Javaneh S. Tarter; Nancy B. Beck, PhD, DABT; Gregory R. Wall; Matthew Z. Leopold; Paul T. Nyffeler, PhD; Hunton Andrews, Kurth LLP07.31.23
On May 3, 2023, EPA released its proposed risk management rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to impose restrictions on the manufacture, import, processing, distribution, and use of methylene chloride, a widely-used solvent in a variety of consumer and commercial applications.
EPA is proposing to prohibit the manufacture, processing, and distribution in commerce of methylene chloride for consumer use; prohibit 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 Section 6(g) of TSCA for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure.
In particular, EPA proposes to prohibit all industrial, commercial and consumer uses of methylene chloride in paints and coatings and removers, other than limited critical uses as described in more detail below. The use of methylene chloride in paint and coating removal for consumer use is not included in the proposed rule’s prohibitions because this use is already prohibited by a risk management rule promulgated by EPA in 2019, codified at 40 C.F.R. § 751.101.
It will be important for the coatings industry to closely track this rulemaking as EPA considers public comments. EPA intends to finalize the rule in June of 2024.
• Prohibition of industrial and commercial use of methylene chloride in paints and coatings and paint and coating removers.
• Prohibition of the manufacture, processing, and distribution in commerce for the consumer use of methylene chloride in brush cleaners for paints and coatings.
• Compliance with a WCPP for industrial and commercial use of methylene chloride in paint and coating removers from safety critical, corrosion-sensitive components of aircraft and spacecraft owned or operated by DOD, NASA, DHS, FAA.
• A time-limited exemption from a prohibition for 10 years (and compliance with a WCPP during this time) and then a prohibition for use of methylene chloride in:
o Paint or coating removal from safety critical, corrosion sensitive components of aircraft owned or operated by air carriers or commercial operators.
o Paint and coating removal from safety critical, corrosion sensitive components of aircraft intended for, or suitable for operation by, air carriers and commercial operators.
o Paint and coating removal from safety critical, corrosion sensitive components of spacecraft used in, or intended for use in, commercial space transportation.
Prohibitions on the manufacture, import, processing and distribution in commerce of methylene chloride for the industrial and commercial uses listed above would go into effect within 90 days of finalization of the rule; within 180 days of finalization for processing; 270 days after finalization for distribution to retailers; 360 days after finalization for distribution to users other than retailers; and 450 days for industrial and commercial uses described above. EPA also proposes downstream notification requirements for companies who ship methylene chloride to customers and recordkeeping requirements.
EPA asserts that the requirements in 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 these critical or essential uses for which EPA is proposing to allow continued use” either through a critical use exemption or a WCPP.
EPA proposes, in lieu of prohibitions, worker protection requirements for the following conditions of use:
1. Manufacturing (for downstream uses that would continue under WCPP).
2. Import (for downstream uses that would continue under WCPP).
3. Processing: As a reactant.
4. Processing: Incorporation into a formulation, mixture, or reaction product.
5. Processing: Repackaging.
6. Processing: Recycling.
7. Industrial and commercial use as a laboratory chemical.
8. Disposal.
9. Industrial or commercial use for paint and coating removal from safety-critical, corrosion-sensitive components of aircraft and spacecraft that are owned or operated by the US DOD, NASA, DHS, and FAA that is performed by the agency or the agency’s contractor 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 specialty batteries for applications that are performed by the DOD, NASA or DHS or their contractors at locations controlled by the agency or the agency’s contractor.
Businesses should be aware that if they do not provide data to EPA demonstrating that they can meet EPA’s proposed ECEL for the particular condition of use proposed to be banned, EPA is taking the position that the ECEL is not achievable for that condition of use and, thus, a prohibition is the most appropriate risk management approach.
Businesses should also consider the feasibility of EPA’s proposed WCPP requirements and consider consistency with OSHA’s existing methylene chloride standard. Businesses should also consider if alternative chemistries exist for methylene chloride if EPA finalizes a prohibition of an essential condition of use for their operations. Finally, businesses should also consider whether their use should be considered a critical use under TSCA Section 6(g) and advocate for a time-limited exemption. The official comment period on the rule ended July 3, 2023, but businesses should not hesitate to contact EPA while the agency continues its work to finalize the proposal.
Javaneh S. Tarter is senior attorney; Nancy B. Beck, PhD, DABT is director of regulatory science; Gregory R. Wall is partner; Matthew Z. Leopold is partner; and Paul T. Nyffeler, PhD is senior attorney with the law firm Hunton Andrews Kurth LLP. They can be reached via the firm’s website: https://www.huntonak.com.
EPA is proposing to prohibit the manufacture, processing, and distribution in commerce of methylene chloride for consumer use; prohibit 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 Section 6(g) of TSCA for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure.
In particular, EPA proposes to prohibit all industrial, commercial and consumer uses of methylene chloride in paints and coatings and removers, other than limited critical uses as described in more detail below. The use of methylene chloride in paint and coating removal for consumer use is not included in the proposed rule’s prohibitions because this use is already prohibited by a risk management rule promulgated by EPA in 2019, codified at 40 C.F.R. § 751.101.
