The 9th U.S. Circuit Court of Appeals plowed into a regulatory thicket last week when it struck down U.S. EPA’s approval of a so-called bee-killing chemical.
At issue: how U.S. EPA assesses pesticide threats to human health and the environment.
The court in Pollinator Stewardship Council v. EPA ordered the agency to dial back its registration of sulfoxaflor, which is used mostly on cotton in the Mississippi Delta. Sulfoxaflor and other chemicals in the neonicotinoid pesticide class have been implicated in the decline of honeybees and other pollinators.
Greg Loarie, an attorney with Earthjustice who argued the case on behalf of the Pollinator Stewardship Council and other beekeeping organizations, said the case is unique in the judges’ attempt to weigh the scientific merits of data.
"Courts tend to be reluctant to wade into these technical scientific disputes," he said.
Under the Federal Insecticide, Fungicide and Rodenticide Act, a registrant — in many cases, the pesticide manufacturer — must provide studies to EPA on the product’s environmental and human health effects. The agency analyzes the data to devise a risk assessment, which forms the basis for the agency deciding an appropriate per-acre rate of pesticide application.
The case is the first challenge to EPA’s approval of neonicotinoids, which environmentalists say is a top factor in the decline of honeybees over the last decade. The judicial panel vacated the unconditional registration of sulfoxaflor, finding that the agency based its decision on limited and flawed data in the "Tier 2" studies — field studies that are conducted when a chemical is shown to negatively affect pollinators in "Tier 1," or laboratory tests (Greenwire, Sept. 10).
Judge Mary Schroeder wrote that data submitted to EPA by sulfoxaflor maker Dow AgroSciences LLC were culled from poorly designed field studies. An example of the numerous limitations was the colony infestation by the varroa mite, Varroa destructor, which can kill bees. The agency also skipped over studying the effects of sulfoxaflor on the overall hive, including bee larvae and pupae, and the long-term health of the colony, she added.
Schroeder, who was appointed by President Carter, criticized not only the studies but EPA’s scientific judgment. EPA had argued that their findings in one experiment, in which only a few of the residue measurements were high enough to trigger the need for field studies, was "close enough" to deem the Tier 2 assessment unnecessary. The answer: no.
"This argument just does not fly," she wrote, later citing a 2013 9th Circuit decision in which the court slammed the agency for picking numbers "in the neighborhood" of a minimum threshold.
This could make it more difficult for EPA to do its work. In the complicated math of deciding a safe level of pesticides and other chemicals, EPA has typically been left alone to weigh the evidence from different sources, said Jim Aidala, a senior government affairs consultant with Bergeson & Campbell P.C., and head of EPA’s chemical safety office under President Clinton.
The level of precision the court is seeking in the evidence presented in the sulfoxaflor case "isn’t necessarily found in the hundreds of decisions EPA makes every day," said Aidala. The opinion shows a lack of deference to the agency’s decisionmaking process, he added.
The 9th Circuit is considered one of the most liberal appeals courts and has historically been more receptive to environmental groups’ challenges to regulations.
In an unrelated pesticide challenge, Dow AgroSciences sought unsuccessfully to move the case to the U.S. Circuit Court for the District of Columbia, where judges could be more sympathetic to industry arguments (Greenwire, Aug. 12).
Judge N. Randy Smith, who was appointed by President George W. Bush, submitted the concurring opinion. In it, he explains the "substantial evidence" standard used in the case offers an agency less deference than an "arbitrary and capricious" standard used to decide whether a decision was made on unreasonable grounds. Both standards offers a high level of deference for agencies and, in this case, gives EPA a "low hurdle" to surmount.
"However, although low, the hurdle exists for a reason, and the EPA cannot simply walk around it," Smith wrote.
Even with a wide berth for deference, there wasn’t enough information to rule in their favor.
"All EPA had to do is show there was evidence for their decision," said Lori Ann Burd, a staff attorney with the Center for Biological Diversity. "They’re looking for some kind of logic."
Environmental and beekeeping organizations applauded the court’s oversight of EPA’s scientific basis for risk assessments on bees and hope the decision will extend to other assessments, primarily the agency’s review of five other neonicotinoid pesticides over the next four years.
The case is a reminder of another neonicotinoid — clothianidin — whose approval led environmental groups to cry foul. Originally approved as a "conditional" registration in 2003, EPA changed the status to unconditional four years later, despite a lack of field studies to justify the less-restrictive registration.
"9th Cir cited bees’ ‘precariousness’ in nixing @EPA approval of sulfoxaflor — an urgency missing from EPA’s leisurely pace on clothianidin," Georgetown Law professor and former EPA counsel Lisa Heinzerling wrote on Twitter.
According to the U.S. Geological Survey, farmers used nearly 3 million pounds of clothianidin in 2012, more than 1,000 times the amount of sulfoxaflor. A group of beekeepers and environmentalists petitioned EPA in 2012 to immediately suspend the registration of clothianidin. The agency denied the request.
There are a number of possible actions EPA could take to comply with the court decision, said Nichelle Harriott, science and regulatory director for Beyond Pesticides, one of the groups that petitioned EPA. The agency could issue a stop-use order for sulfoxaflor, or it might revert the registration to condition.
The most significant impact, however, could be on other pesticides.
"I think what this case does do is it sets a precedent," she said. "There are a lot of [registrations] out there with data gaps that fail to consider all of the human and ecological impacts of pesticides."