LEAGUE OF UNITED LATIN AMERICAN CITIZENS; PESTICIDE ACTION NETWORK NORTH AMERICA; NATURAL RESOURCES DEFENSE COUNCIL; CALIFORNIA RURAL LEGAL ASSISTANCE FOUNDATION; FARMWORKERS ASSOCIATION OF FLORIDA; FARMWORKER JUSTICE; LABOR COUNCIL FOR LATIN AMERICAN ADVANCEMENT; LEARNING DISABILITIES ASSOCIATION OF AMERICA; NATIONAL HISPANIC MEDICAL ASSOCIATION; PINEROS Y CAMPESINOS UNIDOS DEL NOROESTE; UNITED FARM WORKERS; GREENLATINOS, Petitioners, v. MICHAEL S. REGAN, Administrator, United States Environmental Protection Agency; U.S. ENVIRONMENTAL PROTECTION AGENCY, Respondents.
No. 19-71979
United States Court of Appeals for the Ninth Circuit
EPA No. EPA-HQ-OPP-2007-1005
STATE OF NEW YORK; STATE OF CALIFORNIA; STATE OF WASHINGTON; STATE OF MARYLAND; STATE OF VERMONT; COMMONWEALTH OF MASSACHUSETTS, Petitioners, DISTRICT OF COLUMBIA; STATE OF HAWAII; STATE OF OREGON, Intervenors, v. MICHAEL S. REGAN, Administrator, United States Environmental Protection Agency; U.S. ENVIRONMENTAL PROTECTION AGENCY, Respondents.
No. 19-71982
United States Court of Appeals for the Ninth Circuit
Filed April 29, 2021
EPA No. EPA-HQ-OPP-2007-1005; Argued and Submitted July 28, 2020 San Francisco, California
On Petition for Review of an Order of the Environmental Protection Agency
Before: Jay S. Bybee and Jacqueline H. Nguyen, Circuit Judges,
Opinion by Judge Rakoff; Dissent by Judge Bybee
SUMMARY**
Environmental Protection Agency
The panel granted petitions for review, vacated the Environmental Protection Agency (“EPA“)‘s 2017 Order and 2019 Order, and remanded with instructions to the EPA in cases challenging the EPA‘s regulation of the pesticide chlorpyrifos.
The EPA has recognized that when pregnant mothers are exposed to chlorpyrifos residue, this likely harms infants in utero. This proceeding began in 2007, when two environmental non-profit organizations filed a petition asking the EPA to prohibit foods that contain residue of the insecticide chlorpyrifos. The EPA declined to take final action on the 2007 Petition for more than a decade. This Court issued multiple writs of mandamus requiring the EPA to move forward. In 2017, the EPA denied the 2007 Petition, and in 2019 denied all objections to that decision.
The panel held that the EPA had abdicated its statutory duty under the Federal Food, Drug and Cosmetic Act (“FFDCA“). The panel held that the EPA spent more than a decade assembling a record of chlorpyrifos‘s ill effects and repeatedly determined, based on that record, that it could not conclude, to the statutorily required standard of reasonable certainty, that the present tolerances caused no harm. Rather than ban the pesticide or reduce the tolerances to levels that the EPA could find were reasonably certain to cause no harm, the EPA sought to evade through delay tactics its plain statutory duty. Because the FFDCA permitted no further delays, the panel ordered the EPA within 60 days after issuance of the mandate either to modify chlorpyrifos‘s tolerances and concomitantly publish a finding that the modified tolerances are safe, including for infants and children – or to revoke all chlorpyrifos tolerances. The panel also ordered the EPA to correspondingly modify or cancel related Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA“) regulations for food use in a timely fashion consistent with the requirements of
Specifically, the panel first considered whether the EPA lawfully denied the 2007 Petition. The panel rejected the EPA‘s argument that it could leave in effect tolerances, without a new safety finding, when the EPA concluded the petition contained insufficient evidence for the EPA to undertake proceedings to revoke or modify tolerances. The panel held, first, once the EPA became aware, through a petition or otherwise, of genuine questions about the safety of an existing tolerance, the EPA had its own continuing duty under the FFDCA to determine whether a tolerance that was once thought to be safe still is. Here, the EPA‘s own studies and pronouncements still in effect showed that it regarded chlorpyrifos as harmful at levels below the existing tolerances. Second, 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. The panel held that when the EPA publishes a petition seeking revocation of a tolerance and later takes final action denying that petition, the EPA leaves that tolerance in effect. The EPA can only do so if it finds the tolerance to be safe for the general population and for infants and children. The EPA failed to make such findings, directly contrary to the FFDCA.
