European Court of Justice Upholds Decision Annulling Harmonized Classification and Labeling of Titanium Dioxide
On August 1, 2025, the European Court of Justice (ECJ) issued a judgment upholding the 2022 decision of the General Court annulling the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court annulled the European Commission’s (EC) decision to classify titanium dioxide as a suspected human carcinogen. The French government and the EC appealed the decision, arguing that the court exceeded the limits of permissible judicial review of an EC decision and that the court incorrectly interpreted the concept of “intrinsic properties” as it appears in the Classification, Labeling, and Packaging (CLP) Regulation.
Background
In 2016, the competent French authority submitted a proposal to the European Chemicals Agency (ECHA) to classify titanium dioxide as a category 1B carcinogenic substance (carcinogenic to humans). In 2017, ECHA’s Committee for Risk Assessment (RAC) adopted an opinion classifying titanium dioxide as a category 2 carcinogen (suspected human carcinogen), including the hazard statement “H 351 (inhalation).” On the basis of RAC’s Opinion, the EC adopted Regulation 2020/217, implementing the harmonized classification and labeling of titanium dioxide, recognizing that the substance was suspected of being carcinogenic to humans, by inhalation, in powder form containing one percent or more of particles of a diameter equal to or less than ten micrometers (µm). The transition period for adoption of these changes ended October 1, 2021. The applicants, in their capacity as manufacturers, importers, downstream users, or suppliers of titanium dioxide, brought actions before the General Court for the partial annulment of Regulation 2020/217.
The General Court held that the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied. According to the press release, in recognizing that the results of a scientific study on which it based its opinion on the classification and labeling of titanium dioxide were sufficiently reliable, relevant, and adequate for assessing the carcinogenic potential of that substance, RAC committed “a manifest error of assessment.”
ECJ Judgment
According to ECJ’s August 1, 2025, press release, the ECJ “upholds the judgment of the General Court and the annulment of the contested classification of titanium dioxide as a carcinogen.” In its judgment, the ECJ notes that although the lower court erred in finding that “it was for it to assess the appropriateness of the choice of the standard density value of titanium dioxide particles used by the RAC for the purposes of applying the Morrow calculation, it did not err in law in holding that the RAC had failed to take into account all the relevant factors in order to calculate the lung overload for the purposes of the assessment of the Heinrich study by means of that calculation.” The press release states that according to the ECJ, “even though the General Court exceeded the limits of its judicial review, the annulment of the contested classification and labelling is nevertheless justified.” The lower court “was fully entitled to hold that the RAC had failed to take into account all the relevant factors for the purposes of assessing the scientific study in question.”
As reported in our March 11, 2025, blog item, the European Union (EU) Advocate General (EU AG) recommended in February 2025 that the ECJ overturn the lower court’s decision. EU AGs are responsible for presenting, with complete impartiality and independence, opinions in assigned cases, and their opinions are non-binding.
Trump EPA Seeks Reversal of Ruling That Typical Levels of Drinking Water Fluoridation Present an Unreasonable Risk to Health
As reported in our February 13, 2025, blog item, on January 17, 2025, the Biden U.S. Environmental Protection Agency (EPA) filed a notice of appeal of the September 2024 lower court decision finding that the plaintiffs established by a preponderance of the evidence that the levels of fluoride typical in drinking water in the United States pose an unreasonable risk of injury to the health of the public. Food & Water Watch v. EPA (No. 25-384). At that time, it was unknown how the Trump EPA would proceed. On July 18, 2025, EPA filed its opening brief in the U.S. Court of Appeals for the Ninth Circuit, arguing that the lower court’s decision should be reversed. EPA’s arguments include:
Plaintiffs’ only relevant standing declarant has water that naturally contains fluoride, and Plaintiffs do not ask that the water utility remove naturally occurring fluoride. Thus, according to EPA, Plaintiffs’ injury is not caused by the addition of fluoride to drinking water, and no available remedy will redress it.
EPA states that the U.S. District Court for the Northern District of California violated Section 21 of the Toxic Substances Control Act (TSCA) by “permitting Plaintiffs to rely on evidence not first presented to EPA in the petition and reviewed by EPA in denying the petition.” EPA notes that the court’s final decision “overwhelmingly relied on voluminous evidence that did not even exist at the time of the original petition, and which was therefore not presented in the petition to EPA.” According to EPA, “allowing the consideration of new evidence on a rolling basis throughout the proceedings is contrary to statutory text and frustrates the purpose of TSCA Section 21’s mandatory exhaustion requirement.” The approach “would undermine EPA’s ability to meet TSCA’s prioritization, risk-evaluation, and risk-management deadlines, and it would require EPA to proceed to risk management with a record insufficient to satisfy TSCA’s rigorous scientific and regulatory standards.”
EPA claims that the court “abused its discretion by commandeering the trial and administrative proceedings in violation of the party-presentation principle.” Refusing to rule after the close of evidence at the first trial, and “the court’s determination to accumulate more evidence that it, rather than the parties, thought proper, transformed the court from a neutral arbiter into an advocate, and transformed TSCA Section 21 from a citizen-petition provision into a license for judicial rulemaking.”
EPA states that it “continues to disagree with the district court’s merits order purporting to apply TSCA’s scientific standards.” According to EPA, rather than asking the court to review the district court’s factual findings on the “technical, complex scientific issues,” it presents “more straightforward legal grounds for reversal.” Food & Water Watch’s answering brief is due September 17, 2025.
