Cultivation of genetically engineered (GE) crops, for example with corn, soybean, cotton and canola, has become broadly adopted, with approximately 500 million acres cultivated annually across nearly 30 countries. The first GE crops were registered in the mid-1990s. Since then, the development of country-specific registration requirements to support environmental risk assessments (ERA) have been codified for insecticidal and non-insecticidal traits. As with any regulatory system, requirements and ERA schemes change over time based on new regulations, input from scientific advisory panels during expert reviews, and experience gained over–time with new technologies. In some cases, additional requirements have been added over time, however, in many cases requirements have been removed, waived, or streamlined for single trait and/or multiple trait (stacked or pyramided) products. This presentation will provide an overview of the development and implementation of data requirements to support ERA for cultivation approvals worldwide. Specific requirements, and why some requirements have changed overtime, will be highlighted and discussed with examples from the United States, Brazil, Japan, Argentina, Australia, and Europe.
