WASHINGTON, April 15, 2016 - The Environmental Protection Agency is moving ahead with a meeting next week to review epidemiological data on the risks of chlorpyrifos, rejecting requests from the pesticide industry for a postponement.

Fred Jenkins, an EPA biologist who serves as the designated federal official for the Scientific Advisory Panel that will consider the data, confirmed that the meeting will take place April 19-21, as planned. (More meeting materials are here.)

Industry scientists and a wide variety of farm groups have criticized the agency for holding the meeting without giving them enough time to review data behind a key epidemiological study conducted by Columbia University’s Children’s Center for Environmental Health (CCCEH).

Some of the data have been released, but industry scientists have not had enough time to review it ahead of the meeting, chlorpyrifos registrants such as Dow AgroSciences and AMVAC said in comments sent to EPA.

And a report by a four-member “expert panel” study posted in the regulatory docket today cautioned the SAP against using the CCCEH study. The panel was convened by Exponent Inc., which was commissioned by CropLife America, CropLife International and the European Crop Protection Association.

That panel questioned “whether any single epidemiology study, such as the CCCEH cohort, provides evidence of a unique neurodevelopment hazard associated with exposure to chlorpyrifos at levels that are well below those that establish the current critical effect, cholinesterase inhibition, in both experimental animals and humans.”

“At this time, the data do not support a conclusion that prenatal exposure to chlorpyrifos is causally related to unique neurodevelopmental outcomes in children,” the panel said. The members of the panel are: Michael Dourson of the University of Cincinnati, Michael Goodman of Emory University, Judy LaKind of LaKind Associates and the University of Maryland School of Medicine, and Jennifer Seed, an independent consultant who is retired from EPA.

The CCCEH study concluded that children exposed to chlorpyrifos before they were born scored lower on tests of their physical and mental skills. But the Exponent panel raised questions about the accuracy of the cord blood samples taken and whether CCCEH properly considered the “confounding” factor of lead exposure.

But more than the conclusions of the CCCEH report itself, the industry is concerned about the precedent of using an epidemiological study to evaluate product safety. Manufacturers and formulators fear that EPA will use its experience with chlorpyrifos to inform future decisions on other organophosphates.

“This precedent-setting proposal jeopardizes the established, accepted science-based regulatory process,” said Dow AgroSciences, the principal registrant for chlorpyrifos, which is marketed as Dursban and used on dozens of crops.

EPA is tossing aside “over four decades of carefully developed and designed testing programs and risk assessment approaches … without solid justification for such an abrupt and drastic change,” Dow said. 

One of the issues industry has been hammering on for some time is the absence of the full dataset for the CCCEH study. Some of the data have been released and posted in the regulatory docket, but the crop protection industry says it needs more time to evaluate it.

“Some raw data from the Columbia study was previously obtained by (EPA’s Office of Pesticide Programs),” AMVAC said in comments to the agency. “Unfortunately, these raw data were not publicly disclosed to Dow AgroSciences …  until March 1, 2016, one week after the close of the comment period for the human health risk assessments for OP pesticides. AMVAC has been advised that scientists who are reviewing these newly disclosed underlying data have already identified some significant concerns.”

EPA is under a court-ordered deadline to make a final decision by the end of 2016 on whether to revoke tolerances for chlorpyrifos. The agency proposed to revoke the tolerances last October after the 9th Circuit Court of Appeals forced it to act.

EPA also just finished its Biological Evaluations of chlorpyrifos, malathion and diazinon as part of its Endangered Species Act consultation with the Fish and Wildlife Service and National Marine Fisheries Service.

EPA concluded that chlorpyrifos was “likely to adversely affect” 1,725 listed species, meaning that full Biological Opinions would have to be prepared by the Fish and Wildlife Service or National Marine Fisheries Service.


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