Groundbreaking $2 Billion Environmental Settlement Makes History and Holds Polluters Accountable for Contamination in New Jersey
Monday, August 4, the State of New Jersey announced a landmark settlement with DuPont and related companies (“DuPont Defendants”) valued at more than $2 billion, the largest environmental recovery for a single State – and one of the top-20 largest settlements of any kind – in U.S. history.
The landmark agreement settles the State’s case against DuPont regarding PFAS (per- and polyfluoroalkyl substances), also known as “forever chemicals,” contamination across the State and addresses PFAS and other contamination at and from four historical DuPont industrial sites: Chambers Works, Parlin, Pompton Lakes Works, and Repauno. DuPont’s decades-long use and discharge of PFAS has polluted drinking water and natural resources throughout New Jersey.
PFAS are known for their resistance to degradation, meaning they persist in the environment. Several PFAS, like PFOA, have been linked to health effects including kidney and testicular cancer, and reproduction issues. In 2005, the US EPA found that DuPont concealed the toxicological effects of PFOA, including that the chemical passes through the human placenta. New Jersey was the first State to pass a PFAS drinking water standard in 2018. The federal government passed a regulation establishing Maximum Contaminant Levels (“MCLs”) for certain PFAS, including PFOA, in 2024. In 2025, USEPA confirmed that PFOA is likely to be carcinogenic to humans following “the EPA’s systematic review of over 780 human and animal health studies demonstrated PFOA exposure elicits adverse noncancer and cancer health effects.”
The State originally filed suit against E.I. du Pont de Nemours and Co. (now known as EIDP, Inc.), The Chemours Company, Corteva, Inc., and DuPont de Nemours, Inc., and the 3M Company in 2019 due to contamination from the Chambers Works site currently owned by a Chemours, a DuPont spin-off. After years of extensive discovery and mediation guided by Special Master Judge Joel Schneider, the parties were set for trial on May 19, 2025. This marked the first State case in the country to go to trial for PFAS contamination, remediation, and natural resource damages.
Five days before trial was to commence, the State reached a settlement with one of the Defendants – the 3M Company (“3M”) – for $450 million. 3M manufactured PFAS and sold them to other companies, including DuPont, which utilized the chemicals in its manufacturing operations at issue in this case. The funds from the 3M settlement will compensate the citizens of New Jersey for injuries to their natural resources, fund projects to address PFAS contamination of drinking water supplies and other environmental media, and reimburse NJDEP and other arms of the State for costs incurred to investigate and prosecute claims based on PFAS contamination.
The trial against the DuPont Defendants began in Camden, New Jersey on May 19, before Chief Judge Renée Marie Bumb, U.S. District Judge for the District of New Jersey. For four weeks, the State tried five combined bench trials on statutory liability claims against the DuPont entities related to PFAS, including PFOA, and other contamination discharged from DuPont’s Chambers Works site on the banks of the Delaware River. The State litigated its causes of action including alleged violations of the New Jersey Spill Compensation and Control Act (“Spill Act”) and the Water Pollution Control Act arising from DuPont and Chemours’ unauthorized discharge of PFAS and other contaminants into the waters of the State.
The DuPont Defendants asserted numerous defenses to each aspect of the State’s claims, including that the State was barred from pursuing the claims under the doctrines of laches and estoppel, that prior remedial decisions prevented the remediation at and from Chambers Works, that PFAS was not covered under the State’s environmental laws, that DuPont was released for natural resource damages liability through prior administrative actions, that DuPont was exempted from liability under the government contractor defense, that the State’s claims violated DuPont’s due process rights, and numerous other defensive theories and arguments. These issues were all tried this summer as part of the State’s case to establish the liability of DuPont and Chemours under the Spill Act, Brownfield Act, and Water Pollution Control Act.
During trial, the DuPont Defendants stipulated to drop a majority of their pleaded defenses, and to a geographical “nexus” defining the scope of liability under the Spill Act. On May 30, the Court ruled in favor of the State with regard to the administrative defense, finding that the Consent Order did not release DuPont from PFAS liability and contained conditions precedent that were not satisfied by the company. The Court had not ruled on the other claims or defenses at the time of the settlement.
The trial continued with extensive fact and expert witness testimony until June 9, when the Court recessed. Trial was set to resume on June 30 with a sixth bench trial on the State’s fraudulent transfer claims related to DuPont’s 2015 restructuring. The Court also planned to conduct a jury trial in the Fall of 2025 on the State’s common law claims, including negligence and public nuisance, and all damages. However, during the recess, the parties reached this landmark settlement.
Lead counsel for the State of New Jersey was Kelley Drye & Warren LLP, which tried the case alongside New Jersey Deputy Attorney General Gwen Farley and the Law Offices of Jack Dema.
The settlement is valued at more than $2 billion. Foundational to the settlement is the agreement that DuPont is responsible to remediate the Chambers Works, Parlin, Pompton Lakes, and Repauno industrial sites, to address PFAS released from the Chambers Works and Parlin Sites, and to pay all costs and damages called for under the settlement. DuPont operated some of these sites for more than a century, causing massive PFAS and other contamination, and significant injuries to New Jersey’s waters and other natural resources. The remainder of the settling defendants are agreeing to stand behind the remediation and funding obligations of DuPont, ensuring that the polluter pays and not New Jersey taxpayers.
