EPA publishes a proposed rule under TSCA to ban or restrict most uses of methylene chloride

On May 3, 2023, EPA published its proposed risk management rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to impose restrictions on the manufacture, importation, processing, distribution and use of methylene chloride, a solvent used in a variety of commercial and consumer applications. This is the EPA’s first proposed risk management rule since last year it issued revised risk determinations based on its new “comprehensive chemical approach” and its policy to assume that workers do not use the personal protective equipment (PPE). It also reflects a substantial expansion of the regulatory prohibitions applicable to a chemical that was already subject to TSCA, albeit more limited, risk management restrictions under EPA’s prior framework for risk management actions.

EPA proposes to ban the manufacture, processing, and distribution in commerce of methylene chloride to the consumer; ban most industrial and commercial uses of methylene chloride; require a workplace chemical protection program (WCPP) for certain identified conditions of use that are allowed to continue; and provide certain time-limited critical use exemptions under TSCA section 6(g) for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure. Interested parties have until July 3, 2023 to comment on the proposed rule.

Proposed bans on uses of methylene chloride

In proposing risk management actions for methylene chloride, EPA found that several consumer, commercial, and industrial uses of the substance require regulatory action, primarily a ban on use, as shown in Table 3 of the proposed rule. Many of these conditions of use include, but are not limited to, the industrial and commercial use of methylene chloride in cleaning solvents, paints and coatings (and removers), vapor degreasing, adhesives, sealants, caulking, textiles and fabrics, car care products. , lubricants and greases, pipe insulation, oil and gas drilling, toys, playgrounds and sports equipment, and plastic and rubber products. EPA also identified the need for a ban for all consumer uses of methylene chloride that were evaluated.

EPA states that the requirements of this proposal would prohibit uses that account for approximately one-third of the total annual production volume of methylene chloride generated (TSCA and non-TSCA uses), “leaving a sufficient supply in circulation to provide a source for to these. critical or essential uses for which EPA proposes to permit continued use,” either through a critical use exemption or a WCPP.

Chronology of risk management actions

Once EPA finds during risk assessment that a substance poses an unreasonable risk of injury to human health or the environment, it must propose risk management requirements to the extent necessary for the substance to no longer present this risk. In issuing risk management restrictions on a chemical, EPA must take into account considerations such as the economic consequences of the rule, including consideration of costs and benefits, cost-effectiveness, and the rule’s impact on economy, small businesses and technological innovation. . EPA must also consider whether there will be technically and economically viable alternatives as substitutes when the use of a substance is banned.

EPA has proposed the following bans on the use of methylene chloride and the timelines for the bans to take effect:

EPA is also proposing downstream reporting requirements for companies that ship methylene chloride to customers and recordkeeping requirements.

The use of methylene chloride in consumer paint and coating removal is not included in the listed prohibitions because this use is already addressed by an existing risk management rule promulgated by the EPA in 2019, codified at 40 CFR § 751.101.

Critical Use Exemptions (Time-Limited Exemptions)

Section 6(g) of TSCA allows EPA to exempt from the requirement of a risk management rule specific uses that EPA considers to be critical or essential uses for which there is no technically safer alternative and economically viable available or provide a substantial benefit compared to available alternatives. It also allows the waiver if EPA finds that compliance with the requirement would significantly disrupt the national economy, national security, or critical infrastructure. EPA is proposing critical use exemptions for the following conditions of use of methylene chloride:

Ten terms of use permitted to continue but subject to WCPP requirements

EPA’s proposed WCPP for permitted uses of methylene chloride includes comprehensive requirements for protecting workers from exposures, including respiratory protection, use of PPE, exposure control, training, and regulated areas. Of note, EPA is proposing an existing chemical exposure limit (ECEL) for airborne concentrations of methylene chloride greater than 2 parts per million (ppm) based on a time-weighted average (TWA) of 8 hours, which is significantly lower than the current OSHA. permissible exposure limit (PEL) for methylene chloride of 25 ppm. The proposed action level would be a value of half the ECEL which would trigger additional control action to ensure that workers are not exposed to concentrations above the ECEL. EPA also proposes a short-term exposure limit (EPA STEL) of 16 ppm determined over a 15-minute sampling period.

