EPA Issues Draft Risk Evaluation for Flame Retardant TCEP

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EPA has preliminarily determined that tris(2-chloroethyl) phosphate (TCEP) presents an unreasonable risk to human health and the environment, according to its draft risk assessment of the flame retardant released on December 14, 2023.  Animal testing data revealed that exposure to TCEP may increase risk of kidney cancer and other cancers, and could harm neurological and reproductive systems, the draft states.

According to EPA, domestic production of TCEP has decreased by about 99 percent since 2014.  However, the agency notes that TCEP is still used in paints, coatings, and in certain aerospace applications, and that previously-manufactured products containing TCEP—such as fabrics, certain types of foam, and construction materials—may still be in use.  The draft also states that “TCEP may still be found in a wide range” of imported goods.

Because TCEP is mixed into materials rather than being chemically bonded, it can leach out of products, EPA said.  Infant and child exposure from mouthing consumer products containing TCEP was determined to present an unreasonable risk.  The agency also found unreasonable risk of health effects for breastfed infants, people who handle TCEP at work, people who inhale TCEP dust off consumer products, and people who eat TCEP-contaminated fish.

EPA determined that TCEP presents an unreasonable risk to the environment due to studies on chronic exposures in fish and sediment-dwelling organisms.  The draft identified a number of ways by which TCEP can enter the environment, including manufacturing processes, air emissions, and leaching from products and landfills.  Although TCEP is not considered bioaccumulative, it is persistent in the environment, EPA said.

The draft risk evaluation is open for public comment and will undergo peer review by independent scientific and technical experts starting in March 2024.  If EPA still concludes that TCEP presents an unreasonable risk after public comment and peer review, the Toxic Substances Control Act requires the agency to take steps to mitigate its risks.

EPA Proposes TCE Ban

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EPA has released a proposed rule, which, if implemented, would ban the use of trichloroethylene (“TCE”). The substance has numerous industrial, commercial, and consumer applications, including uses in vapor and aerosol degreasing and as lubricants, greases, adhesives, and sealants. Earlier this year, in its final revision to the TCE risk evaluation conducted under section 6(b) of the Toxic Substances Control Act (“TSCA”), EPA concluded that TCE presents an unreasonable risk of injury to human health due to both its carcinogenic and non-carcinogenic health effects including liver and kidney toxicity, and neurotoxicity. The risk evaluation found these effects resulted from both acute and chronic exposures and through all types of exposures, including inhalation and dermal exposure. TSCA section 6(a) requires EPA to impose restrictions on the manufacture, including import, processing, and distribution of substances that present an unreasonable risk of injury to human health or the environment.

The ban would apply to all manufacturing, import, processing, and distribution in commerce of TCE for all industrial and commercial uses. The rule would go into effect one year following the effective date of the final rule for consumer products and most commercial uses. Some commercial and industrial uses would have longer phaseout timelines and set exemption periods. (The difference between phaseouts and exemptions is that phaseouts are active timelines for the elimination of use, whereas the exemptions do not require current action to eliminate the use of TCE by a certain date; presumably, a determination will be made prior to the exemption period ending that will clarify if the exemption is to be extended or if a phaseout period will be established.)

TSCA section 6(g) allows EPA to grant an exemption from a requirement of a rule banning or restricting a chemical substance for a specific condition of use of a chemical substance if the Administrator finds that the specific condition of use is critical or essential and has no technically and economically feasible safer alternative. The phaseout and exemptions in the proposed rule are narrow in scope. They include the following:

  • An 8.5-year phaseout for the manufacture and processing of TCE as an intermediate in the manufacturing of hydrofluorocarbon134a (HFC-134a). HFC-134a is essential to the operation of refrigeration and air conditioning systems.
  • A 10-year phaseout for the manufacture and use of TCE as a solvent for closed-loop batch vapor degreasing for rayon fabric scouring for end use in the production of rocket booster nozzles. This exemption is limited to production by federal agencies and their contractors.
  • A 10-year TSCA Section 6(g) exemption for the manufacture and processing of TCE as a processing aid for battery separator manufacturing, battery separators are used to prevent short-circuiting in lithium-ion batteries.
  • A 50-year TSCA Section 6(g) exemption for the manufacture, processing, distribution in commerce, and use of TCE as a laboratory chemical for essential laboratory activities such as those associated with ongoing environmental cleanup projects under the CERCLA program and other EPA authorities, and some research and development activities being conducted by U.S. Federal Agencies including NASA.

