US Regulatory Hurdles Compounded by New Order

The US regulatory system is under review. After decades of varying interpretations by regulatory agencies under different administrations, President Barack Obama signed an executive order that would require regulatory agencies to include public input into the rulemaking process and order periodic reviews of legislation to determine if they should be modified or repealed.

The measure has widespread implications for the registration of crop protection products, which is governed by the Environmental Protection Agency, Department of Agriculture and the Food and Drug Administration. Such interdepartmental approvals have always been difficult and have led to varying interpretations of the Endangered Species Act, the Fungicide and Rodenticide Act (FIFRA) and other regulations that govern the approval and use of crop protection products.

In February a court decision was issued in favor of agriculture when a district court found that the EPA must follow established regulatory procedures before canceling a product’s registration. The complaint tried to ban 10 rodenticides by saying they were misbranded. The accuracy of the claim was not the central element. Rather, the court focused on the procedure that must take place when removing a registered product from the marketplace.

“The court’s decision is not just an important victory in our industry, but supports and ensures the continuation of a sound and predictable regulatory process, as mandated by Congress in the creation of FIFRA,” said Jay Vroom, president of CropLife America, which submitted an amicus brief in the case. The brief, which the court cited and relied on, detailed the importance of past legislative history to explain the EPA’s overreach.

The decision should prevent the EPA from threatening registrants with criminal or civil enforcement action if they don’t comply with demands to restrict or remove products from the market without proper procedures, thereby balancing the rights and roles of agencies and registrants.

— David Frabotta, Editor