Government and Regulatory Affairs
EPA 1997 Final Regulations Under TSCA

On April 11, 1997, the EPA Office of Pollution Prevention and Toxics published final rules under the Toxic Substances Control Act (TSCA) for the regulation of genetically modified microorganisms. TSCA is used to regulate industrial and environmental uses of microbes not regulated elsewhere in the government, and would be the statute that would cover the use of genetically engineered organisms in bioremediation. This long-awaited regulation formalizes EPA's program of oversight for certain modified microbes in specialty chemical production, waste treatment, agriculture, energy production, and other environmental applications. The final rule reduces the regulatory burden for small-scale field testing of intergeneric microbes, greatly clarifies the requirements for containment of waste treatment and "process stream" reactor vessels, and provides for certain types of commercial exemptions.

David Glass has over 25 years experience working with the EPA TSCA Biotechnology Program. Dr. Glass is currently employed by Joule Unlimited, and  he is no longer offering regulatory consulting services through D. Glass Associates, Inc. For more information, please contact Dr. Glass.