The U.S. Environmental Protection Agency (EPA) issued on May 8, 2024, a final rule to address unreasonable risks of injury to health EPA identified caused by methylene chloride under its conditions of use (COU). 89 Fed. Reg. 39254. According to EPA, the final rule will prevent serious illness and death associated with uncontrolled exposures to methylene chloride by preventing consumer access methylene chloride and by restricting the industrial and commercial use of methylene chloride while also allowing for a reasonable transition period where an industrial and commercial use of methylene chloride is being prohibited, will provide a time-limited exemption for a critical or essential use of methylene chloride for which no technically and economically feasible safer alternative is available, and will protect workers from the unreasonable risk of methylene chloride while on the job. The final rule will be effective July 8, 2024.

As with the asbestos risk management rule, EPA states that it intends that each provision of this rulemaking be severable. In the event of litigation staying, remanding, or invalidating EPA’s risk management approach for one or more COUs in the rule, EPA intends to preserve the risk management approaches in the rule for all other COUs to the fullest extent possible.

EPA acknowledges that after issuance of the rule, federal agencies, their contractors, and other related entities may become aware of important information that indicates a particular use, that would otherwise be prohibited, could meet the criteria of Toxic Substances Control Act (TSCA) Section 6(g) or the requirements of a workplace chemical protection program (WCPP). EPA also notes that there are multiple avenues to ask EPA to revisit issues in this TSCA Section 6(a) rule, both before and after the mandatory compliance dates are set consistent with TSCA Section 6(d). EPA states that it has the authority under TSCA Section 6(g) to consider whether a time-limited exemption is appropriate and, consistent with TSCA Section 6(g)(1), “could expeditiously promulgate such exemptions independently from this rulemaking, including consideration of emergency or interim rulemaking.” EPA will initiate a notice of proposed rulemaking (NPRM) for public comment on this topic and will add it to the spring 2024 Regulatory Agenda. Additionally, any person could petition EPA to request that EPA issue or amend a rule under TSCA Section 6.

Applicability

The final rule prohibits and restricts the manufacture (including import), processing, distribution in commerce, commercial use, and disposal of methylene chloride to prevent unreasonable risk of injury to health in accordance with TSCA Section 6(a). Pursuant to TSCA Section 12(a)(2), the rule applies to methylene chloride even if being manufactured, processed, or distributed in commerce solely for export from the United States because EPA has determined that methylene chloride presents an unreasonable risk to health within the United States. EPA notes that because distribution in commerce did not contribute to its unreasonable risk determination for methylene chloride, and because the final rule permits manufacturing and processing for various uses under the WCPP, “EPA intends this final rule to permit manufacturing and processing in compliance with the WCPP for export, as well as distribution in commerce for export, without regard for the intended use in the destination country.”

Importantly and surprisingly, EPA’s final rule adopts a de minimis threshold of 0.1 percent to account for impurities and the unintended presence of methylene chloride. EPA notes that the final rule applies only when methylene chloride is present in a formulation at 0.1 percent or greater. The final rule predictably applies only to chemical substances as defined under TSCA Section 3 and excludes uses subject to Section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 321]) “when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device” and “any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA] [7 U.S.C. 136 et seq.]) when manufactured, processed, or distributed in commerce for use as a pesticide.”

WCPP

Applicability

EPA is implementing the WCPP for the following COUs: domestic manufacturing; import; processing as a reactant; processing for incorporation into a formulation, mixture, or reaction product; processing in repackaging; processing in recycling; industrial and commercial use as a laboratory chemical; industrial and commercial use as a paint and coating remover from safety-critical, corrosion-sensitive components of aircraft and spacecraft; industrial or commercial use as a bonding agent for solvent welding; industrial and commercial use as a processing aid; industrial and commercial use for plastic and rubber products manufacturing; industrial and commercial use as a solvent that becomes part of a formulation or mixture, where that formulation or mixture will be used inside a manufacturing process and the solvent (methylene chloride) will be reclaimed; and disposal.

