WASHINGTON - Proposed EPA rules regulating microbial products of biotechnology under the Toxic Substances Control Act (TSCA) have drawn fire from the Biotechnology Industry Organization and several agricultural biotechnology companies because they are based on the process by which products are created rather than the risks posed by the products themselves.

The new rule proposes creation of a premanufacture notification system (PMN) for new chemicals under TSCA, approvals for experimental release and notification of commercial activity (see BioCentury Aug. 29). The industry opposition is expressed in comments filed with the agency during the comment period that closed Dec. 31.