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EPA shifting from science to 'public perception' model on pesticides?

The National Cotton Councilrsquos Don Parker holds the stack of paperwork submitted by the NCC to EPA for the reregistration of one product
<p>The National Cotton Council&rsquo;s Don Parker holds the stack of paperwork submitted by the NCC to EPA for the re-registration of one product.</p>
EPA has had an adversarial relationship with crop protection chemical manufacturers and other groups since it was created during the Nixon administration in 1972. But some industry and related organization observers say their dealings with it have become much more strained and antagonistic in recent months.

Farmers are losing crop protection chemicals at an alarming rate, often due to what are being called increasingly arbitrary decisions by the Environmental Protection Agency acting outside of FIFRA.

But what’s even more disturbing is the chilling effect these actions are having on the development of much-needed new herbicide and insecticide compounds — products which can now cost nearly $300 million each to register with the agency.

EPA has had an adversarial relationship with crop protection chemical manufacturers and other groups since it was created during the Nixon administration in 1972. But some industry and related organization observers say their dealings have become much more strained and antagonistic in recent months.

The National Cotton Council is one of those saying it sees disturbing trends in the way the agency regulates pesticides under the Federal Insecticide, Fungicide and Rodenticide Act — or doesn’t. The NCC’s American Cotton Producers segment devoted nearly 90 minutes to discussion of current regulatory issues at its spring meeting in Birmingham, Ala.

“You saw at the ACP that we have been providing numerous comments to EPA on multiple products, and we also have some concerns about the procedures EPA is following,” said Dr. Don Parker, the NCC’s manager of integrated pest management.

“Within the agricultural community as a whole, there seems to be a growing consensus EPA is deviating from the FIFRA process and moving toward the precautionary principle that you see in Europe. And rather than relying on science they are being driven by political action and lawsuits.”

Public perception over science

“In addition to being driven by the lawsuits and the politics, they also seem to be responding more to some of the public reaction, which we all know is not necessarily science-based or risk-based,” said Reece Langley, NCC vice president for Washington operations. “EPA seems to be in a posture now where they’re trying to respond to public perception and setting the science aside.”

CropLife America, the organization representing pesticide manufacturers, formulators and distributors, interacts with EPA on an almost daily basis. The long-term association is becoming increasingly frayed.

“These are the waning months of the Obama administration, and the relationship we used to enjoy with EPA over many different administrations has always been good,” said Beau Greenwood, executive vice president for government relations and public affairs at CropLife America.

“It doesn’t mean we always agreed on every single issue, but as long as agency decisions were made within the FIFRA box, within the four corners of FIFRA, we expected to win some, and we expected to lose some, and that’s part of being a regulated business. The challenge for us is when those agency decisions get outside those four corners of FIFRA.”

In the last 12 to 18 months, CropLife America and other organizations have “begun to connect the dots,” he said, “To build a sufficiently long grievance list so that we can go to those people that will listen and make a case for an agency operating beyond the bounds of FIFRA, beyond the bounds of congressional intent with respect to pesticide regulation.”

Greenwood’s comments came during a briefing for members of the Southern Crop Production Association and allied state organizations who were preparing to make their annual Capitol Hill visits to members of Congress and their staffs.

Trust the science - Play by the rules

Farmers are also becoming critical of what they see as EPA moving away from the science-based decisions that have been used to regulate pesticides under FIFRA over the last 40 years.

“Trust the science and play by the rules — it’s that simple,” said Bill Horan, a farmer who grows a number of innovative crops besides corn and soybeans on his farm in Rockwell City, Iowa. He also serves as chairman of Truth about Trade and Technology, a group founded by the late American Farm Bureau President Dean Kleckner.

“The Environmental Protection Agency should remember those two principles as it thinks about crop protection technology that helps farmers keep bugs away from almonds, peanuts, apples, oranges, cotton and more.”

They and others cite a number of products which have either had their registrations canceled or appear to be in jeopardy because of changes in the way EPA administers the regulatory process.

In the case of sulfoxaflor or Transform, an insecticide manufactured by Dow AgroSciences, the Section 3 registration previously granted by EPA was vacated by the U.S. Ninth Circuit Court of Appeals in San Francisco last September.

The Ninth Circuit Court, which has become a mecca for environmental activist groups seeking to eliminate most pesticide uses in the United States, agreed with organizations representing beekeepers who sued EPA, claiming sulfoxaflor’s use contributed to the decline of honeybee populations.