Overview

EPA states that a WCPP encompasses inhalation exposure thresholds, includes monitoring and recordkeeping requirements to verify that those thresholds are not exceeded, and may include other components, such as dermal protection, to ensure that the chemical substance no longer presents unreasonable risk. According to EPA, “[u]nder a WCPP, owners or operators have some flexibility, within the parameters outlined in this unit, regarding how they prevent exceedances of the identified EPA exposure limit thresholds.” In the case of methylene chloride, meeting the EPA exposure limit thresholds for certain occupational COUs would address the unreasonable risk to potentially exposed persons from inhalation exposure.

These requirements will begin taking effect on May 5, 2025, for the private sector and on November 9, 2026, for federal agencies and federal contractors acting for or on behalf of the federal government, at which point entities would be required to conduct initial monitoring. Additionally, EPA requires that each owner or operator ensure that the airborne concentration of methylene chloride does not exceed the existing chemical exposure limit (ECEL) or EPA short-term exposure limit (STEL) for all potentially exposed persons no later than August 1, 2025, for the private sector, or no later than February 8, 2027, for federal agencies and federal contractors acting for or on behalf of the federal government. Implementation of any needed exposure controls based on initial monitoring and development of an exposure control plan would be required no later than October 30, 2025, for the private sector, or May 10, 2027, for federal agencies and federal contractors acting for or on behalf of the federal government.

ECEL, EPA Action Level, STEL

EPA is codifying as proposed that owners or operators must ensure the airborne concentration of methylene chloride within the personal breathing zone of potentially exposed persons remains at or below 2 parts per million (ppm) as an eight-hour time-weighted average (TWA) ECEL, with an action level of 1 ppm as an eight-hour TWA. EPA notes that the U.S. Occupational Safety and Health Administration (OSHA) “defines the personal breathing zone as a hemispheric area forward of the shoulders within a six-to-nine-inch radius of a worker’s nose and mouth and requires that exposure monitoring air samples be collected from within this space.” EPA is promulgating as proposed that owners or operators must also ensure the airborne concentration of methylene chloride within the personal breathing zone of potentially exposed persons remains at or below a 15-minute TWA, or EPA STEL, of 16 ppm. EPA is adopting the ECEL and EPA STEL for certain occupational COUs to ensure that no person is exposed to inhalation of methylene chloride in excess of these concentrations resulting from those COUs. For the identified COUs for which the concentration thresholds are included in the final rule, EPA states that it “recognizes that the regulated community has the ability to detect the values for the ECEL, ECEL action level, and EPA STEL because of viable detection limits and analytical methods of methylene chloride for monitoring devices that are widely available in commerce, currently in use, and approved by OSHA and [the National Institute for Occupational Safety and Health (NIOSH)], which generally range from 0.2 to 0.4 ppm.” EPA also recognizes that analytical methods for monitoring are available from OSHA and NIOSH that are capable of detecting the exposure limits with a higher degree of accuracy.

Monitoring Requirements

The final rule requires as proposed that owners or operators determine each potentially exposed person’s exposure by taking a personal breathing zone air sample or by taking personal breathing zone air samples that are representative of each potentially exposed person’s exposure. According to the final rule, owners or operators will be permitted to consider personal breathing zone air samples to be representative of each potentially exposed person’s exposure when one or more samples are taken for at least one potentially exposed person in each job classification in a work area during every work shift, and the person sampled is expected to have the highest methylene chloride exposure; or when one or more samples are taken that indicate the highest likely 15-minute exposures during such operations for at least one potentially exposed person in each job classification in the work area during every work shift, and the person sampled is expected to have the highest methylene chloride exposure. According to the final rule, personal breathing zone air samples taken during one work shift may be used to represent potentially exposed person exposures on other work shifts where the owner or operator can document that the tasks performed and conditions in the workplace are similar across shifts. Additionally, air sampling is required to measure ambient concentrations for methylene chloride without taking respiratory protections into account as sampling is being performed. The final rule also requires that the owner or operator ensure, for initial and periodic monitoring, that their exposure monitoring methods are accurate to a confidence level of 95 percent and are within (plus or minus) 25 percent of airborne concentrations of methylene chloride above the eight-hour TWA ECEL or the 15-minute TWA EPA STEL, or within (plus or minus) 35 percent for airborne concentrations of methylene chloride at or above the ECEL action level but at or below the eight-hour TWA ECEL. To ensure compliance for monitoring activities, EPA is adopting recordkeeping requirements and will require that owners or operators document their choice of monitoring method.

