OPINION
RAKOFF, District Judge:
This dispute concerning the documented health risks posed by a widely used pesticide, chlorpyrifos, has been before this Court more than a half-dozen times. The Environmental Protection Agency ("EPA" or the "Agency") has recognized that when pregnant mothers are exposed to chlorpyrifos residue, this likely harms infants in utero. Nevertheless, in derogation of the statutory mandate to ban pesticides that have not been proven safe, the EPA has failed to act, requesting extension after extension. The Agency's present position is effectively more of the same.
The proceeding began in 2007, when two environmental non-profit organizations — Pesticide Action Network North America ("PANNA") and the Natural Resources Defense Council, Inc. ("NRDC") — filed a petition (the "2007 Petition") asking the EPA to prohibit foods that contain any residue of the insecticide chlorpyrifos. Then, and now, the EPA has permitted distribution of food containing chlorpyrifos residue as long as the residue is less than a limit known as a "tolerance," which varies depending on the food. The 2007 Petition argued that, even at levels beneath these tolerances, chlorpyrifos poses neurodevelopmental risks, especially to infants and children.
The Federal Food, Drug and Cosmetic Act ("FFDCA") provides that the EPA's "Administrator may establish or leave in effect a tolerance for a pesticide chemical residue in or on a food only if the Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if the Administrator determines it is not safe."
Since 2007, the evidence of harm has continued to build, primarily through two kinds of studies: experimental studies on live mice and rats and epidemiological studies tracking humans who were exposed to chlorpyrifos in utero. Between 2007 and 2016, the EPA published several Human Health Risk Assessments regarding chlorpyrifos and convened its Scientific Advisory Panel ("SAP") several times. Those assessments and SAP reviews increasingly recognized the persuasiveness of the studies showing chlorpyrifos's risks. Nevertheless, the EPA declined to take final action on the 2007 Petition for more than a decade. Eventually, PANNA, NRDC, and others sought judicial relief, and this Court issued multiple writs of mandamus requiring the EPA to move forward. But, festina lente, the EPA continued to delay ruling on the 2007 Petition. This, moreover, was despite the fact that in November 2015, the EPA published a Notice of Proposed Rulemaking that proposed to revoke all chlorpyrifos tolerances because the EPA could not find them to be safe. Similarly, in 2016, the EPA issued a
In 2017, the EPA, pursuant to a court-set deadline, finally ruled on the 2007 Petition. But in the very face of its own prior acknowledgements of the health risks posed by chlorpyrifos, the EPA denied the 2007 Petition, and in 2019 denied all objections to that decision. In reality, however, this was just one more attempt at delay, because the EPA did not conclude that the tolerances were safe, but simply denied the Petition on the ground that the EPA would forgo further consideration of the question of safety until chlorpyrifos underwent a registration re-review under a separate statute, which could be as late as 2022. As explained below, this delay tactic was a total abdication of the EPA's statutory duty under the FFDCA.
In short, the EPA has spent more than a decade assembling a record of chlorpyrifos's ill effects and has repeatedly determined, based on that record, that it cannot conclude, to the statutorily required standard of reasonable certainty, that the present tolerances are causing no harm. Yet, rather than ban the pesticide or reduce the tolerances to levels that the EPA can find are reasonably certain to cause no harm, the EPA has sought to evade, through one delaying tactic after another, its plain statutory duties. The FFDCA permits no further delay. Accordingly, for the reasons that follow, the Court grants the petitions for review and orders the EPA within 60 days after the issuance of the mandate either to modify chlorpyrifos tolerances and concomitantly publish a finding that the modified tolerances are safe, including for infants and children — or to revoke all chlorpyrifos tolerances. The Court also orders the EPA to correspondingly 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).
BACKGROUND
I. The EPA's Duty to Regulate Pesticides
Congress requires the EPA to regulate the use of pesticides on food pursuant to the FFDCA. Congress also requires the EPA to regulate the use of pesticides more generally under the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA"). This case principally concerns the FFDCA.
The FFDCA begins with a general rule that food containing pesticide residue is unsafe and prohibited.
The EPA's discretion to set such tolerances is circumscribed, however, by an uncompromisable limitation: the pesticide must be determined to be safe for human beings. The EPA "may establish or leave in effect a tolerance for a pesticide chemical
In addition to requiring this general safety finding, the FFDCA also conditions the EPA's authority to set or leave in effect a tolerance on its determination that the tolerance is safe for infants and children. "In establishing, modifying, leaving in effect, or revoking a tolerance ..., the Administrator ... shall ... ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue," and shall "publish a specific determination regarding the safety of the pesticide chemical residue for infants and children."
The FFDCA authorizes "[a]ny person [to] file ... a petition proposing the issuance of a regulation establishing, modifying, or revoking a tolerance."
II. This Administrative Proceeding and Related Litigation
This administrative proceeding began with the filing of the 2007 Petition, which sought revocation of all tolerances and registrations for chlorpyrifos. Chlorpyrifos is an organophosphate pesticide. Organophosphates were first developed as toxic nerve agents for potential use in chemical warfare during World War II, and chlorpyrifos was initially registered as a pesticide in the United States in 1965. Since then, farmers have used chlorpyrifos to protect dozens of types of crops. As of 2017, "[b]y pounds of active ingredient, it [was] the most widely used conventional insecticide in the country."
Chlorpyrifos disrupts the functioning of acetylcholinesterase ("AChE"), a crucial enzyme that breaks down the neurotransmitter acetylcholine.
However, for decades, the EPA has itself expressed concerns that chlorpyrifos might also be causing harm through a different mechanism: neurotoxic effects that are especially harmful to infants and children.
A. 2000-2006: The EPA Finds Certain Chlorpyrifos Tolerances Safe, Despite Concerns
Between 2000 and 2006, even before the Petition was filed, the EPA began taking steps to reduce exposure to chlorpyrifos as part of its reevaluation of chlorpyrifos's safety, as required by the FQPA. The FQPA imposed the requirements, still included in the FFDCA today, that the EPA (1) consider proof of safety as an absolute prerequisite to establishing or leaving in effect a tolerance, without balancing it against other factors; (2) assess a pesticide's cumulative exposure from multiple sources (e.g., drinking water as well as food); and (3) specifically assess the pesticide's potential risks to children. The FQPA also required the EPA to reassess the safety of all then-authorized pesticides using this new standard.
During this period, the EPA began to express concerns that chlorpyrifos might be causing harms through a mechanism other than AChE inhibition. For example, in a 2000 Human Health Risk Assessment, the EPA recognized that studies had preliminarily shown that AChE inhibition might not be the only mechanism of harm.
The EPA also began acting on its concerns about chlorpyrifos safety, in collaboration with the pesticide industry. In 2000, the EPA and the chlorpyrifos technical registrants entered into an agreement regarding chlorpyrifos that eliminated or phased out its use for virtually all residential and termiticide purposes, and on tomatoes and, during the growing season, grapes and apples.
Subject to these changes, however, the EPA determined in February 2002, based upon the evidence then available, that "[d]ietary exposures from eating food crops treated with chlorpyrifos are below the level of concern for the entire U.S. population, including infants and children," and that "[d]rinking water risk estimates... are generally not of concern."
In September 2007, PANNA and NRDC filed an administrative petition with the EPA seeking revocation of all chlorpyrifos tolerances under the FFDCA and the cancellation of all of chlorpyrifos's FIFRA registrations. The 2007 Petition asserted that scientific evidence now available showed that the current chlorpyrifos tolerances were not safe, especially for infants and children; indeed, they argued, "no safe level of early-life exposure to chlorpyrifos can be supported."
The 2007 Petition relied in part upon certain experiments performed on live mice and rats. They were exposed in utero to levels of chlorpyrifos below those previously known to cause AChE inhibition. The scientists found marked declines in thinking and movement, indicative of neurological effects. The declines were sex-linked, harming males more than females.
The 2007 Petition also relied upon an epidemiological study, known as the "Columbia Study." Researchers worked with a cohort of pregnant women and their children, collecting data on the mothers' organophosphate exposure (including chlorpyrifos) during pregnancy, and then following the development of the children for many years. Some of the participating children were born before the EPA and the registrants agreed to end residential use of chlorpyrifos, and others were born after. Over time, the researchers found a correlation between prenatal chlorpyrifos exposure and several negative outcomes:
Like the live animal experiments, the Columbia Study found that in utero exposures were harmful even beneath the levels thought to cause notable AChE inhibition and that harms were sex-linked, disproportionately affecting boys.
Two other groups of researchers also conducted epidemiological studies similar to the Columbia Study (the "Mount Sinai Study" and the "CHAMACOS Study"; collectively with the Columbia Study, the "Human Cohort Studies"). The Mount Sinai and CHAMACOS Studies looked at exposure to organophosphate pesticides and, like the Columbia Study, found a correlation between prenatal organophosphate exposure and cognitive impairments in early childhood.
C. 2008-2011: The EPA Preliminarily Links Chlorpyrifos to Neurotoxic Harms in Infants and Children
Within a year of the 2007 Petition, the EPA, in August 2008, published a Science Issue Paper, which reviewed existing
In September 2008, the EPA convened a committee of experts known as a Scientific Advisory Panel ("SAP") to peer-review its findings. The 2008 SAP considered "the results of the three [Human Cohort Studies] (with an emphasis on the Columbia [S]tudy) ... along with the findings from experimental studies in animals," and concluded that "maternal chlorpyrifos exposure would likely be associated with adverse neurodevelopmental outcomes in humans."
However, the SAP also posited that the effects might not be entirely attributable to chlorpyrifos; rather, they might also reflect exposure to other AChE-inhibiting insecticides. A majority of SAP members agreed that the adverse outcomes of the Columbia Study were concerning, especially "in light of evidence demonstrating that low levels of exposure to toxicants once thought to have adverse neurodevelopmental effects only at high levels (i.e. lead, mercury, and PCBs) are now known to produce significant effects at lower levels."
