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May 15, 2020

NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations

Lynn L. Bergeson Carla N. Hutton

Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  According to EDF’s May 14, 2020, blog item, the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require be included, and then make the revised draft scopes available for public comment.  The NGOs maintain that under both TSCA and EPA regulations codifying the risk evaluation rule, the scope of a risk evaluation must identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
  • The ecological receptors that EPA plans to evaluate; and
  • The hazards to health and the environment that EPA plans to evaluate.

The scope document must also present the “reasonably available information” on which EPA relies to identify these required scope elements.  The NGOs note that EPA regulations make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  Instead, according to the NGOs, “EPA’s draft scopes repeatedly indicate that these required scope elements will be developed and provided later — thereby denying the public an opportunity to provide comment on the specific hazards, exposures and potentially exposed or susceptible subpopulations EPA expects to consider, as required at this stage in the process.”
The NGOs state that EPA also repeatedly refers in each draft scope to “systematic review documentation” that has not yet been made public.  EPA will use this separate document to identify the required scope elements and the reasonably available information on which it relies.  While EPA plans to publish this second document prior to issuing the final scope document, and take public comment on it, “EPA has wholly divorced that process from the public comment process for the draft scopes.”  By doing so, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  The NGOs urge EPA to publish and take comment simultaneously on the systematic review documentation for each scope along with the revised draft scopes themselves.