Natural Res. Def. Council v. U.S. Envtl. Prot. Agency

Decision Date17 June 2022
Docket Number20-70787, No. 20-70801
Citation38 F.4th 34
Parties NATURAL RESOURCES DEFENSE COUNCIL ; Pesticide Action Network North America, Petitioners, v. U.S. ENVIRONMENTAL PROTECTION AGENCY, Respondent, National Association of Wheat Growers; National Cotton Council of America; American Farm Bureau Federation ; National Corn Growers Association; American Soybean Association ; National Sorghum Producers; Agricultural Retailers Association; National Association of Landscape Professionals; Monsanto Company; Golf Course Superintendents Association of America; American Sugarbeet Growers Association, Intervenors. Rural Coalition; Organizacion en California de Líderes Campesinas ; Farmworker Association of Florida; Beyond Pesticides; Center for Food Safety, Petitioners, v. U.S. Environmental Protection Agency ; Michael Regan, in his official capacity as Administrator, Respondents, National Association of Wheat Growers; National Corn Growers Association; National Cotton Council; American Soybean Association ; American Sugarbeet Growers Association; National Sorghum Producers; American Farm Bureau Federation ; Agricultural Retailers Association; National Association of Landscape Professionals; Golf Course Superintendents Association of America; Monsanto Company, Intervenors.
CourtU.S. Court of Appeals — Ninth Circuit

Amy van Saun (argued), George A. Kimbrell, and Ryan D. Talbott, Center for Food Safety, Portland, Oregon, for Petitioners Rural Coalition, Organización en California de Líderes Campesinas, Farmworker Association of Florida; Beyond Pesticides, and Center for Food Safety.

Lucas Rhoads (argued), Aaron Colangelo, and Tom Zimpleman, Natural Resources Defense Council, Washington, D.C., for Petitioners Natural Resources Defense Council and Pesticide Action Network North America.

Philip R. Dupre (argued), Attorney; Robert Williams, Senior Trial Attorney; Benjamin Carlisle, Senior Attorney; Bruce S. Gelber, Deputy Assistant Attorney General; Jean E. Williams, Acting Assistant Attorney General; Environment and Natural Resources Division, United States Department of Justice, Washington, D.C.; Devi Chandrasekaran and Forrest Pittman, Attorney Advisors, Office of General Counsel, United States Environmental Protection Agency, Washington, D.C.; for Respondent.

Richard P. Bress (argued), Philip J. Perry, Stacey L. VanBelleghem, and Andrew D. Prins, Latham & Watkins LLP, Washington, D.C., for Intervenors.

Shannen W. Coffin, Sara Beth Watson, and Mark C. Savignac, Steptoe & Johnson LLP, Washington, D.C., for Amicus Curiae CropLife America.

Before: J. Clifford Wallace, Danny J. Boggs,* and Michelle T. Friedland, Circuit Judges.

FRIEDLAND, Circuit Judge:

Glyphosate, the active ingredient in Roundup, is the nation's most heavily used weedkiller. The Environmental Protection Agency ("EPA") recently assessed whether glyphosate poses "any unreasonable risk to man or the environment" and answered, for the most part, "no." A group of petitioners challenged EPA's decision, arguing, among other things, that EPA did not adequately consider whether glyphosate causes cancer

and shirked its duties under the Endangered Species Act ("ESA"). We agree and remand to the agency for further consideration.

I.
A.

The Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") requires EPA to regulate pesticides, which are defined to include herbicides.1 See 7 U.S.C. §§ 136 et seq. FIFRA's primary regulatory mechanism is called "registration." Id. § 136a(a). A pesticide product may not be distributed or sold in the United States until EPA has issued a registration, which functions as a license setting forth the conditions under which the pesticide may be sold, distributed, and used. See id. § 136a. Those conditions include labeling requirements with directions for proper use. Id. § 136a(c); see 40 C.F.R. § 156.10.

EPA may not issue a registration for a pesticide that causes "unreasonable adverse effects on the environment." 7 U.S.C. § 136a(c)(5)(C) ; see also 40 C.F.R. § 152.112(e). "[U]nreasonable adverse effects on the environment" include "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide." 7 U.S.C. § 136(bb). This is commonly referred to as the FIFRA safety standard.

In 2007, Congress added a new process called "registration review" to the FIFRA scheme governing pesticides, instructing EPA to "periodically review[ ]" pesticide registrations every fifteen years. Id. § 136a(g)(1)(A). For pesticides registered before 2007, such as glyphosate, EPA must complete the first registration review by October 1, 2022. Id.