About three years later, in 2011, the EPA published a Preliminary Human Health Risk Assessment. The EPA discussed the three Human Cohort Studies and noted the 2008 SAP's conclusion that those studies, "in concert with the animal studies[,] indicate that `maternal chlorpyrifos exposure would likely be associated with adverse neurodevelopmental outcomes
D. 2012-2015: The EPA Expresses Increasing Certainty That Chlorpyrifos Causes Neurotoxic Effects in Infants and Children
In April 2012, having received no response from the EPA on the pertinent arguments raised in the 2007 Petition,
Meanwhile, also in April 2012, the EPA convened another SAP. The 2012 SAP opined with more certainty than the 2008 SAP that multiple "lines of evidence suggest that chlorpyrifos can affect neurodevelopment at levels lower than those associated with AChE inhibition, and that the use of AChE inhibition data may not be the most appropriate for ... [assessing] the neurodevelopmental risks of chlorpyrifos."
Specifically, the 2012 SAP, based on its review of all the evidence available at the time, "concur[red] with the 2008 SAP and the Agency in concluding that chlorpyrifos likely plays a role in impacting the neurodevelopmental outcomes examined in the three cohort studies."
Despite all this, the EPA, following issuance of the 2012 SAP report, still did not take final action on the 2007 Petition; but it represented in the mandamus proceedings that it had "a concrete timeline for final agency action that would resolve the 2007 Petition by February 2014."
February 2014 came and went, but the EPA did not take final action on the 2007 Petition. PANNA and NRDC returned to this Court in September 2014 with a second petition for a writ of mandamus.
Shortly thereafter, in December 2014, the EPA published a Revised Human Health Risk Assessment. It expressed greater certainty both that chlorpyrifos was causing the neurotoxic harms seen in the cohort studies and that it was doing so through a mechanism other than AChE inhibition.
Because the EPA concluded that chlorpyrifos could cause harm even if exposure was below the AChE inhibition-related point of departure, the EPA proposed a new method for calculating a point of departure. But with all this, the EPA still did not act on the 2007 Petition.
In August 2015, this Court therefore granted the second mandamus petition.
E. 2015-2016: The EPA Finds That Chlorpyrifos Tolerances Are Unsafe
Once again, this Court's deadline came and went, and the EPA still did not take final action on the 2007 Petition. But in November 2015, the EPA published in the Federal Register a Notice of Proposed Rulemaking "proposing to revoke all tolerances for residues of the insecticide chlorpyrifos."
The EPA adhered to the findings of the 2014 Revised Human Health Risk Assessment. It relied upon "a considerable and still-growing body of literature on the effects of chlorpyrifos on the developing brain of laboratory animals (rats and mice) indicating that gestational and/or postnatal exposure may cause persistent behavioral effects into adulthood."
The EPA acknowledged "significant uncertainties... about the actual exposure levels experienced by mothers and infant participants in the three children's health cohorts," but found that the measured exposures "are likely low enough that they were unlikely to have resulted in AChE inhibition."
Since, however, the proposed rule did not constitute a final response to the 2007 Petition, this Court, in December 2015, ordered the EPA "to take final action by December 30, 2016 on its proposed revocation rule and its final response to ... [the] 2007 [P]etition."
In April 2016, the EPA convened another SAP, which peer-reviewed the 2014 Revised Human Health Risk Assessment. The 2016 SAP "agree[d] that both epidemiology and toxicology studies suggest there is evidence for adverse health outcomes associated with chlorpyrifos exposures below levels that result in 10% red blood cell [AChE] inhibition."
However, the 2016 SAP disagreed with the EPA's method for calculating a new point of departure. Specifically, "with the exception of one Panel member, the Panel stated that using [umbilical] cord blood chlorpyrifos concentrations for derivation of the [point of departure] could not be justified by any sound scientific evaluation."
On the other hand, the 2016 SAP explained that, in general, it "support[ed] the use of measured maternal chlorpyrifos blood concentrations as a surrogate for fetal exposure...."
The EPA returned to this Court in June 2016, claiming that it once again could not meet the much-extended deadline for final action on the 2007 Petition. In August 2016, the Court denied the EPA's request for an additional six months.
In November 2016, the EPA revised its Human Health Risk Assessment again. The 2016 Revised Human Health Risk Assessment remains the EPA's most recent comprehensive assessment of the risks of chlorpyrifos. In the assessment, the EPA "continue[d] to conclude that the [Human Cohort Studies] provide the most robust available epidemiological evidence."
The EPA acknowledged that "the 2016 SAP did not support using the [Columbia Study] cord blood" to derive a new point of departure.
When the EPA compared the resulting safety thresholds against typical pesticide exposure scenarios, it determined that chlorpyrifos tolerances were not safe — even considering food alone, without aggregating other exposure sources, like drinking water.
The EPA announced the findings of the 2016 Revised Human Health Risk Assessment through a Notice of Data Availability published in the Federal Register,
F. 2017-Present: The EPA Denies the 2007 Petition
Faced with this Court's statement that it would brook no further delays in the EPA's ruling on the 2007 Petition, the EPA finally in April 2017 ruled on the 2007 Petition. Notwithstanding the findings in its own 2016 Revised Human Health Risk Assessment, however, the EPA's order denying the 2007 Petition (the "2017 Order") stated that, "despite several years of study, the science addressing neurodevelopmental effects remains unresolved."
The EPA further explained that it was denying the 2007 Petition only because this Court had ordered it to make a decision, but that
PANNA, NRDC, and others objected to the EPA's denial of the 2007 Petition, both by filing objections with the EPA and by seeking relief from this Court. The Court denied mandamus relief on the ground that the EPA had "now complied with our orders" to issue a decision, and "substantive objections must first be made through the administrative process."
But even though the statute required the EPA to rule on petitioners' objections "[a]s soon as practicable after receiving the arguments of the parties," 21 U.S.C. § 346a(g)(2)(C), and even though these objections were simply reiterations of the
The EPA objected to this Court's consideration of the merits of the decision on the ground that, until the EPA ruled on petitioners' administrative objections, this Court lacked jurisdiction. A panel of this Court concluded that "the EPA is engaging in yet more delay tactics to avoid our reaching the merits of ... whether chlorpyrifos must be banned from use on food products because the EPA has not determined that there is a `reasonable certainty' that no harm will result from its use, even under the established tolerances."
Subsequently, however, a majority of nonrecused active judges voted to rehear the case en banc. The en banc Court did not address the jurisdictional question, but instead issued a writ of mandamus requiring the EPA to rule on the objections to the 2017 Order within 90 days.
With the Court's jurisdiction now clear, petitioners petitioned for review of the 2017 and 2019 Orders. Several states moved to intervene. The en banc Court granted the motion to intervene, consolidated the cases, and returned the matter to this panel as a "comeback case."
STANDARD OF REVIEW
The Administrative Procedure Act ("APA") authorizes the Court to "hold unlawful and set aside agency action, findings, and conclusions" if they are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,"
ANALYSIS
I. Merits
The Court first considers whether the EPA lawfully denied the 2007 Petition. Petitioners argue that the EPA's 2017 and 2019 Orders were ultra vires under the FFDCA and arbitrary and capricious under the APA.
A. Whether the EPA Left in Effect a Tolerance Without Determining That It Is Safe
As noted above, the FFDCA provides that the EPA "may establish or leave in effect a tolerance for a pesticide chemical residue in or on a food only if the Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if the Administrator determines it is not safe."
Courts "normally interpret[] a statute in accord with the ordinary public meaning of its terms at the time of its enactment."
The EPA admits that the 2017 and 2019 Orders left in effect tolerances without determining that they are safe, claiming that it could delay this determination for several more years until it had resolved safety-related issues in the 15-year FIFRA registration review. Since, as discussed below, the EPA's duty to engage in a periodic FIFRA registration review is separate from its continuous obligation to ensure safety under the FFDCA, this concession is effectively dispositive in favor of petitioners.
FIFRA aside, the EPA argues that it may leave in effect tolerances, without a new safety finding, "when [the] EPA concludes the petition contains insufficient evidence for [the] EPA to undertake proceedings to revoke or modify tolerances." This argument fails for two reasons. First, once the EPA has become aware, through a petition or otherwise, of genuine questions about the safety of an existing tolerance, the EPA has its own continuing duty under the FFDCA to determine whether a tolerance that was once thought to be safe still is, and here the EPA's own studies and pronouncements still in effect show that it regards chlorpyrifos as harmful at levels below the existing tolerances. Second, in any case, the 2007 Petition, under the EPA's own regulations, contained more than sufficient evidence to undertake a safety review, and the EPA recognized as much, began such a review, and only now, 13 years later, claims for the first time that the 2007 Petition was somehow inadequate.
The FFDCA imposes a continuous duty upon the EPA by permitting it to "leave in effect" a tolerance "only" if it finds it is safe. To "leave" something in effect means "to cause or allow [it] to be or remain in a specified condition."
It should be noted in this respect that, because of the FQPA, assurance of safety for human health is the primary issue the EPA must consider. Before 1996, when Congress unanimously passed the FQPA, the EPA interpreted the FFDCA to permit the balancing of safety against other considerations, such as economic factors. Congress was aware of this,
The EPA argues that one of Congress's purposes was to provide the EPA with regulatory discretion. The EPA points to the fifteen-year registration review cycle under FIFRA
Our dissenting colleague reaches a different conclusion regarding the EPA's obligations, or lack thereof, when confronted with a petition for revocation of tolerances. The Dissent focuses upon two sentences in the FFDCA:
We think that these two simple sentences are — with their emphasis on the word "only" — remarkably straightforward. As here explained, they mean that the EPA can lawfully deny the 2007 Petition and thereby "leave in effect" a tolerance "only if the Administrator determines that the tolerance is safe." The Dissent's more strained reading of these sentences is to the effect that there are three possible scenarios, one in which the EPA "determines that a tolerance is safe," one in which the EPA "determines it is not safe," and one in which the EPA is unwilling or unable to make a safety determination at this time. In this latter, middle world, the Dissent continues, the statute is silent as to the EPA's obligations, leaving the EPA with the discretion to leave in effect a tolerance based on its prior safety finding (here, the 2006 safety finding).
