The implementation of the Toxic Substances Control Act (TSCA) provisions relating to regulating persistent, bioaccumulative and toxic (PBT) chemicals has been anything but smooth. On September 3, 2021, the Environmental Protection Agency (EPA) announced it intends to initiate new PBT rulemaking and anticipates proposing new rules for five PBT chemicals subject to final risk management rules under TSCA Section 6(h). Additionally, and happily, the agency extended the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirements of one of these PBT chemicals, phenol, isopropylated phosphate (3:1) (PIP (3:1)). The action was imperative as EPA’s earlier-issued “No Action Assurance” (NAA) lapsed on September 4, 2021. This article provides key points related to this complicated area of TSCA regulation.
On January 6, 2021, the EPA issued final rules under TSCA for five PBTs: 2,4,6-tris (tert-butyl) phenol; decabromodiphenyl ether; hexachlorobutadiene; pentachlorothiophenol; and PIP (3:1). The final rules limit or prohibit the manufacture/import, processing, and/or distribution in commerce of these chemicals. On March 8, 2021, the EPA announced it needed additional public input on these rules and opened a 60-day comment period.
In its September announcement, the agency noted it’s considering revising all five of the final rules “to reduce exposures, promote environmental justice, and better protect human health and the environment.” The EPA will not propose new rulemaking on all five PBT chemicals until the spring of 2023. The current provisions of the January 2021 rules will remain in effect while the EPA works on the new rulemaking effort, with the exception of PIP (3:1), which is described below.
The EPA extended certain compliance dates for PIP (3:1) to March 8, 2022, to address the many “hardships” brought to its attention in the aftermath of the final rule issued on January 6. The EPA did so “to ensure that supply chains are not disrupted for key consumer and commercial goods.” As readers may know, following the release of the final PIP (3:1) rule, stakeholders informed the EPA that the prohibition on processing and distribution of PIP (3:1) would significantly and adversely impact articles used in a wide variety of electronics, from cell phones, to robotics for manufacturing semiconductors, to equipment for moving COVID-19 vaccines and keeping them at the appropriate temperature (See, “Better Understand TSCA’s Long Reach”).
In response to this, the EPA issued a rare, temporary 180-day NAA indicating it would exercise its enforcement discretion regarding prohibitions on processing and distribution of PIP (3:1). While the six-month reprieve was well received, many stakeholders had advocated for one that would last years, not months.
To ensure supply chains continue uninterrupted, the EPA signed in September a final rule extending compliance dates for PIP (3:1) articles to March 8, 2022. The agency plans to further extend this deadline and the associated recordkeeping requirements to align with comments received and the expected timing for the new rulemaking.
As part of the separate rulemaking on all five PBT chemicals planned for 2023, the EPA will reevaluate the current rules for PIP (3:1) and the other PBTs, and, importantly, describe the information it will require to support any additional extensions to the compliance dates. Without this more-specific information from suppliers, it’s unlikely the EPA will extend the deadline again.
The EPA’s extension of PIP (3:1) compliance is welcome relief. Although some will complain about its seemingly short duration, the agency’s approach is fair. After reviewing the many comments received, the EPA’s view is that many commenters “did not provide sufficiently specific information about their operations to support their assertions” for more time.
Stakeholders are strongly urged to document efforts taken to-date and immediately to gather more specific facts related to how challenging it will be to survey every supplier of every part. These measures will best prepare stakeholders so when the EPA provides its guidance on commenting, commenters will be prepared to provide feedback during what we expect will be a very short comment period.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected]
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.