Regulatory Impact Analysis for New Chemical Reporting Alternatives under Section 5 of TSCA (Toxic Substances Control Act)

摘要

This report presents the results of analysis of various information reporting alternatives for the Premanufacture Notification (PMN) process under section 5 of TSCA. The PMN process is the method by which the Office of Toxic Substances of EPA reviews data submitted by manufacturers and importers of new chemicals. The data must be submitted to EPA for review at least 90 days prior to when actual manufacturing or import begins. The analysis shows that the private costs of the rule range from $5 million to $13 million annually and that Agency PMN review costs are about $7 million per year. Although the data are incomplete, adverse chemical innovation effects associated with the PMN rule are not believed to be large. The PMN process conducted under the final rule is expected to maintain the Agency's effectiveness in preventing adverse human health effects.