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. US 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.

Irene Hantman Presents on EPA’s Audit Policy and TSCA Audits at PSX 2023

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Verdant Law is pleased to report that Irene Hantman gave a presentation on EPA’s Audit Policy and Toxic Substances Control Act (TSCA) audits on October 18 in Boston at PSX 2023.  PSX is the Product Stewardship Society’s annual conference, and its website can be found here.  Ms. Hantman serves on the Conference Planning Committee for PSX and looks forward to next year’s conference in Denver.

The presentation covered the incentives for the self-disclosure of violations provided by EPA’s audit policy, the conditions that must be met to qualify for audit policy penalty mitigation, and the benefits and risks of TSCA audits.  Ms. Hantman discussed important considerations for companies conducting audits, such as compliance with the 21-day self-disclosure deadline and understanding the 5-year statute of limitations that applies to most TSCA violations.  Ms. Hantman also highlighted the role of negotiations with EPA during an audit, for example, to avoid triggering penalties for repeat violations.

Particular attention was given to the New Owner Audit Policy, which allows new owners to get a clean baseline following the purchase of a facility.  Ms. Hantman covered the additional benefits to new owners of conducting TSCA audits, which include the opportunity to seek indemnification from the seller for breach of reps and warranties, the opportunity to submit an insurance claim if the new owner purchased deal insurance, and further reduced economic penalties under the New Owner Audit Policy.

Also presenting was Ashish P. Deshmukh, PhD, Principal at Ramboll, who spoke about the particulars of audit processes and how product stewards can prepare for TSCA audits.  The presentation was moderated by Robert DeMott, PhD, Principal Toxicologist at Ramboll.

If you have questions about the topics of the presentation, please contact Ms. Hantman.

EPA Finalizes TSCA Reporting and Recordkeeping Requirements for PFAS

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EPA has finalized its Toxic Substances Control Act (“TSCA”) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substance (“PFAS”) rule. The rule offers none of the customary TSCA reporting exemptions, such as the di minimus threshold exemption, article exemption, and research and development exemption. Although industry members voiced significant concerns over the proposed rule, the scope of the rule remains expansive. A summary of the final rule is detailed below.

Who does the final rule apply to?

40 CFR § 705.10 identifies the entities that are covered under the rule. The rule, which Congress mandated through the FY2020 National Defense Authorization Act, applies to all entities that have manufactured and/or imported a PFAS for commercial purposes, including those present in a mixture and in an article since January 1, 2011. Those who have only processed, distributed in commerce, used, and/or disposed of PFAS are not subject to this rule.

Which PFAS must be reported under the final rule?

EPA has identified PFAS subject to the rule by a structural definition rather than a list of substance identities (40 CFR § 705.5). However, EPA will provide a public list of substances that meet this definition on its CompTox Chemical Dashboard. The definition of PFAS using a structural definition is as follows:

  • R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons;
  • R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons; and
  • CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons.

This differs from the proposed rule, which defined PFAS as “a substance that includes the following structure: R-(CF2)–C(F)(R′)R″, in which both the CF2 and CF moieties are saturated carbons and none of the R groups (R, R′ or R″) can be hydrogen.”

Reporting threshold

There is no reporting threshold or de minimis level for PFAS reporting. The traditional TSCA reporting exemptions, such as byproducts and impurities, and low volume exemptions, are not being upheld under this rule and require reporting.

Reporting standard

40 CFR § 705.15 states that the reporting standard that applies to this rule is information “known or reasonably ascertainable” by the manufacturer. This means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know” (See 40 CFR 704.3). Under this standard, the manufacturer must evaluate not only their current level of knowledge regarding substances that are manufactured or imported, including those in articles, but also any additional information that a reasonable person, similarly situated, would be expected to know, possess, or control.

To obtain the necessary information for reporting, EPA expects the manufacturer/importer to conduct a reasonable inquiry into their own organization and potentially make inquiries outside the organization. According to the Agency, this may require “phone calls or email inquiries to upstream suppliers or downstream users or employers or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS.”

If data is unknown or not reasonably ascertainable, the submitter should, if possible, submit reasonable estimates. If manufacturers or importers need additional information for reporting, but suppliers are unwilling to provide that information, they can send a request for information through EPA’s reporting tool.

What information must be reported?

