Facing a massive uproar from industry groups and companies, late yesterday EPA put a hold on enforcement of a newly effective prohibition on one "PBT" chemical and announced a new comment period to re-examine the rules issued on January 6, 2021, for five PBTs under section 6(h) of the Toxic Substances Control Act (TSCA).
The five chemicals subject to the PBT rules include:
- Phenol, isopropylated phosphate (3:1) (PIP (3:1))
- Decabromodiphenyl ether (DecaBDE)
- 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
- Hexachlorobutadiene (HCBD)
- Pentachlorothiophenol (PCTP)
Despite a multi-year rulemaking process, it appears that a large majority of effected industries were unaware of how widespread at least one of the regulated PBT substances is in the products or components that they manufacture or import. PIP (3:1) is a widely used plasticizer and flame retardant that is present in a wide range of components, particularly electronics including cell phones, semi-conductor manufacturing equipment, wiring harnesses, and even, as EPA noted, "equipment used to move COVID-19 vaccines and keep them at appropriate temperature." However, PIP(3:1) has not been prominent on the regulatory radar screen until now, in part because it is not regulated as yet in the European Union.
With the prohibition entering into effect on March 8, and only limited exemptions in the current rule, many companies were faced with a major dilemma in that compliance could prevent access to and import of critical parts or materials.
Stakeholders note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging. They assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles. It was not EPA’s intent during the development of the rule to have such a broad disruptive impact.
- U.S. EPA Press Release, March 8, 2021
To avoid imminent supply chain disruptions to large sectors of the economy, EPA agreed to the last minute reprieve and instituted a 180-day pause in enforcement of the PIP (3:1) prohibitions, exercising its enforcement discretion in the form of a "no action assurance" letter.
In addition, EPA is initiating a 60-day comment period seeking input on both the PIP (3:1) compliance issues and whether the PBT rules sufficiently reduce exposure to the five chemicals, with a particular re-examination of exposures to potentially exposed or susceptible subpopulations, and the environment, and whether additional or alternative measures should be considered.
The EPA press release, with links to additional information, is available here.
TSCA section 6(h) requires EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable. Based on the statutory criteria, EPA identified five PBT chemicals for expedited action in 2016 and issued a proposed rule in 2019, with the rule made final two months ago. Under TSCA section 6(h), no additional risk evaluation is required for PBT chemicals. Accordingly, unlike most chemical reviews arising under TSCA, the PBT rulemaking jumps right to the "risk management" phase.
This whole episode is a high profile reminder of the need for companies to have a system in place to track all chemicals that are present in their products, or that are vital to their manufacturing activities, and to monitor regulatory actions that will impact those substances.