Legal and social concerns to the development of bioremediation technologies

The social and legal framework within which bioremediation technologies must be researched, developed, and deployed in the US are discussed in this report. Discussions focus on policies, laws and regulations, intellectual property, technology transfer, and stakeholder concerns. These discussions are intended to help program managers, scientists and engineers understand the social and legal framework within which they work, and be cognizant of relevant issues that must be navigated during bioremediation technology research, development, and deployment activities. While this report focuses on the legal and social environment within which the DOE operates, the laws, regulations and social processes could apply to DoD and other sites nationwide. This report identifies specific issues related to bioremediation technologies, including those involving the use of plants; native, naturally occurring microbes; non-native, naturally occurring microbes; genetically engineered organisms; and microbial products (e.g., enzymes, surfactants, chelating compounds). It considers issues that fall within the following general categories: US biotechnology policy and the regulation of field releases of organisms; US environmental laws and waste cleanup regulations; intellectual property and patenting issues; technology transfer procedures for commercializing technology developed through government-funded research; stakeholder concerns about bioremediation proposals; and methods for assuring public involvement in technology development and deployment