EPA’s TSCA Pre-Prioritization Webinar

On September 30, 2024, a lead toxicologist in the Data Gathering Management and Policy Division within the Office of Pollution Prevent and Toxics presented an overview of prioritization and pre-prioritization efforts for existing chemicals under the Toxic Substances Control Act (TSCA). The Agency’s goal was to collaborate with attendees to evaluate the potential risks of existing industrial chemicals regulated under TSCA. Topics covered included a high-level overview of TSCA authorities, requirements, and timelines for evaluating existing chemicals. Additionally, EPA covered the Agency’s approach for identifying the chemicals that may undergo prioritization.

Under TSCA, EPA is required to evaluate the potential risks of chemical substances comprehensively, taking into account their cradle-to-grave life cycle. This process involves assessing the chemical’s potential exposure and risks from production through disposal and includes all identified uses.  First, the webinar touched on the key aspects for the Risk Evaluation process.

  • Cradle-to-Grave Analysis
    • 6-Year Timeline for Risk Regulation
      • Initiation and Prioritization: 9-12 months.
      • Risk Evaluation: 3 to 3.5 years.
      • Regulation Development: Remainder of the timeline as needed.
  • Public Engagement and Information Gathering

 

EPA then noted that the prioritization process reflects the Agency’s evolving approach to addressing chemical risks efficiently and inclusively under TSCA. EPA identified 27 chemical substances that are being considered for prioritization under TSCA, focusing on their inclusion in the 2014 TSCA Work Plan, the interests of other agencies, and the availability of hazard and exposure data. The 2014 TSCA Work Plan identified approximately 90 chemicals as priorities for risk evaluation based on hazards, exposure risks, and their environmental or health impact. In addition, three chemical substances that were not listed in the 2014 Work plan are being considered for prioritization Two of these chemicals were identified through TSCA Section 21 petitions:  Hydrogen fluoride (HF) and 6PPD.  Bisphenol S (BPS) is also being considered for prioritization.  The Agency explained that BPS could become a priority if bisphenol A (BPA) undergoes prioritization, as BPS is a key alternative to BPA in the market.

EPA reminded participants that the Agency uses Section 4 and Section 8 under TSCA to gather data on the chemicals for prioritization, risk evaluation, and risk management. TSCA Section 4 provides authority for mandatory testing of chemicals to fill data gaps through test orders, test rules, and consent agreements. TSCA Section 8 allows for reporting and recordkeeping of existing chemical-related data, including reports of significant adverse health or environmental reactions.

The Agency noted that it prioritizes chemicals with robust existing data to streamline risk evaluation and reduce delays caused by insufficient information. The inclusion of both 2014 TSCA Work Plan chemicals and newly highlighted substances reflects intent to address historical priorities while also adapting to emerging concerns raised by stakeholders or other agencies.

Work Plan Chemicals:

1-Hexadecanol
2-Ethylhexyl
tetrabromobenzoate (TBB)
4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)-phenol)
Benzene
bis(2-Ethylhexyl) – 3,4,5,6-Tetrabromophthalate (TBPH)
Bisphenol A
Creosote
Di-n-octyl phthalate (DnOP)
Ethylbenzene
Naphthalene
N-Nitroso-diphenylamine
p,p’-Oxybis(benzenesulfonylhydrazide)
Styrene
Tribromomethane
Triglycidyl isocyanurate
m-Xylene
o-Xylene
p-Xylene
Antimony & Antimony Compounds
Arsenic & Arsenic Compounds
Cobalt & Cobalt Compounds
Lead & Lead Compounds
Long-chain chlorinated paraffins (C18-20)
Medium-chain chlorinated paraffins (C14-17)

 

Non-Work Plan Chemicals:

Bisphenol S
Hydrogen fluoride
N-(1,3-Dimethylbutyl)-N’-phenyl-pphenylenediamine (6PPD)

D.C. Circuit Rejects Environmentalist Arguments, Sides with Industry over TSCA CBI Rule

EPA’s 2023 rule revising confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA) is only unlawful insofar as it could lead to certain inadvertent waivers of confidentiality by downstream entities, the D.C. Circuit ruled on December 20, 2024.

The case, Environmental Defense Fund v. EPA, No. 23-01166, consolidated petitions from the Environmental Defense Fund (EDF) and the American Chemistry Council (ACC).  EDF’s arguments in favor of narrower confidentiality protections were rejected by the court, whose ruling leaves EPA’s CBI rule largely intact.