One problem (among others) with the Dissent's imaginative reading is that other statutory provisions are not silent. The FFDCA imposes an overarching obligation that the EPA protect human safety, and
Congress has excluded the middle, not this Court. The EPA can only lawfully take agency action to establish or leave in effect a tolerance (e.g., denying the 2007 Petition) if the EPA finds that the tolerance is safe.
2. The Burdens of Production and Persuasion
The EPA claims that the issue of safety as it bears on an existing tolerance need not be addressed unless a petitioner meets a threshold burden to come forward with evidence that the existing tolerance is unsafe. In this regard, the EPA points to the fact that the FFDCA gives the EPA the authority to "establish the requirements for information and data to support a petition to modify or revoke a tolerance."
We do not doubt that the EPA has gatekeeping authority to reject a wholly frivolous petition — i.e., a petition that fails even to "furnish reasonable grounds for the action sought" — without publishing a notice of its filing if the petition is deficient on its face, and in such circumstances we can assume the EPA need not address the concerns raised by the petition. But the record here unequivocally shows both that the 2007 Petition met all relevant requirements and that, in fact, it caused the EPA to re-evaluate the safety of the chlorpyrifos tolerances, thus triggering the EPA's duty to ensure a reasonable certainty of no harm.
The FFDCA requires the EPA to determine whether a petition satisfies the threshold requirements prior to publishing a notice of the filing of the petition.
Independently, even if the EPA had raised this issue thirteen years ago when the 2007 Petition was filed, the EPA offers no specific way in which the petition failed to comply with the EPA's technical requirements and no plausible argument for
The Dissent contends that a petitioner who seeks revocation of a pesticide tolerance bears not only a burden of production, i.e., to provide "reasonable grounds" for revocation, but also a burden of persuasion, i.e., to offer valid, complete, and reliable data that affirmatively demonstrate that the tolerances are unsafe. However, as previously explained, the Dissent's reading is inconsistent with the FQPA's health protective purpose and the FFDCA's overarching command that the EPA, whenever leaving in effect a tolerance, "assess the risk of the pesticide chemical residue ... and ... ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure...."
B. Whether Denying the 2007 Petition Was Arbitrary and Capricious
Separately, in light of the present record and the EPA's assessment of that record, petitioners argue that, even if the FFDCA does not require a safety finding here (which we find it does), the EPA's denial of the 2007 Petition was arbitrary and capricious. The Court agrees.
An agency has a baseline obligation to "articulate a satisfactory explanation for its action including a `rational connection between the facts found and the choice made.'"
The EPA has not retracted the 2016 Revised Human Health Risk Assessment indicating that chlorpyrifos is not safe at current tolerances and has not issued a new Human Health Risk Assessment or SAP report since 2016. Rather, the 2017 Order denied the 2007 Petition on purely discretionary grounds, relying upon the EPA's purported authority to demand more study through at least 2022. After 13 years of delay, a desire for yet more delay does not rationally support denial of a petition that the EPA's own prior studies indicate raises a genuine issue of ongoing harm to infants and children.
The EPA asserted in the 2017 Order that it "may lawfully re-prioritize the registration review schedule developed by earlier [presidential] administrations."
But the FIFRA registration review, as already noted, is a different animal, in that it permits a balancing of multiple factors, whereas a FFDCA review is limited to the sole issue of safety but allows no balancing as far as that factor is concerned. Chlorpyrifos's wide use and the significance of this issue to the Administration are not valid legal considerations, as the EPA recognized in its 2017 Order.
The reference in the denial to the FIFRA 15-year period of review is, instead, nothing but a red herring, as the 2007 Petition does not concern FIFRA registration
The 2019 Order (unlike the 2017 Order) relied upon a second ground for denial of the 2007 Petition. The EPA found that PANNA and the NRDC bore an initial burden of production that, according to the EPA, they did not meet. The EPA pointed out that the FFDCA requires it to consider "the validity, completeness, and reliability of the available data"
For reasons already stated, this finding is unreasonable and inconsistent with the petition itself. The 2007 Petition claimed in detail that chlorpyrifos posed a risk of neurotoxic harm, especially to infants and children, and it invoked the live animal studies and the Columbia Study as evidence. The EPA acknowledges that it "has, since [2006], consistently concluded that the available data support a conclusion of increased sensitivity of the young to the neurotoxic effects of chlorpyrifos and for the susceptibility of the developing brain to chlorpyrifos."
Because the Court rejects both of the EPA's justifications for refusing to make a safety finding, the Court concludes that the EPA's denial of the 2007 Petition was arbitrary and capricious.
First, the EPA objects, in general, that "the science on this question is not resolved and would benefit from additional inquiry."
Second, the EPA argues that it does not know how chlorpyrifos's neurotoxic effects harm infants and children. But that is not the question before the EPA. The question is whether chlorpyrifos causes such harms. Even if the mechanism is unknown, if a tolerance is unsafe, then the EPA must revoke it.
Third, the EPA argues that the studies of rats and mice applied a "dosing regimen... that differs from internationally accepted protocols."
This argument, apparently raised for the first time in the 2019 Order, is stated in cursory fashion. The EPA does not identify these "internationally accepted protocols" or explain why the EPA did not find deviations from these protocols to be troubling in the 2015 Notice of Proposed Rulemaking, the 2016 Notice of Data Availability, the 2016 Revised Human Health Risk
Fourth and finally, the EPA objects that it has been unable to get the raw data, as well as information concerning how residential pesticides were applied, from the Columbia Study. (Columbia, for its part, has expressed reasonable concerns about the subjects' privacy, especially given that the study covered a small geographic radius. Nevertheless, Columbia suggested to the EPA that it could make at least some of the datasets available for viewing in a secure data center.
The EPA's flip-flopping suggests the weakness of this objection. Nevertheless, even if the Court were to assume for the sake of argument that the underlying data, and information concerning the method of residential pesticide application, would be of some use and that the EPA's inability to access it might diminish the value of the Columbia Study, it would not change the result in this case.
This is because, while the EPA might reasonably conclude that divergences from international protocols and lack of access to raw data might affect the weight the EPA accords to these studies, they are nowhere near enough to show that the studies are entirely unreliable. The FFDCA requires the EPA to consider the "information" that is "available"
II. Remedy
The Court concludes that the EPA lacked power to deny the 2007 Petition without making the safety findings required by the FFDCA and that the EPA's decision was arbitrary and capricious. Therefore, the Court must, at least, "set aside the order or regulation complained of"
The second sentence is more than a mere gloss on the first because the command inherent in the second sentence is important.
On the present record, the only reasonable conclusion the EPA could draw is that the present tolerances are not safe within the meaning of the FFDCA. The EPA can find a tolerance safe only if there is "a reasonable certainty" of "no harm,"
Even in its brief here, the EPA, though it purports to withhold judgment on chlorpyrifos's safety, admits that it cannot conclude there is a reasonable certainty of no harm. Rather, the EPA represents that there are "uncertainties concerning the impact of chlorpyrifos on children" (emphasis added).
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 tolerances are not safe. Accordingly, the EPA's obligation is clear: it must modify or revoke chlorpyrifos tolerances and modify or cancel chlorpyrifos registrations.
The EPA cites cases counseling that upon reversal of agency action, an open-ended remand is the correct approach, "[g]enerally speaking"
Finally, the EPA argues that "any order by this Court unilaterally ordering [the] EPA to revoke the existing tolerances for chlorpyrifos or cancel the existing registrations would raise serious due process concerns" for registrants and "violate Congress's procedures." Here, however, the Court is not unilaterally ordering the EPA to revoke existing tolerances; as explained below, it may instead modify such tolerances if it can make the requisite safety findings.
In any event, remanding with specific instructions does not raise due process concerns. In responding to a petition, the FFDCA explicitly authorizes the EPA to "issue a final regulation modifying or revoking a tolerance ... (which final regulation shall be issued without further notice and without further period for public comment)."
Such a final regulation could take one of two forms: either it could revoke all chlorpyrifos tolerances or it could modify chlorpyrifos tolerances and conclude that under the new tolerances there is a "reasonable certainty that no harm will result" due to "aggregate exposure to the pesticide chemical residue" that would result from such modified tolerances, including "to infants and children."
Nevertheless, during the pendency of this proceeding, in December 2020, the EPA issued a Proposed Interim Registration Review Decision proposing to modify certain chlorpyrifos tolerances. The EPA also convened another SAP in 2020. If, based upon the EPA's further research the EPA can now conclude to a reasonable certainty that modified tolerances or registrations would be safe, then it may modify chlorpyrifos registrations rather than cancelling them.
To be clear, however, this is not an open-ended remand or a remand for further factfinding. The EPA must act based upon the evidence and must immediately revoke or modify chlorpyrifos tolerances.
For these reasons, the Court remands this matter to the EPA with instructions to publish a legally sufficient final response to the 2007 Petition within 60 days of the issuance of the mandate. That response must be a final regulation that either revokes all chlorpyrifos tolerances or modifies chlorpyrifos tolerances and makes the requisite safety findings based on aggregate exposure, including with respect to infants and children.
While the Dissent effectively views this as a "tight deadline[],"
CONCLUSION
We
BYBEE, Circuit Judge, dissenting:
This is a consequential proceeding. EPA has before it a petition to revoke the tolerances for chlorpyrifos, one of the most important pesticides in the United States. This is a very complicated statute and I agree with the majority that EPA dithered far too long before ruling on the petition. Beyond that, I disagree with the majority opinion and judgment. In my view it has misread EPA's obligations to review pesticide chemical residue tolerances EPA has previously found to be "safe" under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 346a(b)(2)(A)(i). Further, the majority has substituted its own judgment for EPA's decision and then concluded that, because there is a difference of opinion, EPA's decision must be arbitrary and capricious. See 5 U.S.C. § 706(2)(A). Difference is not caprice. Finally, among the options Congress entrusted to EPA when an existing tolerance is determined to be unsafe, the majority effectively mandates the option that EPA will enforce.
