FOR PUBLICATION
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
` No. 19-71979
`
`EPA No.
`EPA-HQ-OPP-
`2007-1005
`
`
`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.
`
`
`
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
` No. 19-71979
`
`EPA No.
`EPA-HQ-OPP-
`2007-1005
`
`
`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.
`
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`2
`
`
`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,
`
`
`
` No. 19-71982
`
`EPA No.
`EPA-HQ-OPP-
`2007-1005
`
`
`OPINION
`
`v.
`
`
`MICHAEL S. REGAN, Administrator,
`United States Environmental
`Protection Agency; U.S.
`ENVIRONMENTAL PROTECTION
`AGENCY,
`
`Respondents.
`
`On Petition for Review of an Order of the
`Environmental Protection Agency
`
`Argued and Submitted July 28, 2020
`San Francisco, California
`
`Filed April 29, 2021
`
`
`
`
`
`
`
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`3
`
`Before: Jay S. Bybee and Jacqueline H. Nguyen, Circuit
`Judges, and Jed S. Rakoff,* District Judge.
`
`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 Honorable Jed S. Rakoff, United States District Judge for the
`Southern District of New York, sitting by designation.
`
`** This summary constitutes no part of the opinion of the court. It
`has been prepared by court staff for the convenience of the reader.
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`4
`
`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 21 U.S.C. § 346a(a)(1).
`
`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
`
`
`
`5
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`
`
`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.
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`6
`
`
`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, Attorney
`General; Office of the Attorney General, Albany, New York;
`Xavier Becerra, Attorney General; Christie Vosburg,
`Supervising Deputy Attorney General; Reed Sato, Deputy
`Attorney General; Office of
`the Attorney General,
`Sacramento, California; Robert W. Ferguson, Attorney
`General; William R. Sherman, Counsel for Environmental
`Protection; Attorney General’s Office, Seattle, Washington;
`Brian E. Frosh, Attorney General; Steven M. Sullivan,
`Solicitor General; Joshua M. Segal, Special Assistant
`Attorney General; Office of
`the Attorney General,
`Baltimore, Maryland; Thomas J. Donovan Jr., Attorney
`General; Nichols F. Persampieri, Assistant Attorney
`General; Office of the Attorney General, Montpelier,
`Vermont; Clare E. Connors, Attorney General; Wade H.
`Hargrove III, Deputy Attorney General; Department of the
`Attorney General, Honolulu, Hawaii; Ellen F. Rosenblum,
`Attorney General; Benjamin Gutman, Solicitor General;
`Office of the Attorney General, Salem, Oregon; Maura
`Healey, Attorney General; I. Andrew Goldberg, Assistant
`
`
`
`7
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`
`
`Attorney General; Environmental Protection Division,
`Office of the Attorney General, Boston, Massachusetts; Karl
`A. Racine, Attorney General; Loren L. Alikhan Solicitor
`General; Caroline S. Van Zile, Principal Deputy Solicitor
`General; Brian R. Caldwell, Assistant Attorney General,
`Public Integrity Unit; Office of the Attorney General,
`Washington, D.C.; for Petitioners States of New York,
`California, Washington, Maryland, Vermont, Hawaii,
`Oregon, the Commonwealth of Massachusetts, and the
`District of Columbia.
`
`(argued) and Jessica O’Donnell,
`Mark L. Walters
`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.
`
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`8
`
`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
`Processors Association, Western Growers, and Western
`Plant Health Association.
`
`
`
`
`
`
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`9
`
`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
`
`
`
`10 LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
` 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 Revised Human Health Risk Assessment
`
`1 21 U.S.C. § 346a(b)(2)(A)(i).
`
`2 Id. § 346a(b)(2)(C)(i)–(ii).
`
`
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN 11
`
`
`
`finding that the present tolerances are “not sufficiently health
`protective.”3
`
`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,
`
`3 Chlorpyrifos; Tolerance Revocations; Notice of Data Availability
`and Request for Comment, 81 Fed. Reg. 81,049, 81,050 (Nov. 17, 2016)
`(hereinafter “2016 Notice of Data Availability”).
