Trump Administration Proposes Overhaul of Biden-Era TSCA Risk Evaluation Framework

/in , ,

On September 23, 2025, EPA published a proposed rule that would roll back key provisions of the agency’s May 2024 risk evaluation framework rule, which sets out the procedures EPA uses to assess the risks of existing chemicals under the Toxic Substances Control Act (TSCA).

According to EPA, the proposal is intended to “effectuate the best reading of the statute and ensure that the procedural framework rule does not impede the timely completion of risk evaluations or impair the effective and efficient protection of health and the environment.”

The rollback is a priority for the Trump administration, which first announced its intent to reconsider the rulemaking in March.  The 2024 rule—itself a revision of a rule issued during the first Trump administration—has been criticized by industry groups such as the American Chemistry Council and targeted for revision by the Heritage Foundation’s “Project 2025” initiative.

What Changes is EPA Proposing?

If finalized, the rule would:

  • Grant EPA discretion to narrow the scope of risk evaluations by excluding conditions of use and exposure pathways from its assessments.
  • Require that separate risk determinations be made for each of a chemical’s conditions of use, instead of a single risk determination for the chemical as a whole.
  • Remove language prohibiting EPA from assuming worker protections through PPE usage.
  • Eliminate “overburdened communities” from the list of “potentially exposed or susceptible subpopulations” that must be considered in evaluations.
  • Provide EPA with greater flexibility to revise or supplement scope or risk evaluation documents without restarting the prioritization process.
  • Scale back information collection requirements for manufacturers requesting a risk evaluation.
Stakeholder Responses

The proposal has drawn criticism from environmental groups, who warn that the changes—particularly EPA’s ability to exclude conditions of use and exposure pathways—will jeopardize public health.

“Rather than looking at the full picture of a chemical’s toxic risk, EPA wants to downplay the links these chemicals have to cancer and chronic disease and give the chemical industry a handout at the expense of our health and safety,” an Environmental Defense Fund official said in a statement.

“The chemicals in the pipeline for review under TSCA have been prioritized specifically because of the risks they pose to our health, and rewriting this process to lowball risks will only rig the rules to benefit the chemical industry,” she continued.

The American Chemistry Council, on the other hand, applauded the move.  “This proposed approach demonstrates EPA’s commitment to refining its processes in a way that is both protective and practical,” an official said in a press release.  “The proposal reflects meaningful progress toward a more science-driven regulatory framework for conducting TSCA risk evaluations.”

Comments on the proposed rule are due November 7, 2025.  More on the 2024 rule can be found here.

EPA Stands by CERCLA PFAS Designation Amid Legal Challenge

/in , ,

EPA under the Trump administration will defend a rule issued by the Biden administration designating two PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the agency told the D.C. Circuit Court of Appeals on September 17, 2025.

“EPA has completed its review and has decided to keep the Rule in place,” the agency wrote in a court filing.

The case, Chamber of Commerce of the USA v. EPA, No. 24-1193, consolidates challenges to the May 2024 rule.  It has been held in abeyance since February at EPA’s request while the Trump administration determined how to proceed.

EPA’s decision to defend the rule is somewhat unexpected.  Last month, the New York Times reported that internal EPA documents recommended its repeal, stating that its “cons outweigh pros.”

Key Impacts of the CERCLA Designation

The rule has significant consequences for EPA’s ability to respond to contamination and assign cleanup responsibility for PFOA and PFOS, the two PFAS covered by the designation.

“Designating PFOA and PFOS as CERCLA hazardous substances eliminates barriers to timely cleanup of contaminated sites, enables EPA to shift responsibility for cleaning up certain sites from the Fund to [potentially responsible parties (PRPs)], and allows EPA to compel PRPs to address additional contaminated sites,” the rule states.

Due to the designation, entities that release PFOA and PFOS above reportable quantities must notify authorities.  When releases occur, EPA (and other agencies) can more quickly respond, because they no longer need to first determine that the release “may present an imminent and substantial danger.”

