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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations
Latin Am. Citizens v. Regan, 996 F.3d.
673 9th Cir. 2021. Although EPA
argued that it was not compelled to reconsider its safety determination because the 2007 Petition had failed to meet the threshold requirement of providing reliable evidence that the tolerances were unsafe, the Court found that the Petition provided the necessary reasonable grounds, which triggered EPAs duty to ensure the tolerances were safe. Id. at 695. Since EPAs Denial Order and Final Order failed to make any safety determinations for chlorpyrifos, the Court concluded that EPA violated the FFDCA by leaving those tolerances in place without the requisite safety findings. Id. at 69596.
Moreover, in light of the record before the Court, including the 2016 HHRA
indicating that the current chlorpyrifos tolerances are not safe, the Court found EPAs denial of the 2007 Petition to be arbitrary and capricious. Id. at 697.
Based on the available record, the Court concluded that EPA must grant the Petition and issue a final rule modifying or revoking the tolerances under FFDCA
section 408d4Ai. Id. at 701.
The Court recognized that EPA had been continuing to evaluate chlorpyrifos in registration review and had issued additional regulatory documents concerning chlorpyrifos after the record closed in the litigation, e.g., the 2020
Proposed Interim Registration Review Decision and 2020 SAP, both of which are discussed in more detail in Unit V.
below, and noted that such information could be relevant to a safety determination. Id. at 703. The Court allowed that if the new information could support a safety determination, EPA might issue a final rule modifying chlorpyrifos tolerances rather than revoking them, although the Court directed EPA to act immediately and not engage in further factfinding. Id.
at 703. As a result, the Court ordered EPA to: 1 Grant the 2007 Petition; 2
Issue a final rule within 60 days of the issuance of the mandate that either revokes all chlorpyrifos tolerances or modifies chlorpyrifos tolerances, provided that such modification is supported by a safety finding, and 3
Modify or cancel related FIFRA
registrations for food use in a timely fashion. Id. at 70304. Since the mandate was issued on June 21, 2021, the deadline for issuing this final rule is August 20, 2021.
V. Chlorpyrifos Background and Regulatory History Chlorpyrifos 0,0-diethyl-03,5,6trichloro-2-pyridyl phosphorothioate is a broad-spectrum, chlorinated organophosphate OP insecticide.

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Given the complex scientific nature of the issues reflected in this rule, EPA is alerting the reader that many of the technical terms used in this unit will be described more fully in a subsequent unit.
Chlorpyrifos, like other OP pesticides, affects the nervous system by inhibiting acetylcholinesterase AChE, an enzyme necessary for the proper functioning of the nervous system. This can ultimately lead to signs of neurotoxicity. As discussed in more detail below, while there are data that indicate an association between chlorpyrifos and neurodevelopmental outcomes, there remains uncertainty in the doseresponse relationship and the levels at which these outcomes occur. In an effort to resolve this scientific uncertainty, evaluation of toxicology and epidemiology studies of chlorpyrifos, specific to determining the appropriate regulatory endpoint, has been the focus of EPAs work on chlorpyrifos for over a decade.
Chlorpyrifos has been registered for use in the United States since 1965.
Currently registered use sites include a large variety of food crops including fruit and nut trees, many types of fruits and vegetables, and grain crops, and non-food use settings e.g., golf course turf, industrial sites, greenhouse and nursery production, sod farms, and wood products. Public health uses include aerial and ground-based fogger mosquito adulticide treatments, roach bait products, and individual fire ant mound treatments. In 2000, the chlorpyrifos registrants reached an agreement with EPA to voluntarily cancel all residential use products except those registered for ant and roach baits in child-resistant packaging and fire ant mound treatments. See, e.g., 65
FR 76233, December 6, 2000 FRL
67582; 66 FR 47481, September 12, 2001 FRL67997.
In 2006, EPA completed FIFRA
section 4 reregistration and FFDCA
tolerance reassessment for chlorpyrifos and the OP class of pesticides, concluding that the existing tolerances were safe and that chlorpyrifos continued to meet the FIFRA standard for registration. In that effort, EPA relied on RBC AChE inhibition as the endpoint for examining risk.
Subsequently, given ongoing scientific developments in the study of the OPs generally, EPA chose to prioritize the FIFRA section 3g registration review the subsequent round of re-evaluation following reregistration of chlorpyrifos and the OP class. The registration review of chlorpyrifos and the OPs has presented EPA with numerous novel scientific
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issues which the Agency has taken to multiple independent FIFRA SAP
reviews. Note: The SAP is a federal advisory committee created by FIFRA
section 25d, 7 U.S.C. 136wd, and serves as EPAs primary source of peer review for significant regulatory and policy matters involving pesticides.
These SAPs, which have included the review of new worker and nonoccupational exposure methods, experimental toxicology and epidemiology, and the evaluation of a chlorpyrifos-specific physiologicallybased pharmacokineticpharmacodynamic PBPKPD, see Unit VII. for definitions model. These FIFRA
SAP reviews have resulted in significant developments in EPAs risk assessments generally, and, more specifically, in the study of chlorpyrifoss effects. In particular, and partly in response to the issues raised in the 2007 Petition, EPA
has conducted extensive reviews of available data to evaluate the possible connection between chlorpyrifos and adverse neurodevelopmental effects, and to assess whether the neurodevelopmental effects could be used to determine points of departure PoDs for assessing chlorpyrifos. On this particular topic, EPA has convened three FIFRA SAP reviews. EPA has taken FIFRA SAP recommendations into consideration as it has developed risk assessments and regulatory documents for chlorpyrifos. The remainder of this Unit provides a brief regulatory overview for chlorpyrifos by presenting a summary of the chronology of the FIFRA SAPs and Agency assessments of chlorpyrifos.
The 2008 FIFRA SAP evaluated the Agencys preliminary review of available literature and research on epidemiology in mothers and children following exposures to chlorpyrifos and other OPs, laboratory studies on animal behavior and cognition, AChE
inhibition, and mechanisms of action.
Ref. 3 The 2008 FIFRA SAP
recommended that AChE inhibition remain as the source of data for the points of departure PoDs, see Unit VII.
for definitions, but noted that despite some uncertainties, the Columbia Center for Childrens Environmental Health CCCEH epidemiologic studies is epidemiologically sound and provided extremely valuable information for evaluating the potential neurodevelopmental effects of chlorpyrifos Ref. 3. See Unit VI.A.2.
for neurodevelopmental toxicity.
The 2010 FIFRA SAP favorably reviewed EPAs 2010 draft epidemiology framework. Ref. 4, 5
This draft framework, titled Framework for Incorporating Human
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