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Nov. 30 — The Environmental Protection Agency's unexpected reversal of its position on Dow Chemical's Enlist Duo pesticide is a sign that the agency is feeling increased pressure from the courts, several former EPA officials told Bloomberg BNA.
Just 15 months after granting approval to Enlist Duo, the EPA is now asking the U.S. Court of Appeals for the Ninth Circuit to revoke its own approval of the weed killer, a proprietary mixture of two chemicals that Dow had hoped would be a blockbuster seller (39 CRR 1415, 11/30/15).
In its Nov. 25 court filing, the EPA said it wants to negate its approval for Enlist Duo because the agency has learned of new information showing that the product's two chemicals—glyphosate and 2,4-D—can amplify each other's effects, making the weed killer potentially more toxic than the agency initially thought.
This is the first time the EPA has ever asked a court to nullify a decision it has made on a pesticide, the agency told Bloomberg BNA in an e-mail statement.
Jim Aidala, a former top EPA chemicals regulator who is now a senior government affairs consultant at the law firm Bergeson and Campbell, said the EPA's stunning about-face on Enlist Duo was likely influenced by a string of recent setbacks in the Ninth Circuit, which undermined the agency's confidence in its ability to prevail in this case.
“The EPA’s being very aggressive here,” Aidala told Bloomberg BNA.
In an Aug. 10 opinion, a panel of Ninth Circuit judges excoriated the EPA for its delay in making a decision on whether to ban the insecticide chlorpyrifos (39 CRR 989, 8/17/15).
Then, a month later, the court took the unusual step of invalidating the EPA's approval of the insecticide sulfoxaflor after determining that the safety studies the agency relied on were flawed and incomplete (39 CRR 1075, 9/14/15).
“It’s a brave new world where the courts are vacating registrations instead of telling the EPA to cancel them,” Aidala said.
Another former senior EPA pesticide regulator, speaking on background, told Bloomberg BNA that Ninth Circuit judges recently have been delving into the EPA's pesticide data themselves, increasing the level of scrutiny that the agency is facing.
Even one of the plaintiffs in this case, the Natural Resources Defense Council, was taken off guard by the EPA's move.
Sylvia Fallon, a senior scientist with the environmental organization, said she was surprised not by the revelation that the EPA's approval process for Enlist Duo was flawed but rather by how the agency chose to respond to this revelation.
“What’s shocking in this situation is that EPA has actually asked to pull something back,” Fallon told Bloomberg BNA.
In its court filing, the EPA said it reviewed the scientific data on Enlist Duo that Dow had provided and concluded that mixing glyphosate and 2,4-D would not create any synergistic effects. However, several months later the EPA found that Dow AgroSciences, the company's agricultural subsidiary, had claimed in a patent application for Enlist Duo that the two chemicals would have “synergistic herbicidal weed control” properties.
“If we become aware of data that may affect a decision, we do not hesitate to reconsider our decision and take appropriate action,” the EPA told Bloomberg BNA. The agency “actively seeks out and considers new studies.”
Aidala said it will be important to learn why the information Dow provided to EPA differed from what the company put in its patent application.
“I think the patent attorneys weren’t talking to the regulatory people,” he said. However, “if the EPA thinks that the regulatory findings had intentionally misleading information, that would be a big deal.”
Dow said it believes this situation can be resolved in time for the 2016 spring planting season when farmers would begin using and purchasing Enlist Duo.
“EPA now has all of the data developed by Dow AgroSciences,” Tim Hassinger, the company's president and CEO, said in a statement. “We believe the questions that have been raised about any potential synergy … can be promptly resolved in the next few months.”
Dow's 2014 annual report said the company expects its Enlist crop protection system, which includes genetically modified plants that are designed to be paired with the Enlist Duo herbicide, to generate $1 billion in revenue by 2018.
Dow Chemical's stock price is down by more than 2 percent since Bloomberg BNA first reported the EPA's Nov. 25 decision on Enlist Duo.
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