However, the court agreed with ACC’s challenge to a provision in the rule that allowed downstream entities to waive CBI protections put in place by the upstream manufacturer when reporting information to EPA.  Specifically, ACC argued that the rule’s requirement that downstream entities assert and substantiate confidentiality claims for chemical identities reported via an “accession number” is arbitrary and capricious.  Under the CBI rule, if “any submitting entity fails to substantiate a confidentiality claim for a chemical identity…the chemical identity is no longer entitled to confidential treatment.”

Accession numbers are non-confidential identifiers assigned to chemicals whose identities are claimed as CBI.  Downstream entities reporting information to EPA using an accession number may have no knowledge of the chemical’s actual identity, the court noted, and may not have any incentive to keep it secret.  Nor would they necessarily have the information needed to adequately substantiate a claim, the opinion continues.

“This regulatory scheme cannot be squared with the commands of the statute, which require EPA to protect from disclosure chemical identities for which CBI claims have been properly assessed,” the court held, vacating the CBI rule “to the extent it allows for the unlawful disclosure of confidential information.”

Key Provisions are “Best Reading”

EDF challenged three provisions of the CBI rule.  The court rejected these challenges, explaining that EPA’s positions were  consistent with the “best reading” of the statute—the new legal framework adopted by the Supreme Court in Loper Bright v. Raimondo, the decision that struck down Chevron deference.

EDF argued that the rule’s use of “permissive” language and revised timeframe for when a CBI claim must first be substantiated were arbitrary and capricious.  However, the court found that the CBI rule sufficiently justified why those changes were necessary.  The permissive language at issue included a provision allowing EPA discretion in whether to disclose information that has lost CBI protection, unlike earlier regulations requiring its immediate and automatic release.

EDF also challenged the scope of the CBI rule’s definition of a “health and safety study,” which are statutorily ineligible for CBI protection.  EDF contended that the definition should include the entirety of any written report submitted to EPA that presents findings of a health and safety study, including information like the identity of the company submitting the report and the name of the lab that conducted the study—information which is currently eligible for CBI protection.  The court disagreed, holding that the statutory definition of health and safety study “suggest[s] that the term refers only to the evaluation of a chemical’s health and environmental effects, not the entire document containing that evaluation.”

More on the CBI rule can be found in a previous blog post.  An earlier post on the case, written after EDF filed its statement of issues, can be found here.

Court Approves Tight Deadlines for Overdue Risk Evaluations

The D.C. District Court has entered two consent decrees concerning over twenty overdue Toxic Substances Control Act (TSCA) risk evaluations, holding the incoming administration’s EPA to aggressive deadlines for completing the chemical reviews.

The consent decrees, approved November 22, concern 20 risk evaluations initiated by EPA in December 2019 and two manufacturer-requested risk evaluations initiated in January 2020.  None were completed within TSCA’s 3.5-year deadline.

Under the consent decrees, linked here and here, EPA will be required to complete:

  • Draft risk evaluations for six of the substances, including 1,3-butadiene, by December 31, 2024;
  • Final risk evaluations for TCEP, formaldehyde, 1,1-dichloroethane, and DIDP by December 31, 2024;
  • A final risk evaluation for DINP by January 15, 2025;
  • A draft risk evaluation for one of the remaining substances by March 31, 2025;
  • Final risk evaluations for seven of the substances, including 1,3-butadiene, by December 31, 2025; and
  • Final risk evaluations for the remaining 10 substances by December 31, 2026.

The deadlines are largely unchanged from those in the proposed consent decrees, released in April and discussed in a previous blog post.  Since then, EPA has released a final risk evaluation for TCEP and drafts for 1,1-dichloroethane, DINP, and 1,3-butadiene.  However, as it stands, EPA will be required to complete three more final risk evaluations before the end of 2025—and a fourth before the presidential transition.

Meanwhile, EPA looks likely to designate another five chemicals as “high priority” this December, automatically triggering new risk evaluations.  More on those chemicals can be found here.

CEH Sues Chemical Company over CDR Import Reporting Omissions

The Center for Environmental Health (CEH) has sued AOC, LLC, a resins and specialty materials company, alleging that it failed to report imports under EPA’s Chemical Data Reporting (CDR) rule.  The Toxic Substances Control Act citizen suit is the latest of several complaints filed by CEH against chemical importers for alleged CDR violations.

CEH’s complaint, filed June 20, 2024, alleges that AOC imported hundreds of thousands of pounds of phthalic anhydride, neopentyl glycol, and dicyclopentadiene during the 2020 CDR reporting period.  However, despite the imports greatly exceeding CDR’s 25,000-pound threshold, the complaint claims that no evidence of the imports were found in EPA’s CDR database.

“CDR reporting is an essential tool for tracking the production and use of toxic substances,” the complaint states. “AOC’s failure to report large chemical imports under the CDR rule weakens the ability of EPA and local communities to evaluate and protect against serious threats to health.”