In addition to the DuPont Defendants’ absolute obligations to remediate the contamination at and from these four industrial sites, they have agreed to establish financial assurance mechanisms at the four sites, which may total more than $1.2 billion by the terms of the agreement. In addition,, Corteva and New DuPont have agreed to create another $475 million “Reserve Fund” to be held in trust by a third-party. The fund will back up the primary financial assurance mechanisms and add another layer of protection for the State to ensure these obligations do not fall to the taxpayers of New Jersey.
Additionally, the DuPont Defendants have agreed to pay the State $875 million for PFAS abatement costs and natural resource damages across the State, and to reimburse and pay the State’s costs in addressing PFAS and litigating these claims.
EPA Extends Certain Compliance Deadlines for Oil and Natural Gas Clean Air Act Requirements
On July 31, 2025, EPA published in the Federal Register its highly anticipated Interim Final Rule to extend several deadlines in 40 C.F.R. Part 60, Subparts OOOO, OOOOa, OOOOb and OOOOc that were promulgated in EPA’s 2024 Methane Rule. 90 Fed. Reg. 35966 (July 31, 2025). That same day, environmental groups filed a lawsuit challenging the Interim File Rule. Envtl. Defense Fund v. U.S. EPA, Case #25-1164 (D.C. Cir.). Absent a stay by the court, which the environmental groups are currently not seeking, the Interim Final Rule and the various extended deadlines are effective.
Summary of Deadline Extensions
The Interim Final Rule extends numerous compliance deadlines for oil and gas air emission sources subject to the New Source Performance Standards in 40 C.F.R. Part 60 Subparts OOOO, OOOOa, OOOOb and OOOOc. The previous compliance deadlines were published in a March 2024 final rule. 89 Fed. Reg. 16820 (March 8, 2024). The Interim Final Rule, which became effective upon publication, extends many deadlines in OOOOb, the date that the requirements of the Super-Emitter Program apply with respect to OOOO, OOOOa, and OOOOb, and the date by which states must submit plans to EPA pursuant to the OOOOc emissions guidelines.
EPA extended the following OOOOb compliance deadlines to at least January 22, 2027:
Process Controllers: The date by which process controller affected facilities are required to be zero-bleed devices. 40 CFR §§ 60.5370b(a)(5)(i), 60.5390b(a), 60.5415b(h)(1).
Storage Vessels:
The date by which receiving additional crude oil, condensate, intermediate hydrocarbons, or produced water throughput at tank batteries triggers a modification. 40 CFR § 60.5365b(e)(3)(ii)(C) and (D).
The date by which a legally and practicably enforceable limit used to determine the potential VOC and methane emissions from a storage vessel must include the elements provided in paragraphs 40 CFR § 60.5365b(e)(2)(i)(A) through (F). 40 CFR § 60.5365b(e)(2)(i).
The date by which the potential for VOC and methane emissions from storage vessels must be calculated using a generally accepted model or calculation methodology that accounts for flashing, working, and breathing losses, based on the maximum average daily throughput to the tank battery determined for a 30-day period of production. 40 CFR § 60.5365b(e)(2)(ii).
Covers and Closed Vent Systems: The date by which a required closed vent system or cover must be designed and operated with no identifiable emissions and corresponding inspections must be performed. This new compliance deadline is 18 months after the date the Interim Final Rule is published in the Federal Register or upon startup, whichever is later. 40 CFR §§ 60.5411b(a)(3), § 60.5411b(b)(4), 60.5416b(a)–(b).
Control Devices: The date by which you must install and operate a continuous burning pilot or combustion flame, as applicable, and the date by which an alert must be sent to the nearest control room whenever the pilot or combustion flame is unlit. 40 CFR §§ 60.5412b(a)(1)(viii) and (3)(viii), 60.5413b(e)(2), 60.5415b(f)(1)(vii)(A)(1), 60.5417b(d)(8)(i), 60.5417b(i)(6)(v).
EPA also gave regulated facilities until November 28, 2025, or 180 days after startup, whichever is later, to comply with continuous monitoring system requirements for enclosed combustors or flares. 40 CFR §§ 60.5370b(a)(9)(i) and (iii).
Regarding OOOOc, the EPA emission guidelines that States are required to use when regulating existing sources (i.e., regulated emission sources that commenced construction, modification, or reconstruction on or before December 6, 2022), EPA extended the deadline for States to submit their OOOOc plans to January 22, 2027. 40 CFR § 60.5362c(c). As indicated in our recent Alert, the Pennsylvania Department of Environmental Protection (“PADEP”) has issued public notice and provided an opportunity for comment for its proposed OOOOc plan. The comment period on PADEP’s proposed OOOOc plan closed on July 30, 2025. Several commenters urged PADEP to delay implementation of the OOOOc plan until EPA finalizes its reconsideration of OOOOc, and others raised concerns about PADEP’s analysis, or lack thereof, related to considering the “remaining useful life and other factors” when devising the proposed OOOOc plan requirements. PADEP’s proposed OOOOc plan noted the original March 2026 deadline for submission to EPA. It remains to be seen whether PADEP will continue moving forward with its plan given that it now has an additional 10 months to finalize and submit Pennsylvania’s OOOOc plan to EPA for approval.
EPA also extended deadlines in OOOOa and OOOOb associated with the so-called “super emitter program” created under the March 2024 Methane Rule. In the preamble for the Interim Final Rule, EPA notes that in implementing the “super emitter program,” which would allow EPA-approved third parties (using EPA-approved technologies) to provide EPA with data on super-emission events, “EPA has experienced unanticipated difficulties and concerns that require additional time for effective and lawful administration of various program procedures.” 90 Fed. Reg. at 35976. EPA is delaying implementation of the super-emitter program until after January 22, 2027, during which time EPA will not act on applications seeking approval for remote-detection technologies for use under the program. See 40 CFR §§ 60.5371a and 60.5371b.