Crucially, the designation also allows EPA to compel PRPs to take action in response to significant PFOS or PFOA contamination—often at their own expense.

The rule justifies listing PFOA and PFOS based on their health hazards, persistence and mobility in the environment, and bioaccumulation in humans and other organisms.  EPA also conducted a “totality of the circumstances” analysis, which weighed the pros and cons of their designation.

More on EPA’s PFAS and CERCLA actions can be found on our CERCLA archive.

Prop 65 Warning for Titanium Dioxide Struck Down

/in ,

California’s Proposition 65 warning requirement for respirable titanium dioxide violates the First Amendment, the District Court for the Eastern District of California ruled on August 12, 2025, in The Personal Care Products Council v. Bonta, No. 2:23-cv-01006.

The decision is the latest in a series of rulings invalidating Prop 65 warnings for chemicals with disputed health risks. In 2023, the Ninth Circuit struck down a warning requirement for glyphosate, and in early 2025, the Eastern District of California invalidated a warning requirement for dietary acrylamide.  Blog posts on those cases can be found here and here.

The titanium dioxide order follows the same analytical framework. First, the court held that the warning failed the test set forth in Zauderer v. Office of Disc. Counsel, 471 U.S. 626 (1985), which allows for compelled commercial disclosures when they are “purely factual and uncontroversial.”

“[T]he parties admit that there is a clear debate over whether Listed Titanium Dioxide cases cancer in humans,” the order states.  “The Court finds the Prop 65 warning would likely improperly elevate ‘one side of a legitimately unresolved scientific debate.’”

As in the glyphosate and acrylamide cases, the court focused on how an average consumer would perceive the warning, not just whether each sentence was literally accurate.  “Even though each sentence on its own may be factually true, ‘the totality of the warning’ is nonetheless misleading,” the order states.

Second, the court found that the warning failed intermediate scrutiny under Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980) and was therefore unconstitutional.  The court concluded that the warning does not advance California’s interest in public health because titanium dioxide’s risks are not confirmed, and the state has less burdensome alternatives—such as making information available online.

Titanium dioxide is commonly used as a whitening pigment in cosmetic and personal care products. Its Prop 65 listing applies only to “airborne, unbound particles of respirable size.”

New Mexico to Hold Webinar on PFAS Labeling on September 25

/in ,

On September 25, 2025, the New Mexico Environment Department (NMED) will hold an informational webinar on product labelling requirements for PFAS at 1pm MT (3pm ET).  To register, email NMED-PFAS@env.nm.gov.

Under HB212, enacted in April 2025, NMED is authorized to adopt rules requiring that manufacturers label products containing PFAS.  Earlier this month, New Mexico’s Environmental Secretary reportedly told lawmakers that NMED would soon release draft regulations to implement HB 212, including labeling requirements.

PFAS Restrictions and Reporting Under HB 212
  • Labeling authority: NMED may require PFAS labeling.
  • Phased bans: Restrictions on intentionally added PFAS begin in 2027, expand to more product types in 2028, and culminate in a ban on most products in 2032. Exemptions apply for certain products, such as medical devices, and for uses designated by NMED as “currently unavoidable.”
  • Reporting requirement: By January 1, 2027, manufacturers must report information on intentionally added PFAS, including purpose of use and amount (by CASRN).

More details are available on NMED’s PFAS webpage.

California Legislature Moves to Ban PFAS in Many Consumer Products

/in , ,

On September 12, 2025, California’s Assembly and Senate approved SB 682, a bill imposing sweeping prohibitions on the use of intentionally added PFAS in a wide range of consumer products.  The legislation now heads to Governor Gavin Newsom for consideration.

As reported in a previous post, SB 682 would prohibit the distribution, sale, or offering for sale of cleaning products, dental floss, juvenile products, food packaging, and ski wax with intentionally added PFAS starting in 2028, and cookware beginning in 2030.