The panel held that even if the FFDCA did not require a safety finding here, the EPA‘s denial of the 2007 Petition was arbitrary and capricious. The panel rejected the EPA‘s four objections to the data.
The panel held that its remand with specific instructions did not raise due process concerns. On this record, immediate issuance of a final regulation was the only reasonable action, and the panel ordered the EPA to do so. The panel clarified that this was not an open-ended remand, or a remand for further factfinding.
Dissenting, Judge Bybee wrote that the majority opinion erred by misreading the FFDCA, and misallocating the risk of nonpersuasion; overruling the EPA‘s judgment on the validity and weight to be given technical evidence within the EPA‘s expertise; and, by its decision to give the EPA 60 days to issue a final decision, likely predetermining EPA‘s option.
COUNSEL
Patti A. Goldman (argued), Marisa C. Ordonia, and Kristen L. Boyles, Earthjustice, Seattle, Washington, for Petitioners League of United Latin American Citizens, Pesticide Action Network North America, Natural Resources Defense Council, California Rural Legal Assistance Foundation, Farmworkers Association of Florida, Farmworker Justice, Labor Council for Latin American Advancement, Learning Disabilities Association of America, National Hispanic Medical Association, Pineros y Campesinos Unidos del Noroeste, United Farm Workers, and GreenLatinos.
Frederick A. Brodie (argued), Assistant Solicitor General Of Counsel; Andrea Oser, Deputy Solicitor General; Barbara D. Underwood, Solicitor General; Letitia James,
Mark L. Walters (argued) and Jessica O‘Donnell, Environmental Defense Section, United States Department of Justice, Washington, D.C.; Angela Huskey, Office of General Counsel, United States Environmental Protection Agency, Washington, D.C.; for Respondents.
Shaun A. Goho, Emmett Environmental Law & Policy Clinic, Harvard Law School, Cambridge, Massachusetts, for Amici Curiae American Academy of Pediatrics, Alliance of Nurses for Healthy Environments, American Public Health Association, Migrant Clinicians Network, Physicians for Social Responsibility, and Union of Concerned Scientists.
Edward Lloyd, Jacob Elkin, Claire MacLachlan, and Basil Oswald, Columbia Environmental Clinic, Morningside Heights Legal Services, New York, New York, for Amicus Curiae Congressman Henry Waxman.
Kathryn E. Szmuszkovicz and Andrew C. Stilton, Beveridge & Diamond P.C., Washington, D.C.; Rachel Lattimore, Senior Vice President & General Counsel; Ashley Boles, Counsel; CropLife America, Washington, D.C.; for Amicus Curiae CropLife America.
