Detection of commercialized plant products derived from new genomic techniques (NGT) - Practical examples and current perspectives

Guertler, Patrick; Pallarz, Steffen; Belter, Anke; Eckermann, Kolja N.; Grohmann, Lutz

doi:10.1016/j.foodcont.2023.109869

Cited by 2 publications

(1 citation statement)

References 52 publications

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“…The event-specific identification of NGT plant products, rather than just the detection of the InDel/single nucleotide variant (SNV), appears to pose a considerably greater challenge, particularly when the detected genome edit needs to be distinguished from conventional plant products with identical sequences. The question arises as to whether the detection of a characteristic SNV or InDel at a specific site in the genome of the NGT plant is sufficient for its identification according to EU legislation [33]. Previous studies have used amplicon and primer sets to determine whether a single-point variation in a gene, involving a single nucleotide (adenosine) insertion in the rice variety OsMADS26 (locus: Os08g02070), could be distinguished.…”

Section: Discussionmentioning

confidence: 99%

Specificity Testing for NGT PCR-Based Detection Methods in the Context of the EU GMO Regulations

Zanatta,

Hoepers,

Nodari

et al. 2023

Foods

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The term new genomic techniques (NGTs) is an umbrella term used to describe a variety of techniques that can alter the genetic material of an organism and that have emerged or have been developed since 2001, when the existing genetically modified organism (GMO) legislation was adopted. The analytical framework used to detect GMOs in Europe is an established single harmonized procedure that is mandatory for the authorization of GM food and feed, thus generating a reliable, transparent, and effective labeling scheme for GMO products. However, NGT products can challenge the implementation and enforcement of the current regulatory system in the EU, relating in particular to the detection of NGT products that contain no foreign genetic material. Consequently, the current detection methods might fail to meet the minimum performance requirements. Although existing detection methods may be able to detect and quantify even small alterations in the genome, this does not necessarily confirm the distinction between products resulting from NGTs subject to the GMO legislation and other products. Therefore, this study provides a stepwise approach for the in silico prediction of PCR systems’ specificity by testing a bioinformatics pipeline for amplicon and primer set searches in current genomic databases. In addition, it also empirically tested the PCR system evaluated during the in silico analysis. Two mutant genotypes produced by CRISPR-Cas9 in Arabidopsis thaliana were used as a case study. Overall, our results demonstrate that the single PCR system developed for identifying a nucleotide insertion in the grf1-3 genotype has multiple matches in the databases, which do not enable the discrimination of this mutated event. Empirical assays further support this demonstration. In contrast, the second mutated genotype, grf8-61, which contains a -3 bp deletion, did not yield any matches in the sequence variant database. However, the primer sequences were not efficient during the empirical assay. Our approach represents a first step in decision making for analytical methods for NGT detection, identification, and quantification in light of the European labeling regulations.

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Section: Discussionmentioning

confidence: 99%

Specificity Testing for NGT PCR-Based Detection Methods in the Context of the EU GMO Regulations

Zanatta,

Hoepers,

Nodari

et al. 2023

Foods

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Genome Editing in Biotech Regulations Worldwide

Sprink,

Wilhelm

2023

A Roadmap for Plant Genome Editing

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Since the introduction of genome editing techniques in breeding and the first commercial products on the market, various governments or jurisdictions have attempted to clarify the legal classification of genome editing in relation to their genetic engineering regulations. Only a few countries, including Europe, fully apply their strict genetic engineering laws to genome-edited organisms or products derived from them. Most countries with liberal regulations base classification on the absence of foreign DNA in the final product (including the USA and Canada, which de facto have no specific GMO laws). Countries such as Australia and Japan have introduced subcategories when sequence templates have been used in the genome editing process. Several countries, including Europe, are in the process of revising their GMO legislation. The international legislative landscape is thus dynamic. The heterogeneity of regulatory regimes poses a challenge for international trade. This chapter summarises the status as of June 2023 and provides a brief introduction to the main legal concepts.

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Detection of commercialized plant products derived from new genomic techniques (NGT) - Practical examples and current perspectives

Cited by 2 publications

References 52 publications

Specificity Testing for NGT PCR-Based Detection Methods in the Context of the EU GMO Regulations

Specificity Testing for NGT PCR-Based Detection Methods in the Context of the EU GMO Regulations

Genome Editing in Biotech Regulations Worldwide

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