Mandated by section 5 of the Toxic Substances Control Act (TSCA), EPA’s New Chemicals program helps manage the potential risk to human health and the environment from chemicals new to the marketplace. The program functions as a “gatekeeper” that can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce.


Under section 5 of the Toxic Substances Control Act (TSCA), any person who intends to manufacture (including import) a new chemical substance in the United States for commercial purposes must submit a premanufacture notice (PMN) to the EPA at least 90 days prior to manufacture (including import). EPA’s Office of Pollution Prevention and Toxics (OPPT) performs a risk assessment and makes a risk management decision.


If EPA determines, among other things, that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, EPA is likely to issue a TSCA section 5(e) Consent Order. The section 5(e) Order is likely to require, among other things, that potentially exposed employees of the Company must wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health.


In addition to the actual NCEL concentration, the comprehensive NCELs provisions, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs), include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. EPA generally extends these section 5(e) Order requirements to other manufacturers and processors of the same chemical substances via a section 5(a)(2) Significant New Use Rule (SNUR).


The NCELs table lists the actual NCEL concentrations established by EPA for specific chemical substances regulated by section 5(e) Orders. The NCELs table is intended to provide a convenient list of all NCELs established by EPA (up to the date of Internet posting). This list of NCELs concentrations is not published in the Code of Federal Regulations (CFR) or elsewhere. To protect Confidential Business Information (CBI) under section 14 of TSCA, the NCELs table gives generic descriptions of those PMN substances for which the company claimed the chemical identity as CBI.


What is a “new chemical”?

For purposes of regulation under TSCA, if a chemical is on the TSCA Inventory, the substance is considered an “existing” chemical substance in U.S. commerce. Any chemical that is not on the Inventory is considered a “new chemical substance.”


Learn more about EPA’s Toxic Substances Control Act Chemical Substance Inventory


Who must submit a premanufacture notice (PMN) to EPA?

Section 5 of TSCA requires anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to provide EPA with notice before initiating the activity. This notice is known as a premanufacture notice (PMN).  Refer to chart below that details steps for determining whether a submission is required on a chemical substance.


New Chemical Exposure Limits under TSCA text


To know more about submitting PMN, click here.
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