Abstract
Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops. In the case of a food and feed crop, no single variety is considered the standard for safety or nutrition, so the substantial equivalence of transgenic crops is investigated relative to the array of commercial crop varieties with a history of safe consumption. Although used extensively in clinical medicine to compare new generic drugs with brand-name drugs, equivalence limits are shown to be a poor model for comparing transgenic crops with an array of reference crop varieties. We suggest an alternate model, also analogous to that used in clinical medicine, where reference intervals are constructed for a healthy heterogeneous population. Specifically, we advocate the use of distribution-free tolerance intervals calculated across a large amount of publicly available compositional data such as is found in the International Life Sciences Institute Crop Composition Database.
Highlights
Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops
Distribution-free tolerance intervals (99%-coverage, 95%-certainty) for various compositional components of corn seed that are available in the International Life Sciences Institute (ILSI) crop-composition database are compiled in Table 1, along with the sample sizes used to construct them
Statistical approaches to data analysis are almost universally required when reporting data to regulatory agencies or in peer-reviewed journals
Summary
Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops. It is an approach that is typically applied to the evaluation of new generic drugs. The intent of such bioequivalence studies is to compare the performance and bioavailability of a new generic drug with the performance of a commercially available brand-name drug. The performance of the candidate generic drug is examined to see www.biotechnology-journal.com if it performs within these equivalence limits [31]. These limits are centered on the average performance of the brand-name drug. This is an appropriate approach because the generic and brand-name drug are expected to have the same average performance
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