Environmental Notes - January 2025

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TCE and PCE Eliminated from Most Uses

By: Ethan R. Ware

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:

1. Prohibit the manufacture (including import), processing, and distribution in commerce of TCE for all uses (including all consumer uses);
2. Prohibit the industrial and commercial use of TCE, with longer compliance times for certain uses;
3. 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;
4. 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;
5. 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;
6. 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;
7. 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;
8. Allow for limited use on vessels of the Armed Forces and their systems;
9. Prohibit the emergency industrial and commercial use of TCE in furtherance of the NASA mission for specific conditions which are critical or essential;
10. 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;
11. 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;
12. 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;
13. 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;
14. 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
15. 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:

1. Prohibits most industrial and commercial uses and the manufacture (including import), processing, and distribution in commerce of PCE for those uses;
2. Prohibits the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use;
3. 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;
4. 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;
5. Requires prescriptive workplace controls for use of PCE in laboratories and energized electrical cleaners;
6. Establishes recordkeeping and downstream notification requirements;
7. 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
8. 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”)

D.C. Circuit Court of Appeals Vacates the Confidential Business Rule under TSCA

By: Tanner N. Brantley

The D.C. Circuit Court of Appeals vacated a portion of the Confidential Business Information rule (CBI) in the Toxic Substances Control Act (TSCA) regulations as the panel of judges found it unlawfully allows for the unwanted disclosure of chemical manufacturers' trade secrets.

TSCA Overview

TSCA was established by Congress to prevent unreasonable risks of injury to health and the environment from manufacture, processing, distribution in commerce, use and disposal of chemical substances and mixtures. Through TSCA, EPA is authorized to require reporting, record-keeping, and testing, and to impose restrictions relating to chemical substances and mixtures. Any party that intends to manufacture a chemical substance which is not yet on the TSCA Chemical Substance Inventory (CSI) must submit the required notice of such to EPA. EPA maintains two sections of the CSI in order to protect confidentiality while also facilitating the public knowledge of which chemical substances are already in commerce in the United States. The non-confidential section includes non-confidential chemical substances identified in part by their specific chemical identities and the confidential section includes public identifiers, such as accession numbers, for chemical substances whose identities are claimed as confidential. The confidential portion of the CSI is not available to the public and includes the specific chemical identities of chemical substances claimed as confidential.

Confidential Business Information Rule TSCA Overview

On June 7, 2023, EPA issued the final CBI rule. The CBI Rule concerns the assertion and treatment of confidential business information claims for information reported to or otherwise obtained by EPA under TSCA. Any entity submitting information to EPA under TSCA may claim that certain information is confidential business information, so long as it is permitted by the applicable regulations and TSCA section 2613. Generally, CBI claims must be substantiated and routinely reviewed by EPA. Additionally, CBI claims for chemical identities made prior to commercialization are not to be subject to such substantiation or review. The Rule exempts pre-commercialization CBI claims from substantiation and review until a post-commercialization claim is filed. The court found this consistent with the TSCA's provisions. As clarified by the Court of Appeals, Section 2613(c)(2) mandates that a CBI claim for information as outlined in subsections (A) through (G) shall not be subject to substantiation requirements and are not subject to durational limits to the exemption based upon a discrete period. The Court noted the “prior to” language is only present in subsection (G) and modifies the category of CBI that is exempt from substantiation. The Court held that while there is not a durational limit on the CBI exemption, it is not unconditional and could be waived.

Waiver of the Confidential Business Information Rule

The three-judge panel held that the CBI Rule under the regulations would allow downstream customers, such as processors or importers, that only know of a substance’s chemical name and non-confidential accession number to inadvertently waive confidentiality by submitting a report to the EPA that identifies the substance by its non-confidential referents. Even though the existing regulatory regime requires the downstream users of a chemical substance to submit such a report to EPA, the downstream user may not possess any confidential information regarding the chemical, and therefore would be unable to effectively assert or substantiate a CBI claim. The downstream customer, despite lacking the necessary confidential information, are required to assert and substantiate a CBI claim, even though the report they submit is likely to only contain non-confidential information regarding the chemical. Thus, although the downstream customer does not have the required information necessary to support such a claim, they are afforded no exception to this CBI assertion or substantiation requirement and the EPA may deem the CBI claim waived.

The Court was also concerned with the potential waiver of a competitor’s CBI claim and stated the rule “would allow downstream entities without knowledge to inadvertently or intentionally waive a competitor's CBI claim." Although the EPA has acknowledged this issue and stated it would be better addressed in later rules, the Court held that the current CBI Rule allows for unauthorized disclosures of confidential information and that EPA cannot wait to address the unlawful disclosures that are contrary to law.

Conclusion

The Court of Appeals concluded the CBI Rule is unlawful to the extent it allows a downstream entity reporting on a chemical substance by accession number and without knowledge of the underlying specific chemical identity to waive confidentiality for that specific chemical identity. Note the Court only vacated those specific requirements of the CBI Rule. It is likely that EPA will propose a revised CBI Rule within the year. Entities that utilize chemicals that are subject to TSCA reporting requirements and may be subject to the CBI Rule should stay abreast of any potential regulatory changes.

Environmental Defense Fund v. United States Environmental Protection Agency, 
No. 23-1166, 2024 WL 5176219 (D.C. Cir. Dec. 20, 2024)