Premanufacturing Notice

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”.

Premanufacturing Notice: Open and Free Legal Research of US Law

Federal Primary Materials

The U.S. federal government system consists of executive, legislative, and judicial branches, each of which creates information that can be the subject of legal research about Premanufacturing Notice. This part provides references, in relation to Premanufacturing Notice, to the legislative process, the federal judiciary, and the primary sources of federal law (cases, statutes, and regulations).

Federal primary materials about Premanufacturing Notice by content types:

Laws and Regulations

US Constitution
Federal Statutory Codes and Legislation

Federal Case Law and Court Materials

U.S. Courts of Appeals
United States courts of appeals, inclouding bankruptcy courts and bankcruptcy appellate panels:

Federal Administrative Materials and Resources

Presidential Materials

Materials that emanate from the President’s lawmaking function include executive orders for officers in departments and agencies and proclamations for announcing ceremonial or commemorative policies. Presidential materials available include:

Executive Materials

Federal Legislative History Materials

Legislative history traces the legislative process of a particular bill (about Premanufacturing Notice and other subjects) for the main purpose of determining the legislators’ intent behind the enactment of a law to explain or clarify ambiguities in the language or the perceived meaning of that law (about Premanufacturing Notice or other topics), or locating the current status of a bill and monitoring its progress.

State Administrative Materials and Resources

State regulations are rules and procedures promulgated by state agencies (which may apply to Premanufacturing Notice and other topics); they are a binding source of law. In addition to promulgating regulations, state administrative boards and agencies often have judicial or quasi-judicial authority and may issue administrative decisions affecting Premanufacturing Notice. Finding these decisions can be challenging. In many cases, researchers about Premanufacturing Notice should check state agency web sites for their regulations, decisions, forms, and other information of interest.

State rules and regulations are found in codes of regulations and administrative codes (official compilation of all rules and regulations, organized by subject matter). Search here:

State opinions of the Attorney General (official written advisory opinions on issues of state law related to Premanufacturing Notice when formerly requested by a designated government officer):

Tools and Forms

Law in Other Regions

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