The 9th Circuit Court of Appeals issued a key order to the EPA on April 29, 2021 on next steps in the regulation of chlorpyrifos. This is the first of several expected court actions impacting regulation of high-risk pesticides. Dr. Benbrook has been involved with chlorpyrifos risk assessment, use, human health effects, and regulation since the early 1980s. He serves as an expert witness on behalf of plaintiffs in litigation against Corteva, the major registrant of chlorpyrifos. Chuck has also submitted 2021 comments to the EPA and posted on Hygeia many historical documents on the impact of the FQPA on chlorpyrifos.
Statement by Dr. Charles Benbrook on the 9th Circuit Court of Appeal Ruling on Chlorpyrifos
The just-issued 9th Circuit Court of Appeals order on chlorpyrifos is directed to Michael Regan, the new Administrator of EPA. Welcome to the world of pesticide regulation, Mr. Administrator. Fasten your seat belt, rough air ahead.
The 9th Circuit Court order could not be clearer or more emphatic. The EPA must do one of two things within 60 days. It can revoke all tolerances allowing chlorpyrifos to remain in food. Or, the EPA must issue the key safety finding called for by the 1996 Food Quality Protection Act (FQPA). This safety finding must be based on the best available science and conclude that there is a “reasonable certainty of no harm” from our near-daily dose of chlorpyrifos in one or more commonly consumed food, in the water we drink, or in the air we breathe if we live in farm county.
The EPA cannot issue this FQPA safety finding for reasons laid out clearly in the Ninth Circuit’s 67-page majority opinion. The EPA was unable to issue the FQPA safety finding upon completion of in-depth chlorpyrifos human health risk assessments in 2011, 2014, 2016, and 2020, and almost certainty will not in 2021. The reason is clear: the science linking prenatal exposures to chlorpyrifos and adverse neurodevelopmental outcomes is compelling and has been so since 2011.
The EPA has invested by far more resources in quantifying and mitigating risks from chlorpyrifos than any other pesticide since the Agency took over responsibility for regulating pesticides in 1972.
The science case for removing chlorpyrifos from foods commonly consumed by pregnant women, infants, and children was spelled out in detail in the 1993 National Academy of Sciences report Pesticides in the Diets of Infants and Children.
The Congress passed the historic Food Quality Protection Act in 1996 to give the EPA new authority and a mandate to remove pesticides from the food supply that are known to disrupt neurodevelopment.
As the EPA implemented the FQPA in 1997-2005, chlorpyrifos was the most widely used of the organophosphate (OP) insecticides and the OP that was most regularly present in children’s foods at levels exceeding EPA’s “level of concern.” Chlorpyrifos was the focus of 1,000s of independent scientific studies — the vast majority of which supported linkages between prenatal exposures and damage to the developing nervous system and brain.
By 2011 the EPA had clear data linking chlorpyrifos to adverse neurodevelopmental outcomes, but lacked full understanding of the mechanisms behind such linkages. The EPA also knew it was highly likely that the primary registrant of chlorpyrifos, Dow AgroSciences, would legally challenge the Agency if it initiated the process leading to revocation of chlorpyrifos tolerances and cancellation of chlorpyrifos registrations based on the then-current record.
A decade later, after four additional, updated EPA human health risk assessments, this order by the 9th Circuit will likely bring to an end the presence of chlorpyrifos in the U.S. food supply.
Why it has taken so long to reach closure on chlorpyrifos is worth dissecting because whatever the causes, they need to be fixed and overcome.
This action by the 9th Circuit Court of Appeals is likely the first of several court actions that will hopefully refocus the EPA on the core goal of the FQPA: Assuring a “reasonable certainty of no harm” from pesticides that find their way into the food supply.
Key Passages in the 9th Circuit Order
Pages 39-40, in discussing the standard the Court is apply in reviewing EPA actions or inaction:
“Agency action is arbitrary and capricious where the agency has ‘offered an explanation for its decision that runs counter to the evidence before the agency.’”
Page 59 on the remedies available to the Court:
“Under the APA [Administrative Procedures Act], the Court has the power to ‘compel agency action unlawfully withheld or unreasonably delayed.’”
Page 62-63 on whether the EPA could issue and support the required FQPA safety finding:
“The EPA has not determined, and on this record reasonably could not determine to a ‘reasonable certainty’ that aggregate chlorpyrifos exposures under the current tolerances pose no risk of harm. Therefore, by statutory definition, the present [chlorpyrifos] tolerances are not safe. Accordingly, the EPA’s obligation is clear: it must modify or revoke chlorpyrifos tolerances and modify or cancel chlorpyrifos registrations.”
Page 64 in offering specific instructions to EPA:
“On this record [record of the litigation and Agency action/inaction from 2007-2021], immediate issuance of a final regulation is the only reasonable action, and the Court orders the EPA to do so.”
Page 66 on the consequences of EPA’s delay in responding to earlier 9th Circuit orders:
“The EPA has had nearly 14 years to publish a legally sufficient response to the 2007 petition. During that time, the EPA’s egregious delay exposed a generation of American children to unsafe levels of chlorpyrifos. By remanding back to the EPA one last time, rather than compelling the immediate revocation of all chlorpyrifos tolerances, the Court is itself being more than tolerant. But EPA’s time is now up.”