Exposure Control Plan

The final rule requires that entities implementing the WCPP use elimination and substitution, followed by the use of engineering controls, administrative controls, and work practices prior to requiring the use of personal protective equipment (PPE) as a means of controlling inhalation exposures below EPA’s ECEL or STEL, in accordance with the hierarchy of controls. EPA states that it expects that, for COUs for which EPA is requiring a WCPP, “compliance at most workplaces would be part of an established industrial hygiene program that aligns with the hierarchy of controls.”

Under the final rule, the owner or operator must demarcate any area where airborne concentrations of methylene chloride are reasonably expected to exceed the ECEL or the EPA STEL. The demarcation may be done “in any manner that adequately establishes and alerts potentially exposed persons to the boundaries of the area and minimizes the number of authorized persons exposed to methylene chloride within the regulated area.”

PPE

Where elimination, substitution, engineering, and administrative controls are not feasible or sufficiently protective to reduce the air concentration to or below the ECEL, or if inhalation exposure above the ECEL is still reasonably likely, EPA is codifying its minimum respiratory PPE requirements based on an owner or operator’s measured air concentration for one or more potentially exposed persons and the level of PPE needed to reduce exposure to or below the ECEL. In those circumstances, EPA is requiring that the owner or operator also comply with OSHA’s General Requirements for PPE standard at 29 C.F.R. Section 1910.132 for application of a PPE program. EPA is also requiring that the owner or operator comply with 29 C.F.R. Section 1910.134 for proper use, maintenance, fit testing, and training of respirators.

Required Dermal Protection

The final rule requires the provision and use of chemically resistant gloves in combination with specific activity training for tasks where dermal exposure can be expected to occur. Additionally, EPA requires that owners and operators comply with relevant sections of the methylene chloride OSHA standard to minimize and protect potentially exposed persons from dermal exposure, including 29 C.F.R. Section 1910.1052(h) and (i).

Required Respiratory Protection

The final rule requires respiratory protection, based on the exposure monitoring concentrations measured as an eight-hour TWA that exceeds the ECEL (2 ppm) or 15-minute TWA that exceeds the EPA STEL (16 ppm). EPA notes that these requirements apply after all other feasible controls are exhausted or proven ineffective to control inhalation exposure. EPA is codifying its minimum respiratory protection requirements, such that any respirator affording the same or a higher degree of protection than the proposed requirements may be used. EPA states that under this final regulatory action, “air-purifying respirators (in contrast to air-supplied respirators) are not permitted as a means of mitigating methylene chloride exposure, as they do not provide adequate respiratory protection against this chemical.” EPA acknowledges that there may be respirator limitations dependent upon the nature of the activity in which methylene chloride is used (e.g., a decreased range of motion or access to a small space could hinder PPE use). Nevertheless, according to EPA, “owners and operators must provide respirators that are protective of the measured exposure concentration after all other feasible controls are considered.”

Additional Finalized Requirements

Workplace Participation

EPA states that it encourages owners and operators to consult with potentially exposed persons on the development and implementation of exposure control plans and PPE/respirator programs. The final rule requires that owners and operators provide potentially exposed persons regular access to the exposure control plans, exposure monitoring records, PPE program implementation, and respirator program implementation (such as fit testing and other requirements) described in 29 C.F.R. Section 1910.134(l). To ensure compliance with workplace participation, the final rule requires that the owner or operator document the notice to and ability of any potentially exposed person who may reasonably be affected by methylene chloride inhalation exposure to access readily the exposure control plans, facility exposure monitoring records, PPE program implementation, or any other information relevant to methylene chloride inhalation exposure in the workplace.