Since that earlier update, lawmakers amended the bill to exempt certain components of cleaning products until 2031.  The final version also clarifies that, beginning in 2028, cleaning products must comply with California Air Resources Board volatile organic compound (VOC) regulations without reliance on regulatory variances.

Governor Newsom has until October 12, 2025, to act on the bill.

EPA to Fast-Track Chemical Reviews for AI and Data Center Projects

/in , , ,

EPA will prioritize review of premanufacture notices (PMNs) for chemicals tied to artificial intelligence (AI) and data center projects, the agency announced on September 18, 2025.

“We inherited a massive backlog of new chemical reviews from the Biden Administration which is getting in the way of projects as it pertains to data center and artificial intelligence projects,” EPA Administrator Lee Zeldin said.  “The Trump EPA wants to get out of the way and help speed up progress on these critical developments, as opposed to gumming up the works.”

The policy implements President Trump’s Executive Order 14318, “Accelerating Federal Permitting of Data Center Infrastructure,” which directs the agency to expedite permitting for qualifying projects under a variety of environmental statutes, including the Toxic Substances Control Act (TSCA).

What Projects are Eligible?

Two types of projects can qualify for expedited review:

  1. Data center projects requiring more than 100 megawatts (MW) of new load dedicated to AI inference, training, simulation, or synthetic data generation.
  2. Covered component projects, which include the materials, products, and infrastructure needed to build or operate such facilities—such as energy infrastructure, power plants, semiconductors, networking equipment, and data storage systems or software.

To be eligible, a project must also meet at least one of the following criteria:

  • A commitment of $500 million or more in capital expenditures.
  • An incremental electric load addition of more than 100 MW.
  • Direct relevance to national security.
  • Official designation as a qualifying project by a federal department.
How to Request Priority Review

According to updated EPA guidance, the new priority review process will take effect on September 29, 2025. To request it, PMN submitters must:

  • Attach a cover letter to their PMN submission via EPA’s Central Data Exchange (CDX).
  • Identify the specific data center or covered-component project the chemical will support.
  • Show that the project meets at least one of the executive order’s qualifying criteria.
  • Provide supporting documentation, such as permitting records, project announcements, or letters of support, plus details on how the chemical will be used.

EPA has posted detailed instructions for companies seeking priority review on its PMN guidance webpage.

Verdant Law to Lead ACA Webinar on FTC’s “Made in the USA” Enforcement

/in , ,

Verdant Law is pleased to announce that Phil Moffat and Irene Hantman will lead an American Coatings Association (ACA) webinar on the FTC’s renewed focus on “Made in the USA” claims.  The session will be held on September 25, 2025, from 1–2pm ET.

Although the current Trump administration has generally adopted a deregulatory stance, “Made in the USA” claims have been a notable exception.  This past July, the FTC declared “Made in the USA Month” and announced stepped-up enforcement, including warning letters to major retailers such as Amazon and Walmart.

This webinar will provide insight to help attendees align marketing strategies with legal standards, avoid enforcement risks, and ensure “Made in the USA” claims are both effective and compliant.

Attendance is limited to, but free for, ACA members.  Register here.

Coalition Letter to Congress Calls for Streamlined TSCA Chemical Reviews

/in ,

A collection of over 100 trade associations is calling on Congress to reform the Toxic Substances Control Act (TSCA) to “ensure a regulatory system that balances human health and environmental concerns with domestic supply chain and innovation needs and supports growth in our manufacturing sector.”

The American Alliance for Innovation (AAI) letter, sent to congressional leaders on September 8, 2025, suggests a number of “improvements and clarifications” to the statute, including:

  • Ensuring timely and predictable reviews of new chemicals;
  • Avoiding unnecessary regulation, including overuse of Consent Orders (COs) and Significant New Use Rules (SNURs) that discourage adoption of innovative and sustainable chemicals;
  • Following a risk-based approach to regulating a chemical’s intended use in commerce that is rooted in actual uses and real-world scenarios;
  • Strengthening the scientific standards included in TSCA for what constitutes “the weight of the scientific evidence;” and,
  • Providing additional clarity to other sections of TSCA that govern testing, regulatory petitions, and data sharing.

