EDF files extensive comments critical of EPA’s problem formulations for the first 10 chemicals being reviewed under TSCA

Richard Denison, Ph.D., is a Lead Senior Scientist.

Last night, Environmental Defense Fund (EDF) submitted more than 200 pages of comments providing a detailed critique of each of the “problem formulations” EPA issued in June for the first 10 chemicals in commerce undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  EDF also delivered 45,000 comments to EPA from members of the public across the country echoing our concerns.

The EPA documents lay out the scope of each of the risk evaluations EPA will conduct.  They are highly flawed and deviate in numerous ways both from what TSCA requires and from use of the best available science.  

Some of the deficiencies in EPA’s documents stem from the illegal Risk Evaluation Rule the agency issued in July, 2017.  In that rule, EPA asserted sweeping authority to ignore known uses of and the resulting exposures to chemicals when evaluating their risks under TSCA.  EDF joined with 14 other organizations in litigation challenging that rule, in a case that is being heard by the U.S. Court of Appeals for the Ninth Circuit.  Petitioners’ Opening Brief was filed in April.

EPA strays even farther from the law in its problem formulations, however, now asserting that it can also ignore known exposures to chemicals when they are released into our air, water or land.  EPA also relies on inadequate information, questionable assumptions, and cursory analyses to ignore many exposure pathways as well as certain hazards and relevant subpopulations.

As a result, these documents do not meet TSCA’s requirements that EPA use the best available science based on reasonably available information.

Among EDF’s comments addressing the many serious problems in EPA’s documents are the following:

  • EPA cannot ignore ongoing, real-world exposures that are occurring despite another EPA-administered statute that could potentially cover those exposures.
    • EPA must, based on the clear text and overall structure of TSCA, analyze exposures even if they have been or could be assessed under another statute.
    • EPA cannot accurately evaluate risk to potentially exposed or susceptible subpopulations, such as fenceline communities, if it excludes the vast majority of exposure pathways leading to their greater exposure.
    • EPA’s authorities under other Federal laws cannot be used to sidestep EPA’s authority or obligations under TSCA.
    • EPA ignores the numerous problems with compliance, implementation, and enforcement under the other authorities EPA seeks to rely on instead of TSCA.
  • EPA needs to promptly finalize its proposed bans on high-risk uses of trichloroethylene, methylene chloride and N-methylpyrrolidone, rather than delay the health protections the bans would deliver by subjecting those uses to unnecessary re-evaluation.
  • EPA must evaluate exposures from legacy and other past uses and related disposal of these chemicals.
  • EPA must evaluate the combination of all exposures and risks, and not treat individual exposures or risks in isolation.
  • EPA ignores numerous information gaps in the problem formulations, providing no strategy or intent to fill such gaps despite enhanced information authorities Congress just gave EPA.
    • EPA should utilize its TSCA section 4 and 8 authorities to fill identified data gaps.
    • EPA cannot use an absence of sufficient information as a basis to ignore uses or exposure routes and pathways.
  • EPA should generally utilize its prior hazard assessments that exist for a number of the first 10 chemicals, and must justify any decision to deviate from these values.
  • EPA has not adequately identified potentially exposed or susceptible subpopulations in many of its documents.
    • EPA should identify people living near disposal sites and other sources of contamination as potentially exposed or susceptible subpopulations.
    • EPA needs to ensure that environmental justice is appropriately considered, analyzed, and addressed in the risk evaluations.
    • EPA needs to consider infants, children, and pregnant women who may be more susceptible to those chemicals exhibiting potential for developmental or reproductive toxicity.
  • EPA needs to accurately evaluate real-world occupational and consumer exposures.
    • EPA needs to have a strong empirical basis when characterizing the extent of use and efficacy of occupational exposure controls or compliance with standards or guidelines.
    • EPA should always evaluate exposure scenarios without controls to assess exposures and risks to subpopulations not subject to the controls.
    • EPA should never rely on labeling and personal protective equipment as a basis to assume low or no exposure, given the major real-world limitations of these measures.

See our comments for the details.


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