As to the first point, I part with the majority over EPA's duty with respect to the petition. According to the majority, EPA must find that chlorpyrifos is safe for human use, and EPA did not do so here. Maj. Op. at 691-94. EPA did find chlorpyrifos safe. That was the result of the proceedings in 2006, made final shortly before the present petition was filed. The question EPA had to answer in this proceeding is whether new scientific evidence is sufficient to require EPA to "modify or revoke" its prior determination. Under the FFDCA, EPA must do so "if the Administrator determines it is not safe." 21 U.S.C. § 346a(b)(2)(A)(i) (emphasis added). Because EPA found that chlorpyrifos was safe when it concluded its prior rulemaking in 2006, EPA properly determined here that there was insufficient evidence to conclude that chlorpyrifos is "not safe" and thus it was not required to "modify or revoke" those tolerances. EPA does not start from scratch when it is reviewing a petition to revoke or modify, but may rely on its prior finding. The majority would require, contrary to the FFDCA, that EPA start all over again. I take this point up in Part I.
As to the second point, the majority cherry-picks EPA's careful and honest questions about the safety of chlorpyrifos in light of various studies produced in the petition. Admittedly, it feels like EPA had this question under review for far too long—through three administrations—but the majority then assumes EPA's tentative conclusions are proven and concludes that it was arbitrary and capricious for EPA to determine otherwise. However, EPA never concluded that the studies presented to it were scientifically established. At every step of its overly cautious proceedings, EPA referred these studies to its Scientific Advisory Panel (SAP), which ultimately advised EPA that it could not verify the studies' conclusions. When EPA requested the underlying data, the studies' authors declined to produce it. Left without means of authenticating the studies, EPA concluded there was insufficient verifiable evidence to conclude that chlorpyrifos was "not safe" and to require EPA to modify or revoke its prior approval. The petition failed for lack of scientifically verifiable evidence. EPA explained all of this in detail,
Not only do we decide that EPA's decision was arbitrary and capricious, but we have effectively decided the appropriate remedy. By ordering EPA either to revoke all tolerances or modify the tolerances with the requisite safety findings within 60 days, our order virtually guarantees the EPA will revoke chlorpyrifos tolerances. This is a vast overreach, a clear abuse of our discretion, as I discuss in Part III.
We can be unhappy with EPA's dilatory proceedings, but the remedy for that is a writ of mandamus, which we issued in League of United Latin American Citizens v. Wheeler (LULAC III), 922 F.3d 443 (9th Cir. 2019) (en banc). Now that EPA has complied fully with our directions, we don't get to set aside EPA's decision "simply because [we are] unhappy with the result reached." Vt. Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 558, 98 S.Ct. 1197, 55 L.Ed.2d 460 (1978). Nor do we get to "second-guess[] the [agency's] weighing of risks and benefits." Dep't of Com. v. New York, ___ U.S. ___, 139 S.Ct. 2551, 2571, 204 L.Ed.2d 978 (2019). "[A] reviewing court must remember that" when an agency is acting "within its area of special expertise, at the frontiers of science," we "must generally be at [our] most deferential." Balt. Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103, 103 S.Ct. 2246, 76 L.Ed.2d 437 (1983). I respectfully dissent.
I
For starters, I fundamentally disagree with the majority over its construction of the FFDCA. The majority reads § 346a(b)(2)(A)(i), which is the critical section of the FFDCA for setting standards for pesticide use, as creating a binary choice for EPA: either a tolerance is "safe" or it is "not safe." The majority concludes that because EPA did not conclude that the chlorpyrifos tolerances were "safe" when it denied the petition, EPA must have concluded that they were "not safe" and the petition should have been granted. See Maj. Op. at 691 (EPA "left in effect tolerances without determining that they are safe...."). With respect, the majority has misread the statute and its logic. I will start with some background on the statutes, then turn to how the majority has misread the statute, and conclude by addressing two additional arguments the majority makes.
A
Let's start with some background. EPA regulates pesticides pursuant to two statutes: the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 346a, and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136a-136y. The provisions relevant here were adopted as amendments to those Acts in the Food Quality Protection Act of 1996 (FQPA), Pub. L. No. 104-170, 110 Stat. 1489 (Aug. 3, 1996). See Nw. Coal. for Alts. to Pesticides v. EPA, 544 F.3d 1043, 1046 (9th Cir. 2008). The FFDCA authorizes EPA to regulate pesticides used on food that pose safety risks to humans and to establish pesticide tolerance levels "necessary for the protection of public health." 21 U.S.C. § 346. FIFRA authorizes EPA to "limit the distribution, sale, or use" of pesticides "[t]o the extent necessary to prevent unreasonable adverse effects on the environment" and issue registrations for distribution or sale of pesticides. 7 U.S.C. § 136a(a).
In addition to establishing safe tolerance levels for pesticides under the FFDCA, EPA regulates pesticides under FIFRA by issuing registrations required for distribution or sale. 7 U.S.C. § 136a(a). EPA may register a pesticide where, in addition to other requirements, "it will perform its intended function without unreasonable adverse effects on the environment" and "when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment." Id. § 136a(c)(5)(C), (D). "Unreasonable adverse effects on the environment" are unreasonable risks to man or the environment, including "human dietary risk ... inconsistent with the standard under section 346a of Title 21." Id. § 136(bb). Thus, FIFRA incorporates the FFDCA safety determination into its registration assessment.
At the time the FQPA was passed in 1996, there were a number of existing tolerances in effect. The use of chlorpyrifos, for example, has been federally authorized since 1965. See Chlorpyrifos; Final Order Denying Objections to March 2017 Petition Denial Order, 84 Fed. Reg. 35,555, 35,558 (July 24, 2019) (Final Order). The FFDCA, as amended by the FQPA, provided that "[r]egulations that establish tolerances" issued on or before August 3, 1996, "shall remain in effect unless modified or revoked." 21 U.S.C. § 346a(j)(3). The Act also instructed EPA to "review tolerances and exemptions for pesticide chemical residues in effect on [August 2, 1996]," and to determine whether to leave in effect, "modify or revoke" those tolerances in accordance with the new standards. Id. § 346a(q)(1).
The general standards for establishing, leaving in effect, modifying, or revoking tolerances are found in § 346a(b)(2)(A)(i):
These sentences are awkwardly written. For readability we can transpose them as follows:
These standards are consistent with the presumption against the use of pesticides in food. If EPA determines a pesticide is safe, then EPA may establish a new tolerance or leave in place a tolerance previously established. However, if EPA determines a tolerance is not safe, then EPA shall modify or revoke the tolerance. Establishing or leaving a tolerance in place is not mandatory, even if EPA determines that a pesticide is safe; but if EPA determines a tolerance is not safe, it must modify or revoke the tolerance.
When acting on its own initiative or in response to a petition,
B
Now to the majority's errors. The majority reads § 346a(b)(2)(A)(i) as creating a
We should be familiar with the problem of the excluded middle from other areas of law and life. For example, "guilty" and "not guilty," as logical opposites, describe the universe, so long as we don't care about factual innocence. But if we do, we have to consider a third alternative. Thus, we have examples where courts have gone beyond the binary thinking of guilty/not guilty to declare persons "factually innocent." See Humphries v. Cnty. of L.A., 554 F.3d 1170, 1181-82 & nn. 6, 8 (9th Cir. 2009) (discussing the legality and effect of findings of "factually innocent" by a California criminal court and "not true" by a California juvenile court in a child abuse case), rev'd in part on other grounds, Cnty. of L.A. v. Humphries, 562 U.S. 29, 131 S.Ct. 447, 178 L.Ed.2d 460 (2010). Other countries offer juries the option of a third verdict. See Samuel L. Bray, Comment, Not Proven: Introducing a Third Verdict, 72 U. Chi. L. Rev. 1299, 1299-1300 (2005) ("Not proven and not guilty are both acquittals, indistinguishable in legal consequence but different in connotation. Not guilty is for a defendant the jury thinks is innocent; not proven, for a case with insufficient evidence of guilt"; citing Scottish law as an example). In football, a ruling may be overturned only if there is indisputable evidence that it was wrong. But what if the ruling is not indisputably wrong? Do we care if it was correct, or just "not wrong"? Turns out that we do. The presumption will lie with the official who made the call. If the ruling cannot be overturned, "the ruling on the field stands." But if the ruling on the field is correct, then "the ruling on the field is confirmed." See NCAA Football Rules Book R. 12, § 6, art. 1.d (2019) (distinguishing three options: "the ruling on the field is confirmed," "the ruling on the field stands," and reversing a ruling). There is no practical difference in the immediate effect on the game between "the ruling on the field stands" and "the ruling on the field is confirmed," but there are collateral
The majority's premise that a pesticide is either "safe" or "not safe" ignores an important alternative—namely, that there is insufficient information to reach either of those conclusions. That is why Congress instructed EPA to consider "the validity, completeness, and reliability of the available data"—it understood that the evidence might be inconclusive. 21 U.S.C. § 346a(b)(2)(D)(i). That is also why § 346a(b)(2)(A)(i) allocates a burden of persuasion. I hesitate to use the term "burden of proof" because it suggests that EPA and petitioners are adverse to each other; they are not. EPA is responsible for regulating pesticide use and, as a court, we assume that it has developed an expertise. We also assume that EPA will be an honest broker in assessing the safety of a pesticide; after all, agency employees have to eat the same food we do. So instead of "burden of proof," I am going to use the term "risk of nonpersuasion."
