
The Perfect Remedy
Legal
Ethical
Social

Legal Issues
(5.8)
These three acts/notices established by the Environmental and Protection Agency (EPA) regulate Bioremediation and it’s processes.
Microbial Commercial Activity Notice
Submission of an MCAN requires data describing the genetic makeup and characteristics of the organism, any byproducts of the organism, information relating to risks posed through worker exposure and environmental release, and health effects information. Specifically, an MCAN requires detailed information describing the pathogenicity, toxicity, and immunological effects of the organism as it relates to human health. (5.6)
The Resource Conservation and Recovery Act
The 1986 amendments to RCRA enabled EPA to address environmental problems that could result from underground tanks storing petroleum and other hazardous substances.
When closing a facility under RCRA, current regulations call for either the complete removal of all wastes (clean closure) or leaving wastes and constituents in place (landfill closure). This closure process must typically be completed within 180 days. (5.6, 5.7)
Toxic Substances Control Act (TSCA)
EPA is granted regulatory authority under TSCA because bioengineered organisms are considered “new chemical substances.” Two types of genetically engineered organisms fall under TSCA: (1) “organisms that have been modified by the insertion of genetic material from organisms of different genera,” and (2) “those that are pathogenic or have received genetic material from organisms that are pathogens.” (5.6)