The rule would also require strict workplace controls for those working with TCE for the uses allowed by the proposed rule.  These workplace controls would be detailed in EPA’s proposed  Workplace Chemical Protection Program (“WCPP”). To further reduce worker risks, the proposed rule would prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works.

Under this rule, manufacturers, importers, processors, and distributors (excluding retailers) of TCE and TCE-containing products must provide downstream notification of the TCE prohibition. EPA is asking for comments on timeframes for downstream notification and recordkeeping requirements. EPA is proposing a two-month period for manufacturers and a six-month period for processors and distributors to make the required SDS changes. This notification will be provided through Safety Data Sheets (“SDS”). The suggested SDS language is stated within the proposed rule.

Violations of the rule will be subject to TSCA section 16, which permits civil and criminal penalties, including a civil penalty of up to $46,989 per day for each violation of TSCA or TSCA rules. Comments on the proposed rule are due December 15, 2023.

EPA Proposes Changes to TSCA Risk Evaluation Procedures

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On October 30, 2023, EPA published a proposed rule altering the procedures for chemical risk evaluations under section 6 of the Toxic Substances Control Act (TSCA). The proposed rule revises the existing 2017 framework, which was adopted one year after Congress passed amendments to TSCA requiring EPA to evaluate whether existing chemicals that have been identified as “high priority” present an unreasonable risk of injury to health or the environment.

The rulemaking includes the following proposed changes:

  • The clarification that EPA will include all conditions of use (i.e., circumstances under which the chemical is “intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of”) in the scope of a risk evaluation.
  • The inclusion of all exposure pathways in the scope of a risk evaluation. EPA previously excluded exposure pathways covered under other EPA statutes in its risk evaluations for the first ten chemicals.
  • The removal of the definitions for “best available science” and “weight of the scientific evidence.” Though TSCA requires EPA to use the best available science and make decisions based on the weight of the scientific evidence at 15 U.S.C. 2625, EPA argues that the codification of these definitions inhibits the Agency’s ability to adapt to changing science.
  • The requirement that EPA make a single determination on whether the chemical presents an unreasonable risk. EPA initially made separate risk determinations for each condition of use in its risk evaluations for the first ten chemicals but later issued revised “whole substance” determinations.
  • The cessation of the consideration of “assumed” personal protective equipment (PPE) use when calculating exposure reduction due to PPE.
  • The addition of “overburdened communities” to the list of examples of potentially exposed or susceptible subpopulations.
  • A number of alterations to the process and requirements for manufacturer-requested risk evaluations.

The above changes would apply to all risk evaluations initiated on or after the date of the final rule.  For risk evaluations in progress on the date of the final rule, EPA expects to apply the changes “only to the extent practicable.”

The proposed clarification that EPA includes all conditions of use in the scope of a risk evaluation stems from the Ninth Circuit’s 2019 decision in Safer Chemicals, Healthy Families v. EPA. In the case, petitioners successfully challenged EPA’s exclusion of “legacy uses and associated disposals”—such as the use and future disposal of asbestos in previously installed insulation—from the scope of risk evaluations. Several of the other proposed changes would codify existing EPA practices introduced in 2021, including the requirement that risk evaluations end with a single determination rather than use-by-use determinations.

EPA requests public comments on all aspects of the proposed rulemaking. Comments are due on December 14, 2023.

EPA Releases Draft Supplement for 1,4-Dioxane

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In July 2023, EPA announced the release of a draft supplement to the Risk Evaluation for 1,4-dioxane for public comment and peer review.  1,4-dioxane is solvent used to manufacture other chemicals such as adhesives and sealants.  It is also used as a processing aid and laboratory chemical. In addition, some manufacturing processes, such as the process used for making commercial and consumer dish soaps, result in the chemical being present as a byproduct.

The draft supplement focuses on air and water exposure pathways that were not included in the 2020 Risk Evaluation.  The 2020 Risk Evaluation focused on health risks to workers, consumers, and the general public, but not from drinking water, the air, or exposure where 1,4-dioxane is present as a byproduct.  The omission was identified by the Scientific Advisory Committee on Chemicals (SACC) as an oversight.  The SACC informed EPA that failure to assess the risks posed to the general population from exposure to the chemical may present a risk to human health – with an emphasis on drinking water as an exposure pathway.

