Objections Voiced by EPA SAP to Use of “Single Study” Epidemiology Data in Setting Chlorpyrifos Health and Safety Standards
04/28/2016 -Dow AgroSciences appreciated the opportunity to observe and participate in EPA’s recent Scientific Advisory Panel (SAP) proceedings on the use of epidemiology data in setting health and safety standards for the regulation of chlorpyrifos and other insecticides in the future. We offer thanks to all ag industry presenters for their continuing support and interest during the meeting, and we look forward to the panel’s report of its deliberations, which is expected in the next 90 days.
While clearly struggling with difficult questions of how to integrate the findings of published academic epidemiology with regulatory guideline toxicology research conducted according to predetermined EPA protocols and providing complete Agency access to raw data, the majority of the Panel concurred in public comments at the conclusion of the three-day session that:
- EPA should not use Columbia study data to set regulatory endpoints for quantitative risk assessment for chlorpyrifos,
- This is especially the case since the findings reported by the multiple Columbia publications represent “a single study” that has never been replicated and for which raw data have not been made available for independent scrutiny by EPA and other stakeholders, despite multiple requests from the Agency to the study authors on previous occasions to provide it.
Some panelists also reiterated concerns voiced in two previous SAPs that serious questions of validity and reliability stemming from the Columbia study’s methodology make use of its data by EPA in quantitative risk assessment unacceptable.
Panelists also reflected seriously on concerns expressed by the U.S. Department of Agriculture about the importance of chlorpyrifos to U.S. food production and the need for inter-Agency dialogue in regulatory decision-making for such a highly valued crop input.
Many researchers, policy analysts and ag-stakeholder presenters also voiced concerns during the session about the unsupportable precedent that would be set if the Agency were to place such inordinate weight on unreplicated, unverified data – disregarding 40 years of high-quality animal research – without an established biological mechanism to account for reported adverse findings.
Dow AgroSciences encourages EPA now to finalize its long-delayed Agency policy on use of epidemiology data in pesticide regulation, rather than allowing evolving public policy pressures to continue driving decisionmaking in potentially arbitrary directions.
Dow AgroSciences also echoes the observations made by stakeholders during the session that, while continuing evaluation of epidemiology data remains an important part of risk assessment, these data must be held to the same high standards of transparency and scientific rigor as regulatory guideline research conducted on chlorpyrifos, in which cholinesterase inhibition has been repeatedly found to be the strongest regulatory endpoint for setting health and safety standards.
With the detailed guidance offered by its expert Scientific Advisory Panel, EPA now faces the challenge of reassessing chlorpyrifos in the context of available epidemiology data and the higher quality and far more considerable toxicology data accumulated throughout decades of research. Given the importance of chlorpyrifos to U.S. agriculture and the strength of the data supporting its registration, Dow AgroSciences will continue to support EPA regulatory evaluations with high-quality state-of-the-art research reaffirming the highly precautionary margins of exposure offered to health and safety under current product registrations.
Following are links to presentation material provided at the SAP, regulatory trade press articles on the meeting and other documents which you may find of interest.
Meeting-related news stories:
Meeting-related presentation materials:
Dr. William Banner, practicing pediatrician and board-certified toxicologist:
Excerpts from 2015 comments to the EPA public docket
2015 University of California at Davis report on critical uses of chlorpyrifos