LAUSR

ABSTRACT Resistance genes (R‐genes) from wild potato species confer protection against disease and can be introduced into cultivated potato varieties using breeding or biotechnology. The R‐gene, Rpi‐vnt1, which encodes the VNT1 protein, protects against late blight, caused by Phytophthora infestans. Heterologous expression and purification of active VNT1 in quantities sufficient for regulatory biosafety studies was problematic, making it impractical to generate hazard characterization data. As a case study for R‐proteins, a weight‐of‐evidence, tiered approach was used to evaluate the safety of VNT1. The hazard potential of VNT1 was identified from relevant safety information including history of safe use, bioinformatics, mode of action, expression levels, and dietary intake. From the assessment it was concluded that Tier II hazard characterization was not needed. R‐proteins homologous to VNT1 and identified in edible crops, have a history of safe consumption. VNT1 does not share sequence identity with known allergens. Expression levels of R‐proteins are generally low, and VNT1 was not detected in potato varieties expressing the Rpi‐vnt1 gene. With minimal hazard and negligible exposure, the risks associated with consumption of R‐proteins in late blight protected potatoes are exceedingly low. R‐proteins introduced into potatoes to confer late blight protection are safe for consumption. HighlightsVNT1 protein was introduced into potatoes to provide late blight protection.VNT1 safety was assessed using a Tier I hazard identification.R‐proteins are widely distributed in food providing a history of safe use.VNT1 is similar to other R‐proteins in potatoes, but not to allergens or toxins.VNT1 levels in potato are below detection limits making exposure negligible.