Case 2:17-cv-02401-WBS-EFB Document 23 Filed 12/05/17 Page 1 of 34
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`Philip J. Perry (CA Bar No. 148696)
`Richard P. Bress
`Andrew D. Prins
`Alexandra P. Shechtel (CA Bar No. 294639)
`LATHAM & WATKINS LLP
`555 Eleventh Street NW, Suite 1000
`Washington, DC 20004
`Tel: (202) 637-2200
`philip.perry@lw.com
`(additional counsel on signature page)
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`UNITED STATES DISTRICT COURT
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`EASTERN DISTRICT OF CALIFORNIA
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`NATIONAL ASSOCIATION OF WHEAT
`GROWERS; NATIONAL CORN
`GROWERS ASSOCIATION; UNITED
`STATES DURUM GROWERS
`ASSOCIATION; WESTERN PLANT
`HEALTH ASSOCIATION; MISSOURI
`FARM BUREAU; IOWA SOYBEAN
`ASSOCIATION; SOUTH DAKOTA AGRI-
`BUSINESS ASSOCIATION; NORTH
`DAKOTA GRAIN GROWERS
`ASSOCIATION; MISSOURI CHAMBER
`OF COMMERCE AND INDUSTRY;
`MONSANTO COMPANY; ASSOCIATED
`INDUSTRIES OF MISSOURI;
`AGRIBUSINESS ASSOCIATION OF
`IOWA; CROPLIFE AMERICA; AND
`AGRICULTURAL RETAILERS
`ASSOCIATION,
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`Plaintiffs,
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`LAUREN ZEISE, IN HER OFFICIAL
`CAPACITY AS DIRECTOR OF THE
`OFFICE OF ENVIRONMENTAL HEALTH
`HAZARD ASSESSMENT; AND XAVIER
`BECERRA, IN HIS OFFICIAL CAPACITY
`AS ATTORNEY GENERAL OF THE
`STATE OF CALIFORNIA,
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`Defendants.
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`AT T ORNEYS AT L AW
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`Civil Action No. 2:17-cv-02401-WBS-
`EFB
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`AMENDED COMPLAINT FOR
`DECLARATORY AND INJUNCTIVE
`RELIEF
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`AMENDED COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF
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`Case 2:17-cv-02401-WBS-EFB Document 23 Filed 12/05/17 Page 2 of 34
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`Plaintiffs seek declaratory and injunctive relief against Defendants Lauren Zeise and
`Xavier Becerra, in their official capacities as Director of the California Office of Environmental
`Health Hazard Assessment (OEHHA) and Attorney General of the State of California,
`respectively, and allege as follows:
`PRELIMINARY STATEMENT
`Plaintiffs National Association of Wheat Growers, National Corn Growers
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`Association, United States Durum Growers Association, Western Plant Health Association,
`Missouri Farm Bureau, Iowa Soybean Association, South Dakota Agri-Business Association,
`North Dakota Grain Growers Association, Missouri Chamber of Commerce and Industry,
`Monsanto Company, Associated Industries of Missouri, Agribusiness Association of Iowa,
`CropLife America, and Agricultural Retailers Association bring this suit to prevent Defendants
`from mandating false, misleading, and highly controversial cancer warnings concerning the
`herbicide glyphosate on a wide variety of food, agricultural, industrial, and lawn and garden
`products.
`Glyphosate is a broad-spectrum herbicide approved by the federal government for
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`use in more than 250 agricultural crop applications in all U.S. States. Glyphosate has been subject
`to scientific review by the federal government repeatedly for multiple decades. It is widely utilized
`worldwide, including throughout the U.S., in cultivation of many major crops (such as corn,
`soybeans, canola, wheat, and oats), and in California, in cultivation of almond, citrus, and cotton
`crops, among others. Glyphosate is regarded as one of the safest herbicides ever developed. For
`several decades, the federal government has approved the use of glyphosate under the Federal
`Insecticide, Fungicide, and Rodenticide Act (FIFRA), based on extensive scientific analyses of
`each specific use of the herbicide.1 Likewise, the Federal Food, Drug, and Cosmetic Act (FDCA)
`establishes scientifically-set safe food tolerance levels for herbicide residues in food, and forbids
`misbranding food products with any false or misleading label.
`EPA has repeatedly concluded under FIFRA that use of glyphosate in accordance
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`1 This Amended Complaint uses the term “herbicide” for clarity because glyphosate is an
`herbicide, but under federal law, herbicides, insecticides, rodenticides, and pesticides are all
`referred to under the definitional term “pesticide.” 7 U.S.C. § 136(u).
`AMENDED COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF
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`Case 2:17-cv-02401-WBS-EFB Document 23 Filed 12/05/17 Page 3 of 34
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`with federal label instructions does not present any unreasonable adverse effects on human health
`or the environment, and specifically that glyphosate is not a carcinogen. See infra ¶¶ 37, 38, 46.
