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FIFRA SAP Comes To Close With Emphasis On Need For More Data

WASHINGTON, DC – Last week the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) to review: “Chlorpyrifos: Analysis of Biomonitoring Data,” came to a close. CropLife America (CLA) and other industry representatives requested that this SAP be postponed and that documents used as the foundation for calling the SAP be opened for public comment.  The Environmental Protection Agency (EPA) declined to postpone the SAP. Accordingly, CLA and other industry representatives participated in a three-day SAP that appeared to confirm what opinions of two previous SAPs had advised the EPA (2008 and 2012) – which cautioned against the expansive use of the Columbia University epidemiology study.

CLA, other public commenters, and some panel members expressed concern regarding the rigor of the epidemiology study that formed the foundation of the panel’s charge questions. EPA did not take into account its 2010 Draft Framework for Incorporating Human Epidemiologic & Incident Data in Health Risk Assessment, in which EPA notes, “it is important to evaluate the strengths and limitations of epidemiologic studies when incorporating epidemiologic findings into risk assessment.”  Although the SAP appeared split over the importance of the study’s lack of rigor, several panel members expressed these concerns and recommended, along with CLA and other members of the public, that the lack of scientific consensus would justify a delay in EPA’s final decision on revoking the food tolerance for chlorpyrifos.

Many SAP members agreed that relying on a single epidemiology study did not provide adequate support for regulatory decision making. This concern was voiced multiple times, with panelists agreeing that the study is a “…snapshot in time.” Panelists stated that that they should be able to review “the underlying data,” from the study and that “…one study is not sufficient-the Agency needs to give some serious thought on how to proceed – it must increase the scientific rigor in order to amend its regulatory approach to human health risk assessment.”

“We are pleased that SAP members openly expressed their concerns with the same deficiencies of EPA’s approach to use of the Columbia University epidemiological study data in human health risk assessment, as we addressed in our written and oral comments,” CLA President and CEO Jay Vroom stated. “It is more important than ever to recognize the importance of relevant science and data in making regulatory decisions that could not only remove effective and tested products from the market, but also prevent new technologies with improved environmental and human health profiles from reaching the market at all,” continued Vroom. “In order to ensure consistency of standards for all testing, we encourage EPA to use FIFRA and related regulations to guide these decisions.”

The SAP has 90 days to submit its official recommendations to EPA.  At that time, EPA will proceed with its regulatory decisions by consideration of the SAP’s recommendations, although EPA is not required to follow those recommendations. EPA has publicly stated its intention to finalize revocation of all chlorpyrifos tolerances by December 2016.