It will be important for the coatings industry to closely track this rulemaking as EPA considers public comments. EPA intends to finalize the rule in June of 2024.
Proposed ProhibitionsOn Methylene Chloride Uses
In proposing risk management actions for methylene chloride, EPA found that several consumer, commercial and industrial uses of the substance require regulatory action, which are summarized in Table 3 of the proposed rule. Pertinent for the coatings industry, these proposed restrictions include:• Prohibition of industrial and commercial use of methylene chloride in paints and coatings and paint and coating removers.
• Prohibition of the manufacture, processing, and distribution in commerce for the consumer use of methylene chloride in brush cleaners for paints and coatings.
• Compliance with a WCPP for industrial and commercial use of methylene chloride in paint and coating removers from safety critical, corrosion-sensitive components of aircraft and spacecraft owned or operated by DOD, NASA, DHS, FAA.
• A time-limited exemption from a prohibition for 10 years (and compliance with a WCPP during this time) and then a prohibition for use of methylene chloride in:
o Paint or coating removal from safety critical, corrosion sensitive components of aircraft owned or operated by air carriers or commercial operators.
o Paint and coating removal from safety critical, corrosion sensitive components of aircraft intended for, or suitable for operation by, air carriers and commercial operators.
o Paint and coating removal from safety critical, corrosion sensitive components of spacecraft used in, or intended for use in, commercial space transportation.
Prohibitions on the manufacture, import, processing and distribution in commerce of methylene chloride for the industrial and commercial uses listed above would go into effect within 90 days of finalization of the rule; within 180 days of finalization for processing; 270 days after finalization for distribution to retailers; 360 days after finalization for distribution to users other than retailers; and 450 days for industrial and commercial uses described above. EPA also proposes downstream notification requirements for companies who ship methylene chloride to customers and recordkeeping requirements.
EPA asserts that the requirements in 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 these critical or essential uses for which EPA is proposing to allow continued use” either through a critical use exemption or a WCPP.
Ten Conditions of Use Allowed To Continue but Subject to Worker Protection Requirements
EPA’s proposed WCPP for allowed uses of methylene chloride includes comprehensive requirements for the protection of workers from exposures, including respiratory protection, use of PPE, exposure monitoring, training, and regulated areas. Of note, EPA proposes an Existing Chemical Exposure Limit (ECEL) for airborne concentrations of methylene chloride at 2 parts per million (ppm) based on an eight-hour time weighted average (TWA), which is significantly lower than the current OSHA permissible exposure limit (PEL) for methylene chloride of 25 ppm. The proposed action level, 1 ppm, would trigger additional monitoring to ensure workers are not exposed to concentrations above the ECEL. EPA also proposes a short-term exposure limit (EPA STEL) of 16 ppm as determined over a sampling period of 15 minutes.EPA proposes, in lieu of prohibitions, worker protection requirements for the following conditions of use:
1. Manufacturing (for downstream uses that would continue under WCPP).
2. Import (for downstream uses that would continue under WCPP).
3. Processing: As a reactant.
4. Processing: Incorporation into a formulation, mixture, or reaction product.
5. Processing: Repackaging.
6. Processing: Recycling.
7. Industrial and commercial use as a laboratory chemical.
8. Disposal.
9. Industrial or commercial use for paint and coating removal from safety-critical, corrosion-sensitive components of aircraft and spacecraft that are owned or operated by the US DOD, NASA, DHS, and FAA that is performed by the agency or the agency’s contractor 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 specialty batteries for applications that are performed by the DOD, NASA or DHS or their contractors at locations controlled by the agency or the agency’s contractor.
Key Considerations of EPA’s Proposed Rule for Methylene Chloride
The coatings industry will likely be interested in engaging with EPA on many aspects of this precedent-setting proposed risk management rule.Businesses should be aware that if they do not provide data to EPA demonstrating that they can meet EPA’s proposed ECEL for the particular condition of use proposed to be banned, EPA is taking the position that the ECEL is not achievable for that condition of use and, thus, a prohibition is the most appropriate risk management approach.
Businesses should also consider the feasibility of EPA’s proposed WCPP requirements and consider consistency with OSHA’s existing methylene chloride standard. Businesses should also consider if alternative chemistries exist for methylene chloride if EPA finalizes a prohibition of an essential condition of use for their operations. Finally, businesses should also consider whether their use should be considered a critical use under TSCA Section 6(g) and advocate for a time-limited exemption. The official comment period on the rule ended July 3, 2023, but businesses should not hesitate to contact EPA while the agency continues its work to finalize the proposal.
Javaneh S. Tarter is senior attorney; Nancy B. Beck, PhD, DABT is director of regulatory science; Gregory R. Wall is partner; Matthew Z. Leopold is partner; and Paul T. Nyffeler, PhD is senior attorney with the law firm Hunton Andrews Kurth LLP. They can be reached via the firm’s website: https://www.huntonak.com.