The Interim Final Rule indicates that EPA may make additional, substantive revisions to the 2024 Methane Rule in a separate reconsideration action. EPA invites comments on the revisions in the Interim Final Rule by September 2, 2025, even though the rule became effective on July 31, 2025.
Environmental Groups’ Challenge
Ten environmental groups promptly filed a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit, challenging the Interim Final Rule. The Court has set initial filing deadlines, including a deadline to file any dispositive motions by September 18, 2025. A briefing schedule has not been established.
Press releases by the environmental groups suggest that they may attack the Interim Final Rule on both procedural and substantive groups. Procedurally, the grounds contend that EPA violated the law by offering no opportunity for public input. Substantively, the groups indicate that they plan to defend the 2024 Methane Rule requirements, including the original deadlines and requirements of that rule.
EPA Continues Aggressive Enforcement of Pesticide Laws, and Penalties Are Increasing
While the Trump Administration has emphasized regulatory reform and prioritized agency efficiency across the federal government, EPA continues to pursue aggressive enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Actions taken by EPA over the first six months of President Trump’s current term demonstrate sustained FIFRA enforcement, with notably high penalty amounts being assessed, including one case resulting in a $3 million penalty. These latest enforcement trends signal that pesticide manufacturers, distributors, and sellers must remain vigilant in complying with FIFRA requirements.
Environmental Enforcement Landscape
In the initial weeks of the Trump Administration, EPA and the Department of Justice (DOJ) took time to review enforcement actions ongoing from the Biden Administration and determine their new priorities. Within days of President Trump’s inauguration, DOJ temporarily froze all environmental litigation to allow for review and potential reconsideration of the new administration’s litigation positions. Similarly, on January 24, acting senior career leadership at EPA temporarily halted all communications with external parties—which effectively froze administrative enforcement—while incoming leadership began to review pending actions for consistency with administration policies. On February 19, President Trump issued an Executive Order (EO) titled Ensuring Lawful Governance and Implementing The President’s “Department Of Government Efficiency” Deregulatory Initiative. Among other things, that EO instructed agencies to “preserve their limited enforcement resources by generally deprioritizing” enforcement for rules that are “based on anything other than the best reading of a statute” or that go “beyond the powers vested in the Federal Government by the Constitution.”
On March 12, Jeffrey Hall, then-acting Assistant Administrator of EPA’s Office of Enforcement and Compliance Assurance (OECA) (and now President Trump’s nominee to permanently lead OECA), issued a memorandum to provide initial guidance on implementing the fiscal year 2024–2027 National Enforcement and Compliance Initiatives (NECIs) consistently with the February 19 EO (among others) and the Five Pillars of EPA Administrator Zeldin’s “Powering the Great American Comeback” Initiative.
After the initial temporary freeze and policy realignment, enforcement picked up, with case conclusions beginning to emerge, and the pace increasing over time. According to EPA, between January 20 and May 7, 2025, the Agency concluded 126 national-priority civil enforcement cases under the NECIs, an increase compared to 97 concluded cases over the same period last year. During that time, the Agency also opened 66 criminal cases (60 same period last year) and sentenced 43 criminal defendants (28 same period last year). By contrast, from January 20 through late June, DOJ had filed only three new environmental civil enforcement actions in federal court, compared to 60 cases opened during all of fiscal year 2024.
FIFRA Administrative Enforcement on the Rise
While the government has scaled back civil environmental enforcement in federal court, EPA’s administrative enforcement under FIFRA remains robust and appears to be accelerating. In the past two months alone, EPA has assessed its three largest penalties of the year so far, including one $3 million penalty and two $1.1 million penalties, in three separate actions. Nine additional settlements included six-figure penalties, and 19 more had five-figure amounts.
EPA has already assessed more FIFRA penalties in the first six months of this administration than it did in all of 2022 ($6.7 million) and 2023 ($7.09 million). If this pace continues, total penalties may exceed EPA’s 2021 high-water mark of $12.43 million, when enforcement surged due to Covid-related violations.
As of July 30, 2025, EPA had taken 122 administrative enforcement actions under FIFRA, including:
40 “expedited” settlement agreements (ESA), which are used to resolve easily correctable violations that do not pose significant health or environmental harm and offer a discounted, non-negotiable settlement in lieu of a formal administrative process. In January, EPA launched its FIFRA Pilot Program, which encourages resource prioritization through expedited resolution of cases involving certain minor FIFRA violations. Congruently, the ESAs on the docket resolved violations for failure to file annual pesticide production reports. Penalties have ranged from $300 to $4,000, with an average penalty of about $1,100.
40 consent agreements and final orders (CAFOs), which are legally enforceable agreements the Agency uses to resolve violations that exceed the capacity of an ESA, often for distributing or selling unregistered or misbranded pesticides. Other common violations include utilizing mislabeled bulk tanks and failure to file notices of arrival with U.S. Customs and Border Protection for imported products. Penalties have ranged from $3,000 to $3 million, with an average penalty of about $213,000.
42 Notices of Refusal of Admission (NRAs), all issued by EPA Region 8, denying entry of pesticide imports at the United States’ northern border (Montana or North Dakota) for distribution or sale of misbranded pesticides and failure to correctly file required reports.
