The U.S. Environmental Protection Agency (EPA) announced its intent to initiate a new rulemaking and anticipates proposing new rules for five persistent, bioaccumulative and toxic (PBT) chemicals that are the subject of final risk management rules under the Toxic Substances Control Act (TSCA). These rules address exposure to toxic chemicals that remain in the environment for long periods of time and build up in the body. Additionally, EPA is taking action to extend the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirement of one of these PBT chemicals, phenol, isopropylated phosphate (3:1) (PIP (3:1)).
New Rulemaking on PBT Chemicals
TSCA directs EPA to take expedited action on certain PBT chemicals to reduce exposure and protect human health and the environment. Consistent with that mandate, final risk management rules restricting the use of five PBT chemicals were issued under the previous Administration in January 2021 and went into effect in February 2021.
In a March 2021 notice, EPA announced it was reviewing these rules in light of Executive Orders and other guidance provided by the Biden-Harris Administration and opened a public comment period to collect additional comments or information relevant to compliance dates, specifically requesting comment on the PIP (3:1) compliance dates for use in articles, and any aspect of the final PBT rules. After further review, EPA is considering revising all five of the final rules to further reduce exposures, promote environmental justice, and better protect human health and the environment. EPA plans to issue a proposal for a new separate rulemaking on all five PBT chemicals in the spring of 2023. The current provisions of the January 2021 risk management rules remain in effect while EPA is working on this new rulemaking effort, with the exception of PIP (3:1) as described below.
PIP (3:1) Compliance Date Extension
EPA is extending certain compliance dates for PIP (3:1) to March 8, 2022, to address the hardships inadvertently created by the original applicable compliance dates in the January 2021 final rule to ensure that supply chains are not disrupted for key consumer and commercial goods. EPA will also soon issue a notice of proposed rulemaking that, if finalized, would further extend the compliance dates.
Following the release of the January 2021 rule, stakeholders informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of goods and noted that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.
Despite EPA’s extensive outreach conducted during development of the PBT rules, most stakeholders contacting EPA after the rule was finalized did not comment on the proposal or otherwise engage with the Agency on the PIP (3:1) rulemaking, and do not appear to have previously surveyed their supply chains to determine if PIP (3:1) was being used. As a result, EPA did not have a full understanding of the impact of the prohibition prior to issuing the January 2021 final rules. While some commenters on the 2019 proposed rule indicated that PIP (3:1) may be present in articles, their comments were very general and did not identify specific uses or specific concerns with the March 8, 2021, compliance date. In response to this information, in March 2021, EPA issued a “No Action Assurance” to ensure that the supply chain of these important articles was not interrupted.
In conjunction with issuing the “No Action Assurance,” EPA issued a notice requesting further comments and information from industry stakeholders on the impact of the compliance dates, including specific information about the articles for which the compliance dates would need to be extended and a timeline for removing PIP (3:1) from their supply chains. However, industry commenters indicated the need for varying time frames to remove PIP (3:1) from their supply chains, and many did not provide sufficiently specific information about their operations to support their assertions.
To ensure that supply chains continue uninterrupted, EPA has issued a final rule providing a short-term extension of the specified compliance dates for PIP (3:1) articles until March 8, 2022. Soon, EPA will issue a notice of proposed rulemaking seeking comment on a further extension of the compliance date for PIP (3:1) articles to align with certain comments received and the expected timing for the new rulemaking on PBT chemicals previously mentioned. EPA will be accepting public comments in docket EPA-HQ-OPPT-2021-0598 on www.regulations.gov for 60 days from publication of that proposed rule. EPA intends to finalize this proposed rulemaking, which would further extend certain compliance dates, before March 8, 2022.
As part of the separate rulemaking on all five PBT chemicals planned for 2023, EPA intends to reevaluate the current rules for PIP (3:1) and the other PBTs, as well as provide a description of the specific kinds of information the Agency will require to support any additional extensions to the compliance dates. EPA will expect industry commenters to provide documentation of the specific uses of PIP (3:1) in articles throughout their supply chains, documentation of concrete steps taken to identify, test, and qualify substitutes for those uses, documentation of specific certifications that would require updating and an estimate of the time that would be required. Without this more specific information from suppliers, EPA will be unlikely to extend the compliance dates again.
PIP (3:1)-containing articles covered by the short-term compliance date extension include those that might be used in cellular telephones, laptop computers and other electronic devices. They also include articles that might be used in industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production, as well as other consumer and commercial goods.
This final rule is effective upon publication.
More info on US EPA website