks, and Possible Consequences of a Regulatory System Reform in the Context of Legislative Reforms in Third Countries and Detection Requirements. In: Ricroch, A., Eriksson, D., Miladinović, D., Sweet, J., Van Laere, K., Woźniak-Gientka, E. (eds) A Roadmap for Plant Genome Editing . Springer, Cham. https://doi.org/10.1007/978-3-031-46150-7_33
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