Notification of Monitoring Results

Under the final rule, when a potentially exposed person’s exposure to methylene chloride exceeds the ECEL action level within a regulated area, the owner or operator will be required to inform each potentially exposed person of the quantity, location, manner of use, release, and storage of methylene chloride and the specific operations in the workplace that could result in exposure to methylene chloride, particularly noting where exposures may be above the ECEL or EPA STEL. The final rule further requires that the owner or operator must, within 15 working days after receiving the results of any exposure monitoring, notify each potentially exposed person whose exposure is represented by that monitoring in writing, either individually to each potentially exposed person or by posting the information in an appropriate and accessible location, such as public spaces or common areas, for potentially exposed persons outside of the regulated area. The notice must identify the ECEL, ECEL action level, and EPA STEL and what they mean in plain language, the exposure monitoring results, and any corresponding respiratory protection required. If the ECEL or STEL is exceeded, the notice must also include a description of the actions taken by the owner or operator to reduce inhalation exposures to or below the ECEL or EPA STEL that states the actions to be taken to reduce exposures. The notice must be posted in multiple languages if necessary.

Recordkeeping

For each monitoring event of methylene chloride, the final rule requires that the owner or operator record, similar to OSHA under 29 C.F.R. Section 1910.1052(m), information including but not limited to, dates; operations involving exposure; sampling and analytical methods; the number of samples; durations and results of each sample taken; the type of respirator and PPE worn (if any); the potentially exposed persons’ names, work shifts, and job classifications; and exposure of all the potentially exposed persons represented by monitoring, indicating which potentially exposed persons were actually monitored. The final rule further requires documentation of the following whenever monitoring for the WCPP is required under TSCA Section 6(a):

• All measurements that may be necessary to determine the conditions that may affect the monitoring results;
• All other potentially exposed persons whose exposure was not measured but whose exposure is intended to be represented by the area or representative sampling monitoring;
• Use of established analytical methods such as those outlined in Appendix A of the ECEL memo with a limit of detection below the ECEL action level and accuracy of monitoring within 25 percent for the ECEL and 35 percent for the EPA STEL so that the owner or operator may identify when the implementation of additional exposure controls is necessary, determine the monitoring frequency according to the requirements described in this unit, and properly identify and provide persons exposed to methylene chloride with the required respiratory equipment and PPE;
• Compliance with the Good Laboratory Practice (GLP) Standards at 40 C.F.R. Part 792 or any accredited lab, including the American Industrial Hygiene Association (AIHA) or other analogous industry-recognized program; and
• Information regarding air monitoring equipment, including type, maintenance, calibrations, performance tests, limits of detection, and any malfunctions.

For owners and operators to demonstrate compliance with the WCPP provisions, the final rule requires that owners and operators retain compliance records for five years. EPA notes that this requirement does not supplant any longer recordkeeping retention time periods, such as those required under 29 C.F.R. Section 1910.1020, or other applicable regulations. EPA requires that owners and operators retain records of:

• Exposure control plan;
• Regulated areas and authorized personnel;
• Facility exposure monitoring records;
• Notifications of exposure monitoring results;
• PPE and respiratory protection used and program implementation; and
• Information and training required under 29 C.F.R. Section 1910.1052(l) and Appendix A, provided by the owner or operator to each potentially exposed person prior to or at the time of initial assignment to a job involving potential exposure to methylene chloride.

EPA “emphasizes that all records required to be maintained can be kept in the most administratively convenient form; electronic record form or paper form.” The final rule requires the owner or operator to document training or re-training of any potentially exposed person as necessary to ensure that, in the event of monitoring results that indicate exposure or possible exposures above the ECEL action level or the EPA STEL, the potentially exposed person has demonstrated understanding of how to use and handle methylene chloride safely and how to use required PPE appropriately. In addition, the owner or operator must update the training and requisite documentation when there is reasonable expectation that exposure may exceed the ECEL action level due to change in tasks or procedures.

