EPA Releases Framework for Addressing New PFAS and New Uses Under TSCA

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EPA has released the Framework for Addressing New PFAS and New Uses of PFAS. This document details the Agency’s planned strategy for evaluating Premanufacture Notices  (“PMNs”) for new PFAS compounds and Significant New Use Notices (“SNUNs”) for “new uses” of existing PFAS to ensure they do not pose harm to human health and the environment.

The Agency states that new PFAS substances present challenges for regulators, as there is frequently limited information available to assess their potential risks accurately. Many PFAS compounds are known to persist in the environment, bioaccumulate, and be toxic (known as “PBT”); the framework aims to qualitatively evaluate PFAS based on how likely they truly are to become PBTs in the body and environment.

The framework distinguishes between PFAS uses that may result in environmental releases and potential exposures and those that don’t. For example, PFAS applications that are deemed to have negligible exposure and minimal environmental release, such as in the closed systems used in the manufacture of electronics. EPA generally anticipates allowing the compounds to enter commerce after exposure data is provided.

The framework calls for more comprehensive testing, including toxicokinetic data, for PBT PFAS compounds that are expected to have a low but greater than negligible potential for environmental release and exposure. If initial testing raises concerns about exposure levels and risks, EPA will mandate further testing and risk mitigation before permitting manufacturing. This comprehensive testing would encompass physical-chemical properties, toxicity, and fate analysis. For example, uses of PFAS in spray-applied stain guards inherently involve releases into the environment. If required testing finds potential hazards, EPA has the authority under TSCA section 5 to demand additional testing and risk mitigation strategies or prohibit manufacturing entirely.

If EPA determines a new chemical substance poses an unreasonable risk, lacks sufficient risk information, or involves substantial production with potential exposure, it must issue a section 5(e) order for human health and environmental protection, which may include testing requirements. If PFAS data suggests it’s a PBT chemical and EPA anticipates exposures, the substance or significant new use could be deemed to present an unreasonable risk, therefore requiring either a section 5(f) order or an immediately effective proposed rule under TSCA section 6(a). The section 5(f) order applies to the submitter, while the 6(a) rule covers all users. For a SNUN, the 6(a) rule typically targets the specified new use. The chart below further details the possible EPA determinations and related actions following their review.

Determination Related Action
In the absence of sufficient information to permit a reasoned evaluation of risk from the substance or significant new use, the substance or significant new use may present an unreasonable risk. EPA must issue an order under TSCA section 5(e).
There is insufficient information to permit a reasoned evaluation of risk from the substance or new use. EPA must issue an order under TSCA section 5(e).
The substance or significant new use presents an unreasonable risk. EPA must take action under TSCA section 5(f).
The substance is or will be produced in substantial quantities, and there may be significant or substantial human and/or environmental exposure (exposure-based). EPA must issue an order under TSCA section 5(e).
The substance or significant new use is not likely to present an unreasonable risk. EPA notifies the submitter of its decision and publishes its findings in the Federal Register.

 

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.

TSCA Enforcement Action Taken Over Failure to Comply with PFAS SNUR

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In December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain PFAS substances in violation of the Toxic Substances Control Act (“TSCA”). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.

The first lawsuit was filed by the U.S. Department of Justice, Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (“EPA”).  The second case is a citizen suit filed by the non-profit organizations Center for Environmental Health (“CEH”) and Public Employees for Environmental Responsibility (“PEER”). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.

Defendant Inhance Technologies USA (“Inhance”) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.

According to the Complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (“LCPFAC”)  Significant New Use Rule (“SNUR”) that requires manufacturers to file a Significant New Use Notice (“SNUN”) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 CFR 721.10536. This includes substances that are typically exempt byproducts under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements.  The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.

Inhance received warning of its violation of the LCPFAC Rule by the Plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are byproducts of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the byproducts exemption in 40 CFR § 721.45(e). The Agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the Agency’s warnings.

In March 2022, EPA issued a Notice of Violation (NOV), requesting that Inhance provide the Agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the Agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.

In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.

EPA’s lawsuit was filed on December 19, 2022, with the non-profit lawsuit following about a week behind. The Complaints allege a variety of TSCA violations, namely the following:

  • Section 5(a)(1) of TSCA, which states no person may manufacture or process a chemical substance for a significant new use unless (1) that person submits a Significant New Use Notice (“New Use Notice”) to the EPA; (2) the EPA reviews that notice; and (3) the EPA makes a determination on that use under Section 5(a)(3) of TSCA, 15 U.S.C. § 2604(a)(3). 15 U.S.C. § 2604(a)(1).
  • Title 40 C.F.R. § 721.25 prescribes similar requirements for any person seeking to engage in a significant new use of a chemical substance.
  • Section 15 of TSCA, which states that it is a prohibited act to fail or refuse to comply with any requirement of TSCA or any rule promulgated under TSCA. 15 U.S.C. § 2614.
  • Under 40 C.F.R. § 721.35, it is a violation of Section 15 of TSCA to fail to comply with any provision of Title 40, Part 721 of the regulations implementing TSCA.