`
`
`
`12 LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`including for infants and children – or to revoke all
`chlorpyrifos tolerances. The Court also orders the EPA to
`correspondingly modify or cancel
`related FIFRA
`registrations for food use in a timely fashion consistent with
`the requirements of 21 U.S.C. § 346a(a)(1).
`
`BACKGROUND
`
`I. The EPA’s Duty to Regulate Pesticides
`
`Congress requires the EPA to regulate the use of
`pesticides on food pursuant to the FFDCA. Congress also
`requires the EPA to regulate the use of pesticides more
`generally under the Federal Insecticide, Fungicide and
`Rodenticide Act (“FIFRA”). This case principally concerns
`the FFDCA.
`
`The FFDCA begins with a general rule that food
`containing pesticide residue is unsafe and prohibited.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
`
`is
`tolerances
`to set such
`The EPA’s discretion
`circumscribed, however, by an uncompromisable limitation:
`
`4 Id. §§ 331, 342(a)(2)(B), 346a(a)(1). The FFDCA applies only to
`food and other products in interstate commerce. See 21 U.S.C. § 331.
`
`5 Id. § 346a(b)(1), (b)(2)(A).
`
`6 Id. § 346a(a)(4).
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN 13
`
`
`
`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 residue in or on a food only
`if the Administrator determines that the tolerance is safe.”7
`Furthermore, following enactment of the Food Quality
`Protection Act of 1996 (“FQPA”), it is now clear that the
`EPA must look beyond food to consider all of the ways
`someone might be exposed to a pesticide, “including all
`anticipated dietary exposures and all other exposures for
`which there is reliable information.”8 The EPA can
`determine that a tolerance is safe only if “there is a
`reasonable certainty that no harm will result from aggregate
`exposure to the pesticide chemical residue.”9
`
`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
`
`
`7 Id. § 346a(b)(2)(A)(i) (emphasis added).
`
`8 Id. § 346a(b)(2)(A)(ii).
`
`9 Id. (emphases added).
`
`10 Id. § 346a(b)(2)(C)(ii).
`
`
`
`14 LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`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
`
`
`
`11 Id. § 346a(b)(2)(A)(i).
`
`12 Id. § 346a(d)(1).
`
`13 Id. § 346a(d)(2)(B).
`
`14 40 C.F.R. § 180.32(b).
`
`15 21 U.S.C. § 346a(d)(3).
`
`16 Id. § 346a(d)(4)(A).
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN 15
`
`
`
`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
`
`Separately, the EPA also regulates pesticides pursuant to
`FIFRA. Under FIFRA, pesticides must be registered by the
`EPA before they can be distributed or sold.20 To register a
`pesticide, the EPA must determine, among other things, that
`it does not have “unreasonable adverse effects on the
`environment.”21 FIFRA defines “unreasonable adverse
`effects” to include “a human dietary risk from residues that
`result from a use of a pesticide in or on any food inconsistent
`with” the standards of the FFDCA.22 In other words, FIFRA
`incorporates the FFDCA safety standard for food uses,
`among other considerations. FIFRA requires the EPA to
`reevaluate pesticides as part of a registration review every
`fifteen years.23
`
`
`
`17 Id. § 346a(g)(2)(A).
`
`18 Id. § 346a(g)(2)(C).
`
`19 Id. § 346a(h)(1).
`
`20 See 7 U.S.C. § 136a(a).
`
`21 Id. § 136a(c)(5)(C)–(D).
`
`22 Id. § 136(bb).
`
`23 See id. §§ 136a(c)(1)(F)(iii), (g)(1)(A), 136a-1(a).
`
`
`
`16 LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`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
`
`of
`functioning
`the
`disrupts
`Chlorpyrifos
`acetylcholinesterase (“AChE”), a crucial enzyme that breaks
`down the neurotransmitter acetylcholine.26 In setting
`
`24 Chlorpyrifos; Order Denying PANNA and NRDC’s Petition to
`Revoke Tolerances, 82 Fed. Reg. 16,581, 16,584 (Apr. 5, 2017)
`(hereinafter “2017 Order”).
