Keeping Up with U.S. Regulatory Challenges



American farmers rely on crop protection products including fungicides, herbicides, insecticides and rodenticides to minimize damage from pests, weeds and diseases that can limit growth or destroy healthy crops. These products continue to evolve in how they are formulated and used, and regulatory processes surrounding their development and registration have similarly evolved for more high-tech and precise applications.


The crop protection industry is one of the most heavily-regulated industries in the U.S. CropLife America (CLA) and its member companies remain closely engaged in regulatory matters, frequently collaborating with staff of the U.S. Environmental Protection Agency (EPA) and other federal and state regulatory bodies. From initial discovery of an active ingredient to distribution, responsible use and proper disposal, the industry and regulatory agencies oversee the complete life cycle of every product on the market.

Crop protection products are subject to more than 120 health, safety and environmental tests to ensure their safety and effectiveness before receiving registration approval from EPA. Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), each new product is evaluated for potential effects on humans, wildlife, plants and other non-target organisms. The Federal Food, Drug and Cosmetic Act (FFDCA) also requires that crop protection products be evaluated for any potential residues that may occur in foods. This stringent process requires up to 10 years and, on average, more than $250 million in discovery and development costs. Following initial registration, crop protection products must undergo a periodic review by EPA to assure continuing compliance with current scientific standards.

Neonicotinoid insecticides represent just one class of crop protection product subject to these regulatory standards. As with all other pesticides, neonicotinoids are thoroughly tested and monitored for potential risks to the environment and various beneficial species, including bees and other pollinators. Ongoing research and field studies have consistently found no lasting adverse effects on bee colonies from neonicotinoids that are applied according to federal label directions. Scientific evidence points to a combination of factors that may impact bee health, including parasitic Varroa mites; various viral and bacterial diseases; nutritional challenges; a lack of genetic diversity; and husbandry practices.

EPA is currently focusing resources on additional research that examines integrated pest management (IPM) practices, including applications of crop protection products, and their potential impacts on pollinators. In addition, EPA is pursuing comprehensive and on-going scientific evaluation through its FIFRA Scientific Advisory Panel to help propose a new quantitative, multi-tiered pollinator framework for evaluating the effects of neonicotinoids on bee health. In August 2013, EPA announced the development of specific, precautionary information for certain product labels to enhance protection of pollinators from potential exposure.

The development and implementation of tools that effectively minimize pesticide spray drift is an agricultural industry priority that involves collaboration among chemical companies, equipment manufacturers, retailers and applicators. CLA actively promotes the continued adoption of drift-reducing technologies by applicators. Members of the crop protection industry invest heavily in understanding the science of pesticide applications in order to improve application efficiency and minimize the potential for product movement outside of the intended area of application.

Another regulatory issue of concern to the crop protection industry is resolving the duplicative registration process for pesticides under two federal statutes – FIFRA and the Endangered Species Act (ESA). The agencies involved – EPA, the National Marine Fisheries Service and Fish & Wildlife Service – have already acknowledged some of the flaws and complexities involved in endangered species consultations for crop protection product registration actions, and are currently working on a more unified approach that will save resources, time and manpower. An amendment in the five-year farm bill recently passed by Congress further spurs the agencies to revise the current process based on recommendations within a National Academy of Sciences report.

Crop protection products serve a critical role in growing healthy crops, but the process of regulating these products extends far beyond sustainable production of food, fiber and fuel products. As technology evolves, additional tools become available, and more voices participate in regulatory decision making, registration processes for crop protection products will continue to be refined and improved.