David Y. Chung, Kirsten L. Nathanson, and Elizabeth B. Dawson, Crowell & Moring LLP, Washington, D.C., for Amici Curiae Agribusiness Council of Indiana, Agricultural Retailers Association, American Farm Bureau Federation, AmericanHort, American Seed Trade Association, American Soybean Association, American Sugarbeet Growers Association, Beet Sugar Development Foundation, California Alfalfa and Forage Association, California Citrus Mutual, California Cotton Ginners and Growers Association, California Seed Association, California Specialty Crops Council, California Walnut Commission, Florida Fruit and Vegetable Association, National Agricultural Aviation Association, National Association of Wheat Growers, National Corn Growers Association, National Cotton Council, National Onion Association, National Sorghum Producers, North Dakota Grain Growers Association, Oregonians for Food and Shelter, Washington Friends of Farms & Forests, Western Agricultural
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.”1 The statute also requires that the EPA “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 “publish a specific determination regarding the safety of the pesticide chemical residue for infants and children.”2
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
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.4 Congress empowered the EPA to make exceptions to that rule by promulgating “tolerances” for a pesticide – i.e., threshold levels of pesticide residue that the EPA is reasonably certain will cause no harm.5 If the EPA promulgates a tolerance for a pesticide, then food may contain residue of that pesticide in an amount not exceeding the applicable tolerance.6
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.”10 If a tolerance is not safe – in other words, if the EPA cannot determine that there is a reasonable certainty of no harm across all sources of exposure for infants, children, and adults – then the EPA no longer has discretion. Rather, the
law commands that the EPA “shall modify or revoke [the] tolerance.”11
The FFDCA authorizes “[a]ny person [to] file . . . a petition proposing the issuance of a regulation establishing, modifying, or revoking a tolerance.”12 The EPA, by regulation, may dictate what a petition seeking revocation of a tolerance must contain.13 Pursuant to that authority, the EPA requires that a petition state “reasonable grounds for the action sought,” including “an assertion of facts.”14 If the EPA determines that a petition has met the threshold requirements, then it must publish the petition within 30 days.15 “[A]fter giving due consideration to a petition . . . and any other information available to the Administrator,” the EPA “shall” do one of three things: “issue a final regulation (which may vary from that sought by the petition) establishing, modifying, or revoking a tolerance . . . (which final regulation shall be issued without further notice and without further period for public comment),” “issue a proposed regulation . . . and thereafter issue a final regulation,” or “issue an order denying the petition.”16 If the EPA denies a petition, “any person may file objections
thereto with the Administrator.”17 The Administrator “shall issue an order stating the action taken upon each . . . objection” “[a]s soon as practicable.”18 Those affected may seek “judicial review . . . in the United States Court of Appeals.”19
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.”24 Nevertheless, in 2019, California (and the European Union) announced they would ban the sale of chlorpyrifos.25
Chlorpyrifos disrupts the functioning of acetylcholinesterase (“AChE“), a crucial enzyme that breaks down the neurotransmitter acetylcholine.26 In setting
chlorpyrifos tolerances, the EPA must determine the greatest exposure amount that poses no risk of harm, which is known as a “point of departure.” Since enactment of the FQPA, the EPA has tied the chlorpyrifos point of departure directly to acute AChE inhibition, finding that exposure to chlorpyrifos residue on food would be unsafe if aggregate exposure across all sources caused more than 10% acute AChE inhibition.
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.27 The 2007 Petition was partly
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.28
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.29 In 2002, the
EPA announced certain risk mitigation measures, especially for people exposed to chlorpyrifos through their work.30
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.”31 The EPA reiterated its safety finding in July 2006, stating that chlorpyrifos tolerances “meet the safety standard under Section 408(b)(2) of the FFDCA.”32
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.”33 They cited “[m]any studies published since 2001 [that] report that fetal exposure to chlorpyrifos is more damaging than adult exposure.”34
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:
- at age three, lower performance in motor and mental development tests and higher incidences of attention-deficit hyperactivity disorder and autism spectrum disorder;
- at age seven, changes in brain morphology and lower IQ scores; and
- at age eleven, a greater likelihood of mild or moderate tremors.
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.35
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.”39 The SAP “agreed with [the EPA‘s] conclusion that chlorpyrifos likely played a role in the birth and neurodevelopmental outcomes noted in the three [Human Cohort Studies].”40
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.”41 Nevertheless, the 2008 SAP found that the Human Cohort Studies had “utility for risk characterization, but not as the principal basis for establishing the point of departure.”42
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,47 PANNA and NRDC petitioned this Court for a writ of mandamus.