Here is how the risk of nonpersuasion figures into the FFDCA. When EPA receives a petition, it has a duty of inquiry, but it is a different duty depending on whether the decision on the table is whether to establish or leave in effect a tolerance (the first sentence of § 346a(b)(2)(A)(i)) or to modify or revoke a tolerance (the second sentence in that subsection). EPA (or a petitioner) has the initial burden to show that a proposed tolerance can be safely established. If the proposal does not satisfy that standard, EPA cannot adopt the proposed tolerance. EPA has the same burden when it considers an existing tolerance for reregistration. Recall that when the FQPA was adopted in 1996, that Act tightened the standards for pesticides. Because EPA had approved pesticides in use, the FQPA required EPA to review and reregister all existing tolerances to determine whether to "leave in effect" those tolerances. 21 U.S.C. §§ 346a(j)(3), (q)(1). Additionally, the FQPA, amending FIFRA, mandated that following that reregistration, EPA must review existing tolerances no less frequently than every 15 years. 7 U.S.C. § 136a(a), (g)(1)(A)(iv). In these reregistration proceedings, EPA must conclude that the existing tolerance is "safe" before it can "leave [it] in effect." 21 U.S.C. § 346a(b)(2)(A)(i). What happens if the evidence is inconclusive? Since there is a presumption that all pesticides are "unsafe," id. § 346a(a)(1), the risk of non-persuasion means that EPA must either approve the tolerance or exempt it under other provisions of the FFDCA, see id. § 346a(a)(1)(A), (B). As I transposed § 346a(b)(2)(A)(i) for readability, "only if the Administrator determines that the tolerance is safe may [the Administrator] establish or leave in effect a tolerance."
By contrast, when a petitioner requests modification or revocation of an existing tolerance, the risk of nonpersuasion cuts in the opposite direction. EPA has previously found the tolerance to be "safe." If EPA subsequently determines that the pesticide is "not safe," then it must modify or revoke the tolerance. What happens if the evidence is inconclusive? The risk of non-persuasion means that EPA may, but does not have to, modify or revoke the tolerance. Section 346a(b)(2)(A)(i) is clear (as I have revised it for readability): "If the Administrator determines a tolerance is not safe, the Administrator shall modify or revoke the tolerance." Accordingly, when a petitioner files an appropriate petition claiming that a tolerance is not safe, EPA assumes a duty of inquiry, but not a duty of declaring anew that the tolerance is "safe." Here is the crucial distinction: determining that a tolerance is "not safe" is not the same as not determining that a tolerance is "safe." The majority's either/or
Trifiro v. Nw. York Life Ins. Co., 845 F.2d 30, 33-34 (1st Cir. 1988).
The majority's either/or treatment of § 346a(b)(2)(A)(i) has two important consequences. First, it effectively reads the second sentence of that subsection out of the statute because, in the majority's understanding, EPA always has the burden to show that a tolerance is "safe," which means that it is, by definition, not "not safe." Or, to put it another way, in the majority's view, if at any time EPA does not affirmatively declare that a tolerance is "safe," the tolerance is, again by definition, "not safe." Under the majority's reading, the second sentence of § 346a(b)(2)(A)(i) doesn't do any work because in order to determine that a tolerance is "not safe" EPA must decide that it is not "safe." In other words, for the majority, in every case EPA has a duty of reregistration. The reason the majority has committed this error of logic is that it fails to appreciate the different context for the two sentences in § 346(b)(2)(A)(i). In the first sentence, the presumption runs against the tolerance because EPA is required to establish or reregister ("leave in effect") the tolerance. In the second sentence, EPA has already determined that the tolerance is "safe," so the question is whether there is enough evidence to show that it is "not safe." When EPA denies a petition for insufficient evidence, it may rely on its prior determination that the tolerance is "safe." The two sentences operate in different contexts.
Second, the majority's reading means that petitioners can seize control of the statutory schedule for reviewing existing tolerances. Under the FQPA, EPA had to review all existing tolerances, such as chlorpyrifos, under the new standard. And it had to do so "as expeditiously as practicable," but no later than 2006. 21 U.S.C. § 346a(q)(1). This EPA did in 2006, leaving in effect the chlorpyrifos tolerance. Under the FIFRA and the FFDCA, EPA would have to reevaluate chlorpyrifos for reregistration no later than October 2022. See 7 U.S.C. § 136a(g)(1)(A)(iv); Final Order, 84 Fed. Reg. at 35,558. In the interim, any interested person may petition EPA to modify or revoke the tolerance. Under the majority's reading of the FFDCA, to respond to the petition, EPA must either reregister chlorpyrifos as "safe" or modify or revoke the tolerance—but in either case the petition has altered the statutory review process for chlorpyrifos. Since petitioners can file petitions at will, EPA has lost control over its docket, and the statutory schedule has been derailed. As EPA put it, if
Final Order, 84 Fed. Reg. at 35,565.
C
Despite the (relative) clarity of these provisions, the majority makes two arguments to get around this reading of § 346a(b)(2)(A)(i). First, the majority holds that any time EPA considers a petition to modify or revoke an existing tolerance (which is governed by the second sentence of § 346a(b)(2)(A)(i)), it is "leav[ing] in effect" the tolerance (which is governed by the first sentence). Maj. Op. at 691-92. It concludes that EPA has "a continuous duty" under the FFDCA "to `leave in effect' a tolerance `only' if it finds it is safe." Id. at 692. Second, the majority claims that once EPA accepted the petition, because it was not "wholly frivolous," EPA had an independent duty to determine whether chlorpyrifos is "safe" and cannot now claim that the petition was "somehow inadequate." Id. at 691-92, 694. Neither point withstands scrutiny.
The majority's focus on EPA "leaving in effect" the chlorpyrifos tolerance misconceives the proceedings. Under the FFDCA, any petitioner had the right to petition EPA to "establish[], modify[] or revok[e]" a tolerance. 21 U.S.C. § 346a(d)(1)(A). "Leave in effect" is not mentioned as an option in the petition subsection, and for good reason: "leave in effect" has a particular context and meaning in the FFDCA. As I have explained, prior to the adoption of the FQPA in 1996, which established the current statutory standards in the FFDCA, there were tolerances in place for pesticides such as chlorpyrifos. The FQPA imposed a duty and a schedule on EPA to review all existing tolerances and to decide whether to "leave in effect" those tolerances. 21 U.S.C. § 346a(q)(1). See also id. § 346a(l)(3)(B) (explaining if EPA suspends a tolerance it "shall not be considered to be in effect," but if the suspension is terminated, "leaving the registration of the pesticide for such use in effect," EPA must rescind the suspension). Because the prior tolerances were not established under the same standards demanded by the FFDCA, as amended by the FQPA, EPA had to determine afresh that the preexisting tolerances were "safe." With respect to that review, EPA could "leave in effect a tolerance ... only if the Administrator determines that the tolerance is safe." Id. § 346a(b)(2)(A)(i). Under FIFRA, EPA must also re-certify its tolerances no less than every 15 years and decide whether to leave a tolerance in effect or modify or revoke it. 7 U.S.C. § 136a(g)(1)(A).
That brings us to the majority's second point. The majority attempts to shift the risk of nonpersuasion through a contorted reading of EPA's regulations regarding the filing of a petition. According to the majority, EPA has a "gatekeeping authority to reject a wholly frivolous petition." Maj. Op. at 694. But if EPA accepts a petition, it "trigger[s] the EPA's duty to ensure a reasonable certainty of no harm" by re-evaluating chlorpyrifos and, if it decides to "leave in effect" the tolerance, it must certify chlorpyrifos as "safe." Id. According to the majority, accepting a petition flips the risk of nonpersuasion. But EPA's regulations say nothing of the kind.
In an exercise of its "gatekeeping authority," EPA has adopted "Procedure for modifying and revoking tolerances or exemptions from tolerances." 40 C.F.R. § 180.32. That regulation provides in relevant part:
Id. § 180.32(b). There is not a word in the regulation that would affect the risk of nonpersuasion. The regulation requires little to be a qualifying petition: "reasonable grounds," including "an assertion of facts" which shall be "supported by data if available." Id. (emphasis added). That is the most modest of rules. EPA will generously accept such petitions and consider them. Accepting a petition—which in the majority's phrase means that they are not "wholly frivolous"
Although EPA's Final Order was overdue, there was nothing improper in its form. EPA denied the petition and instead relied upon its 2006 safety determination for chlorpyrifos tolerances because it found that the data and studies supporting the petition were "not sufficiently valid, complete, and reliable" to support revocation. Final Order, 84 Fed. Reg. at 35,562-63. In other words, the data supporting the petition was not sufficient to support a determination that chlorpyrifos tolerances are "not safe." 21 U.S.C. § 346a(b)(2)(A)(i).
The FFDCA does not require EPA to make a new safety determination in response to a petition supported solely by studies that EPA has already considered and found insufficient for revocation while conducting its FIFRA review. Here, EPA considered the petition's cited studies at multiple instances during its own review and found that they were not reliable enough to support revocation without more information. See Final Order, 84 Fed. Reg. at 35,563. The agency's determination that the petition did not present sufficiently valid, complete, or reliable information to support revocation is thus supported by the record. See § 346a(b)(2)(D). Because the 2007 petition did not present reasonable grounds for modification or revocation, EPA was entitled to rely upon its 2006 safety finding while it engaged in its FIFRA review of chlorpyrifos tolerances. The tolerance had already been deemed "safe," and the petition did not raise sufficient grounds to overcome that presumption.
Under a correct reading of the statute, and proper allocation of the risk of nonpersuasion, we should be reviewing EPA's determination that the petition, and the evidence it mustered, was insufficient to determine that the chlorpyrifos tolerance is "not safe." That is not the inquiry the majority conducts, so in Part II I will review the proceedings before EPA, as punctuated by our orders, and its Final Order, which is the only decision we have authority to review. 5 U.S.C. § 704.
II
EPA's denial of the 2007 petition was not arbitrary or capricious. The denial of the petition did not conflict with any final agency findings or conclusions and, to the contrary, was supported by the extensive record of EPA's concerns with the petition's supporting studies over the course of nearly a decade. The only final agency
I will begin with a brief review of EPA's 2006-17 proceedings, with some emphasis on the questions and qualifications EPA raised at each step of those proceedings. I will then turn to the Final Order and our review under the APA.