The complaint does not say how CEH identified the alleged imports.  However, the organization stated that it uncovered a previous violation through a “search of publicly available data” on chemical imports.

CEH filed similar complaints against three importers in June 2021.  A CEH notice also prompted the Chevron Phillips Company to disclose numerous violations concerning 24 chemicals in July 2021, according to a CEH press release.

Update

On October 30, 2024, CEH announced that it had filed additional suits against Entegris, Inc. and Lubrizol Corp. for alleged 2020 CDR reporting period violations.  According to the complaints, Entegris failed to report cobalt sulfate and phosphoric acid imports and Lubrizol failed to report 2-propylheptanol and di-(2-ethylhexyl)amine imports.

The press release also announced that CEH reached a settlement with AOC.  “[AOC’s] diligent response to CEH’s concerns is to be commended,” CEH attorney and former EPA official Bob Sussman said.

California Sues ExxonMobil for Deceptive Marketing on Plastic Recycling

ExxonMobil deceived the people of California by falsely promoting single-use plastics as sustainable, a complaint filed by California’s attorney general on September 23, 2024, alleges.

The lawsuit, filed in the San Francisco County Superior Court, argues that ExxonMobil conducted a “decades-long campaign of deception” to convince the public that plastics recycling was a sustainable solution to plastic waste, despite knowing that plastics recycling “is technically and economically nonviable to handle the amount of plastic waste [the company] produces.”  ExxonMobil is the largest producer of plastic polymers in the world.

“ExxonMobil’s deceptions undermined consumers’ ability to make informed choices to avoid the catastrophic harms we are experiencing,” the complaint states.  The attorney general asserts that “single-use plastic chokes our waterways, poisons our oceans, harms already endangered and threatened wildlife, blights our landscapes, contaminates the recycling stream, increases waste management costs, pollutes our drinking water, and expands landfills.”

Special focus was given in the complaint to ExxonMobil’s claims about “advanced recycling,” a collection of non-mechanical recycling technologies designed to convert certain plastic wastes into “fuels, chemicals, waxes, and petrochemical feedstock.”  According to the suit, ExxonMobil conceals several key limitations of its advanced recycling program, including that only 8% of processed waste becomes new plastic and that its “certified circular polymers” are made of “virtually no waste plastic.”

The lawsuit alleges violations of state nuisance, natural resources, water pollution, false advertisement, and unfair competition laws.  The complaint seeks abatement funds, disgorgement, and civil penalties.  California’s attorney general reportedly said they want “billions of dollars” for the abatement fund.

It has been reported that ExxonMobil responded by claiming that California officials have known for decades that their state recycling program is ineffective, arguing that the officials “failed to act, and now…seek to blame others.” The company has been quoted as asserting that “[i]nstead of suing us, they could have worked with use to fix the problem and keep plastic out of landfills.”

Irene Hantman and Philip Moffat Present on Green Marketing at PSX 2024

Verdant Law is pleased to announce that Irene Hantman and Philip Moffat presented on green marketing and product stewardship at the PSX 2024 conference in Denver.  Their October 16 presentation covered greenwashing, US regulation of green marketing, and enforcement and litigation.

Green marketing is on the rise, partly because consumers are willing to pay more for “green” products. However, many green marketing claims are overstated.  In the presentation, Ms. Hantman and Mr. Moffat described the various ways in which green marketing claims can be misleading and the potential consequences of deceptive marketing.

Special focus was given to the Green Guides, guidance published by the Federal Trade Commission (FTC) that helps advertisers avoid making unfair or deceptive claims.  While the Green Guides are non-binding, they provide insight into what advertising claims the FTC may determine to be illegal.  The presentation noted that the FTC is considering whether the Green Guides should be codified as rules and whether the commission should revisit its guidance for terms like “recyclable” and “degradable.”

The presentation also covered notable enforcement actions and litigation pertaining to green marking, including California’s recent suit against ExxonMobil for deceptive public messaging about plastic recycling.  Ms. Hantman and Mr. Moffat concluded by emphasizing the importance of developing green marketing claims that are clear, specific, and substantiated with evidence.

PSX is an annual conference hosted by the Product Stewardship Society.  According to its website, PSX is “the most comprehensive leadership forum for strategies that guide product stewardship professionals in an ever-changing global economy.”  Ms. Hantman serves on the PSX Conference Program Committee.

If you have any questions about the presentation, please contact Ms. Hantman or Mr. Moffat.