`
`25 Press Release, Cal. Env’t Prot. Agency & Cal. Dep’t of Pesticide
`Regul., Agreement Reached to End Sale of Chlorpyrifos in California
`by February 2020 (Oct. 9, 2019), https://www.cdpr.ca.gov/docs/pressrl
`s/2019/100919.htm; Stephen Gardner, EU to Ban Chlorpyrifos Pesticide
`Starting in February, Bloomberg L. News (Dec. 6, 2019, 6:43 AM),
`https://news.bloomberglaw.com/environment-and-energy/eu-to-ban-
`chlorpyrifos-pesticide-starting-in-february.
`
`26 See EPA, Office of Prevention, Pesticides, and Toxic Substances,
`EPA 738-R-01-007, Interim Reregistration Eligibility Determination for
`Chlorpyrifos 2 (Feb. 2002) (“Chlorpyrifos can cause [AChE] inhibition
`in humans; that is, it can overstimulate the nervous system causing
`
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN 17
`
`
`
`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 based on these concerns. Yet, despite the
`EPA’s expressed concerns, the EPA repeatedly failed to act
`on the 2007 Petition until this Court compelled it to do so.
`The following is a chronological summary both of the EPA’s
`assessment of chlorpyrifos’s safety and of this dispute.
`
`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
`
`nausea, dizziness, confusion, and at very high exposures (e.g., accidents
`or major spills), respiratory paralysis and death.”).
`
`27 This different mechanism of harm might still relate to AChE
`inhibition; the EPA has considered the possibility that chronic AChE
`inhibition at levels of less than 10% might cause permanent damage.
`Herein, unless stated otherwise, AChE inhibition means acute AChE
`inhibition of 10% or more.
`
`
`
`18 LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`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
`
`
`28 EPA, Office of Pesticide Programs, Human Health Risk
`Assessment-Chlorpyrifos 4 (June 8, 2000), https://archive.epa.gov/scip
`oly/sap/meetings/web/pdf/hed_ra.pdf (discussing live animal studies and
`explaining that “new data in the literature also gave rise to uncertainties
`such as the suggestion that the inhibition of [AChE] may not be essential
`for adverse effects on brain development”).
`
`29 Letter to Aaron Colangelo, NRDC, & Margaret Reeves, PANNA,
`from Steven Bradbury, EPA, re: Chlorpyrifos Petition Dated September
`12, 2007 (hereinafter “2007 Petition”), at 6 (July 16, 2012).
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN 19
`
`
`
`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
`
`B. 2007: PANNA and NRDC File a Petition to Revoke
`Tolerances, Citing Mounting Evidence of Harm
`
`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
`
`
`30 Interim Reregistration Eligibility Decision for Chlorpyrifos, supra
`note 26.
`
`31 Id. at 2.
`
`32 EPA, Office of Prevention, Pesticides and Toxic Substances,
`Memo to Jim Jones from Debra Edwards, Finalization of Interim
`Reregistration Eligibility Decisions and Interim Tolerance Reassessment
`and Risk Management Decisions for the Organophosphate Pesticides,
`and Completion of the Tolerance Reassessment and Reregistration
`Eligibility Process for the Organophosphate Pesticides 2 (July 31, 2006).
`
`
`
`20 LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`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;
`
`
`33 Marc S. Wu et al., NRDC, & Susan E. Kegley, PANNA, Petition
`to Revoke All Tolerances and Registrations for
`the Pesticide
`Chlorpyrifos 5 (Sept. 12, 2007).
`
`34 Id. at 6.
`
`
`
`
`
`
`LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN 21
`
`• 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
`
` The EPA Preliminarily Links
`C. 2008–2011:
`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 scientific studies and “preliminarily concluded that
`chlorpyrifos likely played a role” in the low birth rate and
`delays in infant mental development observed in the Human
`
`
`35 Although the Mount Sinai Study and the CHAMACOS Study
`were not cited in the 2007 Petition, they later became part of the
`administrative record.
`
`
`
`22 LEAGUE OF UNITED LATIN AM. CITIZENS V. REGAN
`
`Cohort Studies.36 The EPA recognized that some of these
`studies found these effects despite lesser AChE inhibition,
`suggesting there was a different mechanism of harm.37
`However, the paper also noted that it was “not a
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