Slow to approve emergency exemptions

Some in industry believe EPA mounted a half-hearted defense of its approval of sulfoxaflor in the beekeepers lawsuit. Since then, it has moved very slowly to approve requests for Section 18 emergency use exemptions for the active ingredient against sugarcane aphids in grain sorghum and tarnished plant bugs in cotton.

In early May, Mississippi Sens. Thad Cochran and Roger Wicker sent a letter to EPA Administrator Gina McCarthy asking the agency to move more quickly on approving an emergency exemption for Transform in cotton.

They noted EPA took 129 days to approve a Section 18 exemption for Transform in grain sorghum, although such requests have typically been approved within 50 days of the initial submission. At press time, the clock was ticking on a 15-day comment period for the Section 18 request for Transform in cotton.

NCC officials were hopeful the comment period, which is unusual for a Section 18 submission, would not be extended to 30 or 60 days, which would make it almost impossible for the pesticide to be applied in the 2016 season.

“We hope they stick with the 15-day comment period because it will be critical to provide an added tool to control plant bugs that we know are such a problem in the Mid-South,” said the Cotton Council’s Parker. (Tarnished plant bugs have demonstrated resistance to at least one class of insecticides in the past.)

Cotton Council members are also concerned that EPA has opened a docket for an initial pollinator-only risk assessment for imidacloprid, one of the neonicotinoid class of insecticides that some beekeeper and environmental activist groups have targeted despite little evidence they are responsible for declines in bee populations.

Denial of access to data

NCC and other organizations are also disturbed by EPA decisions concerning the re-registration of chlorpyrifos, the active ingredient in the insecticide Lorsban.

Last November, EPA said it was proposing to revoke all food residue tolerances for chlorpyrifos. The agency based its decision not on an exhaustive review of the scientific data, but on the findings of a single epidemiology study by Columbia University researchers.

During a FIFRA Scientific Advisory Panel EPA subsequently convened to consider and review its chlorpyrifos decision-making in April, CropLife America representatives criticized the agency’s reliance on such “epi” studies, which EPA has said should be approached with caution.

CropLife America’s Dr. Sarah Starks and Dr. Amechi Chukwudebe noted EPA was relying on the Columbia study although the study’s authors had refused to provide access to their raw data or exposure measures used. They also noted the study’s small population size and the inability of EPA or others to replicate its findings.

“CLA calls on EPA to respond to specific scientific questions from EPA expert panelists and public concerns regarding the use of epidemiology studies and develop solid guidance before allowing such data to be used in human health risk assessment,” said Jay Vroom, president and CEO of CropLife America.

“We cannot allow outside pressure to diminish the high standards of our regulatory process and water down the data we use,” he said, noting pesticide registrants are required to follow rigid good laboratory practices and transparency in collecting data for submission to EPA.

Missing glyphosate-is-not-a-carcinogen report

EPA has also come under fire for such actions as withdrawal of its Cancer Assessment Review Committee report after a document marked “Final Report” that said glyphosate was not likely to be carcinogenic to humans. The report was pulled from the EPA website shortly after it was posted.

Agency officials have also been criticized for their failure to develop a process for consultations with the U.S. Fish and Wildlife and the U.S. National Marine Fisheries Services required for regulating pesticides under the Endangered Species Act.

And, in a rare move, one company, Bayer, reject EPA’s request it voluntarily withdraw its registration for flubendiamide-containing products, including Belt, an insecticide registered on nearly 200 crops in the United States.

“EPA requested real-world studies to learn if the product would cause harm to a particular aquatic invertebrate species,” said Dana Sargent, Bayer vice president for regulatory affairs. “EPA has concluded flubendiamide poses no risk of concern to humans, fish, mammals, crustaceans. Mollusks, beneficial insects, pollinators or plants.”

But the agency raised a question about one area. “Over the course of five years, the results of our studies were clear — residues of Belt were below levels EPA said may pose harm,” said Sargent. “Unfortunately, instead of selecting the real world data, EPA based its decision on theoretical computer modeling, which, of course, is dependent on many assumptions and inputs.”

Some believe such actions mean EPA is moving closer to adopting the “precautionary principle,” cited earlier by the NCC’s Parker and Langley.

“This is a flawed approach to regulations that elevates tiny doubts to positions of supreme importance,” says Iowa’s Bill Horan. “Broad acceptance of this half-baked concept has stifled agricultural technology in Europe, where farmers lack access to many safe crop protection tools.”

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