Now More Than Ever, EPA Must Reform the Peer Reviews of Its Draft Risk Evaluations Under TSCA

No one can sincerely question the amount of time and effort that EPA has expended to draft and issue risk evaluations under TSCA. The general public, stakeholders, and the TSCA Science Advisory Committee on Chemicals (SACC) have also spent considerable time, expertise, and resources under demanding deadlines to analyze and comment on EPA’s draft risk evaluations. EPA was already needing an extension to complete its evaluations of the first ten chemicals, and now the Ninth Circuit’s recent decision will force the agency to perform additional work on the pending risk evaluations. Therefore, EPA must seek and achieve efficiencies in the risk evaluation process anywhere it can find them. My review of EPA’s risk evaluation framework rule, response to comments, scope documents, and problem formulations shows that the agency has inadvertently given itself additional flexibility to meet the looming deadlines.

EPA’s risk evaluation framework rule requires the agency to publish its peer review plan in the final scope document for each chemical substance. None of the published scope documents, however, set forth the agency’s plans. Nor do any of the problem formulation documents. In fact, the first time EPA announced its peer review plan for a particular chemical substance has been when the agency releases a draft risk evaluation (see, e.g., here).

As the agency recognizes, “EPA goes beyond what TSCA requires by peer reviewing the risk evaluation it releases in order to increase public transparency in the risk evaluation process and receive expert feedback on the science that underlies the risk determinations.” Peer review has been, and should continue to be, a vital step in the risk evaluation process.

But how EPA submits its draft risk evaluations for peer review remains an open question. In its response to comments document for the final risk evaluation framework rule, EPA stated it will determine what method of peer review is appropriate (e.g., letter review or consensus report) on a case-by-case basis by drawing upon the guidance from the EPA Peer Review Handbook and the OMB Final Information Quality Bulletin for Peer Review. Most importantly, EPA said it would use the SACC “as one potential method of peer review” (emphasis added).

With less than eight months remaining, the time has come for EPA to move away from asking the SACC to review every draft risk evaluation and, instead, determine what method of peer review would provide the best advice and consultation in the most efficient manner. The SACC is composed of scientists and technical experts who have full-time jobs in academia, public interest, and industry. EPA can ask only so much of these individuals. Required to at least double the number of chemicals it is evaluating under TSCA next year, EPA must find other independent third parties to take over peer review in both the short and long term.

This approach would allow the SACC to align its mission more closely with Congress’s original intent of having EPA use the advisory panel for specific scientific and technical issues related to the implementation of TSCA. The agency would no longer have to stagger its peer reviews to accommodate the SACC’s busy schedules. And by having other independent third parties conduct the peer reviews under a particular method, EPA would ensure that it meets the June 2020 deadline to complete the first ten risk evaluations.

The WELL

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