A
In 2006, pursuant to the FFDCA, EPA completed a tolerance reassessment of chlorpyrifos and found that chlorpyrifos was eligible for reregistration and met the standard of 21 U.S.C. § 346a(b)(2). EPA, Office of Prevention, Pesticides and Toxic Substances, Memo to Jim Jones from Debra Edwards, Finalization of Interim Reregistration Eligibility Decisions and Interim Tolerance Reassessment and Risk Management Decisions for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides (July 31, 2006) (2006 Reregistration Decision); see also Final Order, 84 Fed. Reg. at 35,558. In doing so, EPA found that chlorpyrifos tolerances were safe and left them in effect.
1. The Petition is filed; EPA conducts various studies for reregistration
In September 2007, the Pesticide Action Network North America (PANNA) and the National Resources Defense Council (NRDC) filed a petition with EPA to revoke all tolerances for chlorpyrifos based on new studies purporting to show that current chlorpyrifos tolerances were not safe. See Petition to Revoke All Tolerances and Cancel All Registrations for the Pesticide Chlorpyrifos; Notice of Availability, 72 Fed. Reg. 58,845 (Oct, 17, 2007); see also Final Order, 84 Fed. Reg. at 35,556. Petitioners raised ten claims alleging numerous errors in the 2006 Reregistration Decision, including claims that EPA ignored or misinterpreted data.
In the interim, EPA convened scientific panels to evaluate the evidence and published reports. In 2008, as part of its reregistration review, EPA published a Science Issue Paper addressing chlorpyrifos hazards. EPA, Office of Pesticide Programs, Science Issue Paper: Chlorpyrifos Hazard and Dose Response Characterization (Aug. 21, 2008). The paper summarized "data relevant to infants, children, and pregnant women," interpreted this data, and suggested alternatives for updating the mechanism used to assess chlorpyrifos tolerance safety. Id. at 7. The paper "preliminarily concluded that chlorpyrifos likely played a role in" adverse health effects in children. Id. at 52. However, the paper specifically noted that there had not been "a full and complete risk assessment/characterization" of the human health risks of chlorpyrifos and that "the [EPA] has not developed any final conclusions regarding updates to the chlorpyrifos hazard assessment." Id. at 7.
Later that year, EPA convened a Science Advisory Panel (SAP or the Panel), a federal advisory committee "established under the provisions of FIFRA" that "serves as the [EPA's] primary scientific peer review mechanism" for pesticide matters, to peer review the paper. EPA, SAP Minutes No. 2008-04: A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: The Agency's Evaluation of the Toxicity Profile of Chlorpyrifos 2 (Sept. 16-18, 2008). The SAP also considered several new studies concerning the risk of chlorpyrifos to pregnant women and children. The SAP's evaluation noted that "Panel members were concerned that a high degree of uncertainty is evident in the available data...." Id. at 10. First, the Panel expressed concerns about several laboratory studies involving live rodents and the meaning of phrases used and experimental methods employed, and concluded that this data was "insufficient." Id. at 11-12. The Panel also considered three epidemiology studies, referred to as the Mt. Sinai, CHAMACOS, and Columbia University studies. The Columbia Study, which assessed chlorpyrifos risk to pregnant women, infants, and children, commanded particular attention. Id. at 12. The Panel found defects in all three of the studies, including concerns that the Columbia Study—the most robust of the three—did not provide sufficient data to be the sole factor for risk assessment or modifying tolerances and produced uncertainty through its measurement method. Id. at 12-13, 32-35, 43-44. Although the SAP found that the studies "raise concerns," the SAP also agreed that the studies were inconclusive. Id. at 13-14. The SAP concluded that "chlorpyrifos could have contributed to the birth and neurodevelopmental outcomes" indicated in the studies, but "that due to their limitations, the epidemiological data currently available are useful primarily for hazard identification." Id. at 13.
In 2011, EPA published a Preliminary Human Health Risk Assessment (PHHRA) for chlorpyrifos as part of its forthcoming FIFRA review. EPA, Office of Chemical Safety & Pollution Prevention, Chlorpyrifos: Preliminary Human Health
Id. at 42.
In April 2012, EPA again convened the SAP to consider the health effects of chlorpyrifos. EPA, SAP Minutes 2012-04: A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding Chlorpyrifos Health Effects (April 10-12, 2012). The SAP recognized "a growing body of literature with laboratory animals (rats and mice) indicating that gestational and/or early postnatal exposure to chlorpyrifos may cause persistent effects into adulthood" and epidemiology studies "that have reported associations with birth outcomes, childhood neurobehavioral and neurodevelopment outcomes." Id. at 10. In addition to nine new laboratory studies, the 2012 SAP reviewed the same laboratory studies evaluated by the 2008 SAP, again noting the laboratory studies' limitations and "recommend[ing] these experimental outcomes be regarded as exploratory, and hypothesis-generating, as opposed to being evidence of toxicity." Id. at 15. However, the Panel found that, despite concerns about the studies, "the collective weight of evidence from these studies demonstrate that it is probable that there are significant long-term adverse effects from chlorpyrifos exposure." Id. at 16. The 2012 SAP likewise considered the same epidemiology studies analyzed by the 2008 SAP, recognizing their strengths and limitations. Id. at 17-18, 48-50. The Panel noted that the epidemiological studies indicated "that chlorpyrifos likely plays a role in impacting the neurodevelopmental outcomes examined in the three cohort studies" but proposed further study because "the data generated from these studies alone are not adequate enough" to make a definitive risk assessment. Id. at 18-19. The SAP advised EPA to "explore additional ways of using these studies" and conduct additional research. Id. at 19-20.
In December 2014, EPA published a Revised Human Health Risk Assessment (2014 RHHRA) for chlorpyrifos. EPA, Office of Chemical Safety & Pollution Prevention, Chlorpyrifos: Revised Human Health Risk Assessment for Registration Review (Dec. 29, 2014). This revised assessment incorporated comments on the preliminary assessment and included assessment of new data. Id. at 5. The 2014 RHHRA found that data, including the laboratory and epidemiology studies, "indicate that chlorpyrifos likely played a role in the neurodevelopmental outcomes reported by the epidemiologic study (Columbia University) investigators" but that "uncertainties... preclude definitive causal inference." Id. at 6. Yet again, EPA noted that the studies reflected both strengths and "notable limitations." Id. at 43. In this assessment, EPA also revised its approach to calculating chlorpyrifos "points of departure," or the ceiling for safe exposure
In January 2015, EPA announced the availability of the 2014 RHHRA and sought public comments on "the Agency's risk assessment methodologies and assumptions... [and] suggestions for mitigating any risks identified in the [2014 RHHRA]." Chlorpyrifos Registration Review; Revised Human Health Risk Assessment; Notice of Availability, 80 Fed. Reg. 1,909, 1,910 (Jan. 14, 2015). Additionally, in March 2015, EPA advised counsel for the petitioners by letter that it intended to deny the three unresolved claims in the 2007 Petition—the claims at issue in this appeal. EPA, Office of Chemical Safety & Pollution Prevention, Re: Chlorpyrifos Petition Dated September 12, 2007; March 2015 Provisional Response (Mar. 26, 2015). EPA incorporated its prior partial petition responses from 2012 and 2014, which denied seven of the ten claims raised in the petition. Id. With respect to the three remaining claims, which were those related to infants and children and based on the Columbia, Mount Sinai, and CHAMACOS studies, EPA advised counsel that "EPA does not believe the claims raised in your petition establish a basis to revoke all chlorpyrifos tolerances and cancel all chlorpyrifos registrations." Id. at 3. The letter noted that EPA had "risk concerns" with exposure to chlorpyrifos in drinking water, but it was seeking comment on its 2014 RHHRA and would "take appropriate action under the FFDCA and/or FIFRA to ensure that exposures to chlorpyrifos are consistent with the requirements of those statutes." Id. at 3-4.
2. We issue mandamus; EPA proposes to revoke the tolerances
Six months later, in August 2015, we issued a writ of mandamus ordering EPA "to issue either a proposed or final revocation rule or a full and final response to the administrative petition." In re Pesticide Action Network North America (PANNA II), 798 F.3d 809, 815 (9th Cir. 2015). In response, EPA issued a proposed rule to revoke all chlorpyrifos tolerances because "EPA cannot, at this time, determine that aggregate exposure to residues of chlorpyrifos, including all anticipated dietary exposures and all other non-occupational exposures for which there is reliable information, are safe." Chlorpyrifos; Tolerance Revocations, 80 Fed. Reg. 69,080, 69,080-81 (Nov. 6, 2015) (2015 Proposed Rule). EPA advised that it was issuing the proposed rulemaking because of our mandamus order and that the proposal was "in advance of [EPA] completing its refined drinking water assessment." Id. at 69,083. EPA explained that it "believe[d] that acute dietary risk from food only does not present a significant risk" and that "EPA would therefore not be proposing the revocation of chlorpyrifos if dietary exposures were confined to food." Id. at 69,096-97. The basis for the proposed revocation was instead new data indicating that "for some portions of the country, food exposures, when aggregated with residential exposures and potentially more significant drinking water exposures, do present a significant risk concern and support revocation of all chlorpyrifos tolerances." Id. at 69,097. At the same time, EPA stated that it had "insufficient time to address comments received on the [2014] RHHRA," and it would "update this action ... as EPA completes additional work." Id. at 69,083. EPA also cautioned that its analysis was incomplete and that it might yet modify the proposed rule based on the completed analysis and comments. Id. We then ordered EPA to take final action on the proposed rule and on PANNA and NRDC's petition no later than December 30, 2016. In re Pesticide
In March 2016, EPA published a new Chlorpyrifos Issue Paper and solicited comment from the SAP regarding changing points of departure based solely on neurodevelopmental effects measured by the Columbia Study. EPA, Office of Pesticide Programs, Chlorpyrifos Issue Paper: Evaluation of Biomonitoring Data from Epidemiology Studies 9 (Mar. 11, 2016) (2016 Issue Paper). At the time EPA had proposed to revoke chlorpyrifos tolerances, "EPA had not completed a refined drinking water assessment or additional analysis of the hazard from chlorpyrifos that was suggested by several commenters." EPA, Office of Chemical Safety & Pollution Prevention, Chlorpyrifos: Revised Human Health Risk Assessment for Registration Review 3 (Nov. 3, 2016) (2016 RHHRA). After engaging in additional research, EPA—in this Issue Paper—proposed using different "toxicological points of departure" based on data from the Columbia Study, and sought the advice of the 2016 SAP on this new approach. 2016 Issue Paper at 9.