EPA has promulgated regulations delineating an elaborate process for registration review. 40 C.F.R. §§ 155.23 – 155.58. The regulations require EPA to assess any new information regarding risks to human health and the environment that has emerged since EPA last issued a registration decision for a pesticide to verify that the pesticide continues to satisfy the FIFRA safety standard. See, e.g., id §§ 155.40, 155.53(a). The process concludes with a registration review decision, which conveys "the Agency's determination whether a pesticide meets, or does not meet," the FIFRA safety standard. Id. § 155.57. The regulations also permit, but do not require, EPA to issue an "interim registration review decision" prior to the registration review decision. Id. § 155.56. "[T]he interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for ... completing the registration review." Id.

If EPA finds that a pesticide does not satisfy the FIFRA safety standard, EPA may initiate cancellation proceedings to rescind a pesticide's registration, 7 U.S.C. §§ 136a(g)(1)(A)(v), 136d(b) ; 40 C.F.R. § 155.40(a)(2), or may require mitigation measures to reduce risk to acceptable levels, see 40 C.F.R. § 155.58.

B.

Glyphosate is a chemical that kills a broad range of plants by inhibiting an important enzyme. EPA registered the first glyphosate product in 1974, when Monsanto, an agrochemical and agricultural biotechnology company, sought to sell the now-well-known weedkiller Roundup. During its first two decades on the market, Roundup had limited utility to farmers because it killed all vegetation in an application area. But in the mid-1990s, Monsanto developed a "Roundup Ready" crop system, selling Roundup along with seeds genetically modified to tolerate glyphosate. The system allowed farmers to apply glyphosate over genetically modified crops, killing weeds but leaving the crops unharmed. As a result, glyphosate use skyrocketed. The nationwide acreage across which glyphosate is currently used is roughly equivalent to three times the size of California.

Glyphosate is generally applied by being sprayed from planes, ground equipment, or handheld devices. Workers and residential users are exposed to glyphosate when, for example, they handle the chemical during application or enter areas where it was recently sprayed. People are also exposed to glyphosate when they eat food from crops treated with it.

Whether these exposures create health risks has become a hotly debated and litigated issue. Health concerns proliferated when the International Agency for Research on Cancer ("IARC"), a subdivision of the World Health Organization, classified glyphosate as "probably carcinogenic to humans" in 2015. IARC's conclusion stemmed in part from scientific studies that found an association between glyphosate exposure and non-Hodgkin's lymphoma

("NHL"), a type of cancer that affects white blood cells. The IARC classification spurred a wave of lawsuits against Monsanto. Since 2015, tens of thousands of individuals with NHL have sued Monsanto in state and federal court, alleging that Roundup caused their illnesses. See, e.g.,

In re Roundup Prods. Liab. Litig. , 544 F. Supp. 3d. 950, 953 (N.D. Cal. 2021). Monsanto lost the first three lawsuits to go to trial, and the plaintiffs were awarded tens of millions of dollars. Id. at 955–57.

C.

EPA began its registration review of glyphosate in 2009.2 In September 2015, the agency completed a preliminary ecological risk assessment of the pesticide. The assessment considered glyphosate's effects on all "non-target organisms"—that is, animals and plants not intended to be killed by the pesticide. EPA concluded that glyphosate may pose certain risks to mammals and birds. EPA also determined that glyphosate may adversely affect terrestrial and aquatic plants, primarily from spray drift.

Meanwhile, EPA was working on a human-health risk assessment and, in particular, an analysis of glyphosate's carcinogenic potential. EPA's pesticide unit made a preliminary determination that glyphosate was not likely to be carcinogenic and shared that determination with the agency's Office of Research and Development ("ORD"). In December 2015, ORD offered comments in response, including criticisms of the pesticide unit's approach to reviewing epidemiological studies—specifically, studies of human populations investigating whether glyphosate exposure causes cancer

. ORD commented that the pesticide unit seemed to "dichotomize" such studies as "either ‘causal’ or ‘not causal’ " rather than recognize "gradations of causality." According to ORD, that approach contravened the "[f]rameworks for data analysis and causal determinations" employed by "the risk assessment community" and "by EPA" in its 2005 Guidelines for Carcinogen Risk Assessment ("Cancer Guidelines" or "Guidelines"). The Cancer Guidelines are intended to guide EPA in classifying chemicals according to their carcinogenic potential. After stating its methodological concerns, ORD expressed disagreement with the pesticide unit's determination that glyphosate was "not likely to be carcinogenic."

ORD's criticisms did not...

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