The scope of information required is vast. Data elements are detailed at 40 CFR §705.15 and include:

  • Chemical-specific information for all PFAS manufactured each year since January 1, 2011, including PFAS incorporated in mixtures.
  • Categories of use, including information on the sector, industrial processing, commercial and consumer use, and product categories.
  • Concentrations of each PFAS used in consumer and commercial products.
  • Manufactured amounts.
  • Byproduct identification.
  • Environmental and health effects data – which must be submitted according to OECD Harmonized Templates for Reporting Chemical Test Summaries.
  • Worker exposure data.
  • Disposal data.

Reporting on PFAS in Articles

Articles importers are subject to the reporting rule. The fact that there is no de minimis concentration threshold makes the scope of this mandate expansive. Because the known and reasonably ascertainable standard applies to this rule, importers must go beyond simply reviewing the SDSs for the imported articles. To demonstrate compliance with the rule, importers will need to survey their suppliers about the presence of PFAS in all of the articles they have imported since January 1, 2011. However, the rule does not mandate any product testing for article importers.

The rule does exempt some data elements from reporting for PFAS imported in articles, such as byproduct identification, worker exposure data, and disposal data.

R&D exemptions to the reporting requirements

Manufacturers and importers of R&D PFAS substances are subject to the reporting rule.  The reporting requirements are reduced where volumes are below 10 kilograms annually.

Electronic reporting

All information must be submitted electronically through CDX (see 40 CFR § 705.35). A new tool, the Chemical Information Submission System (“CISS”), will be added to the CDX module “Submission for Chemical Safety and Pesticide Program” (“CSPP”). Reporting will be submitted through the CISS, which the Agency is currently developing, and will be live prior to the opening of the reporting period.

CBI claims

PFAS manufacturers reporting under this rule may claim CBI consistent with TSCA section 14, but they must make the CBI claim with their submission for this rule. CBI claims submitted for other reporting requirements will not be considered. See 40 CFR § 705.30 for details.

Reporting timeline

Manufacturers and importers will have one year from the effective date of this rule, November 13, 2023, to collect the data necessary for reporting and an additional six months to submit their reports; reports will be due May 13, 2023. Small manufacturers (as defined in 40 CFR 704.3) will have an additional six months to report, making their reporting deadline November 13, 2024.

Recordkeeping requirements

Manufacturers and importers subject to this rule must maintain records of all documents and information reported to EPA for five years, beginning on the last day of the information submission period.

EPA Settles with Kyocera After Self-Disclosure of TSCA Violations

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On September 5, 2023, EPA signed a consent agreement with Kyocera International, Inc. (“Kyocera”) over three alleged violations of the Toxic Substances Control Act (TSCA). Kyocera’s civil penalty was reduced to $105,937 because of EPA’s audit policy, which rewards companies that “voluntarily discover, promptly disclose and expeditiously correct” violations with reduced fines.

The alleged violations, which pertain to six unnamed chemicals (Chemicals A, B, C, D, E, and F), are as follows:

  1. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without first filing a premanufacture notice (PMN) or an exemption to PMN requirements, in violation of TSCA section 5(a)(1);
  2. Failure to comply with recordkeeping requirements for Chemical D and E’s polymer exemptions to PMN requirements, in violation of TSCA section 5(a)(1); and
  3. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without submission of proper certifications prior to the importation, and importation of Chemical F three times without providing a positive TSCA certification statement for each import, in violation of TSCA section 13(a)(1)(B).

The electronics manufacturer corrected the alleged violations by ceasing importation of Chemicals A, B, C, and D, submitting low-volume exemptions to PMN requirements for Chemicals B and C (which were granted by the Agency), and complying with the polymer exemption requirements for Chemical D. Under the terms of the settlement, EPA gave Kyocera permission to release its self-imposed quarantined stocks of Chemicals B, C, and D.

Kyocera self-disclosed the violations on June 23, 2021, with supplemental information provided in March 2023. The company disclosure and subsequent corrective action satisfied all of EPA’s audit policy conditions except the requirement that the violations be uncovered by “systematic discovery” and was therefore eligible for a 75% reduction in the gravity-based portion of the civil penalty.

The consent decree comes after a June 30, 2022, EPA Inspector General report which found that eDisclosure, EPA’s violation self-disclosure system, “does not have adequate internal controls in place to ensure that the EPA’s screening process is effective and that significant concerns . . . are identified and addressed.” EPA agreed with all four of the report’s recommendations and proposed corrective actions, including the development of national guidance and eDisclosure-specific training for EPA staff who monitor eDisclosure submissions.

