Chemicals, Enforcement and Inspection

New PBT Chemical Rulemaking and Compliance Extension

The EPA announced September 3 it will initiate new rulemaking and plans to propose new rules for five persistent, bioaccumulative, and toxic (PBT) chemicals subject to risk management rules under the Toxic Substances Control Act (TSCA).

In conjunction with this announcement, the EPA is also taking action to provide an extension on 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)).” Because the most recent No Action Assurances expired September 4, 2021, this action was critical for impacted industry.

Final rules under TSCA Section 6 (h) were issued on January 6, 2021, for five PBTs:

  • 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP)
  • decabromodiphenyl ether (decaBDE)
  • hexachlorobutadiene (HCBD)
  • pentachlorothiophenol (PCTP)
  • PIP (3:1)

The National Law Review reports those “final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce for the following:

  • DecaBDE: A flame retardant in plastic enclosures for televisions, computers, audio and video equipment, textiles and upholstered articles, wire and cables for communication and electronic equipment, and other applications;
  • PIP (3:1): A plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles;
  • 2,4,6-TTBP: An intermediate/reactant in processing, and it is incorporated into formulations destined for fuel and fuel-related additives;
  • HCBD: A chemical used as a halogenated aliphatic hydrocarbon that is produced as a byproduct during the manufacture of chlorinated hydrocarbons; and
  • PCTP: A chemical used to make rubber more pliable in industrial uses.”

The EPA announcement states it is considering revising all five final rules.

“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).…”

On March 8, 2021, the EPA issued a press release stating it was opening a public comment period on the five final rules for PBT chemicals to seek input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on PIP (3:1), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

At that time, the EPA noted industry concerns regarding the compliance date for PIP (3:1), which is used in many electronics, from cell phones to laptops and robotics and equipment used to keep COVID-19 vaccines at the correct temperature.

PIP (3:1) compliance date extension

The EPA has extended the compliance date for PIP (3:1) to March 8, 2022, and expressed frustration with stakeholders for not previously providing input on the supply chain impact to consumer and commercial goods.

“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,” according to the EPA announcement. “Despite EPA’s extensive outreach conducted during development of the PBT rules, most stakeholders … 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.”

Although the extension to March 8, 2022, for PIP (3:1) compliance dates may be short, the news should bring relief to impacted industry.

Because the 6-month extension time frame presents so many challenges for industry parties to gather detailed and complex information regarding every item containing PIP (3:1) and will also provide challenges for the EPA to review such detailed information, analysts expect to see an additional short-term compliance extension for this particular PBT chemical.

The National Law Review advises “manufacturers and importers of electric and electronic final products 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 that when EPA provides its guidance on commenting, commenters will be prepared to provide comments during what we expect will be a very short comment period.”