The draft supplement identified cancer risk estimates higher than 1 in 10,000 for 1,4-dioxane present as a byproduct and higher than 1 in 1 million for general population exposure scenarios associated with 1,4-dioxane in drinking water sourced downstream of release sites and in air within 1 km of releasing facilities.

The draft supplement did note that the risk estimates include inherent uncertainties and the overall confidence in specific risk estimates fluctuates.  However, the document also stated that the information is beneficial in helping the Agency make a determination on whether the chemical poses an unreasonable risk to people with occupational exposure, through sources of drinking water, and breathing air near release sites.

EPA Sued Over Delayed Risk Evaluations

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Environmental groups have filed a lawsuit against EPA for failing to complete risk evaluations for 22 substances that may cause harm to humans and the environment.

Under section 6 of the Toxic Substances Control Act, EPA is required to conduct risk evaluations on “high priority” existing substances to determine whether they pose an unreasonable risk to human health or the environment.  Section 6(b)(4)(G) requires EPA to complete risk evaluations “as soon as practicable, but not later than 3 years after” they are initiated, with a one-time six-month extension possible.

According to the complaint, EPA missed this statutory 3.5-year deadline for 22 ongoing risk evaluations which were initiated in 2019 and early 2020.  Plaintiffs allege that this delay harms their members, staff, and children by prolonging their exposure to substances with serious health risks and by depriving them of information about their exposures.

The complaint seeks declaratory and injunctive relief, requesting that the U.S. District Court for the District of Columbia set deadlines for EPA to complete the risk evaluations.

The case is Community In-Power and Development Association v. EPA, No. 1:23‑cv‑02715-DLF.

EPA Proposes Ban on Perchloroethylene

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Using its authority under the Toxic Substances Control Act (TSCA), EPA has released a proposed rule to ban the use of perchloroethylene (“PCE”) for most commercial and industrial uses. (PCE is also referred to as perc and tetrachloroethylene.) PCE is used in a number of applications and industries, including petroleum manufacturing, aerosol degreasing, and dry cleaning.

The proposed rule follows the Agency’s assessment of the risk to human health presented by the substance. EPA conducted a risk evaluation of the substance under TSCA section 6(b). That assessment determined that PCE, as a whole chemical substance, presents an unreasonable risk of injury to human health as PCE exposure causes a variety of adverse health effects. PCE is a known carcinogen; it also causes neurotoxicity, including impaired visual and cognitive function. Various other health effects were noted by the risk evaluation, including central nervous system depression, kidney and liver effects, immune system toxicity, and developmental toxicity.

Under TSCA section 6(a), EPA is required to address, by rule, any unreasonable risk of injury to health or the environment found during a TSCA risk evaluation. Section 6(a) also requires the Agency to identify actions necessary to ensure the chemical does not continue presenting an unreasonable risk by either a) implementing “a requirement [either] prohibiting or otherwise restricting the manufacturing, processing, or distribution in commerce of such substance or mixture,” or b) “limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce.” To meet these requirements, EPA is proposing to prohibit the manufacture, import, processing, and distribution of PCE for a number of commercial and consumer uses, such as in dry cleaning, spot-cleaning operations and degreasing. The prohibition allows a 10-year phaseout period.

The Agency will still permit limited use of PCE for some uses, particularly those which help its efforts in addressing climate-damaging hydrofluorocarbons (an initiative happening under the American Innovation and Manufacturing Act of 2020). PCE will also be used in uses that are important for national security applications or to meet other critical national needs. In these cases, EPA would require the implementation of a PCE workplace chemical protection program. The chemical protection program would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. The Agency has also put forward prescriptive requirements for laboratory use, recordkeeping, and downstream notification.

EPA will permit certain time-limited exemptions from the ban for certain critical or essential emergency uses of PCE when no alternative is technically or economically feasible safer alternative is available.