Plaintiffs in both cases are seeking declaratory and injunctive relief under Section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.

Case Update

In April 2023, the U.S. District Court of the District of Columbia dismissed the lawsuit brought by CEH and PEER. Shortly after CEH and PEER filed their lawsuit, Inhance filed a motion to dismiss the case arguing that the lawsuit was inappropriate under TSCA’s diligent prosecution bar. DOJ filed an amicus brief supporting Inhance’s motion to dismiss. For the CEH and PEER lawsuit to proceed, the organizations would have needed to demonstrate that DOJ was not diligently prosecuting the case. The court granted Inhance’s motion stating that “[n]othing in the eight days between when DOJ filed its lawsuit and when the Plaintiffs filed theirs suggests that [DOJ] was not diligently prosecuting the case.”

On June 13, the court presiding over the DOJ lawsuit scheduled oral arguments for August 23, 2023.

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 Finalizes TSCA CBI Rule

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On June 7, 2023, EPA finalized a rule (88 Fed. Reg. 37155) that puts forth new and amended requirements for parties asserting confidential business information (“CBI”) claims under the Toxic Substances Control Act (“TSCA”). The new rule details specific procedures for the regulated community to submit and support CBI claims and for the Agency to review CBI claims and communicate their determinations to submitters. Additionally, the rule reorganizes existing provisions of the CBI regulations.

The following are the most substantial changes to procedures for submitting and supporting CBI claims under TSCA:

Substantiation Requirements Applicable at Time of Submission

The rule requires that confidentiality claims be asserted and substantiated at the time of submission; substantiation data requires submissions of supporting statements and certification, including but not limited to asserting that the party has taken reasonable measures to protect the confidentiality of the information, and a reasonable basis to believe that the information is not readily available through reverse engineering. (40 CFR 703.5(a)).

Supporting Statement and Certification

Certification of CBI claims is required at the times the statements are submitted.  Submitters will be required to answer a number of questions, many or all of which have been used for some time in EPA’s CBI substantiation templates and certain CDX submissions (e.g., CDR).  Submitters should note that certifications are submitted under penalty of perjury; any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

Electronic Reporting

The final rule mandates that short of very limited exceptions, all CBI claims must be submitted electronically. This requirement is detailed in 40 CFR 703.5(f). Parties should be particularly conscious of this with TSCA Section 8(e) reporting, notifications under TSCA Section 12(b), and polymer exemption notices under TSCA Section 5 because this rule is the first mandating these types of reporting are to be done electronically.

Requirement to Report Health and Safety Information Using Organization for Economic Cooperation and Development (“OECD”) Harmonized Templates

Under the final rule, health and safety information must be provided using OECD harmonized templates. This is in addition to existing requirements that require submitters to provide a full study report. According to the Federal Register notice, the Agency will elaborate on instructions for including OECD harmonized template files (e.g., currently acceptable file types and IUCLID software versions). This requirement can be found at 40 CFR 703.5(g).

Maintenance and Withdrawal of Confidentiality Claims

EPA is requiring that, going forward, company contact information be kept up to date through CDX. When contacting a submitter concerning confidentiality claims, EPA will contact the submitter either through CDX directly or using the contact information provided by the submitter in CDX. When a confidentiality claim is being reviewed, a notice of the review and opportunity to substantiate or re-substantiate the confidentiality claim will be sent to the submitter using the information provided in CDX. Often, this will be done by sending the submitter an email from a CDX account notifying them that a document is available for download from CDX, which is why it is particularly important to have up-to-date information within the CDX platform. The details of this requirement are within 40 CFR 703.5(h).

EPA has also detailed the process for voluntarily withdrawing confidentiality claims submitted either in CDX or by other means. (40 CFR 703.5(i)). For CDX-submitted claims, the submitters must remove confidentiality markings, revise their documents, and resubmit these documents in CDX. For submissions not originally submitted through CDX, there is now a process for withdrawing the CBI claims through CDX using document-identifying details.

EPA Releases Chemical Data Reporting National Review

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EPA has released its first-ever Chemical Data Reporting (CDR) National Review (“Review”), which provides a comprehensive analysis of data submitted to the Agency during the 2020 CDR reporting cycle. The report presents information about chemicals that were manufactured and imported into the US from 2016 through 2019. In its press release on the Review, the Agency stated that the document will assist stakeholders in evaluating and understanding information about the types, quantities, and uses of chemicals produced domestically or imported into the U.S.

