Abstract

BackgroundThe safety assessment of foods and feeds from genetically modified (GM) crops includes the comparison of key characteristics, such as crop composition, agronomic phenotype and observations from animal feeding studies compared to conventional counterpart varieties that have a history of safe consumption, often including a near isogenic variety. The comparative compositional analysis of GM crops has been based on targeted, validated, quantitative analytical methods for the key food and feed nutrients and antinutrients for each crop, as identified by Organization of Economic Co-operation and Development (OCED). As technologies for untargeted metabolomic methods have evolved, proposals have emerged for their use to complement or replace targeted compositional analytical methods in regulatory risk assessments of GM crops to increase the number of analyzed metabolites.Aim of ReviewThe technical opportunities, challenges and strategies of including untargeted metabolomics analysis in the comparative safety assessment of GM crops are reviewed. The results from metabolomics studies of GM and conventional crops published over the last eight years provide context to enable the discussion of whether metabolomics can materially improve the risk assessment of food and feed from GM crops beyond that possible by the Codex-defined practices used worldwide for more than 25 years.Key Scientific Concepts of ReviewPublished studies to date show that environmental and genetic factors affect plant metabolomics profiles. In contrast, the plant biotechnology process used to make GM crops has little, if any consequence, unless the inserted GM trait is intended to alter food or feed composition. The nutritional value and safety of food and feed from GM crops is well informed by the quantitative, validated compositional methods for list of key analytes defined by crop-specific OECD consensus documents. Untargeted metabolic profiling has yet to provide data that better informs the safety assessment of GM crops than the already rigorous Codex-defined quantitative comparative assessment. Furthermore, technical challenges limit the implementation of untargeted metabolomics for regulatory purposes: no single extraction method or analytical technique captures the complete plant metabolome; a large percentage of metabolites features are unknown, requiring additional research to understand if differences for such unknowns affect food/feed safety; and standardized methods are needed to provide reproducible data over time and laboratories.

Highlights

  • The 1975 Asilomar Conference on Recombinant DNA initiated a public discussion of the potential benefits and hazards for the emerging field of molecular biotechnology (Berg et al 1975)

  • To assess the safety and nutritional value of foods and feeds from genetically modified (GM) crops, a comparative process is followed in which the composition of the GM crop is compared to a near isogenic conventional counterpart (Codex Alimentarius 2009; Paoletti et al 2008; Prado et al 2014; Privalle et al 2012)

  • As additional studies are published, the results reported in many publications continue to support the conclusion that the effect of trait insertion on the metabolomics of GM crops is small compared to the effect of naturally occurring factors associated with the cultivation, environmental and/or genetic changes arising from conventional breeding practices (Table 1)

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Summary

Introduction

The 1975 Asilomar Conference on Recombinant DNA initiated a public discussion of the potential benefits and hazards for the emerging field of molecular biotechnology (Berg et al 1975). The OECD recommended components include crop macronutrients and micronutrients and comprise greater than 95% dry matter of the crop composition (Chassy 2010) These comparative composition studies are used to assess whether levels of nutritionally important components and/or components that can affect the safety of the food and feed have not been altered in a manner that would adversely impact human or animal health. The compositional studies are conducted using targeted analytical methods that are validated for accuracy and precision and performed under good laboratory practices (GLP) for each specific crop and tissue matrix analyzed This targeted analysis approach ensures the accuracy and reproducibility of the quantitation of all nutrients and anti-nutrients to provide regulatory agencies with the data required to ensure a safe and nutritious food and feed supply. Page 3 of 15 111 strategies facing implementation of metabolomic analytical tools for GM crop safety assessments; and (3) whether metabolomics can better inform the safety and nutritional assessment of GM crops than the quantitative and validated compositional analytical methods used for more than 20 years as defined by the Codex and OECD guidelines

What have we learned from metabolomics studies of GM and conventional crops?
What is needed for metabolomics to be ready for risk assessments of GM crops?
Summary
Tools to interpret metabolomics data for GM comparative safety assessments
Standardization of the metabolomics method
Conclusion
Findings
Compliance with ethical standards
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