Bloomberg is reporting this week that federal regulators are dragging their heels in creating guidelines for the use of agricultural biostimulants, despite high demand from farmers for products such as seaweed, manure, kelp and peat.
These are natural substances that farmers apply to plants, seeds, or roots to stimulate growth, nutrient uptake, or resistance to environmental stress. They’re similar to biopesticides, which use naturally occurring chemicals to kill pests.
Congress directed USDA and EPA to draft a report proposing a regulatory framework for biostimulants as part of the 2018 Farm Bill. But almost a year-a-half later, attorneys say clear rules for how to register new products remain mired in uncertainty.
“Companies are still asking us really basic questions, like, ‘Which agency has jurisdiction?’ and, ‘What labeling requirements do I need to meet?’” said Sheryl Dolan, a senior regulatory consultant at the Washington-based law firm Bergeson and Campbell PC.
At the heart of the issue, Dolan said, is a failure to develop legal definitions for what constitutes a pesticide, which would be registered through the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act. A fertilizer would be regulated at the state level.
Determining exactly where to draw the line between pesticide and fertilizer isn’t always easy, companies say. The difference in costs can range from millions of dollars to register a conventional pesticide compared to hundreds of dollars for a fertilizer.
Biostimulants aren’t defined under FIFRA or EPA regulations. But Dolan said that doesn’t mean regulators aren’t conducting enforcement actions, including stop-sale orders, for biostimulants they consider mislabeled as fertilizers.
“If you’re investing millions of dollars into a product, you want to have sound compliance platform,” she said. “You don’t want to take risks, and there is significant gray area out there.”
In response to pressure from the biostimulant industry EPA released a draft guidance document in March to help decide how to design labels for fertilizers, pesticides, and soil amendments.
EPA said the draft wasn’t intended to change the regulatory framework but was merely to “clarify the agency’s longtime approach to determine whether a product and its label claims meet the definition of plant-growth regulator, subject to FIFRA registration.”
However, the guidance generated more confusion. For example, it included a list of active ingredients that were already registered as fertilizers at the state level, but that EPA has now determined require registration under FIFRA,” said David Beaudreau, executive director of the U.S. Biostimulant Coalition. Now the EPA is revising the draft and responding to comments, including industry concerns and plans to reissue the draft later this year.
Adding to the uncertainty is the fact that biostimulant products can sometimes share properties of both pesticides and fertilizers depending on whether it’s applied to the soil or leaves. Seaweed extract can function both as a soil amendment (fertilizer) or plant-growth regulator (pesticide), he said. Seaweed extract was listed in the EPA guidance as an example of an active ingredient that would require FIFRA registration.
“So, do all those products have to go back through EPA approval? It’s created a lot of ambiguity,” Beaudreau said.
Requiring naturally-derived ingredients to be registered as a pesticide would financially burden farmers and consumers by increasing costs throughout the supply chain, Jake Wilson of Atlantic Laboratories Inc., the parent company of North American Kelp, wrote to the EPA. “It is our belief that the guidance should take into consideration product label claims, not merely the presence of naturally derived ingredients,” Wilson wrote.
Defining biostimulants and proposing a regulatory framework should be a process led by Congress in consultation with USDA a bipartisan group of five House members told EPA Administrator Andrew Wheeler in February.
“While we appreciate EPA’s effort to provide regulatory clarity to the plant biostimulant industry, we are concerned that moving forward with the draft guidance will disrupt both congress and USDA’s efforts,” Rep. Chellie Pingree, D-Maine, wrote for the group.
The lawmakers urged the EPA to delay releasing any final draft guidance until Congress could review USDA’s recent biostimulants report, which outlines six potential options to address the regulatory review, approval, and labeling of biostimulant products.
“We don’t have luxury of ignoring our state laws,” Rose Kachadoorian, the pesticide program manager at the Oregon Department of Agriculture, said.
State regulators aren’t opposed to biostimulant harmonization, Kachadoorian said, but the question of what constitutes a pesticide is best answered by EPA, not USDA. “If you don’t want something to be regulated as a pesticide, you have to go to the federal agency that regulates pesticides,” she said. “We just want to look at a label and be able to say, ‘Yes, this is a pesticide,’ or, ‘No, this is a soil amendment, or fertilizer,’” she said.
So, this appears to be a fight producers should watch closely as it proceeds since it has at least some potential to increase the food system’s credibility with important consumer groups and increase returns to the sector, Washington Insider believes.
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