USA
March 31, 2016
By: Dana Sargent, Vice President for Regulatory Affairs, Bayer CropScience
You may have seen some media stories about our current disagreement with the U.S. Environmental Protection Agency over registrations for our pesticide flubendiamide, marketed in the U.S. as Belt. In short, EPA asked us to voluntarily withdraw our registrations for flubendiamide-containing products, making them unavailable to growers in the U.S. We rejected that request and, as expected, EPA then filed a formal Notice of Intent to Cancel these registrations.
Today we are officially taking the step that we previously said we intended to take and we have formally asked for a hearing before EPA’s Administrative Law Judge. With this action, I wanted to answer a few basic questions about why we are doing it and what it means.
What does it mean that you’re asking for a hearing?
We have a fundamental disagreement with EPA over science and process surrounding the registration of flubendiamide and Belt. We have been working with them to resolve the disagreement. Now EPA is trying to cancel it through a streamlined hearing in an effort to shield its science from independent peer review and to avoid other government and stakeholder input on its approach. We disagree with this and are invoking our right to have an EPA Administrative Law Judge hear both sides and make a determination on what process should be followed. As a matter of standard practice, the Administrative Law Judge’s initial determination will then be reviewed by the EPA Environmental Appeals Board.
Why are you trying to protect a pesticide EPA says is harmful?
The science is on our side. EPA requested real-world studies to learn if the product would cause harm to a particular aquatic invertebrate species. EPA has concluded that flubendiamide poses no risk of concern to humans (either through diet or worker exposure), fish, mammals, crustaceans, mollusks, beneficial insects, pollinators, or plants. Over the course of five years, we conducted real world monitoring to study Belt’s impact in the one area in which EPA raised a question. The results were clear – residues of Belt were below levels EPA said may pose harm. Unfortunately, instead of accepting that real world data, EPA based its decision on theoretical computer modeling which is, of course, dependent on many assumptions and inputs. We fundamentally disagree with EPA’s over-reliance on theoretical modeling when real-world studies have shown residues are well within previously established safe levels. We think this should be subjected to independent review.
Is this a flaw in EPA’s conditional registration rules that allows an unproven product to be used?
EPA’s conditional registration process actually makes it possible to bring new tools to growers while balancing environmental safety. In this case, for example, we submitted all data and studies to support a full registration and after an extensive review, EPA accepted them. At the time of the original conditional registration, EPA already concluded that flubendiamide poses no risk of concern to humans (either through diet or worker exposure), fish, mammals, crustaceans, mollusks, beneficial insects, pollinators, or plants. It made a particular determination at that time that registering flubendiamide would be in the public’s interest. The conditional registration allowed growers to safely use this tool while additional data was being generated and evaluated by the EPA.
While we want all of our products to receive full registration when introduced, we think the conditional registration process is an important one. Science evolves and our understanding of how products are used is enhanced through experience. Without this, a process that can take 10 years to bring a new tool to growers could take much longer and it would be difficult to make a business case to bring many safe, effective products to the market. We will stand by whatever the science says on our products, but it is critical that science be our guide.
Can’t growers just use something else? Why do they need this one?
Belt is registered for use on nearly 200 crops in the U.S. From tree nuts and fruit in California to soybeans and cotton in the east, growers have used Belt for nearly a decade now. Proper stewardship practices and adherence to integrated pest management practices means growers need access to more technologies, not less. A technology as effective and with a safety profile as favorable as Belt fits the bill perfectly. And if growers can’t preserve access to products like this one, it raises questions about what other tools they may lose.
So what happens next?
Our next step is to have a formal hearing before the EPA’s Administrative Law Judge. As a matter of standard practice, the Administrative Law Judge’s initial determination will then be reviewed by the EPA Environmental Appeals Board. The Hearing can last up to 75 days. In the meantime, growers can still use Belt and retailers and distributors can still sell it. We are asking that the Administrative Law Judge and Environmental Appeals Board address Bayer’s argument about whether a more complete public review will take place.
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