Published December 5, 2024, by Lynn L. Bergeson and Carla N. Hutton
On November 22, 2024, the U.S. District Court for the District of Columbia entered two consent decrees establishing deadlines for completing risk evaluations for 20 High-Priority Chemicals and two manufacturer-requested risk evaluations (MRRE). The Community In-Power and Development Association Inc. (CIDA) v. EPA, Case No. 1:23-cv-02715. Under the consent decree with CIDA, the Learning Disabilities Association of America, Louisiana Environmental Action Network, Sierra Club, and Texas Environmental Justice Advocacy Services (CIDA Plaintiffs), EPA will complete its risk evaluations for the High-Priority Chemicals in accordance with a set schedule. As reported in our May 10, 2024, memorandum, the CIDA Plaintiffs filed suit in the U.S. District Court for the District of Columbia on September 18, 2023, and ACC filed suit in the same court on December 19, 2023. The CIDA Plaintiffs and ACC claim that EPA failed to perform nondiscretionary duties under TSCA to complete timely several risk evaluations. The cases were consolidated on January 17, 2024.
Published December 4, 2024, by Mark N. Duvall, Ryan J. Carra, Robert T. Denney, and Elizabeth Nugent Morrow
With the election of Donald Trump, the implementation of TSCA in 2025 will differ significantly from the pre-election expectations. Here are our projections on the likely developments in the coming year.
Summary
- EPA will continue to implement TSCA, so companies must continue focusing on their TSCA obligations.
- TSCA legislation is coming, at least with respect to fee authority and appropriations.
- Personnel and staffing changes will affect TSCA implementation.
- Policy changes, such as those recommended in Project 2025, are likely.
- The Trump EPA will try to expedite new chemical reviews, but reduced resources will make that challenging.
- EPA will continue to issue significant new use rules.
- The Trump EPA may not prioritize all the chemicals proposed for designation by the Biden EPA.
- The Biden EPA risk evaluations will be reconsidered, but the Trump EPA will have to deal with a consent decree mandating deadlines for completion of those risk evaluations.
- Pending risk management rules will likely be revised.
- The final risk management rules under judicial review will be remanded for reconsideration.
- EPA may face reductions in TSCA fees.
- Staying abreast of developments in 2025 will be important.
Published November 25, 2024, by Mark J. Washko
On November 20, 2024, Senator Ed Markey (D-MA) and Representative Jennifer McClellan (D-VA) introduced the Get Toxic Substances Out of Schools Act of 2024. This is the third consecutive Congress in which Senator Markey has introduced similar legislation. The 118th Congress version, S. 5363 and H.R. 10173, builds on earlier versions by authorizing new grants to address indoor air quality in schools and childcare centers. Congress is unlikely to act on this legislation in the few remaining weeks of the 118th Congress. Introduction of legislation at this late date is more likely an indicator that Senator Markey will continue to pursue this issue in the 119th Congress that convenes January 3, 2025.
Published November 25, 2024, by Ryan J. Carra, Robert T. Denney, Mark N. Duvall, and Emily E. Schwartz
EPA published a final rule revising the regulations for decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)) on November 19, 2024. As discussed in our previous alert on the revisions as proposed last year, EPA first regulated these two substances as persistent, bioaccumulative, and toxic chemicals (PBTs) under TSCA in January 2021. With limited exceptions and under various compliance timeframes, those 2021 rules prohibited the manufacture (including import), processing, and distribution in commerce of decaBDE, and products and articles containing decaBDE. The 2021 rules likewise prohibited the processing and distribution in commerce of PIP (3:1) and products and articles containing PIP (3:1).
The final revised rules grant compliance extensions for certain uses of these substances, such as an extension to the end of service life for decaBDE used in wire insulation for nuclear power plants and ten years for PIP (3:1) used in parts for new manufacturing equipment, including in the semiconductor industry. Further extensions are provided for replacement parts for those kinds of equipment.
Published November 20, 2024, by Dianne R. Phillips, Meaghan A. Colligan, Amy O’Brien, and Halley I. Townsend
EPA on November 14, 2024, issued a Notice of Availability of the Final Supplement to the Risk Evaluation and Revised Unreasonable Risk Determination for 1,4-Dioxane (Final Revised Risk Determination) under TSCA.
EPA’s Final Revised Risk Determination for 1,4-Dioxane comes after the agency’s multi-year evaluation of the potential effects of the chemical on human health and the environment. Through the Final Revised Risk Determination, EPA concluded that 1,4-Dioxane poses an unreasonable risk to human health and environment. As a result, EPA will initiate the next stage of the TSCA chemical review process—risk management—where it will evaluate and develop regulatory mechanisms for reducing the risks posed by the chemical.