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.”48 The 2012 SAP paid particular attention to the Human Cohort Studies and identified “nine strengths” of them, including, among others, the longitudinal design, the use of biomarkers of exposure (rather than only self-reported exposure), and “the relative consistency of findings in different populations while using similar standardized exposure and outcome measures.”49 The 2012 SAP also identified some shortcomings of the Human Cohort Studies, such as a relatively small sample size and uncertainty regarding whether harms could be attributed to chlorpyrifos alone. Overall, though, it found that “[t]he strengths of the three studies support the Panel‘s conclusion.”50
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.”51 It noted that the
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.”53 In light of that representation, this Court, in July 2013, denied PANNA and NRDC‘s petition for a writ of mandamus.
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.54
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.55 The EPA had offered an “ambiguous plan to possibly issue a proposed rule nearly nine years after receiving the administrative petition,” and the Court found this to be “too little, too late.”56 The Court found the EPA‘s delay “egregious” and ordered the EPA “to issue a full and final response to the petition no later than October 31, 2015.”57
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.”58 It wrote: “The agency is proposing to revoke all of these tolerances because [the] EPA cannot, at this time, determine that aggregate exposure to residues of chlorpyrifos, including all anticipated dietary exposures and all other non-occupational
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.”61 It also relied upon the three Human Cohort Studies:
[The] EPA has considered the strengths and limitations of these studies, and believes that random or systematic errors in the design, conduct or analysis of these studies were unlikely to fully explain observed positive associations between in utero [organophosphate] exposure and adverse neurodevelopmental effects observed at birth and through childhood (age 7 years). [The] EPA believes these are strong studies which support a conclusion that [organophosphates] likely played a role in these outcomes.62
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.”63
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.”64 In other words, this Court, despite the EPA‘s repeated disregard of this Court‘s orders, most leniently gave the EPA yet another year to rule on the 2007 Petition.
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.”65
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.”66
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 . . . .”68 And the SAP offered some guidance on how to proceed. “Multiple panel members noted that [physiologically based pharmacokinetic (“PBPK“)] modeling is a valuable tool,”69 and the SAP recommended that the EPA “consider determination and characterization of time-weighted average blood concentrations for different exposure scenarios,”70 rather than measurements based upon umbilical cord blood concentrations at a single point in time.
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.71 The Court did, however, grant the EPA a three-month extension, to March 31, 2017. The Court acknowledged that “evidence may be imperfect . . . [,] the feasibility inquiry is formidable, and . . . premature rulemaking is undesirable,” but the Court found that “at this stage, a claim of premature rulemaking has come and gone.”72 The Court warned that this was “the final extension” and that the Court would “not grant any further extensions.”73
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.”74 The EPA “acknowledge[d] the lack of [an] established” mechanism of action that would explain the neurotoxic effects and also recognized “the inability to make strong causal linkages, and the unknown window(s) of susceptibility.”75 The EPA concluded, nevertheless, that “[t]hese uncertainties do not undermine or reduce the confidence in the findings of the epidemiology studies. The epidemiology studies . . . represent different investigators, locations, points in time, exposure assessment procedures, and outcome measurements.”76 “In summary,” the EPA concluded that “the [Columbia Study], with supporting results from the other [two Human Cohort Studies] and the seven additional epidemiological studies reviewed
The EPA acknowledged that “the 2016 SAP did not support using the [Columbia Study] cord blood” to derive a new point of departure.79 Responsive to those comments, the EPA adopted a different approach.80 It accepted the 2016 SAP‘s statement that the “EPA should use estimated peak blood concentrations or [time-weighted average] blood concentrations within the prenatal period” rather than umbilical cord blood concentrations at the time of delivery.81 Also, consistent with the 2016 SAP‘s comments, the EPA estimated blood concentrations using a PBPK model devised by a chlorpyrifos registrant.82
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.83 For example, the EPA found that expected food exposure for children 1–2 years of age was 14,000% of the threshold level of risk concern.84
The EPA announced the findings of the 2016 Revised Human Health Risk Assessment through a Notice of Data Availability published in the Federal Register,85 and it reopened the comment period on its 2015 Notice of Proposed Rulemaking. In the Notice of Data Availability, the EPA reiterated that the present tolerances are “not sufficiently health protective.”86 The Agency explained that its
revised analyses do not result in a change to the EPA‘s proposal to revoke all tolerances but it does modify the methods and risk assessment used to support that finding in accordance with the advice of the SAP. The revised analysis indicates that expected residues of chlorpyrifos on most individual food crops exceed the ‘reasonable certainty of no harm’ safety standard under the [FFDCA].
