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.

D. Glass Associates, Inc. (DGA) has prepared a report describing this rule and its impact on use of engineered organisms for industrial purposes and in the environment. This report includes:

• Summary of the final rule, including a discussion of the rationale behind the more important portions.
• Summary of major changes from the 1994 proposed rule.
• Analysis of the impact of the final rule on use of genetically modified organisms for bioremediation and other uses, for research and commercial purposes.
• Implications of the final rule for the commercial uses of genetically modified microorganisms in environmental applications.

The report is 19 pages in length, with a detailed flowchart to help explain the rule's provisions. The price of this report is $195. In addition to this general summary, DGA can prepare a second report of approximately 5-10 pages, tailored to address those issues of concern to a given company, for an additional price of $100. DGA can also present a seminar on biotechnology regulation for key company decision makers, and provide strategic counsel on the impact of this regulation on company plans.

Contact D. Glass Associates for more information on obtaining these reports.