CropLife America Cheers Ruling

CropLife America is pleased that the U.S. Court of Appeals for the District of Columbia Circuit has granted the association’s petition for review and vacated the EPA’s moratorium on using human clinical test data in pesticide risk assessment.

“We are pleased that the court recognized that EPA’s moratorium constituted a binding regulation issued without notice and the opportunity to comment,” explained Jay J. Vroom, president, CropLife America. “Not only was this a violation of the Federal Food, Drug and Cosmetic Act, it also contradicted FFDCA’s clear requirement that EPA consider all relevant reliable data in making pesticide decisions.”

The court ruled that the EPA’s “previous practice of considering third-party human studies on a case-by-case basis, applying statutory requirements, the Common Rule, and high ethical standards as a guide, is reinstated and remains in effect unless and until it is replaced by a lawfully promulgated regulation.
Vroom expressed interest in working with EPA officials to utilize the test data in the regulation of industry products.

“Human clinical trials with pesticides are conducted to help refine the parameters and limits of risk and to increase the confidence in risk assessment so that risks are not underestimated or overestimated,” he outlined. “The net benefit to society is that safe use of pesticides can be more closely aligned with efficacy using the least amount of product to accomplish the necessary crop protection and pest control. Sometimes this results in the high crop yields that produce the abundance of fruits and vegetables we need for a healthy diet. Other times it results in products that produce direct public health benefits.”

CropLife America represents the developers, manufacturers, formulators and distributors of plant science solutions for agriculture and pest management in the United States.