Compliance Timeframes

EPA states that, based on consideration of public comments, it is codifying the timeframes considered in the primary alternative action for the private sector and is providing federal agencies and federal contractors acting for or on behalf of the federal government additional time to comply with each of the provisions of the WCPP.

Prohibition of Manufacture, Processing, Distribution, and Commercial Use of Methylene Chloride

The final rule prohibits manufacture, processing, distribution, and all industrial and commercial use of methylene chloride and methylene chloride-containing products, except for those uses that will continue under the WCPP. After consideration of public comments, EPA states that it is codifying timeframes longer than proposed for prohibition of manufacture, processing, distribution, and commercial use of methylene chloride broadly, as well as for particular uses such as commercial use of methylene chloride in adhesives and sealants in aircraft, space vehicles, and turbine applications; and commercial use of methylene chloride in paint and coating removal for the refinishing of wooden pieces of artistic, cultural, or historic value.

The final rule imposes prohibitions in a staggered timeframe, beginning at the top of the supply chain, as proposed. The final rule includes longer timeframes than proposed for prohibition of manufacturing, processing, distributing, or commercial use of methylene chloride, but adopts as proposed for distribution to and by retailers, to remove expeditiously exposures to consumers. The timeframes for prohibitions according to the following staggered timeframe are:

• Within 270 days of publication of the final rule in the Federal Register for prohibitions on distributing to retailers;
• Within 360 days of publication of the final rule in the Federal Register for prohibitions on distribution by retailers;
• Within 360 days of publication of the final rule in the Federal Register for prohibitions on manufacturing;
• Within 450 days of publication of the final rule in the Federal Register for prohibitions on processors;
• Within 630 days of publication of the final rule in the Federal Register for prohibitions on all distributors other than retailers; and
• Within 720 days of publication of the final rule in the Federal Register for prohibitions on most industrial and commercial use after the publication date of the final rule in the Federal Register.

EPA notes that additionally, for two COUs, it is implementing prohibitions that will take effect in five years. Those two COUs are commercial use of methylene chloride in adhesives and sealants in aircraft, space vehicle, and turbine applications for structural and safety-critical non-structural applications, and for commercial use of methylene chloride in refinishing wood pieces of artistic, cultural, or historic value (which also includes interim requirements for minimum exposure controls).

Prohibition of Manufacture, Processing, and Distribution in Commerce for Consumer Use of Methylene Chloride

The final rule prohibits the manufacture, processing, and distribution in commerce of methylene chloride and methylene chloride-containing products for all consumer use. The final rule prohibits retailers from distributing in commerce methylene chloride and all methylene chloride-containing products to prevent products intended for industrial and commercial use under the WCPP from being purchased by consumers. The final rule prohibits distribution in commerce of methylene chloride within 270 days for distributing to retailers, and 360 days for retailers distributing in commerce after the publication date of the final rule in the Federal Register.

Other Requirements

Recordkeeping

For COUs that are not otherwise prohibited under the final rule, manufacturers, processors, and distributors must maintain ordinary business records, such as invoices and bills of lading, that demonstrate compliance with restrictions and other provisions of the final rule, and they must maintain such records for a period of five years from the date the record is generated. EPA notes that this requirement expands the recordkeeping requirements promulgated in 2019 at 40 C.F.R. Section 751.109 affecting manufacturers, processors, and distributors of methylene chloride.