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.”89 Therefore, the EPA concluded that “further evaluation of the science during the remaining time for completion of [FIFRA] registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos.”90
The EPA further explained that it was denying the 2007 Petition only because this Court had ordered it to make a decision, but that
[the] EPA has . . . concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution . . . . Because the [Ninth] 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, [the] EPA is today also denying all remaining petition claims.
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.”91
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,”
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.”92 The panel held that, under these circumstances, the Court had jurisdiction and that, on the merits, “the EPA bears a continuing obligation to revoke tolerances that it can no longer find with a ‘reasonable certainty’ are safe,” and because the Agency could not make such a finding, the tolerance must be revoked.93 The panel vacated the 2017 Order and remanded to the EPA with instructions to revoke all chlorpyrifos tolerances within 60 days after issuance of the mandate.94
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.95 In July 2019, the EPA issued a final order (the “2019 Order“) denying petitioners’ objections and thereby completing the administrative denial of the 2007 Petition. The 2019 Order again relied upon the need for greater scientific certainty, but went further and held that “the objections and the underlying Petition are not supported by valid, complete, and reliable evidence sufficient to meet the Petitioners’ burden under the FFDCA, as set forth in [the] EPA‘s implementing regulations.”96
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.”97
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,”98 and to “compel agency action unlawfully withheld or unreasonably delayed.”99 Agency action is arbitrary and capricious where the agency has “offered an explanation for its decision that runs counter to
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.”101 The statute also specifically requires that the EPA “ensure that there is a reasonable certainty that no harm will result from infants and children from aggregate exposure to the pesticide chemical residue” and “publish a specific determination regarding the safety of the pesticide chemical residue for infants and children.”102
Courts “normally interpret[] a statute in accord with the ordinary public meaning of its terms at the time of its
enactment.103 Furthermore, the
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
The
It should be noted in this respect that, because of the
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
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
The 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.116
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
In establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the Administrator shall assess the risk of the pesticide chemical residue . . . and 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.117
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
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
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
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
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.‘”128 The EPA has not done so because none of the reasons proffered in the 2017 and 2019 Orders provides “a satisfactory explanation for” denying the 2007 Petition.
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.”129 In other words, more delay. Furthermore, while the EPA recognized that the 2007 Petition was filed under the
But the
As already noted, the
The reference in the denial to the
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
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.”137 Therefore, under any reasonable construction, the 2007 Petition met the low bar of stating “reasonable grounds” for revocation with an “assertion of facts” in support. Also, as noted above, the time for finding that the petition did not meet the burden of production was in 2007, before the EPA published the petition in the Federal Register.
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.138
First, the EPA objects, in general, that “the science on this question is not resolved and would benefit from additional inquiry.”139 It will always be possible to conduct additional studies or to reach a greater degree of certainty, but a generalized concern that the science is not resolved is not a rationale sufficient to support denying a revocation petition. The
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.142
Third, the EPA argues that the studies of rats and mice applied a “dosing regimen . . . that differs from internationally accepted protocols.”143 The EPA says:
[T]he in vivo laboratory animal studies generally use fewer days of dosing that are aimed at specific periods of rodent fetal or early post-natal development compared to internationally adopted guideline studies which are intended to cover both pre- and post-gestational periods. The degree to which these shorter dosing periods coincide with comparable windows of susceptibility in human brain development is unclear.144
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.145) The EPA has changed its position over time regarding the value of this data. It initially requested the data, but after meeting with the Columbia researchers in 2014, the EPA abandoned its request for this data.146 Later, when the EPA sought to develop a point of departure based upon the umbilical cord blood measurements in the Columbia Study, it sought the data again. However, the 2016 SAP took issue with an approach based upon those cord blood measurements, so, as explained above, the EPA moved to a time-weighted average approach based upon a registrant‘s PBPK model. As a result, the EPA once again determined that it did not need the Columbia data, explaining that its new approach “does not directly rely on quantitative measures of chlorpyrifos in cord blood obtained from [Columbia], and thus, the lack of access to the raw data from [Columbia] is less of an uncertainty.”147 The EPA has now reversed position yet again, reiterating its desire for the data.
