EPA Proposes Changes to TSCA Risk Evaluation Procedures

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

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

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

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

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

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

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

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.

EPA Releases Final Scope Document for Manufacturer-Requested Risk Evaluation of D4

On March 7, 2022, EPA published the final scope of the risk evaluation for octamethylcyclotetra-siloxane (D4). This risk evaluation may affect producers of goods comprised of and/or utilizing the following: adhesives, sealants, synthetic rubber, electrical equipment, appliances, paint, ink/toner, aircraft maintenance components, automotive care components, cleaning products, fabrics/textile products. This is not intended to serve as an exhaustive list. The publication of this risk evaluation originated from a request made by the American Chemistry Council’s Silicones Environmental, Health, and Safety Center (SEHSC). The scoping document addresses conditions of use, exposures, hazards, and potentially exposed or susceptible subpopulations.

Conditions of Use

Conditions of use for D4 risk evaluation can be sub-divided into the following life cycle stages: manufacturing, processing, distribution in commerce, industrial use, commercial uses, consumer uses, and disposal. EPA’s evaluation will address each of the aforementioned life cycle stages. Notably, processing is the most nuanced of these stages. Specifically, the processing stage is comprised of three subcategories: processing as a reactant; incorporation into formulation, mixture, or reaction product; and repackaging.

Exposures

In the forthcoming risk evaluation, EPA will evaluate human and environmental exposures as well as releases into the environment resulting from these conditions of use identified in the scoping document. The evaluation will contemplate the physical and chemical properties of D4; environmental fate and transport processes, exposure pathways, and potential human and environmental receptors; releases to the environment; environmental exposures (both aquatic and terrestrial); occupational exposures; consumer exposures; and general population exposures.

Hazards

Regarding environmental hazards, EPA will assess the following potential hazard effects of D4 to aquatic and terrestrial organisms including: absorption, distribution, metabolism, and excretion (collectively referred to as “ADME”), developmental, gastrointestinal, mortality, neurological, nutritional, metabolic, reproductive, and respiratory. The scoping document notes that D4 can degrade into dimethylsilanediol (DMSD) under certain environmental conditions. Accordingly, EPA has indicated that it may factor toxicity information regarding DMSD into its risk evaluation.

With respect to human health hazards, EPA intends to examine the relation of D4 exposure to the following: ADME, cancer, endocrine, gastrointestinal, hematological, immunology, hepatic, mortality, neurological, nutritional/metabolic, ocular/sensory, renal, reproductive, developmental, respiratory, and skin/connective tissue. The scope of EPA’s assessment of the human health hazards of D4 may also contemplate hazards associated with exposure to DMSD as mentioned above.

Potentially Exposed or Susceptible Subpopulations (PESS)

In accordance with the requirement of TSCA section 6, the following groups will be considered potentially exposed or susceptible subpopulations in the D4 risk evaluation: children, women who may become pregnant, workers, occupational non-users (ONU), consumers, bystanders, fence line communities, and indigenous and native populations. Environmental justice considerations will also be factored into the PESS analysis. These considerations will follow the best practices discussed within EPA’s Technical Guidance for Assessing Environmental Justice in Regulatory Analysis.

PIP (3:1) Compliance Date Extended to October 31, 2024

On January 6, 2021, EPA issued a rule limiting manufacturing, importing, processing, and distribution of products containing phenol, isopropylated phosphate (3:1) (PIP (3:1)).  That rule was scheduled to take effect on February 5, 2021, with a March 8, 2021, compliance date.  After this date, companies would be prohibited from processing and distributing PIP (3:1) and PIP (3:1)-containing products unless there was an applicable exclusion.  Furthermore, after the compliance date, the rule prohibited the release of PIP (3:1) into water during manufacturing, processing, and distribution.  This final rule also required commercial users to follow existing regulations and best practices to prevent the release of PIP (3:1) and products containing PIP (3:1) into water.  On March 8, 2022, the effective compliance date of the rule was extended to October 3, 2024.

The March 2022 extension applies to the following consumer and commercial goods: cellular telephones, laptop computers, electronic devices, and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.  Notably, this is not an exhaustive list of the goods affected by the rule.  This extension follows the publication of the initial rule in January 2021, no action assurance issued in March 2021, and the September 2021 extension which expired on March 8, 2022.  These milestones are discussed in greater detail below.

In January 2021, EPA released risk management rules under the Toxic Substances Control Act (TSCA) intended to mitigate exposure to five chemicals that are persistent, bioaccumulative and toxic (PBT).  The five chemicals listed under this rule are decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)); 2,4,6-tris (tert-butyl) phenol (2, 4, 6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The rules were designed to either limit or prohibit manufacturing, importing, processing, and distributing the aforementioned chemicals.  Following the publication of these rules, EPA received numerous comments from manufacturers and processors of PIP (3:1) asserting that the March 8, 2021, compliance date did not provide stakeholders with enough time to find viable chemical substitutes.  Consequently, on March 8, 2021, EPA provided a no action assurance letter on enforcement of the rule.  The no action assurance expired on September 4, 2021.  Subsequently, on September 17, 2021, EPA issued a short-term extension of specific compliance deadlines for the processing and distribution of PIP (3:1) and articles containing PIP (3:1) to March 8, 2022. On March 8, 2022, a further extension was granted, which moved the compliance deadline to October 31, 2024.