Maine Releases Draft Language Clarifying Proposals for Currently Unavoidable PFAS

This August, the Maine Department of Environmental Protection (DEP) released draft language to implement April 2024 amendments to Maine’s PFAS in products legislation.  The draft language was described by DEP as an “initial, informal outreach process” with the goal of initiating rulemaking this fall.

Under Maine’s PFAS in Products law, DEP has broad authority to determine whether PFAS uses are “currently unavoidable.”  Currently unavoidable uses (CUUs) will be granted a five-year exemption to the amended statute’s incremental sales prohibitions for products containing intentionally added PFAS.

Tight timelines

Under the draft language, CUU proposals would only be accepted 18–36 months prior to the applicable sales prohibition or 12–24 months prior to the expiration of an existing CUU determination.  However, sales prohibitions for cleaning products, cookware, cosmetics, and other products containing intentionally added PFAS take effect in less than 18 months (January 1, 2026).  In an October 1 email, DEP stated that they “recognize the tight timeline with the new statutory prohibitions starting in 2026 and are making efforts to streamline the process as much as possible.”

DEP solicited currently unavoidable use proposals for the 2026 prohibitions earlier this year, before the April amendments forced the department to redraft its rulemaking.  In the email, DEP clarified that they are “still considering” whether they will be able to utilize some of the previously submitted information and that “manufacturers may need to resubmit information” to meet the requirements of the eventual final rule.

Proposal requirements

According to the draft language, proposals for CUU determinations could be submitted by manufacturers individually or collectively.  A separate proposal would be required for each combination of product category and industrial sector.  As part of the proposal, manufacturers would be required to include:

  • An explanation of why use of PFAS in the product is “essential for health, safety or the functioning of society” and “essential to the function of the product”;
  • A description of whether alternatives to the use of PFAS are reasonably available;
  • Information on whether and how other states have regulated the use of PFAS in the product; and
  • Known or reasonably ascertainable information on the product’s health and environmental impacts.

The draft language “strongly recommends that all proposals for currently unavoidable use determinations do not contain claims of confidentiality” because “the Department may determine that there is insufficient publicly available information to justify a rulemaking.”

Other provisions of the draft rulemaking, including the notification requirements for manufacturers of products covered by a currently unavoidable use determination, largely mirror the requirements of the amended statute.  More information on the April 2024 amendments can be found in a previous blog post.

Third Circuit FIFRA Preemption Ruling Creates Circuit Split

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts a Pennsylvania law that allegedly requires Monsanto to include a cancer warning on its “Roundup” weedkillers, the Third Circuit ruled on August 15, 2024.  The decision in Schaffner v. Monsanto Corp. creates a split with the Ninth and Eleventh Circuits, which have found that similar state-level duty to warn laws were not preempted because the state-law labelling requirements were equivalent to a requirement under FIFRA.

Like the Ninth and Eleventh circuits, the Third Circuit applied a “parallel requirements” test outlined by the Supreme Court in Bates v. Dow Agriscience LLC to determine whether the state law diverged from FIFRA requirements.  Those circuits determined that the state laws were not preempted because they were equivalent to FIFRA’s statutory definition of “misbranding.”

But the Third Circuit ruled that those circuits erred when conducting the test by failing to take into account EPA regulations limiting the modification of precautionary statements on labels.  According to the court, these regulations would require Monsanto to seek EPA approval before adding a warning.

“If EPA regulations specifically identify the contents required to be included on a pesticide label, a state-law requirement is preempted unless it is equivalent to that specific regulatory requirement,” the court said.  “The state-law duty cannot survive preemption simply because its standard of liability is equivalent to the broad statutory definition of misbranding.”

The highly technical decision had to contend with the Supreme Court’s holding in Bates, which it acknowledged “plausibly indicates that [FIFRA] does not on its own preempt all state-law duties to include a warning omitted from” its label.  The Third Circuit concluded that there was no discrepancy because the Supreme Court had not considered how regulations would affect preemption under FIFRA section 136v(b), which addresses preemption.

Writing for the panel, Chief Judge Michael A. Chagares rejected arguments that the Third Circuit should be bound to the Ninth Circuit’s decision.  “The complex subject of preemption under FIFRA has not been comprehensively analyzed in prior caselaw, and the Supreme Court has yet to address FIFRA preemption in the specific circumstances presented by this case,” the decision states.

He also noted that the Supreme Court’s recent overruling of Chevron deference did not undermine EPA’s authority to promulgate FIFRA regulations, including those requiring agency preapproval of product labels, because FIFRA explicitly grants EPA authority “to prescribe regulations to carry out the [statute’s] provisions.”

