Premanufacturing Notice in the United States

Premanufacturing Notice (PMN) in Environmental Law

The notice that must be filed with the Environmental Protection Agency (EPA) before a new chemical is manufactured or imported. The premanufacturing notice is required by the Toxic Substances Control Act.

If a person wants to begin manufacturing or importing a chemical, he or she must first determine whether it is on the Toxic Substances Control Act inventory. If it is not, the person checks the exemptions and exclusions. Finally, if the chemical is not exempt or excluded, a premanufacturing notice must be filed. A PMN may cover only one chemical or may cover two or more chemicals with similar molecular structure. Two or more companies may file a joint PMN, thereby increasing the resources available to get the notice through the process.

The PMN includes information about the chemical itself, such as identification, categories of use, byproducts, and amounts to be manufactured or imported. The EPA also wants to know how many employees have been exposed to the chemical during research and testing and proper disposal methods. Test data and impacts on health and environment are naturally a part of the PMN.

Within ninety days of receipt, the EPA must review the notice. It may extend the period another ninety days, or it may limit the sale or manufacture of the product, place conditions on it, or ban it. The EPA may ask for additional information if the data is insufficient to determine the risk. If the EPA does nothing within the first ninety days, the manufacture or import may begin after a thirty day prior notice of intent is sent to the agency.

Exclusions from the premanufacturing notice requirements are chemicals regulated under another statute, such as the Federal Insecticide, Fungicide, and Rodenticide Act or the Food, Drug, and Cosmetic Act. Exempted chemicals either fit into one of the categories the EPA has created or fall under research and development. Some polymers and chemicals that are byproducts of manufacturing are exempt, for example.
Based on “Environment and the Law. A Dictionary”.