What It Takes to Get an EPA Label
September 6, 2020 Growers are mindful of EPA pesticide labels. After all, they “always read and follow” them regularly when applying the materials needed to grow a successful cotton crop. But it can become an afterthought in day-to-day operations.
The recent ruling vacating three key dicamba herbicide labels by the Ninth Circuit Court of Appeals has brought heightened attention to labels from both growers and the larger public.
The fact that the labels were vacated by the three-judge panel in the Ninth Circuit might give the impression that the registrants for these herbicides were flippant in the label registration process. But a closer look shows that, by its very nature, acquiring a label doesn’t work that way. It is a very involved process that takes time and money.
The Process
The EPA describes its registration of a pesticide as a scientific, legal and administrative process. In order to be registered, a product must undergo a gauntlet of a minimum 120 tests on safety and actual effectiveness. That number could easily rise if the label is challenged, and they often are. Because of the rigorous nature of the process, only a small fraction of products achieve label registration.
The agency examines the following:
- The ingredients of the pesticide.
- The particular site or crop where it is to be used – the amount, frequency and timing of its use; and storage and disposal practices.
- The possible environmental impacts – harm to humans, wildlife, fish and plants, including endangered species and non-target organisms; plus contamination of surface water or ground water from leaching, runoff and spray drift.
The process of evaluating environmental risks and harm to humans and other forms of life is particularly rigorous. A large portion of the dicamba court challenge centered around herbicide drift.
Mike Aerts is the Director of Science and Regulatory Affairs for the Florida Fruit and Vegetable Association. He works with registrants on seeking EPA labels. He says the process really varies depending on the molecule being brought to market. And EPA’s labeling evaluation is only a final step in a long and expensive process.
“Regulatory-wise, the biggest challenge could come from any of a dozen different directions,” Aerts says. “From a marketing standpoint, the biggest challenge is being able to get a return on investment back. If something can’t be registered for use on major-acre crops like field corn, soybeans, cotton or wheat, you’ll never be able to sell enough product before the patent runs out to recoup the monetary registration investment requirements.”
Fees and Time
According to EPA, the cost of acquiring a label varies by registration type whether it’s a new active ingredient or a new use for an existing one. The same goes for the length of time the agency needs to process and evaluate the product before approval.
The fees charged by EPA to evaluate labels range from thousands to hundreds of thousands of dollars. The time EPA requires to process labels can range from a few months up to two years, according to the label type. And that’s assuming no delays in processing.
But Aerts adds for a company to go from R&D to market, the costs and timeframe are much more than just the fees charged by EPA and time for its own internal processes. “It’s a 10-year timeframe and only covers the actual registration process,” he says. “Not included in this 10-year number is the discovery and screenings of new materials. So, figuring all of those aspects into the equation, it takes a company closer to 12-14 years.
“A joint CropLife America and European Crop Protection Association report shows that the cost of developing and registering new pest and disease prevention products has rocketed from an average of $152 million per product in 1995 to $256 million for the 2005-2008 period. As these numbers are more than a decade old already, you could easily add another $50 million onto that figure.”
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