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May 19, 2020

NGOs State That EPA Fails to Meet Regulatory Requirements

Christopher R. Blunck

As we noted in our May 15, 2020, blog item “NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations,” 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.  In the comments, linked to in EDF’s May 14, 2020, blog item on the subject (the comments are not yet posted to the EPA dockets), 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 to be included, and then make the revised draft scopes available for public comment.  In their comments, the NGOs note that TSCA Section 6(b)(4)(D) requires that EPA, “not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider” (emphasis added) and that under EPA’s risk evaluation rule at 40 C.F.R. Section702.41(c), the scope of a risk evaluation must, among other things, 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;
  • The hazards to health and the environment that EPA plans to evaluate; and
  • The “reasonably available information” on which EPA relies to identify these required scope elements.

The NGOs state that EPA regulations at 40 C.F.R. Section 702.41(c)(7) make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  According to the NGOs, despite the regulatory requirements, EPA has not addressed the specific obligations and “Instead, EPA has only generally described some broad categories of hazards, exposures, and potentially exposed or susceptible subpopulations, and has suggested it will identify the specific hazards, exposures, and subpopulations — and the reasonably available information it relies on to identify them — only later, well after the current comment periods have closed and possibly even after the scopes are finalized.”  This, the NGOs state, is not allowed under TSCA and the TSCA risk evaluation rule.

Furthermore, the NGOs state that EPA also refers in each draft scope to “systematic review documentation” that has not yet been made public.  While EPA states it plans to publish this second document prior to issuing the final scope document, and take comment on it, the comments state that “EPA has wholly divorced any public comment opportunity it will provide on that systematic review document from the current public comment opportunity” and “[g]iven that the systematic review document is not yet available, the public is unable to consider its content in preparing comments on the draft scope document.”

The NGOs indicate that given these faults, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  They request EPA simultaneously to publish and take comment on, for a period of no less than 30 days, revised draft scope documents that reflect the planned systematic review, and the systematic review documentation for each scope.

We agree that the faults identified by the NGOs on the draft scope documents and the associated process are significant and that if not remedied, any risk evaluations with scopes founded on the drafts would be legally vulnerable as not comporting with TSCA and EPA’s risk evaluation rule.  EPA may wish to consider taking corrective measures along the lines urged.  This change would include adding into revised draft scopes for comment the reasonably available information EPA has indicated it will identify through the yet-to-be-completed systematic review process, and will identify the specific hazards, exposures, and potentially exposed or susceptible subpopulations that EPA expects to consider in the risk evaluations.