EPA Proposes Methylene Chloride Ban

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On April 20, 2023, EPA released a proposed rule under Section 6(a) of the Toxic Substances Control Act (“TSCA”) that would drastically limit the use of methylene chloride. Section 6(a) of the statute provides EPA authority to ban or restrict the manufacture, processing, distribution, and use of chemical substances that pose an unreasonable risk of injury to human health or the environment. EPA explains that its decision is driven by concerns about the risks posed to workers, occupational non-users, consumers, and individuals in close proximity to consumer usage. The Agency stated that it is particularly concerned about adverse health effects such as neurotoxicity, liver damage, and cancer resulting from inhalation and dermal exposure to methylene chloride.

EPA’s proposed rule seeks to “rapidly phase down” the manufacturing, processing, and distribution of methylene chloride for consumer use, as well as most industrial and commercial uses. The phase down is expected to be completed within 15 months of the effective date of the final rule. EPA’s analysis indicates that alternative products with similar cost and effectiveness to methylene chloride are generally available for most of the that the Agency intends to prohibit.

According to EPA, methylene chloride poses an unreasonable health risk, without considering costs or other non-risk factors, including an unreasonable risk to potentially exposed or vulnerable subpopulations identified as relevant in the 2020 methylene chloride risk evaluation, under specific conditions of use (“COU”). (EPA defines COU as the circumstances in which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.) To address the unreasonable risk, EPA proposes the following restrictions:

  • Prohibit the manufacture, processing, and distribution of methylene chloride for all consumer use.
  • Prohibit most industrial and commercial uses of methylene chloride.
  • Enforce a workplace chemical protection program (“WCPP”) that includes inhalation exposure concentration limits, workplace exposure monitoring, and exposure controls for ten specific conditions of use of methylene chloride.
  • Require recordkeeping and downstream notification requirements for the manufacturing, processing, and distribution of methylene chloride in commerce.

The rule does provide an exemption to the prohibition on industrial uses for ten years for civilian aviation uses to prevent significant disruptions to critical infrastructure. This exemption will be subject to conditions such as compliance with the WCPP.  An exemption is also provided for emergency use of methylene chloride in support of the National Aeronautics and Space Administration’s mission. The exemption is limited to specific critical or essential conditions when no technically and economically feasible safer alternatives are available. This exemption will also require compliance with the WCPP. It too is time-limited to ten years.

EPA clarified that all COUs of methylene chloride under TSCA (except its use in consumer paint and coating removers, which was previously addressed under TSCA Section 6) will be covered by this proposal.

Regarding the WCPP for methylene chloride, EPA’s press release states that the agency collaborated with the Occupational Safety and Health Administration (OSHA) during the development of the proposed rule, taking into account existing OSHA requirements to ensure comprehensive worker protections. The Agency asserts that the proposed risk-based limits are based on up-to-date data and fulfill the TSCA mandate to eliminate unreasonable risks. If the rule is finalized, employers would have one year to comply with the WCPP and would be obligated to periodically monitor the workplace to ensure that workers are not exposed to methylene chloride at levels that pose an unreasonable risk.

In the Federal Register notice, EPA particularly requested comments on the feasibility and effectiveness of the proposed worker protection requirements from parties that would be responsible for implementing the program. (The comment period closed on July 3.) Additionally, EPA hosted a public webinar on June 7 to present overview of the proposed regulatory action and provide an opportunity for participation in discussion on the proposed WCCP. Materials from the webinar are available on EPA’s website.

EPA Finds TCE as a Whole Chemical Substance an Unreasonable Risk to Human Health

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Earlier this year, EPA announced the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under the Toxic Substances Control Act (“TSCA”). EPA found that TCE presents unreasonable risks to the health of workers, occupational non-users, consumers, and bystanders. The risks identified include adverse human health effects unrelated to cancer, such as neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to TCE and risks for cancer from chronic inhalation and dermal exposures to TCE. The revised risk determination supersedes the conditions of use (“COU”) specific “no unreasonable risk” determinations that the EPA previously issued in its 2020 TCE risk evaluation.

TCE is a volatile organic compound (“VOC”) used mostly in industrial and commercial processes. Consumer uses include cleaning and furniture care products, arts and crafts, spray coatings, and automotive care products like brake cleaners. EPA determined that 52 of the 54 COUs evaluated drive the unreasonable risk determination.

