The Nickel Report

On August 30th, EPA granted the 2007 Petition from the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all chlorpyrifos tolerances. This followed the Ninth Circuit order earlier this year for EPA to: “(1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA "has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information," including for "infants and children"; and (3) modify or cancel related FIFRA registrations for food use in a timely fashion consistent with the requirements of 21 U.S.C. § 346a(a)(1).”

In granting the petition, the agency states that: “EPA is unable to conclude that the risk from aggregate exposure from the use of chlorpyrifos meets the safety standard of the Federal Food, Drug, and Cosmetic Act (FFDCA).” The long regulatory and scientific history that precedes this action is described by EPA here. There are many decision points in EPA’s action. The following are some key highlights:

• EPA is revoking all chlorpyrifos tolerances because EPA is unable to determine, based on data available at this time, that aggregate exposures to chlorpyrifos are safe.
• For evaluating hazard, EPA relied upon 10% red blood cell acetylcholinesterase inhibition and applied a 10x margin of safety (FQPA safety factor) to account for uncertainties related to the potential for neurodevelopmental effects to infants, children, and pregnant women.
  • EPA states that “the primary factor that undercuts a determination that a different safety factor would be safe for children is the uncertainty around the potential for pre- and post-natal toxicity for infants and children in the area of neurodevelopmental outcomes.”
  • Regarding neurodevelopmental effects, and EPA’s efforts to evaluate them, EPA states “these efforts ultimately concluded with the lack of a suitable regulatory endpoint based on these potential effects. However, these efforts do not alleviate the Agency’s concerns regarding potential neurodevelopmental effects.”
• For the aggregate exposure, EPA combined exposure through food, residential use, and drinking water. EPA found that drinking water concentrations from chlorpyrifos will exceed the safe allowable level and as such the aggregate exposure exceeds the Agency’s safe level for chlorpyrifos exposure.
  • Considering food exposures alone, the Agency did not identify risks of concern.
  • For residential exposures, EPA determined there are no risks of concern.
  • For drinking water, EPA acknowledged the refinements made in the 2020 Drinking Water Assessment; however, EPA notes that the current registrations for chlorpyrifos go beyond a limited geographic region and as such the Agency is required to assess all exposures. EPA found that estimates of the drinking water concentrations exceeded the drinking water level of concern in certain vulnerable watersheds.
• EPA acknowledges that in the 2020 PID, EPA did propose to conclude that the Agency could make a safety finding, while maintaining the 10x FQPA factor, if chlorpyrifos use was limited to 11 crops in certain geographic regions of the US In this current final rule, EPA states “The Agency’s ability to make the safety finding for any remaining uses would be contingent upon significant changes to the existing registrations, including use cancellations, geographical limitations, and other label changes.”

Effective Dates and Objections:

While the rule becomes effective October 29, 2021, tolerance revocations for all commodities will not become effective until February 28, 2022. EPA notes that this date was chosen to satisfy international trade obligations.  After February 28, 2022, consistent with FFDCA Section 408(l)(5), products that were treated with chlorpyrifos and may contain residues can still be sold. As stated by EPA, any residues of these pesticides in or on such food shall not render the food “adulterated” so long as it is shown to the satisfaction of the Food and Drug Administration that:

1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and
2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance that was in effect at the time of the application. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.

All objections and hearing requests are due to the EPA Hearing Clerk by October 29, 2021. Any person affected by the rule may file an objection to any aspect of the rule and may also request a hearing on those objections. Electronic requests can be submitted through EPA’s E-filing system. Note that this requires advance registration which may take 1-2 business days.

If you have questions about the effects of this decision on pesticide use or on commodities treated with chlorpyrifos, or if you are considering filing objections, Hunton Andrews Kurth LLP can assist.