In April 2016, the SAP convened to review the Issue Paper. EPA, SAP Minutes No. 2016-01: A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Chlorpyrifos: Analysis of Biomonitoring Data (April 19-21, 2016) (2016 SAP Minutes). The SAP expressed significant disagreement with the substance of the paper, including a lack of confidence that the Columbia Study "c[ould] accurately be used" in determining new points of departure. Id. at 18. The panel "thought the quality of the [Columbia Study] data is hard to assess when raw analytical data have not been made available, and the study has not been reproduced." Id. The SAP noted that review of the raw data from the Columbia Study could resolve some uncertainty regarding the study's conclusions. Id. at 20.
By mid-2016, claiming "extraordinary circumstances," EPA requested a six month extension on our order of final action. In re Pesticide Action Network North America (PANNA IV), 840 F.3d 1014, 1015 (9th Cir. 2016). EPA advised us that it had "issued its proposed rule before completing two studies that may bear on the Agency's final rule." Id. at 1015. We characterized EPA's request as "another variation on a theme `of partial reports, missed deadlines, and vague promises of future action.'" Id. (quoting PANNA II, 798 F.3d at 811). We denied EPA's request and ordered final action by March 31, 2017. Id.
In November 2016, EPA released yet another Revised Human Health Risk Assessment, responding to the 2016 SAP's concerns. EPA, Office of Chemical Safety & Pollution Prevention, Chlorpyrifos: Revised Human Health Risk Assessment for Registration Review (Nov. 3, 2016) (2016 RHHRA). EPA recounted that in 2013 it had sought the raw data used in the Columbia Study, and although the researchers would not agree to provide EPA with the data, EPA "gained valuable insight into the conduct of the study." Id. at 9-10. EPA concluded that the SAP had rejected both the approach in the 2015 Proposed Rule and the new method based on the Columbia Study. Id. at 3. EPA agreed with the SAP that, despite uncertainties in the studies, there was "sufficient evidence that there are neurodevelopmental effects occurring at chlorpyrifos exposure levels" below the tolerances. Id. at 13. As a result, EPA proposed following the 2016 SAP's recommendation to use a hybrid point of departure, rather than relying solely on the data from the Columbia Study. Id. at 13-14.
Id. Importantly, EPA warned that its proposed course of conduct was not fixed:
Id.
3. EPA denies the petition; we issue mandamus
In April 2017, EPA reversed course, issuing a final response to the 2007 petition, which denied it in full. Chlorpyrifos; Order Denying PANNA and NRDC's Petition to Revoke Tolerances, 82 Fed. Reg. 16,581 (April 5, 2017) (2017 Denial). The order stated:
Id. at 16,583. EPA thus denied the petition without resolving all scientific uncertainty concerning the tolerances "[b]ecause the 9th Circuit's August 12, 2016 order has made clear, however, that further extensions to the March 31, 2017 deadline for responding to the Petition would not be granted." Id. (referring to PANNA IV, 840
Id. EPA concluded that "given the importance of this matter and the fact that critical questions remain regarding the significance of the data addressing neurodevelopmental effects, EPA believes there is good reason to extend the registration review of chlorpyrifos and therefore to deny the Petition." Id.
Various organizations petitioned our court for review of EPA's order. On review of EPA's 2017 Denial, the panel ordered EPA to revoke the chlorpyrifos tolerances. League of United Latin American Citizens v. Wheeler (LULAC I), 899 F.3d 814, 829 (9th Cir. 2018). Judge Fernandez dissented on the grounds that the 2017 Denial was not a final action. Id. at 830-32 (Fernandez, J., dissenting). We granted en banc review, vacated the panel opinion, and ordered EPA to issue a final order. League of United Latin American Citizens v. Wheeler (LULAC II), 922 F.3d 443, 445 (9th Cir. 2019) (en banc). EPA issued its Final Order in July 2019, and we referred the petition back to the three-judge panel. League of United Latin American Citizens v. Wheeler (LULAC III), 940 F.3d 1126, 1127 (9th Cir. 2019).
B
EPA's Final Order responded to the two objections raised in LULAC I: (1) that the "EPA has unlawfully left chlorpyrifos tolerances in place without making the safety finding required by the FFDCA"; and (2) that EPA must revoke the tolerances because it "has previously found that chlorpyrifos tolerances are unsafe and has not disavowed those findings." Final Order, 84 Fed. Reg. at 35,561.
1. Failure to find that chlorpyrifos is "safe"
EPA first addressed Petitioners' argument that EPA was required to make a new safety finding to deny the petition. EPA found that it was not required to make a new safety determination in response to every revocation petition, the FFDCA did not require revocation in the absence of a new safety determination for each petition, and even if a new safety determination was required, both the FFDCA and EPA implementing regulations "require petitioners seeking withdrawal of a tolerance to support this request with valid, complete and reliable data that set forth why the tolerances are unsafe." Id. at 35,562.
The agency found that petitioners had not met their burden of presenting evidence
EPA explained that a majority of the 2016 SAP had concluded that use of the scientific studies under review for developing points of departure "could not be justified by any sound scientific evaluation." Id. at 33,564. The SAP "expressed significant reservations" about using the studies as the sole source of revised points of departure and "noted the incompleteness of the information," including the "reproducibility" of the data. Id. EPA concluded that "[b]ased on the uncertainties identified by the 2016 SAP," the data were "not complete." Id. EPA further laid out its requests to obtain the raw data underlying the studies and "visit[] [to] Columbia University in an attempt to better understand their study results and what raw data exist." Id. at 33,565. Although the university initially had pledged to share its data, it failed to produce it, citing "privacy concerns." Id. As a result, "EPA cannot validate or confirm the data analysis performed, the degree to which the statistical methods employed were appropriate, or the extent to which (reasonable or minor) changes in assumptions may have changed any final results or conclusions." Id. As a consequence, EPA concluded petitioners had "failed to meet their initial burden of providing sufficiently valid, complete, and reliable evidence that neurodevelopmental effects may be occurring at levels below EPA's current regulatory standard." Id.
EPA further concluded that denying the 2007 petition was appropriate because the claims in the petition would be subject to FIFRA registration review, which is a "more up-to-date, thorough and methodical" review. Id. EPA reiterated its commitment to complete FIFRA and FFDCA review of chlorpyrifos tolerances in advance of the October 2022 deadline, anticipating some updates "by summer of 2020." Id. at 35,566.
2. EPA's prior finding that chlorpyrifos is "not safe"
EPA also addressed petitioners' objection that the agency had already found chlorpyrifos to be unsafe in its 2015 proposed tolerance revocation. Id. at 35,566. EPA, however, was quite clear that "EPA
C
EPA's decision to deny the petition in its entirety in response to our writ of mandamus is entirely reasonable. We ordered EPA to grant or deny the petitions; EPA did as we ordered. It has explained why it did so and explained how it will proceed with the chlorpyrifos reregistration, in which it will have to decide whether it is "safe." There is nothing arbitrary or capricious in EPA's decision.
Although petitioners can argue that the denial of the petition conflicts with EPA's prior proposal, the 2015 Proposed Rule is just that—a proposed rule. 2015 Proposed Rule, 80 Fed. Reg. at 69,083 ("EPA may update this [proposed rule] with new or modified analyses as EPA completes additional work after this proposal."). "Agencies are entitled to change their minds." Defenders of Wildlife v. Zinke, 856 F.3d 1248, 1262 (9th Cir. 2017) (citation omitted); see also Nat'l Ass'n of Home Builders v. Defenders of Wildlife, 551 U.S. 644, 658-59, 127 S.Ct. 2518, 168 L.Ed.2d 467 (2007) ("[T]he only `inconsistency' respondents can point to is the fact that the agencies changed their minds—something that, as long as the proper procedures were followed, they were fully entitled to do."). "The federal courts ordinarily are empowered to review only an agency's final action, see 5 U.S.C. § 704, and the fact that a preliminary determination ... is later overruled ... does not render the decisionmaking process arbitrary and capricious." Nat'l Ass'n of Home Builders, 551 U.S. at 659, 127 S.Ct. 2518. Agencies that change their mind are not "subjected to more searching review." FCC v. Fox Television Stations, Inc., 556 U.S. 502, 514, 129 S.Ct. 1800, 173 L.Ed.2d 738 (2009). What is important is that the agency "display awareness that it is changing position" and has explained itself. Id. at 515, 129 S.Ct. 1800. EPA did not act arbitrarily and capriciously merely because it reversed course from its 2015 Proposed Rule—a reversal that EPA explained.
Nor was the 2016 RHHRA a final agency action. Human Health Risk Assessments are part of FIFRA reregistration review but are not in themselves safety determinations. 2016 RHHRA at 3. It is the final Reregistration Eligibility Decision —which in this case was issued in 2006—that serves as the final EPA action for determining safety pursuant to the FFDCA. 2006 Reregistration Decision at 1-2. Although the 2016 RHHRA stated that the studies cited by the petition provided "sufficient evidence that there are neurodevelopmental effects occurring at chlorpyrifos exposure levels below" current tolerances, this conclusion is tentative until the agency adopts it as part of a final order or rule. 2016 RHHRA at 13. The 2016 RHHRA remains part of a broader review process that will culminate in another Registration Eligibility Decision no later than 2022. In the meantime, however, relying on its Scientific Advisory Panel,
As it is entitled to do, EPA has sufficiently explained its rationale for reversing course from the 2015 Proposed Rule and 2016 RHHRA and denying the petition. EPA was required to "examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made." Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983) (quotations marks and citation omitted). EPA did articulate an explanation for its departure from the 2015 Proposed Rule and the 2016 RHHRA in its 2017 Denial and Final Order. In its 2017 Denial of the petition, EPA explained that responses from the 2016 SAP and comments received in response to the 2015 Proposed Rule raised "considerable areas of uncertainty" regarding the studies. 2017 Denial, 82 Fed. Reg. at 16,590. Based on this uncertainty, EPA concluded that it should instead "explore approaches raised by the SAP and commenters on the proposed rule, and possibly seek additional authoritative peer review of EPA's risk assessment prior to finalizing any regulatory action in the course of registration review." Id.
