January 17, 2022

Volume XII, Number 17

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January 15, 2022

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EPA Publishes a Final Rule Revoking All Tolerances for Chlorpyrifos, Impacting Raw Agricultural Commodities and Food Uses

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.

Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.National Law Review, Volume XI, Number 242
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Nancy Beck Regulatory Science Professional Environmental Compliance Hunton Andrews Kurth
Director of Regulatory Science

Nancy provides industry leaders with advice related to the impact of environmental policy, including chemical regulations and compliance programs, applying her in-depth knowledge and applied public health experience as a PhD toxicologist.

Nancy has over twenty years of applied public health experience, sixteen of which were from her time in government, including senior leadership positions at the Environmental Protection Agency (EPA) and the White House. As a PhD toxicologist she has a deep scientific understanding of chemical risk assessment,...

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John Bobka Environmental Lawer Energy Hunton Andrews Kurth
Associate

John maintains a diverse environmental practice, with a focus on natural resource projects.

John has assisted on myriad permitting, regulatory, enforcement, and litigation projects arising under environmental statues such as the Clean Water Act (CWA) and the Endangered Species Act (ESA), among others. In addition, he works closely on regulatory compliance matters related to chemical and toxic substances and wastes under the Resource Conservation and Recovery Act (RCRA); the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and the Toxic Substances Control Act (TSCA)....

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Matthew Z. Leopold Environmental & Energy Attorney Hunton Andrews Kurth Washington, DC
Partner

Matt advises and defends clients across industries with the strategic insights as former General Counsel for the US Environmental Protection Agency, former General Counsel for the Florida Department of Environmental Protection and a former environmental litigator at the US Department of Justice.

Matt provides his clients with in-depth experience and knowledge respecting the pivotal recent changes in environmental regulation. As EPA General Counsel, he counseled on the development and defense of virtually every significant regulation proposed by EPA since 2017 and was personally...

202-419-2041
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