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
II. Remedy
The Court concludes that the EPA lacked power to deny the 2007 Petition without making the safety findings required by the
The 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.152
The second sentence is more than a mere gloss on the first because the command inherent in the second sentence is important.153 To be sure, the “only if” clause in the first sentence, standing alone, limits what the EPA may do when it determines that a tolerance is unsafe: it may not leave it in effect. But what are the EPA‘s options? May it order additional study? Convene another SAP? Wait for fifteen years to see if further evidence appears? No. The second sentence makes clear that, once the EPA has determined that a tolerance is not safe, it has no discretion to temporize pending additional research; it must modify or revoke the tolerance. For these reasons, if the EPA has determined that the present chlorpyrifos tolerances are not safe - or if that is the only conclusion the EPA could reasonably draw on this record - then the EPA has unlawfully withheld the relief that petitioners request.
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
- 2012 SAP: “[E]vidence suggest[s] 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 dose-response modeling and
derivation of a point of departure for assessment of the neurodevelopmental risks of chlorpyrifos.155
- 2014 Revised Human Health Risk Assessment: “[C]hlorpyrifos likely played a role in the neurodevelopmental outcomes observed in these epidemiology studies.”156 Moreover, “it is unlikely mothers enrolled in the [Human Cohort Studies] experienced [red blood cell] AChE inhibition.”157
- 2015 Notice of Proposed Rulemaking: “[The] 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.”158
- 2016 SAP: “[B]oth 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.”159
- 2016 Revised Human Health Risk Assessment: The Columbia Study, “with supporting results from the other [Human Cohort Studies] and the seven additional epidemiological studies reviewed in 2015, provides sufficient evidence that there are neurodevelopmental effects occurring at chlorpyrifos exposure levels below that required for AChE inhibition.”160
- 2016 Notice of Data Availability: “[E]xpected residues of chlorpyrifos on most individual food crops exceed the ‘reasonable certainty of no harm’ safety standard under the
[FFDCA] . . . . [The] EPA has not identified a set of currently registered uses that meets the FFDCA safety standard . . . .161
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”162 and “except in
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).”164 On this record, immediate issuance of a final regulation is the only reasonable action, and the Court orders the EPA to do so.
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.”165 To be clear, the EPA may only choose to modify chlorpyrifos tolerances, rather than to revoke them, if at the same time it publishes such a safety determination.166 On this record, it may well be that the EPA cannot make such a determination. In 2016, the EPA explained that it “ha[d] not identified a set of currently registered uses that meets the FFDCA safety standard,”167 a finding consistent with more than a decade of EPA
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.168
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[],”169 it agrees that the “EPA dithered far too long.”170 The EPA has had nearly 14 years to publish a legally sufficient response to the 2007 Petition. During that time, the EPA‘s egregious delay exposed a generation of American children to unsafe levels of chlorpyrifos. By remanding back to the EPA one last time, rather than compelling the immediate revocation of all chlorpyrifos tolerances, the Court is itself being more than tolerant. But the EPA‘s time is now up.
CONCLUSION
We GRANT the petitions for review. The 2017 Order and the 2019 Order are vacated, and the matter is remanded to the EPA, with instructions to (1) grant the 2007 Petition; (2) issue a final regulation within 60 days following issuance of the mandate that either (a) revokes all chlorpyrifos tolerances or (b) modifies chlorpyrifos tolerances and simultaneously certifies that, with the tolerances so modified, the EPA “has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information,”171 including for “infants and children“;172
VACATED AND REMANDED, WITH INSTRUCTIONS.