EPA Proposes SNURs for Flame Retardants

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EPA has proposed significant new use rules (SNURs) for three flame retardants under the Toxic Substances Control Act (TSCA). The three flame retardants are tris(2-chloroethyl) phosphate (TCEP), tetrabromobisphenol A (TBBPA), and triphenyl phosphate (TPP).  All three substances are currently undergoing TSCA risk evaluations.  The proposed significant new uses are manufacture (including import) or processing for any use, except for those uses being considered in the risk evaluations.  In the Federal Register notice, EPA explained that significant new uses would encompass the following categories:

  • Manufacture and processing for uses that have ceased;
  • Manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and
  • Manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States.

The Agency sought public comment on its description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency in the risk evaluation scope documents.

EPA noted that “The issuance of a SNUR is not a risk determination itself, only a notification requirement for ‘‘significant new uses,’’ so that the Agency has the opportunity to review the [Significant New Use Notification] for the significant new use and make a TSCA section 5(a)(3) risk determination.”  In other words, “Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence.”

In its discussion of the significant new use determination, EPA explained that the Agency considered information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2):

  • The projected volume of manufacturing and processing of a chemical substance,
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance and
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

According to the Federal Register Notice, current uses of TCEP are as follows:  TCEP is imported into the United States and processed for commercial use in paints and coatings, for industrial or commercial use in polymers for use in aerospace equipment and products, and for commercial use as a laboratory chemical.

EPA found that TBBPA is currently manufactured (including imported) in the United States. It is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture, or reaction products; and incorporated into articles. The Agency noted that the predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products and as an additive flame retardant in electrical and electronic products. In addition, epoxy resin containing TBBPA can be used in adhesives, laminate for aviation and automobile interiors and building/ construction materials.

The Agency reported that TPP is manufactured (including imported) in the United States.  It is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles.  Commercial uses include in plastic and rubber products and in paints and coatings. The chemical is also used in lubricants and greases.  In addition, consumer uses were reported in foam seating and bedding products.

Comments can be viewed in docket EPA–HQ–OPPT–2023–0012 at regulations.gov.

Audit Finds EPA’s New Chemicals Program Lacks Sufficient Guidance

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On August 2, 2023, EPA’s Office of Inspector General (“OIG”) released a report on its audit of EPA’s New Chemicals Program. The audit identified recordkeeping and quality assurance issues with the program as administered by EPA’s New Chemicals Division (“NCD”). The audit, which began in October 2021, was conducted in response to several internal complaints submitted to OIG.

The New Chemicals Program reviews whether new chemicals or significant new uses of existing chemicals pose an “unreasonable risk” to human health or the environment under the Toxic Substances Control Act (“TSCA”). According to the report, NCD did not have finalized, up-to-date guidance for recordkeeping or for many of the steps in the new chemicals review process, contrary to EPA protocol.  OIG stated that these issues resulted from insufficient staff resources, which prevented NCD from both conducting the chemical reviews within statutory time frames and finalizing guidance for the activities composing the review process. The report also found frequent technical issues with NCD’s TSCA Confidential Business Information systems.

Some of the complaints to OIG alleged that staff were pressured to focus on deadlines rather than chemicals’ potential risks during the new chemical review process. However, OIG found no evidence of this; for example, the report notes that NCD employees were not evaluated on the speed at which they reviewed chemicals.

OIG made the following four recommendations to EPA’s Office of Pollution Prevention and Toxics (“OCSPP”) based on its findings:

  1. Develop a plan to regularly review NCD’s guidance documents,
  2. Develop a plan to periodically assess the effectiveness of NCD’s recordkeeping system,
  3. Develop a plan to identify the root causes of the technical issues, and
  4. Conduct periodic reviews of NCD’s workload.

OCSPP’s response, which was included in the report, agreed with each of OIG’s recommendations and proposed corrective actions in line with the recommendations.

This audit was not the first to find issues with EPA’s implementation of TSCA provisions. A 2019 GAO report identified similar issues, such as insufficient guidance and resources, with the new chemicals review process. In 2020, OIG found that EPA had missed deadlines on existing chemical risk evaluations and that EPA’s ability to meet future deadlines was at risk. EPA has since proposed a fee adjustment designed to increase TSCA fee collections. Most recently, in February 2023, GAO determined that EPA had missed most TSCA deadlines for reviewing new and existing chemicals.  In general, EPA agreed in part or in full when recommendations were made in these reports and corrective actions have been completed or are pending.

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.