TSCA Tuesday: Major Policy Rule, TCE, PBTs, and More

EPA has proposed a handful of new TSCA rules recently with potential to impact chemical manufacturers, distributors, and users—including a procedural rule to cement the Agency's comprehensive approach to chemical risk evaluations, which began in June 2021.

Major TSCA Procedural Rule Proposed 

A recently proposed rule aims to incorporate EPA's current approach to risk evaluations—outlined in a June 2021 TSCA policy update—into Agency procedures moving forward.

The 2021 policy update shifted the way that EPA conducts risk evaluations in three major ways, all of which are addressed in the new proposed rule: 

1. EPA now makes “unreasonable risk” determinations for each chemical as a whole.

   While EPA continues to evaluate individual conditions of use, a final risk determination is made for "the chemical substance" and not for each individual use. 

2. More exposure pathways are now considered as part of TSCA risk evaluations. The policy update stated that, before June 2021, EPA’s work on risk evaluations wrongly disregarded certain pathways like air, water, or disposal. 

   Disregarding exposure pathways because they are “already regulated” or “could be regulated” under an existing environmental program, EPA says, “resulted in a failure to consistently and comprehensively address potential exposures to the general population, as well as to certain potentially exposed or susceptible subpopulations.“ 

3. EPA will not assume that personal protective equipment (PPE) is always provided to employees, always worn properly, or always effective at eliminating exposure.

   Assuming every worker is always protected “could result in risk evaluations that underestimate risks, and in turn, prevent risk management rules for affording necessary protections.” 

The proposed rule would also amend provisions concerning manufacturer-requested risk evaluations under TSCA, including the process and requirements for manufacturers to follow to request a risk evaluation.

EPA will accept comments from stakeholders and the public until December 14, 2023. 

TCE Prohibition: Comment Period Closes 12/15

On Halloween, EPA proposed to totally prohibit (i.e., ban) the manufacturing (including import), processing, and/or distribution in commerce of trichloroethylene (TCE). The proposal includes compliance timelines, phase-out periods, and limited time exemptions for some uses.  

The 60-day public comment period on this rulemaking ends on December 15, 2023. 

Read more: TSCA Section 6 Prohibitions and Regulations (Updates)

Revisions for Two PBTs: decaBDE and PIP 3:1

After finalizing new requirements for five persistent, bioaccumulative, and toxic (PBT) substances in 2021, EPA received additional comments about the rule. Those comments have led EPA to propose revising the requirements for two of the five PBTs—decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) or "PIP 3:1." 

For decaBDE, the proposed rule would: 

• Require the use of PPE in domestic manufacturing and processing.
• Require labeling on plastic shipping pallets known to contain decaBDE. 
• Prohibit releases to water from activities involving decaBDE.
• Extend the compliance date for phasing-out use of the chemical to insulate nuclear power plant wires and cables (and add export related export notification requirements.. 

For PIP 3:1, the rule would: 

• Require the use of PPE in domestic manufacturing and processing.
• Phase-in prohibitions on processing distribution for certain uses. 
• Add new exclusions concerning wire harnesses and electric circuit boards.
• Introduce a 5-year compliance timeframe for the ban on processing and distribution to allow for use of PIP 3:1 in certain pesticide products.

The rule does not change any regulations related to the other three PBTs covered in the 2021 Final Rule. EPA will accept comments on the proposed rule until January 8, 2024. 

New TSCA PFAS Reports Due in 2025

EPA also recently set a deadline (May 8, 2025) for sites to report on PFAS production, distribution, and use since 2011. Read more: TSCA PFAS Reporting Rule Gets May 2025 Deadline.

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Tags: TCE, TSCA, TSCA Section 6