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),
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 41-46. 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.”
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 (1978). Nor do we get to “second-guess[] the [agency‘s] weighing of risks and benefits.” Dep‘t of Com. v. New York, 139 S. Ct. 2551, 2571 (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 (1983). I respectfully dissent.
I
For starters, I fundamentally disagree with the majority over its construction of the FFDCA. The majority reads
A
Let‘s start with some background. EPA regulates pesticides pursuant to two statutes: the Federal Food, Drug, and Cosmetic Act (FFDCA),
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.
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.”
The general standards for establishing, leaving in effect, modifying, or revoking tolerances are found in
The 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.
These sentences are awkwardly written. For readability we can transpose them as follows:
Only if the Administrator determines that a tolerance for a pesticide chemical residue in or on a food is safe may the Administrator establish or leave in effect the tolerance.3 If the Administrator determines a tolerance is not safe, the Administrator shall modify or revoke the tolerance.
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,4 the FFDCA requires EPA to consider “the validity, completeness, and reliability of the available data from studies of the pesticide” as well as other available information concerning risks and effects.
B
Now to the majority‘s errors. The majority reads
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 (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.
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
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 nonpersuasion means that EPA may, but does not have to, modify or revoke the tolerance.
Confronted by such conflict a reasonable person investigates matters further; he receives assurances or clarification before relying. A reasonable person does not gamble with the law of the excluded middle, he suspends judgment until further evidence is obtained. Explicit conflict engenders doubt, and to rely on a statement the veracity of which one should doubt is unreasonable. The law does not supply epistemological insurance. Nor does it countenance reliance on one of a pair of contradictories simply because it facilitates the achievement of one‘s goal.
Trifiro v. Nw. York Life Ins. Co., 845 F.2d 30, 33-34 (1st Cir. 1988).
The majority‘s either/or treatment of
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.
EPA were required to truncate its ongoing registration review process to make a new FFDCA safety finding every time it received a petition to modify or revoke tolerances, petitioners would effectively have the authority to re-order the Administrator‘s scheduling of registration review decisions under FIFRA and dictate
the extent of inquiry EPA may put to a matter before reaching a resolution.
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
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.
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 47. 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.”
Any person may file with the Administrator a petition proposing the issuance of a regulation modifying or revoking a tolerance or exemption from a tolerance for a pesticide chemical residue. The petition shall furnish reasonable grounds for the action sought. Reasonable grounds shall include . . . an assertion of facts (supported by data if available) showing that new uses for the pesticide chemical have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the application of
the tolerance or exemption from tolerance may justify its modification or revocation.
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.”
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
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.
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
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
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.8 EPA was able to resolve seven of the ten claims relatively quickly. In July 2012 and July 2014, EPA issued interim responses indicating its intent to deny all but the three claims at issue here (grounds 7–9 in the petition), and it informed Petitioners of its intent to finalize all interim conclusions (grounds 1–6, and 10) when it resolved the remaining three claims, a decision to which Petitioners did not object. Final Order, 84 Fed. Reg. at 35,556; see also In re Pesticide Action Network North America (PANNA I), 532 F. App‘x 649 (9th Cir. 2013) (denying petition for mandamus). The three claims not addressed by EPA in those responses were interrelated and concerned the potential for chlorpyrifos exposure at current tolerance levels to cause neurodevelopmental effects in children. Final Order, 84 Fed. Reg. at 35,556. However, EPA did not give these claims short shrift. Instead, early in its review, in 2009, the agency found the issues raised important
expedited reregistration review). Despite its 2022 statutory deadline, EPA announced that it planned to prioritize review of chlorpyrifos and complete reevaluation by 2015, years ahead of schedule. Id. at 35,558. However, this review proved to be complex, particularly with regard to the potential human health risks and neurodevelopmental effects of chlorpyrifos tolerances. Id.