Manufacturers and importers of chemical substances listed on the Toxic Substances Control Act (“TSCA”) Inventory are required to report data to the EPA every four years if they manufacture or import substances at or above specific thresholds unless the chemical has been exempted from the reporting requirement. Typically reporting is required when an entity manufactures or imports 25,000 pounds or more of a chemical during any year in the reporting period at any single site. Companies must report how chemicals are processed or used (industrial processing and use data), and whether they are used in commercial or consumer products (commercial and/or consumer use data) in addition to manufacturing and import volumes.

According to EPA, the CDR database is the most comprehensive source of basic screening-level, exposure-related information on chemicals that is available to the Agency. EPA uses the database to screen and prioritize chemicals for further review.

The Review summarizes data from the most recent CDR reporting cycle data (2020), covering activities from 2016 to 2019, and provides trend data for reporting over the past decade. During this reporting period, more than 7.2 trillion pounds of chemicals were manufactured or imported at 5,238 sites.

The Review provides interactive trend analysis, including an interactive map of CDR sites and characteristics of the communities in which these sites are located.  It also includes maps displaying CDR reporting sites by state, and figures with production volumes. In addition, the Review contains informational charts and figures to increase understanding of a variety of CDR data elements, such as analyses of chemical use information. Environmental justice tools from EPA’s EJScreen, the Agency’s environmental justice mapping tool, are also contained in the document.

The Review’s key findings include:

  • Of the more than 8,000 chemicals reported for the 2020 CDR reporting cycle, about 54% were manufactured domestically, and 46% were imported. This is a 10% increase in imported chemicals from the 2016 CDR.
  • Two industry sectors manufactured and imported the bulk of the volume reported to the 2020 CDR: petroleum and coal products manufacturing (64%) and chemical manufacturing (14%). Although it produced less volume than the petroleum and coal products sector, the chemical manufacturing sector produced the majority of chemicals (84%) reported to the 2020 CDR and represented nearly half (43%) of all sites.
  • 180 PFAS were reported by 57 sites for a total production volume of about 678 million pounds.
  • Of the 37 Chemicals undergoing Risk Evaluation, 33 chemicals were reported to the 2020 CDR; that is, they were manufactured or imported at above threshold volumes (2,500 lbs.) in at least one year during the reporting cycle. Thirty-four Risk Evaluation chemicals were reported in both the 2012 and 2016 reporting cycles.
  • Total production volume for the 33 TSCA Risk Evaluation chemicals was about 38 billion pounds. The volume was reported across 254 sites.
  • The number of sites that manufactured and/or imported TSCA Risk Evaluation Chemicals has increased by 40% over the past 10 years, while the manufactured and imported volumes have generally remained consistent.

Community Sues EPA Over Terms for Production of Petrochemical Fuel

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Cherokee Concerned Citizens, on behalf of the Cherokee Forest neighborhood  a fenceline community in Pascagoula, Mississippi, has filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit for review of a TSCA section 5(e) consent order. The consent order covers 18 chemicals that were the subject of premanufacture notifications submitted by Chevron in 2021. In its press release announcing the litigation, Earthjustice asserted that the production of these chemicals would result in air pollution that would pose a 1 in 4 cancer risk (25 % of the residents living nearby could develop cancer over their lifetime), 250,000 times greater than what the Agency typically considers unreasonable.

TSCA requires EPA to regulate the manufacturing, processing, and distribution of substances that present an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors. The Statute states that the Administrator shall issue consent orders and significant new use rules “to the extent necessary to protect against such risk.”

EPA identified skin and eye irritation; acute toxicity; systemic toxicity (neurotoxicity, body weight effects, and liver, kidney, blood, spleen, and other organ effects); reproductive and developmental toxicity; oral and inhalation portal of entry effects; genetic toxicity; and carcinogenicity as hazards of these New Chemical Substances. These hazards were identified based on the substance’s estimated physical/chemical properties by comparing them to compositionally analogous mixtures for which there is information on human health hazard, using available human hazard information on representative constituents of these New Chemical Substances, and other structural information. As is often the case with PMNs, there were no experimentally derived hazard data for these New Chemical Substances.  For a number of the substances, risks were identified for the general population (infants) for systemic and/or oral portal-of-entry effects via drinking water. Risks to adults for this exposure route were also identified. In addition, risks were identified for the general population for systemic and/or inhalation portal-of-entry effects via fugitive air inhalation for some of the substances at issue.

The consent order imposes worker protection and limitations on the distribution of the new chemical substances. It does not restrict air emissions or wastewater discharges of the substances. The Chevron facility called out by Earthjustice is permitted under the Clean Air and the Clean Water Acts.

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.