Obligatory metabolomic profiling of gene‐edited crops is risk disproportionate

Abstract

SUMMARY It has been argued that the application of metabolomics to gene‐edited crops would present value in three areas: (i) the detection of gene‐edited crops; (ii) the characterization of unexpected changes that might affect safety; and (iii) building on the track record of rigorous government regulation in supporting consumer acceptance of genetically modified organisms (GMOs). Here, we offer a different perspective, relative to each of these areas: (i) metabolomics is unable to differentiate whether a mutation has resulted from gene editing or from traditional breeding techniques; (ii) it is risk‐disproportionate to apply metabolomics for regulatory purposes to search for possible compositional differences within crops developed using the least likely technique to generate unexpected compositional changes; and (iii) onerous regulations for genetically engineered crops have only contributed to unwarranted public fears, and repeating this approach for gene‐edited crops is unlikely to result in a different outcome. It is also suggested that article proposing the utility of specific analytical techniques to support risk assessment would benefit from the input of scientists with subject matter expertise in risk assessment.

Evaluation of the use of untargeted metabolomics in the safety assessment of genetically modified crops

“…In the current state, there are major hurdles ahead of utilizing untargeted metabolomics in regulatory safety assessments and thus are not considered useful in the risk assessment of GM crops or gene-edited crops (Delaney et al 2019 ; Fedorova and Herman 2020 ). For hypothesis driven risk assessment, quantitative crop-specific targeted compositional analysis (Codex Alimentarius 2009 ; EFSA 2006 ) is central to safety reviews of food and feed from GM crops.…”

Transparency in risk-disproportionate regulation of modern crop-breeding techniques

“…11 Contrary to the intention of improving public acceptance, risk-disproportionate regulation may be leading to increased, rather than decreased, consumer distrust of modern breeding techniques, thus strengthening opposition in regions where these beneficial products are already distrusted at an emotional level. [12][13][14][15] When this occurs, a cycle of increasing public distrust leading to increased regulatory requirements can perpetuate both public distrust and riskdisproportionate regulation (Fig. 1).…”

“…Furthermore, it seems doubtful that applying omics technology to composition studies would actually improve consumer acceptance due to the low awareness of omics technologies by the general public and the unlikely outcome that applying omics technology to composition studies would quell the underlying consumer distrust of corporations and governments and the perceived “unnaturalness” of modern breeding techniques. 14 It is noteworthy that there are also technical difficulties in interpreting omics data in the context of safety assessment due to the absence of baseline data that delineate profiles that raise safety concerns. 31 , 32 Consequently, requiring omics data will not only fail to improve public acceptance, but also is likely to worsen regulatory decision-making and increase risk.…”

“…Thus, entangling safety studies with those primarily intended to improve consumer acceptance, at best, does not respect the public’s ability to understand the difference in the motivations for requiring these studies, and, at worst, is deceptive in implying that the technologies being assessed are a higher risk than alternative technologies that are largely unregulated, or that more data equals greater rigor. 12 , 14 , 28 …”