Gimme three steps” (with apologies to Lynyrd Skynyrd) EPA outlines a significant change of course in its TSCA Chemicals Risk Assessment Protocol.

The United States Environmental Protection Agency’s (“EPA”) June 30, 2021, announcement regarding a revision to the risk evaluation process under the Toxic Substances Control Act (“TSCA”) marks a significant step towards in the Biden administration’s strategy to layer non-statutory policy goals on top of existing statutory/regulatory schemes.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act, the first revision to TSCA since its enactment in 1976, directed EPA to review the risks associated with high-priority chemicals already approved and on the market, determine if unreasonable risks caused by the use of these products exits, and address those risks accordingly.  Although EPA began the review process under the Trump administration, the agency now intends to restart its analysis on the first ten chemicals subject to this process.  In a not so subtle rebuke of its own prior evaluation, EPA states that it is undertaking this new review to “restore public trust, provide regulatory certainty, and most importantly, ensure that all populations that may be exposed to these chemicals are protected.”

EPA’s announcement illuminates how the evaluation of chemicals will change for this initial group of chemicals and evaluation of chemicals going forward:

Exposure Pathways Regulated Under Other EPA-administered Statutes.  EPA claims that the agency’s previous review “did not assess air, water or disposal exposures to the general population because these exposure pathways were already regulated, or could be regulated, under other EPA-administered statutes such as the Clean Air Act, Safe Drinking Water Act, or Clean Water Act.”  EPA now contends that the previous analysis failed to take into account “additional exposure pathways” such as drinking water, ambient air exposure, as well as “conditions of use where 1,4-dioxane is generated as a byproduct that were excluded from the supplemental and final risk evaluations.”   EPA plans to examine the “policy decision” that excluded the consideration of certain exposure pathways from analysis in the risk evaluation process for six of the first ten chemicals: 1,4-dioxane methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, NMP, and 1-bromopropane. 

Fenceline Screening Assessments.  The Biden Administration’s Environmental Justice Initiative is seeking a whole-of-EPA approach to addressing inequities and overburdened communities.  TSCA is not spared from this evaluation. The agency is already in the process of developing “a screening-level approach to conduct ambient air and surface water fence line assessments.” EPA states that if these assessment show no unreasonable risk to the surrounding communities, approval can move forward.  Alternatively, if the screening-level demonstrates that there may be unreasonable risk from these chemicals that cannot be addressed without supplementing the risk assessment or through “risk management approaches,” the agency will conduct more thorough fence line assessments in order to supplement the respective risk evaluations.  Without committing to a specific timeline, EPA states that it plans to submit these screening approaches for peer review by the Scientific Advisory Committee on Chemicals and make it available for public comment.

Evaluation of Worker Safety.  EPA has also questioned the Trump Administration’s risk assessment assumption that employees are always given and use personal protective equipment (“PPE”).  The exposure analysis of the first ten risk assessments included assumptions with and without PPE.  The conclusions for methylene chloride, 1-bromopropane, HBCD, NMP, perchloroethylene, and 1,4-dioxane may change once the assumptions based on the usage of PPE are excluded.

Evaluation of “Whole Chemical.”  EPA indicates that it will apply a “whole chemicals” approach to the current 10 chemicals and evaluations going forward.[1]  In defining this approach, EPA has rejected the Trump Administration’s approach of analyzing risks based upon each use of a chemical.  Instead, the agency will make the determination once for the “whole chemical when it is clear the majority of the conditions of use warrant one determination.”  It will withdraw the orders previously issued that found “no unreasonable risk” was found, issue revised unreasonable risk orders reflecting the “whole chemicals” approach, and seek public comment regarding this new approach to chemicals regulation.

The policy changes contained in this carefully crafted announcement have the potential to be sweeping in their scope.  Implicit in EPA’s “fence line” approach is the contention that the agency can superimpose new requirements in addition to a number of existing regulatory schemes such as the Clean Air Act, Clean Water Act, and various OSHA regulations.  Although EPA states that these proposals are made to ensure that the risk evaluations follow the law and science, it fails to provide specific citations that support this contention.  Likewise, the agency’s plan to seek public comment on the new approach after it is put in place presents a significant risk of applying different standards for risk assessments moving forward.


[1] EPA has reviewed the risk evaluations issued for HBCD, PV29, and asbestos (part 1: chrysotile asbestos) and believes that “the risk evaluations are likely sufficient to inform the risk management approaches being considered and these approaches will be protective;” however, the agency is planning to amend the risk analysis to exclude the use of PPE.

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