`Likewise, California itself has twice examined glyphosate in its own reviews—in 1997 and in
`2007—and on both occasions concluded that glyphosate is “unlikely to pose a cancer hazard to
`humans.” Infra ¶ 43. The same is true for every other regulatory body worldwide that has
`evaluated glyphosate, including regulatory agencies in Europe, Canada, New Zealand, Australia,
`Japan, and South Korea, and the International Programme on Chemical Safety (the recognized
`authoritative body on these issues in the World Health Organization), as well as the Joint Food and
`Agricultural Organization and World Health Organization Meeting on Pesticide Residues (JMPR).
`See infra ¶¶ 36-43, 47-50 (listing more than a dozen regulatory and scientific agencies that have
`reviewed glyphosate and found that it is not likely to be a carcinogen).
`Under California’s Proposition 65, businesses must warn Californians about the
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`presence of chemicals that are “known to the state to cause cancer.” Despite the overwhelming
`scientific consensus that glyphosate is not a carcinogen, OEHHA issued a determination on July
`7, 2017 that glyphosate has been added to the list of chemicals “known to the state to cause cancer”
`that are subject to Proposition 65. OEHHA did not issue its Proposition 65 determination because
`OEHHA or any other California agency conducted a scientific or regulatory review and reached
`the conclusion that glyphosate was actually carcinogenic—in fact, OEHHA had previously
`reached the opposite conclusion. Instead, under what California refers to as its “Labor Code”
`listing mechanism under Proposition 65, certain determinations by a foreign non-governmental
`entity known as the International Agency for Research on Cancer (IARC) automatically require a
`Proposition 65 cancer listing no matter whether the IARC determination is supported by the
`consensus of worldwide scientific bodies or not. Indeed, a listing under the Labor Code
`mechanism is automatically required even if IARC is absolutely alone in its views, as is the case
`here where IARC’s conclusion is opposed by every global regulatory body that has examined the
`issue, including OEHHA itself.
`Under this framework, California has designated glyphosate as a chemical “known”
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`to cause cancer based solely on IARC’s conclusion that glyphosate is “probably carcinogenic.”
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`AMENDED COMPLAINT FOR DECLARATORY AND
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`Case 2:17-cv-02401-WBS-EFB Document 23 Filed 12/05/17 Page 4 of 34
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`Not only does the scientific community firmly disagree with IARC’s substantive conclusion,
`IARC’s internal process for reviewing glyphosate has also been roundly criticized. See infra
`¶¶ 51-54 (identifying multiple published reports that IARC purposely declined to share critical
`data with its glyphosate review panel).
`California has no administrative or regulatory mechanism for reviewing the validity
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`of an IARC conclusion before a Proposition 65 listing is made. Once IARC designates a substance
`as carcinogenic, OEHHA takes the position that Proposition 65 listing is then a “ministerial” task.
`That listing then triggers Proposition 65’s compelled speech requirements in the form of consumer
`“warnings.” And any relevant product without an appropriate warning—including consumer
`products, foods, and crops—will be subject to Proposition 65’s enforcement mechanisms,
`including private strike suits filed by so-called bounty hunters, who are entitled to retain one-fourth
`of the $2,500 per violation per day in civil penalties that are potentially available under California
`Health & Safety Code section 25249.12(d). Such suits are already threatened regarding numerous
`food products that allegedly contain trace residues of glyphosate.
`California’s listing of glyphosate as a carcinogen and the attendant warning
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`requirement violate the First Amendment of the U.S. Constitution by compelling Plaintiffs and
`other entities to make false, misleading, and highly controversial statements about their products.
`The listing and warning requirement also conflict with, and are preempted by, the FDCA, and
`violate the Due Process Clause of the Fourteenth Amendment.
`In addition to being illegal, California’s treatment of glyphosate under Proposition
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`65 threatens significant disruption to multiple of the nation’s supply chains, including the nation’s
`food production and processing supply chains. As set forth herein, the listing threatens to change
`the way of life for many farmers who currently rely on glyphosate herbicides as a mainstay of their
`farming practices. It is no surprise, then, that Plaintiffs—a national coalition of farming interests,
`food producers, glyphosate manufacturers, and others—have coalesced to bring this suit. Had
`California conducted any sort of reasonable scientific review before taking the action challenged
`here, it would have determined—as more than a dozen other global regulatory and scientific
`agencies already have—that the cancer listing at issue is false and inappropriate. This suit,
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`AMENDED COMPLAINT FOR DECLARATORY AND
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`Case 2:17-cv-02401-WBS-EFB Document 23 Filed 12/05/17 Page 5 of 34
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`accordingly, should be unnecessary. In addition to being enjoined, Defendants should be assessed
`Plaintiffs’ fees and costs under 42 U.S.C. § 1988(b).