EPA proposes, instead of prohibitions, worker protection requirements for the following conditions of use:

1. Manufacturing (for downstream uses that would continue under WCPP)
2. Import (for further uses that would continue under WCPP)
3. Processing: As a reagent. Note that EPA is allowing this use to continue under WCPP because it believes that a large volume of methylene chloride is processed for this use condition, which goes almost entirely to the manufacture of the hydrofluorocarbon HFC-32. HFC-32 is one of the regulated substances subject to a phase-out under the American Innovation and Manufacturing Act (AIM Act) of 2020. EPA expects that by allowing continued and controlled use of methylene chloride in the manufacture of HFC-32, efforts to switch to chemicals with lower global warming potential would not be impeded by this rule.
4. Elaboration: incorporation into a formulation, mixture or reaction product
5. Processing: Repacking
6. Processing: Recycling
7. Industrial and commercial use as a laboratory chemical
8. Disposition
9. Industrial or commercial use for paint removal and coating of safety-critical and corrosion-sensitive components of aircraft and spacecraft owned or operated by the United States’ DOD, NASA, DHS, and FAA Units that the agency or the agency’s contractor perform at locations. controlled by the agency or the agency’s contractor
10. Industrial or commercial use as a bonding agent for acrylic and polycarbonate in mission-critical military and space vehicle applications, including in the production of special batteries for applications performed by DOD, NASA, or DHS or their contractors in sites controlled by the agency. or the agency’s contractor

Key Considerations of the Proposed Rule

Stakeholders who manufacture, process, distribute, or otherwise use methylene chloride for any of the use conditions evaluated by EPA will likely be interested in commenting on many aspects of this precedent-setting proposed rule. Stakeholders may consider providing input to EPA in the following areas:

• Risk Management Approach for Evaluated Use Conditions: Stakeholders may wish to evaluate whether the proposed risk management requirements for each use condition are consistent with EPA’s conclusions from their assessment of the risk of methylene chloride for each condition of use and EPA’s statutory authority under Sec. 6 of TSCA. For example, if EPA found that the unreasonable risk is driven by dermal exposure to methylene chloride from a particular condition of use, and if EPA requires more than dermal protection to mitigate the risks, interested parties may wish to assess whether these additional requirements are appropriate.
• Costs: EPA estimates the incremental and non-closure costs of this proposed rule to be $13.2 million per year over 20 years at a 3 percent discount rate and $14.5 million per year for 20 years with a discount rate of 7 percent. Stakeholders may wish to assess whether these projected costs adequately include all aspects of implementing the proposed rule, including reformulation costs (for prohibited uses) or compliance with the WCPP for conditions of use that are permitted to continue , including ECEL compliance of 2 ppm.
• WCPP Requirements: For the conditions of use that EPA proposes to prohibit, interested parties may assess whether they have data to support that compliance with a WCPP would sufficiently reduce exposures in lieu of a prohibition (in particular, for the conditions of use for which EPA is proposing a WCPP). as an alternative to the prohibition in the primary alternative option provided for in the proposed rule). Stakeholders may also wish to evaluate the feasibility of WCPP requirements and consider consistency with OSHA’s methylene chloride standard.
• Timeframes: Stakeholders may consider whether the proposed timelines for prohibitions are feasible and whether other uses are appropriate for consideration for a time-limited critical use exemption based on the statutory criteria for use exemptions critical
• Alternatives: Stakeholders may wish to comment on EPA’s evaluation of alternatives for methylene chloride and whether the proposed prohibited uses under the rule have safer transition alternatives.
• De minimis Level: EPA specifically requests comment on the number of entities that could potentially be put out of business, as well as the associated costs, with a ban on methylene chloride for certain industrial and commercial conditions of use identified in the proposed rule. EPA also wishes to comment on whether it should consider a de minimis level of methylene chloride in formulations for certain continued industrial and commercial uses to account for impurities (for example0.1% or 0.5%) at the end of the bans and, if so, what level should be taken into account de minimis
• Certification and training: EPA explains in the proposal that it also examined the extent to which a certification and limited access program restricting the use of methylene chloride to trained and licensed users could ensure that only certain workers employed by a facility could buy and use methylene chloride. Stakeholders may wish to comment on whether a certification and training program would effectively reduce worker exposure as a risk management approach for certain conditions of use, including conditions of use that EPA is proposing to prohibit.