These enforcement trends are noteworthy for several reasons. First, they demonstrate that FIFRA violations can carry steep penalties, particularly where one type of violation occurs on many separate occasions. For example, the $3 million penalty involved more than 2,000 instances of distributing or selling unregistered pesticides and over 1,400 violations of a Stop Sale, Use, or Removal Order. Second, despite the highly complex and technical nature of pesticide regulation, many FIFRA violations are relatively straightforward to investigate, prove, and penalize. This makes them easy targets for enforcement under current directives to preserve agency resources and prioritize administrative enforcement actions. Third, despite this year’s earlier enforcement pauses, these FIFRA settlements continue to be approved, even with penalties in the six- and seven-figure range.
The continued approvals likely reflect EPA’s view that FIFRA enforcement is considered part of EPA’s “core” enforcement work. FIFRA enforcement is not part of the NECIs, and was not addressed in OECA’s March 12 NECI memo. Focusing on core work is one of EPA Administrator Zeldin’s top priorities for the Agency.
Changes in Criminal Enforcement
On May 9, President Trump issued an EO titled Fighting Overcriminalization in Federal Regulations. That EO discourages enforcement of “criminal regulatory offenses,” stating that “prosecution of criminal regulatory offenses is most appropriate for persons who know or can be presumed to know what is prohibited or required by the regulation and willingly choose not to comply, thereby causing or risking substantial public harm.” In addition, the EO disfavors criminal remedies for strict liability offenses—i.e., offenses that do not require proof of intent or knowledge—and instead encourages agencies to prioritize civil or administrative enforcement to address them. Among other things, the EO directed agencies to publish in the Federal Register (1) within 45 days of the EO, criminal referral guidance;[1] and (2) within one year of the EO and annually thereafter, a comprehensive list of regulatory offenses that carry criminal penalties, including the statutory authority and the rationale for criminal enforcement.
Like many other federal environmental laws, FIFRA authorizes both civil and criminal penalties. And like many other federal environmental laws, FIFRA’s criminal liability is based on knowledge (or negligence)—not strict liability. Nearly all FIFRA’s criminal penalties are characterized as misdemeanors, though the statute does provide for one felony—where a registrant uses or reveals product formulation with an intent to defraud. Depending on the facts of a case, someone who violates FIFRA may also be subject to prosecution for other federal crimes under Title 18 of the U.S. Code, such as making false statements to the government, wire or mail fraud, and conspiracy.
Historically, FIFRA criminal enforcement has been limited, generally reserved for cases involving serious harm to the environment or human health, highly culpable or egregious conduct, or extremely toxic pesticides. EPA did, however, expand the use of its FIFRA criminal enforcement authority during the height of the Covid-19 pandemic to address the marked public health risks associated with potentially false or misleading anti-Covid claims on disinfectant products. To the extent EPA has continued its expanded FIFRA criminal enforcement practices since the height of the Covid pandemic, the EO may curtail those practices and cause the Agency to revert to pursuing civil enforcement in some cases.
While the EO may narrow the scope of EPA’s criminal enforcement, companies should not assume criminal exposure has been eliminated. Under the policy, EPA may still focus FIFRA criminal enforcement on intentional misconduct, egregious behavior, and violations that result in serious harm. The EO also does not reach federal crimes under Title 18, which, as noted, can arise in a FIFRA enforcement case.
Conclusion
Despite broader shifts in regulatory efforts and enforcement priorities, EPA remains fully committed to FIFRA enforcement. The first half of 2025 has already seen a significant number of administrative actions and substantial penalties. FIFRA noncompliance can result in serious consequences, including financial penalties, operational disruptions, and reputational harm. Regulated entities should proactively review their compliance programs and engage counsel early when responding to EPA inquiries or enforcement activity.
[1] On July 31, 2025, EPA published its referral guidance in the Federal Register. 90 Fed. Reg. 36,044. That guidance largely restates what EPA historically has considered as a matter of formal policy when referring alleged criminal regulatory offenses to DOJ (and when deciding whether to open a formal investigation in the first instance). According to the guidance, when deciding whether to make a criminal referral, the Agency should consider factors such as the harm or risk of harm from the alleged offense, the potential gain to the putative defendant from the offense, whether the putative defendant had any special knowledge, expertise, or license related to the rule or regulation at issue, and any evidence concerning the putative defendant’s awareness or lack thereof concerning the law.
European Commission Has a Fresh Attempt at Trying to Clarify the Legal Status of Chemical Recycling
On 8 July 2025, the European Commission released a new Draft Implementing Decision on the calculation, verification and reporting of data on recycled plastic content in single-use plastic beverage bottles.
This act under the framework of the Single-Use Plastics Directive (EU) 2019/904 aims to provide a methodology for the calculation of the recycled content of PET bottles made from materials that have been either mechanically recycled, or chemically recycled. The methodology is accompanied by certification obligations as well as an enforcement system.
While an act addressing mechanically recycled PET was already adopted back in 2023 (Implementing Decision (EU) 2023/2683), chemical recycling was not included at that stage – the adoption of an act addressing chemically recycled PET was subject to more hurdles. A first attempt at addressing chemical recycling was made in a draft Implementing Decision from February 2024, which was withdrawn following opposition notably from the European Parliament’s ENVI Committee.
This new attempt maintains general principles from the previous February 2024 version – the choice to rely on the “fuel-use exempt” mass calculation model is included, but with many more specificities for when reattribution of credits is allowed. The restriction on reattribution between different facilities of a company or between different companies is maintained.
