NGOs call on EPA to revise the draft scopes for its upcoming risk evaluations to comply with TSCA and its own regulations

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

Environmental Defense Fund, Earthjustice, Natural Resources Defense Council, and Safer Chemicals Healthy Families yesterday told the Environmental Protection Agency (EPA) that the 20 draft scope documents the agency released for public comment on April 9 and April 23, 2020, fail to meet TSCA and EPA regulatory requirements.  The groups called on EPA to revise the drafts 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. 

Under both TSCA and EPA regulations codifying its Risk Evaluation Rule (40 CFR 702.41(c)), the scope of a risk evaluation must identify:

  • the potentially exposed populations, including any potentially exposed or susceptible subpopulations as identified as relevant to the risk evaluation by the Agency 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.

It must also present the “reasonably available information” on which EPA relies to identify these required scope elements.

EPA’s regulations – specifically section 702.41(c)(7) – make clear that these elements are to be included in the draft scope EPA makes available for public comment, not just in the final scope.

Instead, 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.

EPA also repeatedly alludes in each draft scope to another document – “systematic review documentation” – that it has not yet made public. EPA states it will use this separate document to identify the required scope elements and the reasonably available information on which it relies.  While EPA says it plans to publish this second document prior to finalizing the scope document, and take public comment on it, EPA has wholly divorced that process from the public comment process for the draft scopes.

Given that the systematic review documentation is not yet available, the public is unable to consider its content in preparing comments on the draft scopes EPA issued last month.  By proceeding in this manner, EPA jeopardizes the integrity and legality of the entire risk evaluation process.

Our organizations called on EPA to simultaneously publish and take comment on its systematic review documentation for each scope along with the revised draft scopes themselves.  Only in this manner will all of the information directly relevant to the scopes of the 20 risk evaluations EPA has initiated be able to be reviewed and commented on at the same time and in an integrated manner, rather than piecemeal.  EPA should not finalize the scopes until this additional comment period concludes and EPA has sufficient time to address the comments received.

See the comments our four organizations submitted yesterday for more detail.



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