Monday, January 16, 1995
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.