The U.S. Environmental Protection Agency (EPA) finalized a rule to extend the deadline for manufacturers and importers of 16 chemicals to report certain unpublished health and safety studies to the EPA as required by a December 2024 Toxic Substances Control Act (TSCA) Section 8(d) Health and Safety Data Reporting Rule.
The data collected through the EPA's Health and Safety Rule will be used to inform TSCA responsibilities including prioritization, risk evaluation and risk management plans. The data submitted could significantly alter the agency's findings relating to scope, conditions of use, health risks identified in internal industry testing and other significant findings within the unpublished health and safety studies.
Ten days before the original reporting deadline set by the Biden-era EPA, on March 13, 2025, the Trump Administration EPA issued a final rule extending the deadline for 15 of the 16 chemicals to June 11, 2025, and Sept. 9, 2025, for vinyl chloride. As the reporting deadline approached once more, the EPA on June 5, 2025, intervened again to extend the reporting deadline to May 22, 2026, for all 16 chemicals. This gives manufacturers and importers of the selected chemicals nearly an additional year to submit their data, potentially making it difficult for the EPA to meet statutory deadlines under TSCA for the chemicals already in the TSCA pipeline.
The Biden-era EPA required manufacturers and importers of 16 chemicals to submit health and safety studies required under 40 CFR 716.10 and 40 CFR 716.50 by March 13, 2025.
According to the EPA's December 2024 statement, the selected chemicals were "of particular interest to EPA because they are either in the process of prioritization as candidates for high-priority designation for risk evaluation or are expected to be candidates in upcoming years." Of the 16 chemicals, 10 are actively part of either the TSCA prioritization or risk evaluation process.1
The chemicals subject to the reporting requirements and their stage in the TSCA process are as follows:
Chemicals Designated as High-Priority Substances for Risk Evaluation
In December 2024, the EPA completed the 12-month statutory prioritization process for these substances. TSCA requires the EPA to issue the scope of these chemicals' work evaluations by June 18, 2025. This designation also subjected importers and manufacturers to TSCA fees as required by 40 CFR 700.45, with the publication of a preliminary list of companies believed to be responsible for paying the total fee of $4.287 million for each chemical substance undergoing EPA-initiated risk evaluation. Manufacturers and importers would be required to submit 50 percent of payment within six months of the draft scope's release, with the rest of the payment due 545 days after publishing the final scope of a risk evaluation. The final rule extending reporting requirements for these substances until May 22, 2026, raises the potential that the EPA could significantly delay the risk evaluations for these substances or, at minimum, begin its work without being able to review and incorporate the health and safety studies and other data that is subject to this rule. There could also be delays in fee collection if the draft and final scopes are delayed:
- acetaldehyde
- acrylonitrile
- benzenamine
- 4,4'-Methylenebis(2-chloroaniline) (MBOCA)
- vinyl chloride
Chemicals Initiated for Prioritization
In December 2024, the EPA initiated the prioritization process for the chemicals below. The prioritization process takes nine to 12 months, containing two 90-day public comment periods, with a statutory deadline for the EPA to complete the process by December 2025. The final rule extending reporting requirements for these substances until May 22, 2026, raises the potential that the EPA could also delay other elements of the statutory prioritization process and, at minimum, delays the EPA's ability to review and incorporate the health and safety studies and other data that is subject to this rule into its prioritization efforts:
- 4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)-phenol)
- benzene
- ethylbenzene
- naphthalene
- styrene
Third Batch of Six Chemicals
As part of efforts to improve the efficiency of the risk evaluation process, the EPA had started to let stakeholders know of its "pre-prioritization" efforts, including naming chemicals it was considering for future prioritization cycles, so that stakeholders could begin assembling any information the agency might find useful earlier in the process. The EPA had also announced plans to begin the prioritization process for five chemicals each year in order to improve efficiency and sustainability across the entire multiyear TSCA prioritization, risk evaluation and risk management life cycle. The last six chemicals whose reporting deadline was extended by this rule are among those the EPA was considering for future prioritization efforts, but the EPA has yet to indicate whether it plans to initiate the prioritization process for an additional five chemicals in 2025:
- 4,4'-methylene bis(2-chloraniline) (CASRN 101-14-4)
- benzenamine (CASRN 62-53-3)
- bisphenol A (CASRN 80-05-7)
- hydrogen fluoride (CASRN 7664-39-3)
- N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8),
- 2-Anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD quinone) (CASRN 2754428-18-5)
Members of Holland & Knight's Environmental Team will continue to focus on TSCA and chemicals to monitor ongoing developments and evaluate the potential impacts to businesses and industries.
We assist clients with mitigating liability across the entire life cycle of chemicals, including strategic counseling, policy advocacy and legislative efforts with respect to product stewardship, marketing, distribution, use, compliance, permitting, importation, contamination and spills management, and end-of-life management. For more information, please contact the authors.
Notes
1 For more details on the current status of specific chemicals, please refer to the EPA's Ongoing and Completed Chemical Risk Evaluations under TSCA.
