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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations at exposure levels below EPAs existing regulatory standard 10% RBC AChE
inhibition. Because the claims relating to the potential for neurodevelopmental effects in children raised novel, highly complex scientific issues, EPA
originally decided it would be appropriate to address these issues in connection with the registration review of chlorpyrifos under FIFRA section 3g and decided to expedite that review, intending to finalize it in 2015, well in advance of the October 1, 2022
registration review deadline Ref. 2.
EPA decided as a policy matter that it would address the Petition claims raising these matters on a similar timeframe. Id. at 16583.
The complexity of these scientific issues precluded EPA from finishing its review according to EPAs original timeline, and the Petitioners brought legal action in the Ninth Circuit Court of Appeals to compel EPA to either issue an order denying the Petition or to grant the Petition by initiating the tolerance revocation process. The result of that litigation was that on August 10, 2015, the Court ordered EPA to issue either a proposed or final revocation rule or a full and final response to the administrative Petition by October 31, 2015. In re Pesticide Action Network N.
Am., 798 F.3d 809, 815 9th Cir. 2015.
In response to that 2015 order, EPA
issued a proposed rule to revoke all tolerances for chlorpyrifos on October 28, 2015 published in the Federal Register on November 6, 2015 80 FR
69080, based on its unfinished registration review risk assessment. EPA
acknowledged that it had had insufficient time to complete its drinking water assessment and its review of data addressing the potential for neurodevelopmental effects.
Although EPA noted that further evaluation might enable more tailored risk mitigation, EPA was unable to conclude, based on the information before EPA at the time, that the tolerances were safe, since the aggregate exposure to chlorpyrifos exceeded safe levels.
On December 10, 2015, the Ninth Circuit issued a further order requiring EPA to take final action on its proposed revocation rule and issue its final response to the Petition by December 30, 2016. In re Pesticide Action Network N. Am., 808 F.3d 402 9th Cir. 2015. In response to EPAs request for an extension of the deadline in order to be able to fully consider the July 2016
FIFRA Scientific Advisory Panel SAP
report regarding chlorpyrifos toxicology, the Ninth Circuit ordered EPA to complete its final action by March 31, 2017. In re Pesticide Action Network of
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North America v. EPA, 840 F.3d 1014
9th Cir. 2016. Following that order, EPA published a Notice of Data Availability NODA, seeking comment on EPAs revised risk assessment and water assessment and reopening the comment period on the proposal to revoke tolerances. 81 FR 81049, November 17, 2016 FRL995465.
On March 29, 2017, and as published in the Federal Register on April 5, 2017, the EPA issued an order denying the Petition the Denial Order 82 FR
16581. The specific responses are described in full in that Denial Order and summarized again in the Agencys denial of objections 84 FR 35555, July 24, 2019 FRL999706. EPAs Denial Order did not issue a determination concerning the safety of chlorpyrifos.
Rather, EPA concluded that, despite several years of study, the science addressing neurodevelopmental effects remained unresolved and that further evaluation of the science on this issue during the remaining time for completion of registration review was warranted. EPA therefore denied the remaining Petition claims, concluding that it was not required to complete and would not completethe human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without resolution of those issues during the ongoing FIFRA
registration review of chlorpyrifos.
C. Objections and EPAs Denial of Objections In June 2017, several public interest groups and states filed objections to the Denial Order pursuant to the procedures in FFDCA section 408g2.
Specifically, Earthjustice submitted objections on behalf of the following 12
public interest groups: Petitioners PANNA and NRDC, United Farm Workers, California Rural Legal Assistance Foundation, Farmworker Association of Florida, Farmworker Justice, GreenLatinos, Labor Council for Latin American Advancement, League of United Latin American Citizens, Learning Disabilities Association of America, National Hispanic Medical Association and Pineros y Campesinos Unidos del Noroeste. Another public interest group, the North Coast River Alliance, submitted separate objections.
With respect to the states, New York, Washington, California, Massachusetts, Maine, Maryland, and Vermont submitted a joint set of objections Ref.
1. The objections focused on three main topics: 1 The Objectors asserted that the FFDCA requires that EPA apply the FFDCA safety standard in reviewing any petition to revoke tolerances and that EPAs decision to deny the Petition
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without making a safety finding failed to apply that standard; 2 The Objectors contended that the risk assessments EPA conducted in support of the 2015
proposed rule and the 2016 Revised Human Health Risk Assessment HHRA
demonstrated that chlorpyrifos results in unsafe drinking water exposures and adverse neurodevelopmental effects and that EPA therefore was required to issue a final rule revoking all chlorpyrifos tolerances; and 3 The Objectors claimed that EPA committed procedural error in failing to respond to comments, and they specifically pointed to comments related to neurodevelopmental effects, inhalation risk, and Dow AgroSciences now doing business as Corteva AgriScience physiologically based pharmacokinetic model PBPK model used in EPAs 2014 and 2015 human health risk assessments, which are discussed further in Unit V.
On July 18, 2019, EPA issued a final order denying all objections to the Denial Order and thereby completing EPAs administrative denial of the Petition the Final Order 84 FR 35555.
Again, the Final Order did not issue a determination concerning the safety of chlorpyrifos. Rather, EPA denied the objections in part on the grounds that the data concerning neurodevelopmental toxicity were not sufficiently valid, complete, and reliable to meet the petitioners burden.
D. Judicial Challenge to Objections Denial and 2021 Ninth Circuit Order On August 7, 2019, the Objectors LULAC Petitioners and States petitioned the Ninth Circuit for review of the Denial Order and the Final Order.
The LULAC Petitioners and States argued that EPA was compelled to grant the 2007 Petition and revoke chlorpyrifos tolerances because 1 EPA
lacked authority to maintain chlorpyrifos tolerances without an affirmative finding that chlorpyrifos is safe, 2 EPAs findings that chlorpyrifos is unsafe in the Agencys risk assessments from 2014 and 2016, compel it to revoke chlorpyrifos tolerances, and 3 The 2007 Petition provided a sufficient basis for EPA to reconsider the question of chlorpyrifoss safety and was not required to prove that a pesticide is unsafe.
On April 29, 2021, the Ninth Circuit issued its decision, finding that when EPA denied the 2007 Petition to revoke chlorpyrifos tolerances, it was essentially leaving those chlorpyrifos tolerances in effect, which, the Court noted, the FFDCA only permits if EPA
has made a determination that such tolerances were safe. League of United
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