The approach to equivalence testing required by the [European Food Safety Authority, EFSA] creates unwarranted barriers to the introduction of GE crops. Given the abundant evidence that there is less variation in composition created through the process of developing GE crops than through conventional breeding and that, therefore, compositional changes that pose a health risk are highly improbable, there is little scientific rationale for the generation of data that actually hinder the development of new GE crops that address urgent societal challenges.
[Editor’s note: The authors are researchers at the biotech firm Corteva.]
The current experimental design required by the EFSA to satisfy their approach to statistical analysis results in the conduct of the single most expensive study (>US$1 million) in support of GE-crop regulatory approvals for products that have the potential to improve agricultural production and food safety. These obstacles can be surmounted by multinational corporations that develop seed for large-scale commodity crops, but these impediments create impenetrable barriers for non-commodity products and smaller companies and universities.
We therefore agree with van der Voet and Paoletti that it is perhaps time to refine or even reconsider the current EFSA compositional equivalency approach. If compositional equivalence studies remain a requirement for political purposes, it would be beneficial to develop a new approach that maintains the benefits of statistical equivalence testing (strict control of falsely declaring equivalence) while maximizing correct identification of true equivalence through use of extensive crop composition data to establish meaningful equivalence limits.
Current regulation in the European Union seems to be driven largely by consumer fear of GE crops, resulting in the cultivation approval of only a single GE event that is grown on extremely limited acres. Compositional study designs that are biased toward falsely implicating lack of equivalence of GE to non-GE crops only reinforces those fears.
The health benefits (e.g., reduced mycotoxins in Bt maize grain) and environmental benefits (e.g., reduced insecticide use and greater adoption of reduced tillage) have largely been foregone within the European Union, calling into question the effectiveness of the current regulatory approach in “maximizing consumer protection”.
In our opinion, change must include policy revisions that clearly set the direction for regulators and support the public good, along with implementation of factual public education programs communicating the risks and benefits of GE crops.