Modifications compared to the previous draft on the other hand include the introduction of “calculation points” with a view to adapt the method of calculation to the different stages of the supply chain concerned. The first point, where the input material is present in a liquid form, is thereby distinguished from other points down the line.
The Commission further explicitly confirms the possibility to rely on the use of post-consumer recycled materials coming from outside the EU.
The draft act is currently subject to a public consultation that runs until 19 August 2025. Should the process go swiftly, the act could be adopted by the end of 2025.
EFRAG Launches Consultation on Simplified European Sustainability Reporting Standards (ESRS) under the CSRD
On 31 July 2025, the European Financial Reporting Advisory Group (EFRAG) launched its much anticipated 60-day consultation on the revised and simplified European Sustainability Reporting Standards (ESRS) for companies in scope of the Corporate Sustainability Reporting Directive (CSRD).
EFRAG’s mandate from the European Commission, received in March 2025, as part of the “Omnibus” initiative to streamline corporate sustainability reporting, was to deliver a more manageable and accessible reporting framework via revamped ESRS without undermining the core objectives of the European Green Deal or the CSRD. The current consultation on the revised ESRS is a direct response to this mandate and is central to the EU’s broader simplification agenda to reduce burdens on companies.
We set out below key areas of the consultation, which will run until 29 September 2025.
Headline Changes in the Draft Amended ESRS
EFRAG’s proposed amendments published in the consultation are intended to make the ESRS more practical, accessible and less resource-intensive, particularly for companies newly brought into scope by the CSRD. The impact of the proposed changes is significant:
mandatory datapoints (if material) have been cut by 57%; and
the overall length of the standards has been reduced by over 55%.
The main changes are as follows:
Simplified Double Materiality Assessment: The process for determining what is “material” for reporting has been streamlined. Companies are now expected to start with their business model and only need to provide evidence that is reasonable and proportionate. This is intended to reduce unnecessary scoring.
Clearer Structure and Language: The revised standards use more consistent terminology across the ESRS and a clearer structure. The relationship between impacts, risks and opportunities (IROs) and the topics to be reported is newly explained, which is intended to help companies understand better what is required and reduce duplication. The explanation of “connected information” has also been revised to support reducing repetition and fragmentation of information.
Executive Summary Option: Companies can include a short summary at the start of their sustainability statement, making it easier for stakeholders to grasp the key information.
Voluntary Disclosures Removed: Only mandatory disclosures remain in the main standards. Voluntary disclosures have been changed to separate “Non-Mandatory Implementation Guidance”, so companies can focus on what is legally required.
Relief Mechanisms: New exemptions have been introduced for situations where reporting would be excessively costly or difficult, drawing inspiration from international standards such as the ISSB’s IFRS S1 and S2.
Materiality and Financial Effects: A major clarification addresses what EFRAG describes as the “gross versus net” issue in impact materiality. Companies may now consider, in the impact materiality assessment, the outcomes of mitigation or prevention measures if there is supportable evidence that these actions reduce the severity or likelihood of negative impacts. It is likely that companies will welcome the ability to take into account their mitigation and remediation actions when assessing a negative impact’s severity and scale.
On reporting financial effects, EFRAG is seeking feedback on two options for companies to disclose financial effects:
Mandatory quantitative disclosure, with reliefs if not possible, defaulting to qualitative information; or
Mandatory qualitative disclosure, with optional quantitative information.
What Remains Unchanged
Certain requirements, such as the definition of value chain for financial institutions, exemptions for financial holdings, and rules on confidential information, are not addressed in this round of amendments. Instead, these areas, and others, will be negotiated and amended via implementing directives as agreed by the Council of the European Union, European Parliament and the European Commission.
Voluntary Standard for Non-Listed SMEs
Separately, the Commission has adopted EFRAG’s Voluntary Sustainability Reporting Standard for non-listed micro, small, and medium-sized enterprises (VSME). This is intended to be a practical, proportionate framework for SMEs with fewer than 250 employees, designed to help them respond to increasing ESG data requests and improve access to finance. While voluntary, it signals the encouraged direction of travel for smaller entities and their advisors.
Next Steps
EFRAG Public Event: September 2025
Consultation closes: 29 September 2025
EFRAG review and revision: Autumn 2025
Final standards submitted to the Commission: Late 2025
Intended Implementation: Phased in from 2026
Conclusion
EFRAG’s draft amendments to the ESRS, developed in response to the EU Omnibus simplification package, represent a decisive shift towards a more streamlined sustainability reporting regime under the CSRD. Affected stakeholders are encouraged to review the Exposure Drafts closely, assess the implications for their organizations or clients and consider submitting feedback before the consultation closes.
EC Action Plan for the Chemicals Industry Includes Measures to Strengthen the Sector
The European Commission (EC) released on July 7, 2025, a Chemicals Industry Action Plan (Action Plan) to strengthen the competitiveness and modernization of the European Union’s (EU) chemical sector. According to the EC, the Action Plan addresses key challenges, “namely high energy costs, unfair global competition, and weak demand, while promoting investment in innovation and sustainability.” The EC also released a simplification omnibus on chemicals to streamline and simplify further key EU chemicals legislation, as well as a proposed regulation to strengthen the governance and financial sustainability of the European Chemicals Agency (ECHA).