EPA states that it used the whole chemical risk determination approach for TCE because there are benchmark exceedances for multiple COUs spanning across most aspects of TCE’s life cycle, from manufacturing (including import), processing, commercial use, consumer use, and disposal for health of workers occupational non-users (workers nearby but not in direct contact with this chemical), consumers, and bystanders. EPA holds that this approach is appropriate because the health effects associated with TCE exposures are “severe and potentially irreversible,” including developmental toxicity, reproductive toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, and cancer. EPA notes that the revised risk determination for TCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE). EPA states that as it moves forward with a risk management rulemaking for TCE, it will “strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk.

Additionally, EPA stated it is conducting a screening-level approach to assess potential risks from the air and water pathways for several of the first 10 risk evaluation chemicals, including TCE. The goal of the screening approach is to evaluate the surface water, drinking water, and ambient air pathways for TCE that were excluded from the 2020 risk evaluation and to determine if there are risks that were unaccounted for in that risk evaluation. EPA expects to describe its findings regarding the chemical-specific application of this screening-level approach in its proposed risk management rule for TCE.

EPA Releases Proposed Approach for Considering Cumulative Risks Under TSCA

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EPA recently released two documents regarding cumulative risk assessments under TSCA section 6, Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act, and Draft Proposed Approach for Cumulative Risk Assessment of High-priority Phthalates and Manufacturer-Requested Phthalate under the Toxic Substances Control Act. The first document details a set of principles for evaluating the cumulative risk of substances under TSCA; the second document presents a proposed approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals which are currently undergoing TSCA section 6 risk evaluation.

In the  Draft Proposed Principles of Cumulative Risk Assessment Under TSCA, EPA explained that it plans to alter its approach to individual substance evaluations under TSCA section 6 by taking a cumulative assessment approach when appropriate. Previously, the Agency looked at the risks posed by a single substance under its specific conditions of use. The Agency now intends to implement a new approach to evaluating human health effects, which it believes is more appropriate when considering human exposure to these substances. People are often exposed to many chemical substances with similar effects at the same time, and looking at the combined exposure health risk will paint a more complete picture. The Agency believes that this approach will allow for more effective mitigation of identified unreasonable risks and provide particularly useful information for communities that face higher than normal levels of chemical pollution.

Phthalates will be subjected to a cumulative risk assessment because the group of substances has similar effects on human health and has generally been found concurrently in the human body. The phthalates to be assessed as a group include DEHP, BBP, DBP, DIBP, DCHP, DINP, and DIDP. The chemical group is often used in industrial and consumer products to make plastics more flexible and durable. The draft proposal requests comment and peer review on its assessment that six phthalate substances are toxicologically similar, and the U.S. population is frequently co-exposed to these substances, making a cumulative risk assessment the most appropriate course of review action under TSCA.

The Agency is accepting comments on these documents through April 28, 2023.

EPA Releases Draft Revised Risk Determination for PV29

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On March 7, 2022, EPA released a draft revision to the risk determination for C.I. Pigment Violet 29 (PV29).  Manufacturers and commercial clients use PV 29 as a weather fast and heat stable pigment in paints and coatings.  These paints and coatings are primarily used in automobiles and industrial carpeting.  The draft revision comes as part of the path forward EPA released in June 2021 for the first 10 risk evaluations under TSCA.

Risk evaluations are conducted under TSCA section 6.  TSCA requires the Agency to conduct risk evaluations to determine whether high priority substances present an unreasonable risk of injury to health or the environment.  EPA has determined that PV29, presents an unreasonable risk of injury to health.  This determination regarding PV29, evaluated the substance as a “whole chemical,” replaces previous determinations which were based on evaluations of individual conditions of use.

The draft revision risk determination for PV29 does not include an assumption of personal protective equipment (PPE) for workers. Instead, EPA stated that the Agency would consider the use of PPE, and any other potential mitigating factors, during its determination of risk management measures.  Note that the January 2021 risk evaluation for PV29found an unreasonable risk to workers, even when proper use of PPE is assumed.  The January 2021 risk evaluation identified 14 categories of use and found unreasonable risk exists in 10 of those categories including:

  • manufacture,
  • processing,
  • paints/coatings and merchant ink for commercial printing categories of Industrial/commercial use, and
  • disposal.

The draft revision states these same conditions of use will continue to drive EPA’s determination of unreasonable risk for PV 29.  The categories of use that were not found to present an unreasonable risk are: distribution in commerce, industrial/commercial use in plastic and rubber products, and consumer uses.