Court Approves Tight Deadlines for Overdue Risk Evaluations

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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.

Science Advisory Board to Review Co-exposure Approach to TSCA Risk Evaluations

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This October, the Science Advisory Board (SAB) received an EPA briefing on a proposed “screening level analysis” that could account for cumulative chemical exposures in Toxic Substances Control Act (TSCA) risk evaluations.

Released in September 2023, EPA’s draft approach is designed to support the identification of potentially exposed or susceptible subpopulations (PESS) and co-exposures with other chemicals.  It relies heavily on AirToxScreen, a modelling tool already used by EPA to estimate chemical inhalation exposure and risk at the national level.

The draft approach “can be used to better inform chemical co-exposure, highlight geographic areas or population groups that may experience disproportionate impacts, and identify areas that may need more targeted or higher tier exposure and risk characterization.”  It is not intended to be “used as a sole basis for health or regulatory action,” however.

Limitations to the draft approach include its narrow focus on industrial releases to air and reliance on annual data, which makes it impossible to determine whether releases occurred concurrently.  In addition, the model does not calculate “a total additive exposure or total additive risk across the chemicals included in the analysis.”

Historically, TSCA risk evaluations have evaluated a single chemical and considered routes of exposure separately.  However, in a slideshow from the October 15–16 SAB meeting, EPA noted that there is “wide acknowledgement in [the] scientific and regulatory community [that] multiple facility and chemical exposures” meaningfully intersect.

The agency also emphasized the environmental justice concerns tied to cumulative exposures, which disproportionately affect marginalized communities.

The SAB is expected to provide formal comments on the approach in the coming months.

Industry Petitioners Challenge EPA’s Use of TSCA to Regulate Workplace Chemical Exposures

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Industry petitioners are arguing before the D.C. Circuit that EPA has overstepped its authority under the Toxic Substances Control Act (TSCA) by assuming powers to regulate worker chemical exposures—powers that they argue that rightfully belong to OSHA.

United Steel Workers v. EPA, No. 24-1151, consolidates multiple cases challenging EPA’s May 2024 revisions to the procedures for TSCA risk evaluations.  That rule reversed key Trump-era policies by requiring the agency to consider all possible uses of a chemical, issue a single risk determination, and not assume PPE usage.

The industry petitioners, which include the Texas Chemistry Council and the American Chemistry Council, are challenging these changes in full.  However, their October 10 brief also questions EPA’s ability to circumvent OSHA’s role in regulating workplace chemical exposures, arguing that “TSCA is not, and was not intended to be, a worker protection law.”

Their arguments center on TSCA section 9, which allows EPA to report a chemical’s unreasonable risks to another agency if EPA believes they could mitigate the risks.  “In context, TSCA requires EPA to refer regulation of TSCA chemicals that pose unreasonable risks to workers to OSHA if regulation under the OSH Act may prevent or reduce risks of chemical exposure in the workplace,” the industry petitioners’ brief states.  “Only if the referral agency fails to act may EPA proceed to regulate those risks to workers.”

The industry petitioners additionally argue that EPA should give greater consideration to existing OSHA regulations, including those requiring the use of PPE, when considering chemical exposures to workers.  However, a collection of labor petitioners in the case contend that EPA should be prohibited from considering PPE entirely during risk evaluations, asserting that the agency’s approach “confuses risk evaluation with risk management.”

EPA has declined to exercise its referral powers in recent rulemakings, arguing that “gaps exist between OSHA’s authority to set workplace standards under the OSH Act and EPA’s obligations under TSCA section 6 to eliminate unreasonable risk.”  For example, according to EPA, OSHA must consider the economic and technological feasibility of regulation in circumstances where EPA does not.

More on EPA’s 2024 revisions to the procedures for TSCA risk evaluations can be found in a previous blog post.

California Sues ExxonMobil for Deceptive Marketing on Plastic Recycling

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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

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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.

eBay Not Liable for Environmental Violations on Its Platform, Court Rules

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A federal judge has dismissed a lawsuit brought by the Justice Department against eBay for allegedly selling products that violate environmental statutes, holding that eBay cannot be held liable under an internet speech law.

The September 30 order in United States of America v. eBay, Inc., No. 23-CV-7173, applies section 230 of the Communications Decency Act (CDA), which shields providers of interactive computer services from being “treated as the publisher” of information “provided by another information content provider.”

Because eBay did not “materially contribute to the illegal products’ ‘alleged unlawfulness,’” it is immune for content on its platform, the U.S. District Court for the Eastern District of New York held.

The government’s complaint alleged the sale of “hundreds of thousands” of products in violation of the Clean Air Act (CAA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA), including automobile aftermarket defeat devices and unregistered pesticides.

The court also held that the challenges under the CAA and FIFRA would have failed regardless of CDA immunity because those laws require illegal products to be “sold” for a violation to occur.  “To ‘sell’ an item one must either possess the physical item or its title” and eBay possesses neither, the order states.

But the alleged TSCA violations—the distribution of products illegally containing methylene chloride—could have proceeded, the court noted, because TSCA only requires that a product be “introduc[ed] into commerce” for a violation to occur.

An earlier blog post on the case can be found here.

Maine Releases Draft Language Clarifying Proposals for Currently Unavoidable PFAS

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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

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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.

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

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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.

EPA Issues Seldom-Used Emergency Order to Suspend Registrations of Pesticide DCPA

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For the first time in almost 40 years, EPA has issued an emergency order under section 6(c)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act to suspend the registrations of all pesticide products containing the active ingredient dimethyl tetrachloroterephthalate (DCPA).

The emergency measure is based on DCPA’s thyroid effects in fetuses, which EPA deemed so severe that continued use of DCPA during the time period required to cancel its registrations would pose an imminent hazard.  According to EPA, thyroid hormone perturbations linked to DCPA “can lead to downstream health problems such as low birth weight, impaired brain development, decreased IQ, impaired motor skills, and decreased bone deposition.”

Occupational exposures to DCPA can be over twice as high (as a factor of body weight) as the level at which the thyroid effects were observed in mouse fetuses, and the herbicide’s residues present risks of concern even 30 days after application to crops, EPA said.  DCPA is also registered for non-agricultural uses, including on golf courses and athletic fields.

American Vanguard Corporation (AMVAC), the sole registrant of DCPA, voluntarily canceled all but two of its DCPA products and their use on turf.  It also voluntarily ceased sale and distribution of the only remaining end-use product until EPA approved product labels that would address DCPA’s risks.  However, EPA “determined that there is no combination of practicable mitigations under which DCPA use can continue without presenting an imminent hazard.”

DCPA is currently undergoing registration review, which occurs every 15 years.  EPA assessed DCPA’s health risks in 2023 after AMVAC submitted a study on its thyroid effects and other information requested by the agency.

The agency intends to issue a notice of intent to cancel DCPA registrations within 90 days of the order, which was published on August 7, 2024.

Also known by its trade name Dacthal, DCPA is used on a variety of crops for weed control.  According to EPA, the emergency order will have a negligible impact on produce prices but may impact growers of crops including bok choy, collards, kale, green onions, and leeks.

Update:

On August 28, 2024, EPA announced that it is initiating a voluntary cancellation of DCPA after AMVAC notified the agency of its intent to cancel the remaining pesticide products.  According to EPA, AMVAC also intends to cancel its international registrations.