Downstream Notification

For COUs that are not otherwise prohibited under the final rule, manufacturers (including importers), processors, and distributors, excluding retailers, of methylene chloride and methylene chloride-containing products must provide downstream notification of certain prohibitions through Safety Data Sheets (SDS) by adding to Sections 1(c) and 15 of the SDS the following language:

After February 3, 2025, this chemical substance (as defined in TSCA section 3(2))/product cannot be distributed in commerce to retailers. After January 28, 2026, this chemical substance (as defined in TSCA section 3(2))/product is and can only be distributed in commerce or processed with a concentration of methylene chloride equal to or greater than 0.1% by weight for the following purposes: (1) Processing as a reactant; (2) Processing for incorporation into a formulation, mixture, or reaction product; (3) Processing for repackaging; (4) Processing for recycling; (5) Industrial or commercial use as a laboratory chemical; (6) Industrial or commercial use as a bonding agent for solvent welding; (7) Industrial and commercial use as a paint and coating remover from safety critical, corrosion-sensitive components of aircraft and spacecraft; (8) Industrial and commercial use as a processing aid; (9) Industrial and commercial use for plastic and rubber products manufacturing; (10) Industrial and commercial use as a solvent that becomes part of a formulation or mixture, where that formulation or mixture will be used inside a manufacturing process, and the solvent (methylene chloride) will be reclaimed; (11) Industrial and commercial use in the refinishing for wooden furniture, decorative pieces, and architectural fixtures of artistic, cultural or historic value until May 8, 2029; (12) Industrial and commercial use in adhesives and sealants in aircraft, space vehicle, and turbine applications for structural and safety critical non-structural applications until May 8, 2029; (13) Disposal; and (14) Export.

EPA states that to provide adequate time to update the SDS and ensure that all products in the supply chain include the revised SDS, the final rule requires manufacturers to revise their SDSs within 150 days of publication and processors and distributors to revise their SDSs within 210 days of publication of the final rule.

TSCA Section 6(g) Exemptions

The final rule includes a ten-year exemption for emergency use of methylene chloride in furtherance of the National Aeronautics and Space Administration’s (NASA) mission for the following specific conditions of use: Industrial and commercial use as a solvent for cold cleaning; Industrial and commercial use as a solvent for aerosol spray degreaser/cleaner; Industrial and commercial use in adhesives, sealants, and caulks; Industrial and commercial use in adhesive and caulk removers; Industrial and commercial use in metal non-aerosol degreasers; Industrial and commercial use in non-aerosol degreasers and cleaners; and Industrial and commercial use as a solvent that becomes part of a formulation or mixture. The exemption includes additional requirements, pursuant to TSCA Section 6(g)(4), including required notification and controls for exposure, to the extent feasible: (1) NASA and its contractors must provide notice to the EPA Assistant Administrators of both the Office of Enforcement and Compliance Assurance (OECA) and the Office of Chemical Safety and Pollution Prevention (OCSPP) of each instance of emergency use within 15 working days and; (2) NASA and its contractors would have to comply with the WCPP to the extent feasible.

Commentary

Bergeson & Campbell, P.C. (B&C^®) considers EPA’s final risk management rule on methylene chloride as a more defensible outcome than we expected from the proposed risk management rule. It provides for robust consumer and workplace protection based on a strong scientific record. For discussion, see our memorandum dated April 25, 2023. The public comment period may have prompted various methylene chloride users to submit previously unsubmitted workplace monitoring data to EPA that led to substantive changes in the final rule. We were also pleased to see that EPA provided a de minimis threshold for methylene chloride in formulations. Below we have elaborated on each of these points.

B&C anticipated EPA’s decision to issue in final its proposal to prohibit the manufacture, processing, and distribution of methylene chloride for all consumer uses, in addition to consumer paint and coating removers, which EPA banned on May 28, 2019. EPA’s inclusion of all other consumer uses was expected and warranted, given the significant acute and chronic hazard concerns and limited options for controlling exposures.

B&C was pleased by EPA’s acceptance of submitted monitoring data and its decision not to prohibit specific conditions of use as EPA had initially proposed. These data demonstrated to EPA’s satisfaction that its initial concerns about compliance with its WCPP, including the ECEL of 2 ppm as an eight-hour TWA, were not warranted. For example, EPA proposed to prohibit industrial and commercial use of methylene chloride in plastic and rubber products manufacturing, including polycarbonate manufacturing. In the final rule, EPA permits this use because of the demonstrated ability of persons working with this COU to comply with the WCPP.

