Recently, the U.S. Environmental Protection Agency (EPA) announced a settlement with Wilbur-Ellis Company, LLC, a world-renowned international giant. The company has agreed to pay a civil penalty of $630,737 to resolve claims of multiple violations concerning chemical notification and data reporting requirements under the U.S. Toxic Substances Control Act (TSCA). Wilbur-Ellis has since returned to compliance by retroactively submitting the missing regulatory filings.
As a significant cautionary tale for securing global chemical supply chains, REACH24H has compiled a technical breakdown of the core non-compliance items and their corresponding TSCA statutory standards.
Core Non-Compliance Facts vs. Statutory Standards
According to the Consent Agreement and Final Order (CAFO) issued by the EPA, Wilbur-Ellis committed three major categories of TSCA violations across its facilities:
Item 1: Unauthorized Manufacturing of a "New Chemical Substance" Without Notification
Non-Compliance Facts: Between 2020 and 2021, the company manufactured a proprietary new chemical substance (Chemical A) on 29 separate occasions without submitting any Pre-manufacture Notice (PMN) to the EPA.
Statutory Standards & Provisions: TSCA Section 5(a)(1) [15 U.S.C. § 2604(a)(1)] and its implementing regulations under 40 C.F.R. § 720.22(a)(1).
Compliance Metric: Any entity intending to manufacture or import a "new chemical substance" (a substance not listed on the TSCA Chemical Substance Inventory) for commercial purposes in the U.S. must submit a PMN to the EPA at least 90 days in advance. Commercial activities may only commence after navigating the EPA's risk assessment and securing clearance.
Item 2: Unauthorized Processing of an "Inactive Substance" on the Inventory Without Forward-Looking Notification
Non-Compliance Facts: After August 5, 2019, the company processed an existing chemical substance (Chemical B) that had been officially designated as "Inactive" by the EPA on at least one occasion without providing any advance notification.
Statutory Standards & Provisions: TSCA Section 8(b)(5)(B)(i) [15 U.S.C. § 2607(b)(5)(B)(i)] and its implementing regulations under 40 C.F.R. § 710.25(c) & 40 C.F.R. § 710.30(b).
Compliance Metric: Since the EPA formalized the active-inactive status of the TSCA Inventory, if an existing U.S. chemical substance is designated as "Inactive" due to a lack of commercial activity, any entity wishing to manufacture, import, or process it for a non-exempt commercial purpose must officially submit a Notice of Activity (NOA) Form B prior to reintroduction. Failure to do so constitutes a direct violation.
Item 3: Failure to Report Quadrennial Chemical Data Reporting (CDR)
Non-Compliance Facts: During the 2019 calendar year, two of the company’s domestic facilities manufactured three existing chemical substances (Chemicals C, D, and E) in quantities exceeding 25,000 pounds each. However, the company failed to submit the required Form U site reports during the 2020 CDR submission window.
Statutory Standards & Provisions: TSCA Section 8(a)(1)(A) [15 U.S.C. § 2607(a)(1)(A)] and its implementing regulations under 40 C.F.R. Part 711 (specifically §§ 711.8, 711.15, 711.20).
Compliance Metric: Except for certain exempt small manufacturers, if a company manufactures or imports an existing TSCA Inventory chemical substance at a single site in an amount reaching or exceeding 25,000 pounds (or 2,500 pounds for certain highly regulated, high-risk substances) during any given baseline calendar year, it is mandatory to submit core data regarding production volume, processing, and downstream uses during the quadrennial CDR reporting cycle.
REACH24H Regulatory Insights
This robust enforcement action by the EPA serves as a stern compliance reminder to global companies exporting to or operating within the United States. Amy Miller, EPA Pacific Southwest Enforcement and Compliance Assurance Director, emphasized in her statement: “Companies that produce chemicals must accurately report them in order to protect the public from possible chemical exposures carrying unknown risks.”
REACH24H would like to remind industry stakeholders of the following:
Do Not Equate "Inventory Listing" with "Immediate Commercialization Eligibility": Many companies mistakenly believe that if a substance is found on the massive TSCA Inventory, they are completely safe. However, if the substance's status is designated as "Inactive," failing to execute an NOA Form B activation filing constitutes a severe regulatory violation.
Prioritize Supply Chain Screening & Dynamic Tracking: Although the CDR is a quadrennial obligation, its compliance evaluations trace back through the actual manufacturing or import volumes of multiple calendar years. Companies must transition away from "last-minute reporting" and instead build robust internal record-keeping and tracking mechanisms to ensure that new substance PMNs, CDR quadrennial data submissions, and dynamic Inventory status cross-checks are handled accurately and responsively.
Not sure where to start? Our regulatory experts are ready to help.
Email: customer@reach24h.com
