New Chemicals (PMNs)

EPA’s New Chemicals Program helps manage the potential risk to human health and the environment from new chemicals sold on the market. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initiating the activity.

This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical. When submitting a PMN, all available data on chemical identity, production volume, byproducts, use, environmental release, disposal practices and human exposure are required to be submitted.

The New Chemicals Program can also require additional data, including newly
generated data from testing, when the information provided is not adequate to determine potential risk.

Several serious problems can arise if procedures for completing and submitting all required information for a PMN are not strictly followed. Such problems can include unforeseen delays in production plans and give rise to additional costs. TSG’s consultants assist clients throughout the entire PMN application process, and ensure that the application contains all required information and presents the best possible case to avoid the negotiation of a Section 5(e) Consent Order.

In the event EPA determines that the risks associated with a new chemical may be unacceptable, experienced TSG
toxicologists will apply highly sophisticated quantitative and modeling techniques to accurately assess potential exposure and risk. A properly conducted risk assessment can be critical in freeing companies from the restrictions of a 5(e). In addition, our consultants assist clients with pre-existing consent orders, including risk assessment support and assistance with additional, required toxicity testing.