`PARTIES
`Plaintiff National Association of Wheat Growers is a federation of twenty state
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`associations whose members are wheat farmers. The mission of the National Association of Wheat
`Growers is to mobilize wheat farmers to advocate for beneficial policies, cultivate productive
`relationships with partners and the public, and champion opportunities through research,
`innovation, education, and stewardship. Members of the National Association of Wheat
`Growers—many of whom sell their wheat into California or sell their wheat to milling facilities
`that in turn sell into California—depend on glyphosate as a critical tool in their farming practices.
`Plaintiff National Corn Growers Association is a 501(c)(5) trade association
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`chartered in Iowa, with 40,000 members across the country. Most of its members are farmers who
`use glyphosate as an important means for weed control. Members of the National Corn Growers
`Association deliver their crops to elevators, feed mills, corn processing plants, and ethanol plants,
`a portion of which makes its way to California.
`Plaintiff United States Durum Growers Association is a national organization
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`comprised of around 175 durum wheat producers, most of which are located in North Dakota and
`Montana, and other businesses that use and rely on durum. Durum is a specialty wheat product
`that is used primarily for the production of semolina, the primary ingredient in pasta. The purpose
`of the United States Durum Growers Association is to promote and address the issues that affect
`producers of durum. Many members of the United States Durum Growers Association sell their
`durum for incorporation into products that are sold into California. Glyphosate is an integral tool
`for the sustainable harvesting of durum and the preservation of soil.
`Plaintiff Western Plant Health Association is a California based association that
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`represents the interests of fertilizer and crop protection manufacturers, distributors, and
`agricultural retailers (including those that sell and use glyphosate) in California, Arizona, and
`Hawaii. The Western Plant Health Association’s mission is to promote agronomically sound and
`environmentally safe use and handling of plant health products and services for the production of
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`AMENDED COMPLAINT FOR DECLARATORY AND
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`Case 2:17-cv-02401-WBS-EFB Document 23 Filed 12/05/17 Page 6 of 34
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`safe and high quality food. The association’s members comprise more than 90% of all companies
`marketing plant nutrients, soil amendments, agricultural minerals, and crop protection products in
`California, Arizona, and Hawaii, including glyphosate products.2
`Plaintiff Missouri Farm Bureau is a collective of about 126,000 families that have
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`organized together with the goals of improving the quality of life for rural Missourians and
`protecting Missouri’s agricultural economy. Missouri Farm Bureau has numerous members that
`cultivate corn, soybeans, wheat, and other crops that are treated with glyphosate and sold into
`California. Glyphosate is an integral tool in their farming activities because, among other reasons,
`it is cost effective and facilitates environmentally friendly no-till farming that reduces soil erosion.
`Plaintiff Iowa Soybean Association has the mission of expanding opportunities and
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`delivering results for Iowa soybean farmers. In that capacity, the Iowa Soybean Association
`advocates for farmers, works to increase soybean exports out of Iowa, and helps build consumer
`confidence in today’s farm and food system. Members of the Iowa Soybean Association use
`glyphosate on their crops, and consider the herbicide to be a critical part of their farming toolkit.
`The crops of members of the association are incorporated into products that are sold in California.
`Plaintiff South Dakota Agri-Business Association is an organization of crop input
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`professionals including retailers, distributors, and manufacturers of equipment, fertilizer,
`pesticides, and seed. For its pesticide members, Monsanto Company’s glyphosate-based product
`Roundup® is a huge part of their market. Many clients of the association’s members apply
`Roundup® to their pre-plant young corn and pre-harvest wheat, some of which ends up in
`California.
`Plaintiff North Dakota Grain Growers Association is the premier voice for North
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`Dakota’s wheat and barley producers. The association’s mission is to educate its members and
`represent them to increase profitability. Many of the association’s members use glyphosate on
`their wheat products (including right before harvest), a portion of which makes its way into
`California.
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`2 Plaintiffs Western Plant Health Association and Monsanto Company join only Claim I of this
`Amended Complaint.
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`Plaintiff Missouri Chamber of Commerce and Industry is Missouri’s largest
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`business organization. The Missouri Chamber works with all of its member organizations to
`protect their interests and address their concerns regarding economic and policy issues. Its
`members include entities involved in farming and food production. Glyphosate-treated crops that
`are produced, processed, and stored by its members are milled and refined into food, a portion of
`which is sold in California. Further, the Missouri Chamber has members that are involved in the
`processing and storage of crops treated with glyphosate.
`Plaintiff Monsanto Company (Monsanto) is a corporation headquartered in St.
