New Chemical Exposure Limits (NCELs)
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 Environmental Protection Agency (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 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).
NCELs Table -- 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.
CAVEAT -- The NCELs Table is for informational purposes only and is NOT itself legally controlling. Any discrepancies should be resolved in favor of the corresponding section 5(e) Order or section 5(a)(2) SNUR. The NCELs Table does not describe the other comprehensive requirements that are associated with the actual NCEL concentration and that are also imposed by the section 5(e) Order or section 5(a)(2) SNUR. These requirements are described in the NCELs section 5(e) Consent Order Boilerplate (below).
NCELs section 5(e) Order Boilerplate (PDF) (102 pp, 149K, about PDF) -- The NCELs section 5(e) Consent Order Boilerplate presents the generic template from which individual chemical-specific section 5(e) Consent Orders are drafted, including the standard NCELs provisions. The comprehensive NCELs requirements govern performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. The actual NCEL concentration is an empty blank to be completed depending on the toxicity of the specific chemical involved. Actual chemical-specific NCELs concentrations are listed in the NCELs Table (above).
NCELs Response-to-Comments Document (PDF) (54 pp, 133K, about PDF) -- The NCELs Response-to-Comments Document presents public comments on, and EPA's rationale for, EPA's standard NCELs requirements. In 1991, EPA solicited public comment on an early draft of standard NCELs provisions. The 1995 Response-to-Comments Document presents verbatim the comments EPA received and EPA's responses to those comments, including revisions to the NCELs section 5(e) Order requirements. The major topics addressed include: Inter-Agency Coordination; Establishment of the NCEL; Analytical Method; Monitoring Requirements; Respiratory Protection; and Recordkeeeping. Among other things, this document compares and contrasts EPA's NCELs and OSHA's PELs.