CropLife America (CLA) submitted a letter on Sept. 22, 2016, to U.S. Environmental Protection Agency Administrator Gina McCarthy requesting that the agency publish for public comment in the Federal Register its proposed framework for the use of epidemiological studies in human health risk assessments for the regulation of crop protection products.

The letter is a follow-up to a 2010 CLA petition to EPA asking the agency to “promulgate a rule establishing clear and scientifically sound criteria for selection of epidemiological studies to be incorporated into the Office of Pesticide Programs (OPP) risk assessment for a given pesticide product.”

EPA denied the 2010 petition in April 2011, stating that the agency “plans to release a revised version of [draft guidelines] for public comment this year.” One month prior to EPA’s response to the CLA petition, the White House issued a “Memorandum for the Heads of Executive Departments & Agencies” addressing Principles for Regulation & Oversight for Emerging Technologies, which specifically directed agencies to use the “best available scientific evidence,” develop “ample opportunities for stakeholder involvement and public participation” and recognize benefits and costs of oversight and regulation. EPA has yet to release the draft guidelines, which calls into question its support of the use of sound scientific data in the regulation of crop protection products.

In the letter to McCarthy, Jay Vroom, president and chief executive officer of CLA, wrote, “As we look back at the landscape of the past six-plus years since our petition and EPA’s denial of that petition, it is our belief that much, much more has been said about the use of 'epi' data, how it is evaluated for scientific veracity and whether epidemiological information has had consistent and meaningful impacts on risk assessments. In fact, looking at two recent EPA risk assessment approaches on two different chemicals, it seems there is significant inconsistency in the EPA approach.”

Vroom continued, “Based on need for consistency, and to account for all the new and deliberative discussions [in which EPA] has taken part related to epidemiological data in the last six years — and to follow the 2011 White House directive — CLA is asking that EPA at minimum publish for public comment in the Federal Register [its] proposed Epidemiological Framework.”

“The memo from the White House in 2011 was clear about the importance of sound science and public participation in the rule-making process,” stated Dr. Janet E. Collins, senior vice president of science and regulatory affairs at CLA. “We are in urgent need of guidance on the use of epidemiological studies in risk assessments. The crop protection industry must be able to develop the most precise and scientifically studied products possible; our nation’s farmers depend on the continual advancement of crop protection technology to get high-quality and nutritious produce to consumers.”