Support for New Chemical Premanufacturing Notice Reviews

Under Section 5 of the Toxic Substances Control Act, companies are required to submit a Premanufacture Notification at least 90 days prior to commercial production (including importation) of new chemicals. The U.S. Environmental Protection Agency’s New Chemicals Division is responsible for identifying and mitigating potential risks associated with the stated and potential uses of these new chemicals. To help manage the large volume of work involved, NCD sought contractor support.

Since 1994, ERG has supported NCD by generating Initial Review Engineering Reports that estimate occupational exposures to and environmental releases from new chemicals during their import, manufacture, processing, and use. Our engineers have reviewed more than 20,000 PMN submissions over the past 30 years. In support of this work, we have developed dozens of new methodologies to help estimate chemical releases and exposures based on our understanding of industrial process operations. We also developed the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) model, a screening-level computerized application that streamlines complex engineering assessments for PMN reviews and preparation of IRERs. Our chemical engineers have used ChemSTEER to assess thousands of PMNs since we developed it, and EPA has published it as a resource for industry for their internal use.