Action Plan
The EC states that the Action Plan proposes the following measures:
Resilience and level playing field: The EC will work with EU member states and stakeholders to establish a Critical Chemical Alliance to address the risks of capacity closures in the sector. According to the EC, the Alliance will identify critical production sites needing policy support and tackle trade issues such as supply chain dependencies and distortions. The EC will also “swiftly apply trade defence measures to ensure fair competition, while expanding chemical import monitoring through the existing Import Surveillance Task Force.” The Alliance will align investment priorities, coordinate EU and national projects, including Important Projects of Common European Interest (IPCEI), and support EU critical production sites to boost innovation and regional growth.
Affordable energy and decarbonization: The EC will implement “at full speed” the Affordable Energy Action Plan to help reduce high energy and feedstock costs. According to the EC, the Affordable Energy Action Plan has introduced clear rules for low-carbon hydrogen and will update state aid to lower electricity costs for more chemical producers by the end of 2025. The Affordable Energy Action Plan also encourages using clean carbon sources like carbon capture, biomass, and waste, alongside support for renewables. As reported in our July 31, 2025, blog item, the EC has begun a public consultation on improving chemical recycling.
Lead markets and innovation: The Action Plan highlights fiscal incentives and tax measures to boost demand for clean chemicals. According to the EC, the upcoming Industry Decarbonisation Accelerator Act will set EU content and sustainability rules to support market growth and clean technology investment. The EC notes that the upcoming Bioeconomy Strategy and Circular Economy Act will boost the EU’s resource efficiency and chemicals recycling, and strengthen the market for biobased and recycled alternatives to fossil-based inputs. The EC states that it will also launch EU Innovation and Substitution Hubs and mobilize EU funding under Horizon Europe (2025–2027) to accelerate the development of safer, more sustainable chemical substitutes.
Taking action on per- and polyfluoroalkyl substances (PFAS): The Action Plan reaffirms the EC’s commitment to minimize PFAS emissions “through a robust, science-based restriction, while ensuring continued use in critical applications under strict conditions where no alternatives are available which will be proposed swiftly after ECHA’s opinion.” The EC states that it “will also invest in innovation, promote remediation based on the polluter pays principle, and prioritise the development of safer alternatives.”
Simplification Omnibus
As part of its ongoing efforts to boost the EU’s competitiveness, the EC states that it adopted “a sixth simplification omnibus to reduce compliance costs and administrative burden for the chemical industry while ensuring strong protection of human health and the environment.” This includes simplifying hazardous chemical labeling rules, clarifying EU cosmetics regulations, and easing registration for EU fertilizing products by aligning information requirements with standard Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) rules for chemicals. According to the EC, it expects these measures “to save at least €363 million annually for the industry.” The EC’s fact sheet states that the omnibus will simplify the following areas:
Classification, labeling, and packaging of products:
Simplify formatting rules for hazardous chemicals;
Lighten obligations for advertisements;
Exclude professional transactions from the specific obligations on advertisements and distance sales;
Clarify labeling of fueling stations; and
Simplify labeling rules;
Cosmetics:
Define procedural timelines and transitional periods for the cosmetics industry;
Provide guidance on use of natural complex substances in cosmetics; and
Abolish redundant notification and reporting obligations for businesses and EU member states; and
Fertilizers:
Streamline information requirements by applying the standard REACH registration requirements;
Pave the way for more efficient assessments of microorganisms for use in plant biostimulants; and
Advance digitalization of documentation and reporting requirements.
The EC states that the proposal for the ECHA Basic Regulation would equip ECHA with the resources, flexibility, and structural adaptations required to fulfil the duties under its growing mandate, which now includes responsibilities under multiple EU regulations, namely spanning classification and labeling, biocidal products, import and export of hazardous chemicals, waste management, and water.
Commentary
With the release of the Action Plan, simplification omnibus, and ECHA Basic Regulation, the EC is taking steps to address regulatory and funding issues affecting the chemical industry. Stakeholders have been waiting for REACH revisions since the EC published its Chemicals Strategy for Sustainability, a key building block of the European Green Deal, in 2020. According to the EC’s questions and answers (Q&A), the simplification omnibus “stems from a review of chemicals legislation with stakeholders, targeting red tape and inefficiencies to cut costs, ease market access, support innovation, and strengthen competitiveness.” The EC intends to support the production of affordable essential chemicals such as steam crackers, ammonia, chlorine, and methanol, through the Critical Chemicals Alliance. The EC states that it will also identify critical chemicals at risk from trade issues to guide policy and improve monitoring. Stakeholders should be prepared to engage with the EC regarding these issues.
Climate Tort Lawsuit in South Carolina Dismissed by State Court
On August 6, 2025, a state court judge in South Carolina dismissed the climate change tort lawsuit filed by the City of Charleston against a number of major fossil fuel companies. (This lawsuit was one of approximately three dozen that have been filed over the past decade on behalf of state and local governments against fossil fuel companies, asserting damages due to climate change under various state tort laws.) In his decision, Judge Young not only held that “Federal law precludes and preempts Plaintiff’s claims,” but also determined that the “Court lacks personal jurisdiction over certain Defendants because Plaintiff’s claims are not related to and do not arise out of those Defendants’ alleged activities in South Carolina.” This legal reasoning, which echoes other decisions that have dismissed these type of claims (e.g., in Pennsylvania, Delaware, Maryland, New Jersey, and New York), provides further support for the legal arguments that these claims are ultimately not viable.
