Section 5 of the Toxic Substances Control Act (TSCA) mandates that new chemicals and chemicals subject to significant new-use rules (SNURS) must be reviewed by EPA’s Office of Pollution Prevention and Toxics (OPPT) New Chemicals Program prior to being manufactured, imported, or distributed in the United States. Premanufacturing Notice (PMN) reporting requirements and exemptions are summarized on
EPA’s new chemical website. Chemicals for which there may be no PMN reporting requirements, but that still warrant a Section 5 exemption notice, include:
- Low Volume Exemptions (LVE) substances (those that are manufactured in amounts of 10,000 kilograms or less yearly)
- Those not in commerce and prepared in small quantities for research and development only
- Those prepared only for test marketing (TME)
- Polymers that meet criteria defining the substance as not chemically active or bioavailable
- Those subject to low releases and low exposures (LOREX)
The premanufacture notice (PMN) must be submitted at least 90 days prior to the manufacture or import of the chemical. The New Chemical Program functions as a “gatekeeper” to evaluate applications. If the application is complete or not challenged within the 90 day review period after submission, the PMN is considered acceptable. The submitter must then provide a Notice of Commencement of Manufacture or Import (NOC, EPA Form 7710-56) to the Agency, within 30 days of the substance first being manufactured or imported.
EPA does not specify a minimum or maximum set of PMN data requirements. Rather, the PMN application requires the submitter to provide information about the manufacturing process and waste streams, worker and consumer exposures, mammalian and environmental risk, and physicochemical data. The PMN data application may include both laboratory data and modeled estimates. The development of a PMN regulatory package should be approached on a case-by-case basis and to identify potential areas of regulatory concern in the planning stage. This approach avoids the unnecessary expenditure of laboratory resources and regulatory setbacks from TSCA Section 5(e) consent-order negotiations that may cause marketplace entry delays. Exponent’s scientists have the expertise to assist throughout the PMN process: planning, modeling and data development, submission of the package to EPA, and follow-on discussions should a TSCA 5(e) challenge result.