We question EPA’s insistence that it must know, in advance, that uses in workplaces demonstrate compliance with the proposed ECEL and therefore to prohibit most industrial and commercial uses of methylene chloride even if those workplaces could demonstrate compliance with the WCPP as required by the rule. EPA appears, however, to be interpreting the “extent necessary” provision of TSCA Section 6(a) based on an ability of persons to demonstrate compliance with its risk management measures prior to EPA issuing its final rule as opposed to prior to using methylene chloride in the workplace. EPA’s basis for this position is unclear. EPA has concluded that compliance with the WCPP is protective, thereby meeting the “extent necessary” threshold. This calls into question why EPA cannot impose the WCPP industry-wide without the additional burden of having to parse risk for individual uses. This approach would amount to a ban on any workplaces that are unable to demonstrate compliance with the protective WCPP, regardless of the use. EPA could impose this requirement through lowering OSHA’s permissible exposure limit from 25 ppm (i.e., 86.8 mg/m³) to 2 ppm. Doing so would build upon existing and familiar workplace protection compliance schemes and extend the protective level to uses not subject to TSCA (e.g., pharmaceutical manufacturing).

Critically, the final rule includes a de minimis threshold of 0.1 wt%. A de minimis threshold for the applicability of any rule is critical because one cannot prove the absence of a chemical — one can only show no presence above a level of detection. The threshold value was informed by OSHA’s hazard communication standard and EPA’s Toxics Release Inventory program; both groups apply this threshold for carcinogenic substances. EPA evaluated risks at this concentration for workers, occupational non-users (ONU), and consumers under specific conditions of use and found no unreasonable risk. EPA evaluated risks to workers and ONUs for the modeled aerosol degreasing scenario using the brake servicing model. EPA’s risk estimates demonstrated that no unreasonable risks were present for worker or ONU inhalation exposures, or worker dermal exposures at 0.1 wt%. Non-cancer risk estimates were at least one order of magnitude from EPA’s benchmark margin of exposure (MOE); cancer risk estimates were several orders of magnitude from EPA’s benchmark cancer risk level.

As worst-case scenarios, EPA evaluated acute inhalation and dermal risks to consumers using the coil cleaner scenario and the adhesives remover scenario, respectively, and provided the weight fraction tipping points (the concentrations at or above which EPA would identify unreasonable risk) for unreasonable risks from inhalation exposures and dermal exposures. Each of the tipping point concentrations was greater than 0.1 wt%. EPA could improve transparency by including both MOE and tipping-point analyses for both worker and consumer scenarios. Doing so provides more confidence for the public that EPA’s threshold is sufficiently protective. We are hopeful that EPA will include these types of analyses as part of its future draft risk evaluations.

A critical, disappointing aspect of the final rule and, more importantly, EPA’s public statements about it, is that EPA undermined its own pledge to communicate risk better in its Section 6 actions. In the final “Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)” rule, EPA stated “EPA is aware of concerns that a single risk determination on the chemical substance — especially where only certain uses are contributing to that determination — could lead to public confusion regarding the chemical’s risks. EPA believes these risk communication issues are addressable, and it is a priority area the Agency is committed to improve upon” and “EPA is committed to being clearer in its communications on this point,” Yet, in its technical analysis for risks from methylene chloride, EPA finds that with proper protective measures, methylene chloride is not an unreasonable risk. Nevertheless, that conclusion does not appear in EPA’s press release and therefore is absent from subsequent media reporting. In the press release, EPA does not state that it found COUs that were not an unreasonable risk. The closest EPA comes to this conclusion is that EPA is requiring workplaces to comply with a protective WCPP. By omitting the fact that EPA has data demonstrating that many workplace exposures are not an unreasonable risk, EPA’s communications wrongly imply that absent the requirement in the rule, workers are at risk. We believe EPA’s communications could be clearer in this regard.