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
be based on a full scientific weight of evidence approach that considers the best available science and integrates all key lines of evidence, from empirical animal toxicology to observational human epidemiology studies, in an integrated framework analysis and will transparently address and clearly characterize the strength of the evidence and areas of remaining uncertainty and variability.
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 Action Network North America (PANNA III), 808 F.3d 402, 403 (9th Cir. 2015).
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.
In the proposal, EPA proposed revoking all tolerances largely because the agency could not make a safety finding based on drinking water exposure in highly-vulnerable watersheds. EPA reasoned if it could better identify where such vulnerable areas might be, it could be possible for registrants to amend product labeling in ways that might make unnecessary some number of the proposed tolerance revocations.
Id. Importantly, EPA warned that its proposed course of conduct was not fixed:
Since EPA is still in the process of deliberating the provisions of a final rule, EPA cannot definitively state whether this information will provide support for any provision of the final rule, or that the agency has determined that it is appropriate to rely on this information in developing the final rule.
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:
Following a review of comments on both the November 2015 proposal and the November 2016 notice of data availability, EPA has concluded that, despite several years of study, the science addressing neurodevelopmental effects remains unresolved and that further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos. EPA has therefore concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution on those issues.
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 F.3d at 1015). EPA explained that the comments received in response to the 2015 Proposed Rule “suggest that there continue to be considerable areas of uncertainty with regard to what the epidemiology data show and deep disagreement over how those data should be considered in EPA‘s risk assessment.” Id. at 16,590. It then explained why it was denying the petition, rather than continuing its prior course:
As the 9th Circuit has made clear . . . EPA must provide a final response to the Petition by March 31, 2017, regardless of whether the science remains unsettled and irrespective of whatever options may exist for a more complete resolution of these issues . . . .
Although past EPA administrations had chosen to attempt to complete [FIFRA] review several years in advance of the statutory deadline (and respond to the Petition on the same time frame), it has turned out that it is not possible to fully address these issues early in the registration review period . . . . Accordingly, EPA is denying these Petition claims and intends to complete a full and appropriate review of the neurodevelopmental data before either
finalizing the [2015] proposed rule . . . or taking an alternative regulatory path.
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
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
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
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 (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
Nor was the 2016 RHHRA a final agency action. Human Health Risk Assessments are part of
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 (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
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
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 (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. 54-58, 60-63. 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.
* * *
The
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
so, Maj. Op. at 67. It is more than a little ironic that this court will have taken over a year since the filing of the last brief to decide this case, but we will expect EPA to make an informed decision in the next 60 days.
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 35,558.10 That, of course, is not an argument for finding chlorpyrifos safe, as EPA recognized, but it should sharpen our focus on what we are doing. See 2017 Denial, 82 Fed. Reg. at 16,590 (“Although not a legal consideration, it is important to recognize that for many decades chlorpyrifos has been and remains one of the most widely used pesticides in the United States, making any decision to retain or remove this pesticide from the market an extremely significant policy choice.“). That is why EPA should be considering the options Congress
made available, not us. And we have not given anything but the most fleeting consideration to the options.11
Despite several years of study, the science addressing neurodevelopmental effects remains unresolved. . . . Notwithstanding,
EPA recognizes that the science is evolving on this topic, and that there may be new information available prior to the completion of registration review that may impact the agency‘s conclusions about these effects.
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,
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
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
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
a jumble of disjointed facts and analyses. It appears to be the result of exactly what we would imagine happens when an agency is ordered to produce an important opinion on an extremely complicated and technical subject matter covering multiple federal and state agencies and affecting millions of acres of land and tens of millions of people.
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
IV
There are manifest errors in the majority opinion. It has misread the
Notes
What does [the] EPA‘s revised human health risk assessment show?
This assessment shows dietary and drinking water risks for the current uses of chlorpyrifos. Based on current labeled uses, the revised analysis indicates that expected residues of chlorpyrifos on food crops exceed the safety standard under the [FFDCA]. In addition, the majority of estimated drinking water exposure from currently registered uses, including water exposure from non-food uses, continues to exceed safe levels . . . .
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).