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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On February 6, 2020, Corteva Agriscience (Corteva), announced it will discontinue all production of the organophosphate (OP) insecticide chlorpyrifos by the end of the year.  Corteva and its corporate predecessor, Dow AgroSciences, have been the principal global manufacturers of chlorpyrifos.  Corteva announced that its decision to stop selling chlorpyrifos was based entirely on financial considerations.  This announcement came on the same day that Corteva had previously agreed it would end further sales of chlorpyrifos in California, and less than a week after the date the European Union (EU) ended all sales of chlorpyrifos in member states.  These actions followed a number of prior actions taken by other national and state governments to ban or severely restrict chlorpyrifos.  Corteva emphasized in its public statements that the science demonstrates that chlorpyrifos can be safely used, but that the company made a business decision based on the declining markets for the product.  In an interview reported by the Washington Post, Susanne Wasson, Corteva's President for Crop Protection said, “It’s a tough decision for us to make, but we don’t feel like it’s viable going forward.” In other statements, Corteva noted that in the last ten years their share of the global chlorpyrifos market had declined from 75% to less than 20%.

Chlorpyrifos has been registered for use in the U.S. for over 50 years, but has become increasingly controversial in the dozen years since the Pesticide Action Network of North America and the Natural Resources Defense Council filed a petition in 2007 to cancel all registrations and revoke all tolerances for chlorpyrifos.  Following a protracted court battle and a decision by the Ninth Circuit Court of Appeals to force the U.S. Environmental Protection Agency (EPA) to take final administrative action concerning the 2007 petition, EPA proposed near the end of the Obama Administration to revoke all existing tolerances for chlorpyrifos.  A significant basis for this proposal was a controversial decision by a panel of EPA scientists that the default tenfold safety factor established by the Food Quality Protection Act (FQPA) for infants and children, which EPA had previously waived based on studies establishing a threshold for acetylcholinesterase (AChE) inhibition, should be reinstated.

The new EPA safety factor determination was based in large measure on epidemiology studies that reported an association between exposure to chlorpyrifos at levels below the presumed threshold for AChE inhibition and adverse neurodevelopmental effects in children.  Many industry scientists disputed the scientific basis for this EPA determination because confounding exposures and methodological biases in the epidemiology studies may have influenced the reported association with neurodevelopmental effects and because the EPA determination made unprecedented use of epidemiology data.  Beyond the effect on chlorpyrifos, the EPA decision will likely continue to be controversial because EPA included a similar safety factor determination for all OP pesticides, even though the mechanism responsible for the reported neurodevelopmental effects attributed to chlorpyrifos has not been identified and the other OP products were not studied in the epidemiology studies.

In the first year of the Trump Administration, EPA Administrator Scott Pruitt decided not to adopt EPA’s previously proposed tolerance revocation and instead to deny formally the 2007 petition, citing unresolved scientific issues.  This reversal of course, however, was not accompanied by any new scientific assessment or by any explicit revision of the prior FQPA safety factor determination.  Later, the California Department of Pesticide Regulation (DPR) decided to designate chlorpyrifos as a Toxic Air Contaminant, a decision that was noteworthy because it was based primarily on new toxicology studies that DPR stated reported neurodevelopmental effects well below the threshold for AChE inhibition.  DPR deemphasized the epidemiology data relied on in the EPA safety factor determination in its decision.  Although EPA later stated that it would address these new toxicology studies as part of an accelerated registration review process, there were intervening decisions by the EU and by California to ban new sales, which may have contributed to Corteva’s February 6, 2020, decision to cease chlorpyrifos production.

Commentary

The decision by Corteva to cease manufacturing chlorpyrifos reminds us that the decision to continue marketing any chemical substance cannot be based solely on the scientific data, but must also consider the regulatory climate and the economic viability of the product.  For those of us with a long memory, the decision by Corteva is reminiscent of the decision nearly 40 years ago by the Dow Chemical Company to pull the plug on 2,4,5-T and silvex, after Dow had expended millions of dollars and many years of effort to contest an emergency suspension and subsequent cancellation of these herbicides.  Dow made this decision even though it believed that the available data demonstrated the safety of those products.


