The application of insect biotechnology is promising for the development of environmentally compatible pest management solutions.  As we have refined and enhanced genetic engineering techniques in several insect species that cause significant economic loss and public health injury, it has become clear that insect biotechnology will move forward as one of the key tools of pest management in agriculture and in the human environment.  Well characterized genetic elements can be manipulated toward specific aims and maintain a viable insect, albeit one with diminished capacity to exchange genetic material, vector a virus or bacterium, or complete its life cycle.  Despite this degree of knowledge and precision, there remain unanswered questions regarding environmental fate, release and public acceptance of this technology.  The uncertainty surrounding any novel technology inevitably increases the level of regulatory scrutiny associated with its use.  Although the term 'insect biotechnology' has many connotations, it certainly includes the genetic modification of symbiotic or commensally associated microbes as a means of delivering a trait (e.g., a toxin) to manage plant and human diseases and insect pests.  The distinction between this paratransgenic approach and direct genetic modification of insect pests is an important one biologically as well as from a regulatory standpoint.  The regulatory framework for microbial applications to agriculture is in many instances in place; however, we must strive to forge the development of guidelines and regulations that will foster deployment of insect biotechnologies.