The remainder of this Holland & Knight alert provides an outline of TSCA’s section 6 chemical review process, an overview of EPA’s risk evaluation of 1,4-Dioxane, the conclusions of the Final Revised Risk Determination and considerations for regulated entities whose business and operations may be impacted by the regulation of 1,4-Dioxane.
Published November 19, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
On August 1, 2023, Earthjustice filed a petition under section 21 of TSCA asking EPA to establish regulations prohibiting the manufacturing, processing, use, and distribution of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) for and in tires. Earthjustice filed the petition on behalf of the Yurok Tribe, the Port Gamble S’Klallam Tribe, and the Puyallup Tribe of Indians, and EPA granted the petition in November 2023. On November 19, 2024, EPA released an advance notice of proposed rulemaking (ANPRM) to solicit and collect information from the public on the potential risks associated with 6PPD and its transformation product, 6PPD-quinone. 89 Fed. Reg. 91299. EPA also seeks information about potential alternatives and regulatory options to help inform its consideration of potential future regulatory actions under TSCA.
Published November 14, 2024, by Mark J. Washko
Elections bring significant change, especially in Presidential election years. During the 76-day period between Election Day and Inauguration Day, President-elect Trump and his transition team are busy selecting people to serve in his administration. Congress has even less time, only 59 days from the election until the 119th Congress convenes January 3, 2025, at noon. A previous post looks at what Congress may do during the lame duck period. This post looks at who will lead on environmental policy in the Trump administration and in Congress beginning in January 2025, and identifies an important, under-the-radar issue that the next Congress must address—the expiration of TSCA fees on September 30, 2026.
Published November 13, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
On October 31, 2024, EPA Administrator Michael S. Regan signed a final rule revising the regulations for decaBDE and PIP (3:1), two of the five PBT chemicals addressed in final rules issued under TSCA in January 2021. According to the pre-publication version of the final rule (which is only available on EPA’s website), after receiving additional comments, EPA “has determined that revisions to the decaBDE and PIP (3:1) regulations are necessary to address implementation issues and to further reduce the potential for exposures to decaBDE and PIP (3:1) for humans and the environment to the extent practicable.”
Published November 6, 2024, by Amy L. Edwards, Andy Emerson, Alexandra E. Ward, and Maggie P. Pahl
In response to a decision by the U.S. Court of Appeals for the Ninth Circuit finding that EPA’s updates to its lead paint hazard standards were deficient because they improperly took into account factors other than health, EPA announced a rule that strengthens the prior requirements for identifying and cleaning up lead paint dust in pre-1978 homes and childcare facilities under TSCA. The rule decouples the standards for dust level reportable levels and dust-lead action levels. Under EPA’s new rule, any level of lead is considered hazardous, and the permissible amount of lead dust that may be detected on floors, window sills and window troughs after a lead paint abatement is drastically decreased.
Published October 17, 2024, by Thomas C. Berger and George G. Misko
Many substances used in TSCA-exempt applications also are used in nonTSCA-exempt applications. If a substance is manufactured, processed, or distributed for undifferentiated uses, the substance is presumed to be subject to TSCA. If a substance does not appear on the Inventory, then manufacture or import of the substance for a nonexempt purpose results in a violation of TSCA’s PMN reporting requirements. In the case of foods and food additives, because the definition of a “chemical substance” only excludes a substance to the extent that the substance falls within the U.S. Food and Drug Administration’s (FDA’s) jurisdiction, it is advisable to determine where FDA jurisdiction under the FD&C Act ends and EPA jurisdiction under TSCA begins.
Published October 9, 2024, by Mark N. Duvall, Thomas Richichi, Erika H. Spanton, and Jack B. Zietman
In a groundbreaking decision, a federal district court has ordered EPA to regulate the “unreasonable risk” it found to be posed by the fluoridation of drinking water. The order came in the long-running case Food & Water Watch, Inc. v. EPA, No. 17-cv-02162-EMC, 2024 WL 4291497 (N.D. Cal. Sept. 24, 2024).
While the court did not specify what EPA must now do, its decision could significantly impact municipal drinking water systems and public health.