EPA again explained the rationale for its departure from the 2016 RHHRA in its Final Order. EPA explicitly recognized its denial of the petition was "at odds with" the 2016 RHHRA, but it explained that it had "undertaken considerable efforts to assess the available chlorpyrifos data," summarizing its longstanding concerns about the studies relied on by petitioners. Final Order, 84 Fed. Reg. at 35,564. EPA discussed its decision to convene the SAP in 2016 to specifically consider the EPA's proposal to use information derived from the Columbia Study to develop a point of departure—a meeting EPA noted "was unique in focus compared to the previous meetings"—and the SAP's rejection of using that data alone as the basis for the new point of departure. Id. EPA explained that the 2016 SAP's feedback on the proposal based on the Columbia Study data was "consistent with concerns raised in public comments EPA received on the use of the epidemiology data throughout the course of registration review." Id. EPA further noted that, although the 2008 and 2012 SAPs recognized strengths in the Columbia Study, neither recommended changing points of departure based on the study, and the 2016 SAP expressed even more reservation about using the study in this way. Id. Thus, despite preliminary assessments that recognized potential in the Columbia Study data, EPA ultimately concluded that "the shortcomings of the data identified raise issues of validity, completeness and reliability under the FFDCA that direct against using the data for risk assessment at this time." Id. EPA also noted that this was not its final conclusion regarding the validity of the studies and that it "intends to continue its exploration of the uncertainty" with regards to the studies' conclusions. Id. Because these studies —which met the threshold requirements for consideration on the merits— were not sufficiently valid, complete, and reliable to support revocation, EPA decided not to modify or revoke the chlorpyrifos tolerances.
Nothing in EPA's explanations is arbitrary or capricious. It is clear that the agency has struggled with the scientific studies before it. But nothing in either the procedure or the substance of EPA's actions —aside from playing Hamlet—suggests that the agency has been irresponsible.
So how do we assess this convoluted history? It is certainly true that the agency had some stops and starts along the way, but that is evidence of deliberate decisionmaking, not dereliction of duty. We, of all institutions, should respect that there will be give-and-take in complicated matters of consequence. The FFDCA does not demand unanimity within EPA, any more than it requires unanimity from this court before we may issue a judgment in this case.
In my view, the majority has intervened in ongoing debates within EPA over what the evidence proves and how it should be weighed. It is not our place to second-guess EPA's scientific assessment of laboratory and epidemiological studies supporting the petition. "Deference to an agency's technical expertise and experience is particularly warranted with respect to questions involving ... scientific matters." United States v. Alpine Land & Reservoir Co., 887 F.2d 207, 213 (9th Cir. 1989). When an agency makes determinations "within its area of special expertise, at the frontiers of science ... a reviewing court must generally be at its most deferential." Balt. Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103 S.Ct. 2246, 76 L.Ed.2d 437 (1983). The majority improperly makes its own assessment of the reliability of the studies and whether EPA's concerns are sufficient to determine that chlorpyrifos tolerances are "not safe." Maj. Op. 697-700, 700-02. But EPA's assessment of the scientific strength of the studies supporting the petition is precisely the type of analysis that should be given deference. FFDCA safety determinations are within EPA's area of expertise. We should not second-guess EPA's scientific conclusions with regards to the value of these studies. EPA's denial of the 2007 petition was neither arbitrary nor capricious.
* * *
The FFDCA does not require EPA to engage in a full-blown FFDCA safety evaluation in response to every petition filed with the agency. Instead, where a petition presents reasonable grounds for revocation, EPA must consider whether the petition puts forth data that supports a determination that a pesticide tolerance is not safe. Where the data supporting a petition are not sufficiently valid, reliable, or complete, EPA may deny the petition and rest on its operative safety determination. Here, EPA complied with its statutory obligation: the agency considered the petition on the merits and determined that the data supporting the petition was insufficient to support revocation. Based on this determination, EPA denied the petition
III
Even if I thought the majority had read the statute correctly and had a clear-eyed view of the validity and weight to be given to the scientific evidence, the remedy ordered by the majority is an abuse of our discretion. Assuming that petitioners have demonstrated that chlorpyrifos is "not safe," the FFDCA gives EPA the discretion to decide whether to modify or to revoke the tolerance. See 21 U.S.C. § 346a(b)(2)(A)(i); Maj. Op. at 700 ("[O]nce the EPA has determined that a tolerance is not safe, ... it must modify or revoke the tolerance."). Concluding that on this record "the present tolerances are not safe," Maj. Op. at 701, the majority orders EPA to "modify or revoke chlorpyrifos tolerances and modify or cancel chlorpyrifos registrations,"
The 60 days the majority gives EPA is not a number drawn from the statutes, but one made up by the majority, and it may well foreordain the option EPA must choose. In my view, the stakes in this case are too high for the majority to take upon itself to decide what the United States will do with respect to chlorpyrifos. "By pounds of active ingredient, [chlorpyrifos] is the most widely used conventional insecticide in the country" and for some crops it is "currently the only cost-effective choice for control of certain insect pests." Final Order, 84 Fed. Reg. at 35,558.
Id. It further advised that it had convened a SAP in September 2020 "to assess new approval methodologies that might used to evaluate developmental neurotoxicity in EPA's assessment of risks to human health." Id.; see also id. at 40, 63. The SAP's report was issued a week later in December 2020. EPA, FIFRA Scientific Advisory Panel Meeting Minutes and Final Report No. 2020-02: Peer Review of the Use of New Approach Methodologies (NAMs) to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment (Sept. 15-18, 2020) (report released Dec. 15, 2020). For the reasons I have explained, in this latest proceeding, the risk of nonpersuasion runs against the existing tolerances. That means that EPA will have to decide the issues reserved in its interim proceedings—and, specifically, the question of safe tolerances for children and youth—and it must do so by 2022, the deadline set by Congress.
What effect the majority's order will have on EPA's latest proceeding is unclear, but the majority's order presents it with two unsatisfactory choices: either issue modified tolerances outside the procedure required by the FFDCA, FIFRA, and APA, or revoke the tolerances. Given the 2020 Proposed Interim Registration Decision, maybe EPA will be comfortable issuing modified tolerances, but in order to do so it will have to accelerate its schedule, and that may mean skipping some steps. See 2020 Proposed Interim Registration Decision at 4, 8-9 (explaining that EPA is awaiting revised biological opinions from the National Marine Fisheries Service and the U.S. Fish & Wildlife Service). Alternatively, EPA may be forced to revoke tolerances that it has tentatively concluded it will reregister or reregister with modifications. Perhaps EPA will again approve registration of chlorpyrifos at some future date once it completes full FIFRA and FFDCA review, but our precipitous order
Finally, I have to comment on the artificial schedule that our court has imposed on EPA, not only in this case, but time and again in these proceedings. EPA took the 2007 petition to revoke chlorpyrifos very seriously. Unlike reregistration under FIFRA, there is no statutory deadline for dealing with a petition, although in principle twelve years seems like more than enough time. The extraordinary delay, however, makes more sense in context: EPA initially believed that it could accelerate the FIFRA reregistration due in 2022 and address both the petition and the reregistration at the same time and well before that date. In the meantime, the petitioners asked us to intervene and order EPA to rule on its petition. EPA repeatedly advised us that it could not meet those demands if it was to complete the reregistration process properly. We insisted. Eventually, but reluctantly, EPA proposed to revoke the tolerances—even as it stated that it was doing so without complete information. See, e.g., 2016 Request for Comments, 81 Fed. Reg. at 81,050; 2015 Proposed Rule, 80 Fed. Reg. at 69,080. After further proceedings, EPA concluded that it was better to deny the petitions outright because the petitioners had failed to show that the tolerances were not safe, and then complete the FIFRA reregistration process, where it would have a full record. EPA's decision is consistent with the FFDCA, as amended by the FQPA. Although in hindsight the process took much longer than EPA anticipated, that was a reasonable decision on EPA's part at the time.
When we intervene in scientific inquiries with impatience and impose artificial deadlines, we bear some responsibility for the confusion that results. In San Luis & Delta-Mendota Water Authority v. Jewell, 747 F.3d 581 (9th Cir. 2014), the district court ordered the U.S. Fish & Wildlife Service to produce a complex, 400-page biological opinion in less than a year. The resulting biological opinion was
Id. at 605; see also id. at 605 n.15 (noting that "the FWS had less time to produce its opinion than either the district court or we will have had to review it"). We "wonder[ed] whether anyone was ultimately well-served by the imposition of tight deadlines in a matter of such consequence." Id. at 606. When we interject ourselves into technical proceedings, our "[d]eadlines become a substantive constraint on what an agency can reasonably do.... Such scientific tasks may not be as well suited to deadlines as producing written copy; the final product will necessarily reflect the time allotted to the agency." Id. We can only hope that "[f]uture analyses [will] be given the time and attention that these serious issues deserve." Id.
In any event, our order is an abuse of any discretion the APA confers on us. We have the power to "compel agency action... unreasonably delayed," 5 U.S.C. § 706(1), but we do not have the power to choose among the options available to EPA. Our deadline may effectively make the choice for EPA.
IV
There are manifest errors in the majority opinion. It has misread the FFDCA and
FootNotes
EPA, Revised Human Health Risk Assessment on Chlorpyrifos, available at https://www.epa.gov/ingredients-used-pesticide-products/revised-human-health-risk-assessment-chlorpyrifos (last accessed Apr. 17, 2021).
Although some of the statutes I will cite here refer to exemptions, EPA did not consider exemption of chlorpyrifos in this proceeding.
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