Strategies for Traceability to Prevent Unauthorised GMOs (Including NGTs) in the EU: State of the Art and Possible Alternative Approaches

Abstract

The EU’s regulatory framework for genetically modified organisms (GMOs) was developed for “classical” transgenic GMOs, yet advancements in so-called “new genomic techniques (NGTs)” have led to implementation challenges regarding detection and identification. As traceability can complement detection and identification strategies, improvements to the existing traceability strategy for GMOs are investigated in this study. Our results are based on a comprehensive analysis of existing traceability systems for globally traded agricultural products, with a focus on soy. Alternative traceability strategies in other sectors were also analysed. One focus was on traceability strategies for products with characteristics for which there are no analytical verification methods. Examples include imports of “conflict minerals” into the EU. The so-called EU Conflict Minerals Regulation requires importers of certain raw materials to carry out due diligence in the supply chain. Due diligence regulations, such as the EU’s Conflict Minerals Regulation, can legally oblige companies to take responsibility for certain risks in their supply chains. They can also require the importer to prove the regional origin of imported goods. The insights from those alternative traceability systems are transferred to products that might contain GMOs. When applied to the issue of GMOs, we propose reversing the burden of proof: All companies importing agricultural commodities must endeavour to identify risks of unauthorised GMOs (including NGTs) in their supply chain and, where appropriate, take measures to minimise the risk to raw material imports. The publication concludes that traceability is a means to an end and serves as a prerequisite for due diligence in order to minimise the risk of GMO contamination in supply chains. The exemplary transfer of due diligence to a company in the food industry illustrates the potential benefits of mandatory due diligence, particularly for stakeholders actively managing non-GMO supply chains.

Challenges for the Post-Market Environmental Monitoring in the European Union Imposed by Novel Applications of Genetically Modified and Genome-Edited Organisms

“…In the context of PMEM, the availability of a detection method for the respective GMOs and the establishment of a register indicating the release locations or production facilities of GMO applications will facilitate the identification of pathways into natural habitats and the environment, thus ensuring appropriate and focused post-market environmental monitoring. Challenges addressing the detection, identification, and traceability of plants obtained by NGT have recently been reviewed elsewhere [ 170 , 171 ] and may also apply to other novel types of GMOs. Recently, two EU-funded projects have been launched to address the detection challenges for products developed by new genomic techniques [ 172 , 173 ].…”