Risk assessment is a science-based tool that regulatory agencies are increasingly using to make informed decisions about the impact of genetically modified (GM) crops on the environment. Considerable effort has been made to develop a systematic approach to assess environmental risk based on the U. S. Environmental Protection Agency (EPA) guidance. The EPA guidance framework consists of four steps: problem formulation (hazard identification), analysis (characterization of exposure), risk characterization (hazard x exposure) and risk management. GM crops have been divided into two groups: Pesticide Incorporated Products (PIPs), such as Bt crops, and non-PIPs, such as enhance lysine maize or Roundup Ready crops. For PIPs, activity towards target organisms is expected, and therefore the need for characterization of risk is clear, and EPA has developed guidance to proceed with these types of products. For Non-PIPs, however, hazard may not be apparent or plausible and a different approach is taken. An overview of the conceptual model developed at Monsanto to perform environmental risk assessment of non-target organisms to meet regulatory concerns for non-PIPs will be discussed.