Transgenic maize event TC1507: Global status of food, feed, and environmental safety

Abstract

Maize (Zea mays) is a widely cultivated cereal that has been safely consumed by humans and animals for centuries. Transgenic or genetically engineered insect-resistant and herbicide-tolerant maize, are commercially grown on a broad scale. Event TC1507 (OECD unique identifier: DAS-Ø15Ø7–1) or the Herculex®# I trait, an insect-resistant and herbicide-tolerant maize expressing Cry1F and PAT proteins, has been registered for commercial cultivation in the US since 2001. A science-based safety assessment was conducted on TC1507 prior to commercialization. The safety assessment addressed allergenicity; acute oral toxicity; subchronic toxicity; substantial equivalence with conventional comparators, as well as environmental impact. Results from biochemical, physicochemical, and in silico investigations supported the conclusion that Cry1F and PAT proteins are unlikely to be either allergenic or toxic to humans. Also, findings from toxicological and animal feeding studies supported that maize with TC1507 is as safe and nutritious as conventional maize. Maize with TC1507 is not expected to behave differently than conventional maize in terms of its potential for invasiveness, gene flow to wild and weedy relatives, or impact on non-target organisms. These safety conclusions regarding TC1507 were acknowledged by over 20 regulatory agencies including United States Environment Protection Agency (US EPA), US Department of Agriculture (USDA), Canadian Food Inspection Agency (CFIA), and European Food Safety Authority (EFSA) before authorizing cultivation and/or food and feed uses. A comprehensive review of the safety studies on TC1507, as well as some benefits, are presented here to serve as a reference for regulatory agencies and decision makers in other countries where authorization of TC1507 is or will be pursued.

Stacking transgenic event DAS‐Ø15Ø7‐1 alters maize composition less than traditional breeding

“…To provide a science‐based evaluation of the crop‐compositional effects of stacking GM events and to provide context around the regulatory requirement for composition studies with GM breeding stacks, we examined the grain composition of seven breeding stacks containing DAS‐Ø15Ø7‐1 maize (Baktavachalam et al ., ) and other approved GM maize events. DAS‐Ø15Ø7‐1 expresses the Cry1F insecticidal protein and the phosphinothricin N‐acetyltransferase (PAT) herbicide‐tolerant enzyme.…”

Evidencias sobre seguridad alimentaria con relación a proteínas en alimentos transgénicos

“…Bioequivalence tests are recognized as valuable for determining the safety of an event to be introduced. This means demonstrating that no significant differences exist between the use of the food from the new event and the use of the original food under the same conditions and dose 31,32 .…”

The CRISPR/Cas9 System for Crop Improvement: Progress and Prospects

“…In fact, adding multiple genes that confer different trait improvement in a single plant is a common practice to produce elite cultivar. For instance, the TC1507 maize that contains both the Bacillus thuringiensis (Bt) gene that confers insect resistance and acetyltransferase gene that is herbicide tolerance [56]. To date, the most common and efficient method used is to collocate all the desired genes into a single molecular stack, whereby all of the genes will now behave as a single locus or better known as gene stacking [52].…”