EPA late last year finalized rules banning use of trichloroethylene (TCE) in the United States and certain consumer uses of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). Both chlorinated chemical solvents have been linked by EPA to cancer and are common industrial solvents. The chemicals must be phased out over the next few years.
TSCA Background
“Under TSCA section 6(a) (15 U.S.C. 2605(a)), if the Agency determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk.” 89 Fed. Reg. 102571 and 103562. Consistent with this provision of TSCA, EPA has determined TCE and PCE present unreasonable risks of injury to health, without consideration of costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations (PESS).
TCE Phase Out
In the final regulation, EPA prohibits the manufacture and processing of TCE for most commercial and all consumer products within one year. Other uses of TCE in the workplace will gradually be eliminated over a longer period, but in the meantime strict worker safety requirements will apply. For example, permissible exposure limits will be enforced, although it is increased from what was proposed from 0.0011 to 0.2 parts per million (ppm) as part of the final regulation.
The TCE Rule applies to facilities involved in manufacture, process, distribute in commerce, use, or dispose of TCE or products containing TCE. TSCA section 3(9) defines the term “manufacture” to mean “to import into the customs territory of the United States, produce, or manufacture.” Therefore, unless expressly stated otherwise, importers of TCE are subject to any provisions regulating manufacture of TCE.
According to the TCE Rule, EPA is issuing this final rule to:
- Prohibit the manufacture (including import), processing, and distribution in commerce of TCE for all uses (including all consumer uses);
- Prohibit the industrial and commercial use of TCE, with longer compliance times for certain uses;
- Prohibit the manufacture (including import) and processing of TCE as an intermediate for the manufacturing of hydrofluorocarbon 134a (HFC-134a), following an 8.5-year phase-out;
- Prohibit the industrial and commercial use of TCE 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 phase-out;
- Prohibit the manufacture (including import), processing, distribution in commerce, and use of TCE as a laboratory chemical for asphalt testing and recovery, following a 10-year phase-out;
- Prohibit the manufacture (including import), processing, distribution in commerce, and industrial and commercial use of TCE as a solvent in batch vapor degreasing for essential aerospace parts and components and narrow tubing used in medical devices, following a 7-year TSCA section 6(g) exemption;
- Prohibit the manufacture (including import), processing, distribution in commerce, and industrial and commercial use of TCE as a solvent in closed loop vapor degreasing necessary for rocket engine cleaning by Federal agencies and their contractors, following a 7-year TSCA section 6(g) exemption;
- Allow for limited use on vessels of the Armed Forces and their systems;
- Prohibit the emergency industrial and commercial use of TCE in furtherance of the NASA mission for specific conditions which are critical or essential;
- Prohibit the manufacture (including import), processing, distribution in commerce, disposal, and use of TCE as a processing aid for manufacturing battery separators for lead acid batteries, following a 20-year TSCA section 6(g) exemption;
- Prohibit the manufacture (including import), processing, distribution in commerce, disposal, and use of TCE as a processing aid for manufacturing specialty polymeric microporous sheet materials following a 15-year TSCA section 6(g) exemption;
- Prohibit the manufacture (including import), processing, distribution in commerce, and 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 to limit exposure to TCE, including compliance with a TCE workplace chemical protection program (WCPP), which would include requirements for an interim existing chemical exposure limit (ECEL) at half of the 8-hour interim ECEL, or 0.1 ppm as an 8-hour TWA;
- Prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works, through a phaseout allowing for longer times for disposal necessary for certain industrial and commercial uses along with a 50-year TSCA section 6(g) exemption for disposal for cleanup projects before prohibition and interim requirements for wastewater worker protection; and
- Establish recordkeeping and downstream notification requirements.
PCE Use Restrictions
EPA also issued a final rule aimed at addressing risks associated with the widely used PCE. According to EPA, “PCE is used for the production of fluorinated compounds, as a solvent for dry cleaning and vapor degreasing; in catalyst regeneration in petrochemical manufacturing; and in a variety of commercial and consumer applications such as adhesives, paints and coatings, aerosol degreasers, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish and wipe cleaners.” 89 Fed. Reg. 103564. Like TCE manufacturers, unless expressly stated otherwise, importers of PCE are subject to provisions regulating manufacture of PCE.
To address the unreasonable risk posed by PCE, the PCE Rule:
- Prohibits most industrial and commercial uses and the manufacture (including import), processing, and distribution in commerce of PCE for those uses;
- Prohibits the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use;
- Prohibits the manufacture (including import), processing, distribution in commerce, and commercial use of PCE in dry cleaning and spot cleaning through a 10-year phaseout;
- Requires a Workplace Chemical Protection Program (WCPP), including an inhalation exposure concentration limit of 0.14 ppm (0.98 mg/m3) for inhalation exposures as an 8-hour time-weighted average (TWA), direct dermal contact controls, and related workplace exposure controls, for many occupational conditions of use of PCE not prohibited;
- Requires prescriptive workplace controls for use of PCE in laboratories and energized electrical cleaners;
- Establishes recordkeeping and downstream notification requirements;
- Provides a 10-year time limited exemption under TSCA section 6(g) for certain emergency uses of PCE in furtherance of National Aeronautics and Space Administration’s (NASA) mission, for specific conditions of use which are critical or essential and for which no technically and economically feasible safer alternative is available; and
- Identifies a regulatory threshold for products containing PCE for the prohibitions and restrictions on PCE.
Conclusion
Restrictions for use and manufacture of TCE and PCE are now in force. Companies should work now to identify compliance requirements to avoid dramatic changes to production and waste management controls.
89 Fed. Reg. 102568 (Dec. 17, 2024) (“TCE Rule”)
89 Fed. Reg. 103560 (Dec. 17, 2024) (“PCE Rule”)