Published October 2, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
On September 26, 2024, EPA released the final risk evaluation for Tris(2-chloroethyl) phosphate (TCEP), a flame retardant and plasticizer. 89 Fed. Reg. 78868. EPA states that it determined that TCEP poses an unreasonable risk of injury to human health and the environment. According to EPA’s September 23, 2024, press release, TCEP “has the potential to cause kidney cancer, damage the nervous system and kidneys, and harm fertility.” EPA notes that this is the first risk evaluation issued in final for the 20 high-priority substances designated in 2019.
Published September 26, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
EPA announced on September 3, 2024, the release of the draft risk evaluation for diisononyl phthalate (DINP) under TSCA for public comment. 89 Fed. Reg. 71270. EPA states in its August 30, 2024, press release that it preliminarily determined that two industrial uses and one consumer use “significantly contribute to the unreasonable risk of DINP out of the 45 uses evaluated.” EPA preliminarily determined that DINP has the potential to cause developmental toxicity and harm the liver and that it could cause cancer at higher levels of exposure. EPA notes that it also preliminarily determined that DINP does not pose unreasonable risk of injury to the general population or pose unreasonable risk to the environment.
Published September 24, 2024, by Lynn L. Bergeson and Carla N. Hutton
On September 20, 2024, EPA filed a motion in the U.S. Court of Appeals for the District of Columbia Circuit for a voluntary remand of the case brought by Cherokee Concerned Citizens or review of an Order for a New Chemical Substance under section 5 of TSCA. Cherokee Concerned Citizens v. EPA (No. 23-1096). EPA states that it wishes to withdraw the Order and reconsider the 18 PMNs covered by the Order. According to EPA, Cherokee Concerned Citizens does not oppose EPA’s request for remand but rather supports remand with vacatur.
Published September 23, 2024, by Ryan J. Carra, Mark N. Duvall, and Robert T. Denney
EPA is amending TSCA Chemical Data Reporting (CDR) regulations to extend the September 30, 2024 submission deadline for 2024 reports to November 22, 2024. EPA explained that this extension is in response to technical issues with the 2024 CDR data submission tool, and the amendment is being released as a final rule that will be effective as of the date of publication.
Published September 20, 2024, by Martha E. Marrapese, Sara Beth Watson, and Scott M. Sherlock
The U.S. District Court for the District of Columbia recently found, in what it described as a “question of first impression,” that section 5(b)(3) of TSCA, a provision requiring public disclosure of information on the receipt of new TSCA section 5 filings and health and safety data, was a “freestanding right to information” obligation and independent of a TSCA regulatory function. This court, in its August 20, 2024 opinion, reiterated the position that public right-to-know about chemicals in commerce is a central function of TSCA.
Published September 19, 2024, by Lynn L. Bergeson and Carla N. Hutton
EPA announced on September 18, 2024, the launch of an Outdoor Use Safer Choice label. According to EPA, this new label expands on its existing Safer Choice label and will identify outdoor use products—such as pet care products, fire defense products, and car, boat, or grill cleaners—that meet additional EPA criteria to help protect the environment.
Published September 18, 2024, by Sarahann Rackl, Ph.D., P.E., Allie Gobeil, Ph.D., Devin Millions, Madeleine Bee, Ph.D., Sara Hearon, Ph.D., M.P.H., and Kyle Wilson
On September 5, 2024, EPA delayed the data submission period for new reporting requirements for PFAS under TSCA. The final rule requires any person who manufactures or imports or has manufactured or imported PFAS or PFAS-containing articles any time since January 1, 2011, to electronically report on specific PFAS uses, production volumes, disposal, exposures, and hazards.
This data submission period was scheduled to begin November 12, 2024, but due to budgetary issues and resource limitations, EPA delayed the beginning of the reporting period until July 11, 2025.
Published September 11, 2024, by Dianne R. Phillips, Amy L. Edwards, and Meaghan A. Colligan
While product importers were spending the summer poring over the Instructions for Reporting PFAS Under TSCA Section 8(a)(7) (May 2024), EPA was working on a Direct Final Rule and Proposed Rule to extend the deadline for a TSCA one-time reporting rule that was finalized on October 11, 2023, under section 8(a)(7) of TSCA (15 U.S.C. § 2607(a)(7)).
Relying upon its common tactic of publishing both a direct final rule and a proposed rule together in the Federal Register, the EPA reported on September 5, 2024, that it will not be ready to accept the reporting that was due to commence on November 12, 2024, and conclude for most parties on May 8, 2025. Rather, the EPA proposed to extend the deadline for most reporting to January 11, 2026, and plans to open the reporting tool for submissions on July 11, 2025—two months after reporting was supposed to be complete for most parties.
