New Year, New TSCA Rules

The U.S. Environmental Protection Agency (EPA) has been working overtime recently to complete many actions under the Toxic Substances Control Act (TSCA).

Yesterday, the U.S. Environmental Protection Agency (EPA) published the final rules for five persistent, bioaccumulative, and toxic (PBT) substances previously determined to meet the requirements for expeditious review under the authority of TSCA Section 6(h). As we previously discussed—here, here, and here—the final PBT regulations apply to decabromodiphenyl ether (DecaBDE), phenol, isopropylated, phosphate (3:1) (PIP (3:1)), 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD), and pentachlorothiophenol (PCTP). These rules place significant prohibitions on the five chemicals that either greatly limit or prohibit altogether the manufacture, importation, processing, and distribution in commerce of these chemicals and products containing them beginning as early as this March. We fully expect to see these final rules litigated, especially given many of EPA’s tenuous legal arguments and failure to conduct any meaningful risk evaluations on the PBT chemicals.

On Tuesday, EPA signed a final rule that reopens the reporting period for retrospective active chemical notifications for the TSCA inventory. Wiley has previously written about the TSCA Inventory Reset and the associated confidential business information (CBI) issues here. This action will provide an opportunity for companies to either submit, amend, or withdraw a Notice of Activity required by law for all chemical substances that are active on the TSCA Inventory. A chemical is considered active if manufactured, imported, or processed between June 21, 2006, and June 21, 2016. EPA decided to reopen the reporting period based on the feedback that it received in response to its May 2020 posting of the interim list of chemicals slated to lose their CBI status. Submitters informed EPA that there was significant confusion regarding CBI claims during the first reporting period. Therefore, the reporting period will reopen for a 60-day period 30 days after the final rule is published in the Federal Register. We cannot urge strongly enough for personnel responsible for CBI substantiations within their company to check with their counsel to ensure that they meet the heightened TSCA requirements, as we expect EPA to increase its scrutiny of these claims. We also would not be surprised if EPA’s final rule—issued without prior notice and comment—is challenged in federal court. Therefore, impacted companies and industries may want to monitor whether litigation occurs and intervene in any legal challenge. If that litigation were successful, the court may invalidate any submissions provided to EPA during the reopened reporting period.  

As always, please contact Wiley for all your TSCA and environmental law needs.


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