The Supreme Court denied Monsanto’s petition for certiorari in the Ninth Circuit’s case, Hardeman v. Monsanto Co., in 2022.  A blog post on the Eleventh Circuit’s case, Carson v. Monsanto Co., can be found here.

Class Action Targets 3M and Chemours for Suppressing PFAS Risks in Carpeting

Two Minnesota consumers who own PFAS-treated carpeting have sued 3M and Chemours, alleging that the chemical companies collaborated for decades to suppress information about the health and environmental risks of PFAS.

According to the complaint, the defendants knew that PFAS were dangerous as early as the 1950s but knowingly withheld evidence of their harms from EPA and the public.  The plaintiffs allege that when these companies shifted from using long-chain PFAS like PFOA and PFOS to shorter-chain variants like GenX and PFBS, they baselessly claimed that the shorter-chain variants were safer.  And even after many carpet manufacturers and retailers stopped making and selling carpeting containing PFAS, the complaint states that the defendants “continued to lie about the harms caused by [these] products.”

Products made by the defendants were used to treat carpets to make them stain- and soil-resistant.  However, the suit claims that carpet manufacturers were unaware that these products were dangerous, in part due to false or misleading safety data sheets provided by the defendants.  The proposed class action seeks to represent all persons who had carpeting installed prior to 2020, alleging that the defendants’ PFAS products were applied to “virtually all carpets manufactured in the United States” until that year.

The proposed class action’s claims are partially based on internal company documents released through other litigation, including a 2018 settlement reached between 3M and Minnesota over PFAS contamination in drinking water.  That case unearthed documents allegedly showing that 3M discouraged its scientists from discussing the chemicals in writing and stymied research efforts, despite knowledge that PFAS were severely toxic and widely present in human blood.

More large settlements were reached last year.  But the defendants “have not paid a dime for the grievous harms caused by carpets in homes and day-care centers infused with PFAS,” said the plaintiffs, who are seeking damages to replace contaminated carpeting.  These alleged harms include property damage resulting from PFAS emissions from the carpets, which reportedly continue throughout the carpet’s lifespan.

The suit alleges that the defendants violated the Racketeer Influenced and Corrupt Organizations Act as participants in a scheme to conceal PFAS harms for commercial gain.  The suit’s 127 counts also include a myriad of state law claims, including strict products liability and nuisance claims.

The complaint also includes allegations against PFAS manufacturer Daikin, which is not named as a defendant.

The case is Peterson v. 3M Co. (D. Minn.), No. 0:24-cv-0349.

Court Vacates EPA Test Order, Citing Incomplete Evidence in Public Record

On August 28, 2024, the D.C. Circuit issued an order in Vinyl Institute v. EPA, a case challenging a Toxic Substances Control Act (TSCA) test order issued in March 2022.  The mandate signals that neither party intends to appeal the court’s July 5 ruling, which found EPA’s justification for the test order inadequate.

The test order, which required an avian reproduction study of 1,1,2-Trichloroethane, was vacated and remanded to EPA.  However, the panel noted several places in which additional EPA materials would have satisfied TSCA’s “substantial evidence” standard if they were included in the public record, suggesting that EPA would not necessarily be required to perform additional analyses to justify future test orders as long as the analyses were included in the record.

For example, the court ruled that EPA’s “conclusory statements” in the public record on why vertebrate testing was necessary were inadequate, but also said that other documents showed that EPA considered new approach methodologies (as required by TSCA).  However, the court ruled that these documents—although covered by EPA’s brief—were not part of the administrative record that was available to the public, and that therefore “they are not part of the record subject to our review.”

According to the decision, not all studies referenced in the statement of need accompanying the test order were explained or even identified.  Nor did EPA publicly explain why those studies’ findings could not be used to fill the data gap, the court said.

“EPA should have explained why it could not extrapolate mammalian chronic exposure data to avian chronic exposure in its Statement of Need description of reasonably available information,” Judge Karen LeCraft Henderson wrote.  “Identifying close but ultimately inapplicable studies and explaining, in the record, why it could not extrapolate other potentially relevant findings could constitute substantial evidence.”

However, the court upheld EPA’s decision to issue a test order rather than pursuing a rule or consent agreement, agreeing with EPA that timeliness in acquiring the data was sufficient justification. EPA initiated the risk evaluation for 1,1,2-Trichloroethane in December 2019 but has yet to issue a report on its findings.

Judge Henderson also agreed that EPA was not required to demonstrate that exposure may exist at potentially toxic levels before issuing a test order.  That would “reverse[]…TSCA’s allocation of burdens,” the decision states.

Judge Henderson was joined in full by Judge Florence Pan and in part by Judge Justin Walker.  A previous blog post on the case, written after the December 2023 oral argument, can be found here.