Unsurprisingly, the U.S. Environmental Protection Agency (EPA) proposed on Oct. 31, to ban all uses of trichloroethylene (TCE) after determining it presents an unreasonable risk of injury to human health under conditions of use pursuant to the Toxic Substances Control Act (TSCA). TCE is widely used in cleaning and furniture-care products, degreasers, brake cleaners and tire repair sealants. Alternatives are available for many uses. The proposed rule would ban TCE’s manufacture, processing and distribution. It would take effect in one year for all consumer products and most commercial uses and would implement stringent worker protections on the limited remaining uses to be phased out over time.
The EPA determined TCE presents an unreasonable risk of injury to health without considering costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations. “Conditions of use” means the circumstances under which a chemical substance is intended, known or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of. The EPA notes all TSCA TCE use conditions are subject to the proposed rule. Here’s a partial list of proposed restrictions:
Public comment is expected to be robust.
- Prohibit the manufacture (including import), processing and distribution of TCE for all industrial, commercial and consumer uses, with longer compliance timeframes for manufacture and processing related to certain uses.
- Prohibit the manufacture (including import) and processing of TCE as an intermediate for the manufacture of hydrofluorocarbon-134a (HFC-134a), following an 8.5-year phaseout.
- Prohibit TCE’s industrial and commercial use as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in rocket booster nozzle production by federal agencies and their contractors, following a 10-year phaseout.
- Prohibit use of TCE as a laboratory chemical for essential laboratory activities and some research and development activities, following a 50-year TSCA Section 6(g) exemption.
- Require strict workplace controls, including compliance with a TCE workplace chemical protection program (WCPP), which would include requirements for an inhalation exposure limit and dermal protection to reduce TCE exposure, for conditions of use with long-term phaseouts or time-limited exemptions under TSCA Section 6(g).
- Prohibit, due to worker risks, the disposal of TCE to industrial pretreatment, industrial treatment or publicly owned treatment works, with a 50-year TSCA Section 6(g) exemption for cleanup projects.
- Establish recordkeeping and downstream notification requirements.
Regulated entities that use TCE in their supply chains will find the EPA’s proposal alarming. Interestingly, the most impactful aspect of this proposal goes far beyond banning one chemical, however. At issue is how the EPA defines “best available science” and “to the extent necessary” to identify unreasonable risk. Regarding the former, the EPA relied on a study, the results of which have proven to be non-reproducible, to establish an existing chemical exposure limit (ECEL).
As to the latter, some find it troubling that compliance with the TCE WCPP is insufficient to satisfy the “extent necessary” standard. They argue the EPA’s proposed ban is inconsistent with TSCA Section 6(a), which states that EPA shall “apply one or more of the following requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk …” (emphasis added). Given that the agency concluded that compliance with the WCPP will mitigate unreasonable risk concerns, it’s difficult to understand how the EPA justifies a ban.
The ramifications of the EPA’s use of a lower-quality study as its basis for an ECEL and to impose bans even when a WCPP is sufficiently protective are far-reaching. Some speculate that if unchallenged, these decisions will empower the agency to ban chemicals that can be adequately controlled and rely upon science that is not the “best available” on which to base public health decisions. Public comment is expected to be robust.