Bayer Announces Decision on Next Steps for Flubendiamide Cancellation

Wednesday, September 28, 2016
By: Charlotte Sanson, Crop Science, a Division of Bayer, Director - Registrations
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Earlier this year, we announced our intent to contest a decision by EPA to cancel one of our pesticide products, flubendiamide, marketed in the U.S. as Belt.  Bayer’s action was an unprecedented step for a company to take against the EPA, but one we felt strongly about in our desire to protect safe, effective tools for our growers and to ensure that regulatory decisions are based on the best available science.


We were driven by the  belief that EPA had acted unlawfully and without scientific justification.  Specifically, we believed that EPA should not be permitted to force a cancellation through a streamlined process devoid of a public discussion of scientific findings and benefits of the product, and that EPA’s conduct presented a dangerous precedent for the industry.


We had hoped that the process, which included hearings before an EPA Administrative Law Judge followed by EPA’s Environmental Appeals Board, would focus on the science.  Unfortunately, it did not and the final ruling focused on process and procedure arguments.  EPA’s Environmental Appeals Board (EAB) issued its final ruling on Bayer’s appeal of EPA’s notice to cancel flubendiamide (Belt®), upholding an earlier EPA decision to cancel all flubendiamide registrations but modifying the cancellation order to allow sales of existing stocks to growers by distributors and retailers.


Following the EAB decision, we were faced with three options: 1) appealing to a Federal Appeals Court; 2) re-applying for a new, full registration for flubendiamide; or 3) accepting the gains from the EAB ruling.


While the first two options may have given us an opportunity to be heard on the science, that opportunity was far from certain. Additionally, growers would not have access to the products as the process played out, potentially over several years’ time. Perhaps more importantly, both options carried a fair amount of risk, including the potential that some of the gains we made with the EAB decision would be lost.


Specifically these gains are:

  • The EAB did not rule on the issue of whether the “voluntary” cancellation condition was lawful, leaving it an open question. The EAB vacated an earlier ruling by the Administrative Law Judge which had found the condition lawful, leaving the Agency uncertain about the legality of similar actions going forward.

  • The EAB’s decision was based in part on EPA’s commitment that it will never again use the “unique” voluntary cancellation condition and the EAB’s reliance on that commitment.  Bayer, Nichino, and others should never face this type of condition again.

  • Registrants now have a clearly defined path to challenge conditions they do not agree with.

  • The EAB also overturned the ALJ’s decision to not allow distributors and retailers to sell existing stocks to growers; instead allowing such sales and thereby allowing growers access to further stocks for use until exhausted.  This ruling speaks to the inherent benefits of the product to growers and the public, and was largely the result of stakeholders’ efforts to support our case.

Ultimately, we are accepting the gains from the EAB’s ruling and will not engage in further legal dispute over this matter.


We believe that our decision to pursue this administrative challenge through to a final EAB decision also demonstrates to EPA that the industry will oppose Agency efforts to pursue a quick and easy cancellation process that would extinguish the procedural and substantive rights of registrants.


As a direct result of these efforts, growers can continue to use supplies of Belt that they have on-hand and can purchase more from distributors and retailers while existing stocks last. They will however lose future access to a valuable product that even EPA had concluded posed no risk of concern to humans (either through diet or worker exposure), fish, mammals, crustaceans, mollusks, beneficial insects, pollinators, or plants.


Nevertheless we will continue to stand  up for our growers’ access to safe, effective technologies and we will continue to push to ensure all regulatory decisions are based on the best available science.


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