Significantly, the court opined that “Plaintiff’s theory of liability appears almost limitless” and that “[t]hese lawsuits promise to create a chaotic web of conflicting legal obligations for Defendants as each state and municipality (sometimes within the very same state) imposes its own de facto regulations on the worldwide production, marketing, transport, and sale of fossil fuels.” Focusing on these practical concerns with the legal architecture of the climate change tort claims, the court stated that “[a]ny resolution to the climate-change issues Plaintiff seeks to remedy must rest with the federal political branches that are legally and substantively equipped to address them.” (Indeed, the courts’ reliance as a legal matter on the political question doctrine and federal preemption to dismiss the claims at issue echoes these practical concerns.)
While this decision does not directly impact the multitude of other climate change tort lawsuits predicated on state law tort claims currently wending their way through the courts, it is nonetheless significant as providing yet another example demonstrating the lack of success of these type of claims. Although additional lawsuits based upon this theory may yet be brought–especially as certain cases remain pending and there has not yet been a full adjudication on the merits–the rate of these lawsuits certainly appears to be decreasing. If this legal avenue ultimately proves fruitless, it is likely that activists will pursue other options in an effort to hold fossil fuel companies accountable for climate change.
Charleston, South Carolina’s climate lawsuit cannot move forward because the city’s claims exceed the bounds of state tort law, according to a state judge who dismissed the case Wednesday. “Although Plaintiff’s claims purport to be about deception, they are premised on, and seek redress for, the effects of greenhouse gas emissions,” wrote Judge Roger M. Young of the South Carolina Court of Common Pleas, siding with Exxon Mobil Corp., Chevron Corp., and other energy defendants. “While the scope of the state-law claims alleged here exceeds the recognized bounds of South Carolina law, Plaintiff’s theory of liability appears almost limitless,” said Young, who was openly skeptical of Charleston arguments during dual hearings in May.
news.bloomberglaw.com/…
EPA Submits Draft Proposed Risk Evaluation Framework Rule to OMB for Review
On August 4, 2025, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a proposed rule entitled “Further Reconsideration of Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA).” As reported in our March 14, 2025, memorandum, on March 10, 2025, EPA announced its intent to reconsider the May 2024 rule amending the procedural framework rule for conducting TSCA risk evaluations. According to EPA’s March 10, 2025, press release, consistent with President Trump’s Executive Order 14219 requiring the review of regulations to ensure consistency with Administration policy and agencies’ statutory authority, EPA reviewed the 2024 final rule. After completing its review and considering public comments and concerns, including those from other federal agencies, EPA intended to review whether the approach taken by the Biden Administration to make a single risk determination for a chemical is consistent with TSCA, whether the Agency must evaluate all conditions of use (COU) of a chemical at the same time in the three years generally allotted by Congress to conduct this review, and whether and how the use of personal protective equipment (PPE) and industrial controls in an occupational work environment should be incorporated into risk evaluations. According to EPA, it will reconsider regulatory definitions expanded by the Biden Administration and evaluate whether the regulation should define terms more broadly than the definitions in the statute. More information on the 2024 risk evaluation framework rule is available in our May 14, 2024, memorandum. The draft proposed rule submitted to OMB is not publicly available.
Public Comment Period Opens for USDA’s Structural Overhaul
On August 1, 2025, the U.S. Department of Agriculture (USDA) opened a 30-day public comment period inviting feedback on a reorganization plan that would significantly reshape the agency’s structure and functions.
The reorganization plan was outlined in a July 24, 2025, memorandum which includes shutting down the agency’s South Building in Washington D.C. and relocating approximately 2,600 positions to various regional hubs around the country.
This shift reflects President’s Trump’s second-term commitment to decentralize federal agencies and relocate operations outside of the nation’s capital.
The reorganization plan is built around four pillars: (1) aligning USDA’s workforce size with available financial resources and agricultural practices; (2) relocating headquarters staff to regional hubs to better serve constituents; (3) consolidating redundant functions to improve efficiency; and (4) preserving critical public safety and national security roles.
USDA has exempted 52 position classifications from the federal hiring freeze. These roles are considered essential for national security and include wildfire responders, FSIS food safety inspectors, and other public safety functions. These positions still remain but may be affected by the relocation.
Comments can be submitted via email at [email protected]. The comment period is open through August 26, 2025.
FDA’s Position on Medical Devices and PFAS
On Aug. 6, 2025, the U.S. Food and Drug Administration (FDA) set forth its position on “PFAS (per- and polyfluoroalkyl substances) in Medical Devices” [PFAS in Medical Devices | FDA]. Ultimately, the FDA concludes that, based on its evaluation, “currently there is no reason to restrict [PFAS] continued use in devices,” and discusses the important distinction between small and large molecule fluoropolymers, emphasizing that large molecule fluoropolymers used in medical devices “have been safely used for decades.” The FDA also recognizes the unique properties of fluoropolymers in medical device applications and notes that currently no materials exist that can perform these critical applications.
For now, FDA has determined that it will not seek to impose a blanket PFAS restriction for medical device applications, as seen in many regulatory and legislative PFAS bans. That said, other U.S. agencies at the federal and state levels continue to issue regulations that may impact operations and the supply chain. Uncertainty also remains as to how, if at all, the concept of essential use and the recognition of distinctions between fluoropolymers and non-polymers will be sorted out in other markets such as the European Union, where significant restrictions on the use of PFAS in medical devices have been proposed.
Finally, even where, as here, FDA sets forth its basis to draw the distinction and declines to pursue restrictions, PFAS, along with adverse publicity and ongoing litigation, will continue to present challenges that call for close monitoring.