CropLife America (CLA) representatives spoke to the importance of transparency in regulatory actions, data reliability, the availability of raw data and the need for high scientific standards Wednesday during the second day of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) to review: “Chlorpyrifos: Analysis of Biomonitoring Data.” The SAP is considering the use of results from a Columbia University epidemiology study (the Columbia Study) in regulating chlorpyrifos even though two previous SAPs (2008 and 2012) cautioned the U.S. Environmental Protection Agency (EPA) against using the Columbia Study results in the manner it now proposes. Sarah E. Starks, Ph.D., and Amechi Chukwudebe, Ph.D., presented a strong scientific rebuttal to the use of these epidemiology studies on behalf of CLA noting the limitations of the Columbia Study, including:

  • Lack of access to raw data;
  • Exposure measures used;
  • Small population reported in the study; and
  • The inability of EPA or others to replicate the study outcomes.

“Protection of public health is at the foundation of pesticide regulation. We need to ensure that EPA always uses the most appropriate and reliable data possible for human health risk assessments,” stated Dr. Tamika Sims, CLA director of human health policy. “This meeting of the SAP does not address the most relevant question – are the epidemiological data from the epidemiological studies robust and reliable enough for use in human health risk assessment? Specific guidance in which criteria can be established to determine the validity of the data are needed prior to acceptance of those data for regulatory decision making.”

EPA has acknowledged the limitations of relying on epidemiology studies for regulatory decision-making. In its own 2010 Draft Framework for Incorporating Human Epidemiologic & Incident Data in Health Risk Assessment, EPA notes, “it is important to evaluate the strengths and limitations of epidemiologic studies when incorporating epidemiologic findings into risk assessment.”

“CLA calls on EPA to respond to specific scientific questions from EPA expert panelists and public concerns regarding the use of epidemiology studies and develop solid guidance before allowing epidemiologic data to be used in human health risk assessment,” stated Jay Vroom, president and CEO of CLA. “We cannot allow outside pressure to diminish the high standards of our regulatory process and water down the data we use. CLA’s members remain dedicated to developing the most advanced, precise pesticide technology based in hard science that is protective of human health. Our farmers and our national food supply depend on our work.”

Vroom, who also provided brief comments at the SAP in introducing Drs. Starks and Chukwudebe, will testify next week before the House Committee on Agriculture, Biotechnology, Horticulture and Research Subcommittee on how EPA’s recent actions, such as using epidemiology studies to justify the application of a 10X safety factor, undermine the purpose of the protections established in the Food Quality Protection Act. Echoing CLA’s SAP presentation, Vroom will speak to the importance of toxicological studies as the basis of pesticide regulation and promote a more proper role for epidemiology studies.