Listen Carefully: TSCA Risk Management May Include New Risk Assessments

Yesterday, I gave a presentation on TSCA litigation at Chemical Watch’s TSCA Developments 2021 Virtual Conference. I shared the stage with EPA’s current leadership and members of the NGO community. Most of what I heard was not new, but one statement caught me by surprise and would have a significant impact on TSCA risk management actions. 

Not surprisingly, EPA informed the audience that it is reviewing all of the first 10 risk evaluations to determine whether the Agency needs to reopen those risk evaluations to include additional pathways that were previously excluded (e.g., EPA had determined not to include air emissions that were already regulated under the Clean Air Act) and, if so, whether the risk determinations for those chemicals need to change. EPA also reiterated that it would not assume the use of personal protective equipment (PPE) when assessing the safety a chemical substance. Therefore, even if every entity in a particular industry provided EPA with documentation that they require their workers to wear specific PPE sufficient to protect themselves, EPA will assume that there is some worker, somewhere, who does not wear the required PPE or their employer fails to provide such PPE. This new assumption will obviously lead to additional conditions of use being found to present an unreasonable risk.

But the one revelation from this conference came during the question-and-answer session during my panel: the NGO community is openly advocating for EPA to forego the time-consuming revisions of the completed risk evaluations and address any perceived flaws during the Agency’s risk management actions. In other words, if EPA wants to include a previously excluded pathway, these NGOs are telling the Agency that it can do so by merely including this new pathway and the associated risk assessment in a proposed risk management rule (I intentionally use “risk assessment” here because it would not be a true TSCA “risk evaluation.”). To the new administration’s credit, it appears that EPA is not currently adopting such an approach for risk management, as the Agency’s recent court filings indicate that EPA will release for public comment any revised risk evaluations. Of course, EPA may change course and adopt the NGO community’s preferred path forward.

Needless to say, it is vital to engage EPA as it writes the risk management rules for the fist 10 chemicals. The Agency has an open-door policy and is absolutely willing to work with industry during this phase. Knowing and understanding what EPA is planning to do in risk management may mean the difference between continuing to use a critical chemical to your business or needing to move manufacturing offshore. 

Please feel free to contact me if you have any questions or would like to discuss further on how to engage EPA during risk management. 



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