AAI suggests that these changes be incorporated into any legislation to extend TSCA’s fee authority, which expires at the end of fiscal year 2026.

Are You Ready for Mandatory GRAS Notifications?

/in ,

The second Trump administration’s first Unified Regulatory Agenda of Federal Regulatory and Deregulatory Actions, published September 4, 2025, indicates that FDA is close to initiating a rulemaking to overhaul the generally recognized as safe (GRAS) regulations—a change that could significantly raise regulatory expectations for food manufacturers and ingredient suppliers.

What Does the Unified Agenda Say?

According to the unified agenda listing, “the proposed rule, if finalized, would amend the [GRAS] regulations…to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.”  Substances that are listed as GRAS for the intended use by regulation, or have been granted a “no questions” letter by FDA, would be exempted.

The listing further notes that the rulemaking would clarify that FDA maintain and regularly update a public-facing GRAS notice inventory for all substances subject to the mandatory GRAS notice requirement for their intended uses.  It would also clarify the process by which FDA would determine that a substance is not GRAS.

The agenda indicates that a proposed rule is expected to be published in October 2025.

Putting It in Context

Under current regulations, companies can self-affirm that a substance—which includes ingredients as well as substances added indirectly (such as from food packaging)—is GRAS based on scientific evidence.  FDA’s GRAS notification program is voluntary; companies may notify FDA but are not required to.

The proposed rule would shift the system so that formal submission (notice) to the FDA becomes mandatory for most substances purported to be GRAS, except those already regulated or with prior FDA “no questions” letters.

The agenda listing follows Health and Human Services Secretary Robert F. Kennedy, Jr.’s March 2025 directive to FDA to explore revising the GRAS final rule and related guidance to eliminate the self-affirmation pathway.  “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again,” Secretary Kennedy said.

EPA Withdraws SNURs for 18 Chemicals Following Community Challenge

/in , ,

EPA has withdrawn proposed Toxic Substances Control Act (TSCA) significant new use rules (SNURs) for 18 chemical substances developed by Chevron USA, after a community organization argued that EPA’s regulation failed to address “extreme health risks” to residents near industrial sites in Mississippi.

EPA previously withdrew the corresponding TSCA section 5(e) order and premanufacture notice (PMN) determinations for the chemicals in December 2024, following a voluntary remand in a D.C. Circuit challenge to the order, Cherokee Concerned Citizens (CCC) v. EPA, No. 23-01096.

“Consistent with the withdrawal of the TSCA 5(e) Order” and received comments, “EPA is withdrawing the proposed rules,” EPA’s July 9, 2025, Federal Register notice states.

Petitioner Arguments

In the associated case, CCC argued that the 5(e) order—which restricted uses of the chemicals beyond those proposed by Chevron in its PMNs and mandated worker protections—did nothing to protect fenceline communities from health risks identified by EPA in its analyses.

“[T]he Order summarizes numerous risks that exceed by orders of magnitude the risk levels EPA has consistently defined as ‘unreasonable’ and then recites trivial requirements for Chevron’s production and use of the waste plastic chemicals that could not possibly mitigate the risks to people living near the refinery,” CCC’s opening brief stated.

Among the risks identified by EPA was a one-in-four chance that people exposed to long-term air pollution generated by one chemical would develop cancer—a risk 250,000 times greater than EPA’s one-in-a-million cancer risk benchmark, according to CCC.  In its motion for voluntary remand, EPA acknowledged it had “substantial concerns that the Section 5 Order may have been made in error.”

The SNURs identified significant new uses to include uses that did not conform to the 5(e) order, as well as the manufacture or processing of the chemicals using feedstocks containing PFAS or other chemicals of concern.

The PMNs stated that the chemicals would be used as a fuel, fuel additive, fuel blending stock, or refinery feedstock.  EPA reports that their manufacture had not yet commenced at the time the order was withdrawn.