 

By Susan M. Kirsch and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has announced that it will be hosting several events to gather input on regulatory actions that could be repealed, replaced or modified as part of EPA’s regulatory reform efforts under Executive Order (EO) 13777. 

The Office of Pesticide Programs (OPP) will host a public meeting on the Pesticide Program Dialogue Committee (PPDC) on May 3, 2017, from 9:00 a.m. to 4:45 p.m. (EDT), and on May 4, 2017, from 8:30 a.m. to 12:00 p.m. (EDT).  The session on May 4, 2017, will focus on receiving public feedback on pesticide regulatory reform issues.  Registration will be required to attend the May 4, 2017, meeting only.  Interested participants may register here.  The deadline for registration is April 27, 2017

The Office of Water (OW) will also host a listening session on May 2, 2017, from 11:00 a.m. to 2:00 p.m. (EDT) and participants may either pre-register here to join by phone (space limited) or join via web conference here.  Pre-registration is not required for web participation.  The deadline for registration is April 27, 2017.

In the pesticide space, EPA-OW is responsible for the National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit (PGP), which requires NPDES permitting for pesticide applications into, over and near “Waters of the United States,” including mosquito abatement activities.  The U.S. Court of Appeals for the Sixth Circuit issued a 2009 decision requiring EPA to regulate pesticides under the NPDES program.  Both industry and state co-regulators have criticized PGP requirements as duplicative, burdensome, and unnecessary for pesticides applied in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Attempts to pass legislation that would eliminate NPDES permitting for FIFRA-compliant pesticides applications have not been successful to date.  EPA’s actions under EO 13777 may offer an administrative mechanism to repeal the PGP.  It is unclear, however, if a repeal would be legally defensible in light of the Sixth Circuit ruling.  Alternatively, EPA could modify the PGP to eliminate the reporting and recordkeeping requirements that opponents find overly burdensome.  Pesticide stakeholders may wish to join the May 2, 2017, OW listening session to provide recommendations.

Written comments on regulatory reforms on all regulatory reforms, including OW and OPP issues, will also be accepted in docket EPA-HQ-OA-2017-0190, Evaluation of Existing Regulations, currently open through May 15, 2017.  More details on the NPDES permit for pesticides are available in our blog item EPA Issues Final 2016 NPDES Pesticide General Permit.


 

By Lisa M. Campbell and James V. Aidala

 

On April 9, 2015, the California Department of Pesticide Regulation (DPR) held the first of a planned series of workshops intended to help DPR develop “regulation concepts” for possible notifications prior to field fumigations.  The presentations and video from that workshop are now available on DPR’s website.

 

DPR’s presentation at the workshop focused on the background that it believes supports the consideration of a notification requirement, and on current methyl bromide notification regulations and fumigant labeling requirements that it believes potentially could be used as a foundation to assist in the development of a rulemaking concept for soil-applied field fumigants. 

 

In addition, DPR considered whether the concept can be reconciled with the current label requirements as emergency preparedness and response requirements, or maintained as a separate “right-to-know” requirement.  DPR recommended expanding notification to all field fumigations, including applications of chloropicrin, 1,3-dichloropropene, methyl bromide, or pesticides that generate methyl isothiocyanate.

 

This potential regulatory development is of significant interest to pesticide registrants in general.  The application of a right-to-know model to pesticide applications, pursuant to which growers and applicators would have to notify those in a defined proximity to the planned pesticide application, would have far-reaching ramifications.  DPR’s further development of this potential regulation should be monitored closely.

 

Of note are similar notification schemes reportedly under consideration by the U.S. Environmental Protection Agency (EPA) as part of its pollinator protection proposals.  EPA staff has spoken of how one essential component of any pollinator protection program will be some kind of notification scheme for beekeepers, or at least commercial beekeepers, who have hives in the vicinity of the use area for certain pesticides.  As that issue evolves, it will invite comparison with EPA’s position on other requirements for mandatory notification, where generally EPA has not supported blanket federal requirements for notification of nearby pesticide applications.  This development in the pollinator area could lead to reconsideration at the federal level regarding broader advance notification requirements for specified pesticide applications.