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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

New Chemical Exposure Limits under TSCA

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.

Go to the NCELs table.

Review the NCELs section 5(e) Order Boilerplate insert here.