EPA Releases Minutes from Third FIFRA SAP Questioning Role of Epidemiological Studies

WASHINGTON, DC – On July 20, the U.S. Environmental Protection Agency (EPA) released the minutes from a Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) titled, “Chlorpyrifos: Analysis of Biomonitoring Data.” During an open public meeting held by the SAP on April 19-21, panel members listened to comments from a diverse audience regarding EPA’s proposed use of an epidemiological study produced by the Columbia Center for Children’ s Environmental Health (CCCEH) in human health risk assessments. The minutes, dated July 15, and the final transcript confirm that the SAP questioned the usefulness of the outcomes from this specific epidemiological study.

“We see yet again, in the minutes submitted to EPA by the SAP, that the panelists question EPA’s shift to the use of certain epidemiological study outcomes, rather than toxicological data, in human health risk assessments,” stated Jay Vroom, president and CEO of CropLife America (CLA). “In our written comments submitted to the SAP, we specifically asked panelists to examine the question, ‘Can these epidemiological studies be appropriately used for quantitative risk assessment purposes?’ The answer is loud and clear – a resounding no. The crop protection industry now calls on EPA to base regulatory decision-making on hard toxicological data, helping farmers get and keep access to highly advanced products and keeping our food production standards high.”

Highlights from the SAP minutes include:

  • The SAP agrees with EPA that applying additional safety factors to the existing point of departure to account for a potential new mode of action would be problematic due to the challenges in justifying any particular value for such an adjustment;
  • Some SAP members stated that the sample size may have limited the CCCEH study’s ability to examine the association of chlorpyrifos blood concentration on neurodevelopment in more vulnerable populations; and
  • With respect to fetal exposure, the Panel noted that much uncertainty in the use of cord blood as a measure would be removed if the raw data from CCCEH were provided for reanalysis.

“We applaud the report of the SAP as the majority of the panel did not agree with the Agency’s use of the results from a single longitudinal study to make a decision based on the use of cord blood measures of chlorpyrifos to initiate risk assessment,” noted Dr. Janet Collins, senior vice president of science and regulatory affairs at CLA. “These epidemiologic studies were not designed to demonstrate cause of any human health impact and the effects of exposure to a single compound.”

Collins added, “We further applaud the SAP in its determination the panel did not have confidence that the CCCEH analytical data could accurately be used in quantitative risk assessment as a point of departure, due to the many uncertainties that cannot be clarified, since the raw data are not available for verification or validation of the analytical data. CLA has maintained for years that epidemiological data have an important role for EPA in decision making, but that the CCCEH study and EPA’s various considered uses of it do not serve a human health purpose.”

Michael Leary