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`Louis, Missouri and incorporated in Delaware. Monsanto is the leading manufacturer of the
`herbicide glyphosate, which is a main ingredient in Monsanto’s Roundup® branded line of
`products. Monsanto also maintains patents covering many varieties of glyphosate-tolerant crops,
`which Monsanto has obtained federal approval to plant and market along with glyphosate itself.
`Monsanto distributes multiple glyphosate-tolerant crops, including soybeans, corn, canola, alfalfa,
`sugar, beets, and cotton throughout California and the United States. Monsanto and its business
`partners also distribute glyphosate-based herbicides in California and throughout the United States,
`including to municipal, county, and other government agencies, to control vegetation in utility
`right-of-ways, along roadsides and railways, in aquatic environments, in residential home and
`garden settings, and to reduce the risk associated with the rapid spread of wildfires.
`Plaintiff Associated Industries of Missouri is the oldest general business trade
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`association in Missouri. Its mission is to promote a favorable climate for business, manufacturing,
`and industry by empowering its members through communications, education, and advocacy.
`More than half of this association’s members are manufacturers, many of whom are in the direct
`business of manufacturing products that contain glyphosate. The Associated Industries of
`Missouri also has many food producer members who produce products with trace amounts of
`glyphosate residues, a portion of which are sold in California.
`Plaintiff Agribusiness Association of Iowa is an Iowa-based organization with over
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`1,100 members. Among other things, this organization protects the reputation of its members and
`advances their business interests. More than half of this organization’s members are agricultural
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`retailers, such as cooperatives and independent retailers who sell agronomy products or who have
`grain storage facilities or are in the business of manufacturing. Glyphosate is very important to
`this organization’s members, many of whom sell the herbicide or use it as their primary weed
`control product.
`Plaintiff CropLife America is a national, not-for-profit trade association that
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`represents developers, manufacturers, formulators, and distributors of crop protection products and
`plant science solutions for agriculture and pest management in the United States. CropLife
`America’s many registrant member companies produce pesticides registered with EPA for use in
`the United States under FIFRA, including glyphosate. CropLife America’s members sell
`glyphosate products, as well as other pesticide products, in California.
` Plaintiff Agricultural Retailers Association is a nationwide, not-for-profit
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`association representing agricultural retailers and distributors of agronomic crop inputs with
`members in 48 states, representing over 70% of all crop input materials sold to America’s farmers.
`The Association’s mission is to advocate, influence, educate, and provide services to support its
`members, including helping its members adapt to a changing world and preserving their freedom
`to operate. The Association’s retail members provide their farmer customers with essential crop
`inputs like fertilizer, seed, pesticide, and equipment; application services; and crop consulting
`services, including conservation methodology.
`Defendant Lauren Zeise is the Director of OEHHA and is its highest-ranking
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`administrative officer. Director Zeise is sued in her official capacity. She performs her official
`duties in Sacramento. Director Zeise shall be referred to as OEHHA.
`Defendant Xavier Becerra is the Attorney General of the State of California and the
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`highest-ranking officer in the California Department of Justice. Attorney General Becerra is sued
`in his official capacity. He performs his official duties in Sacramento and throughout the State of
`California.
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`JURISDICTION AND VENUE
`This Court has jurisdiction over this action under 28 U.S.C. § 1331, which confers
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`original jurisdiction on federal district courts over actions arising under the Constitution or laws
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`of the United States.
`Venue is proper under 28 U.S.C. § 1391(b)(1) and (b)(2), because Defendants are
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`located within this district and a substantial part of the events giving rise to Plaintiffs’ claims
`occurred in this district.
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`FEDERAL REGULATORY FRAMEWORK
`Federal law comprehensively regulates the sale and use of herbicides, including
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`their labeling and permissible presence on food. Likewise, the federal government extensively
`regulates the labeling of food products.
`FIFRA
`A.
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` Under FIFRA, all commercial herbicides must be “registered” with EPA. 7 U.S.C.
`§ 136a(a). Before EPA grants a registration, it must determine that the herbicide will not cause
`“unreasonable adverse effects on the environment” or “human dietary risk.” Id. §§ 136(bb), 136a.
`EPA’s review extends not only to the herbicide itself, but to formulations and particular uses of
`the herbicide. See generally id. § 136a; 40 C.F.R. pt. 152. EPA also evaluates each specific use
`of the herbicide (i.e., its use on each particular type of crop) and, when necessary, prescribes use
`restrictions to protect human health and the environment. See 7 U.S.C. §§ 136(bb), 136a(a).
`EPA’s extensive scientific safety review includes an evaluation of whether the herbicide is
`potentially carcinogenic. See, e.g., EPA, Guidelines for Carcinogen Risk Assessment (Mar. 2005),
`https://www.epa.gov/sites/production/files/2013-09/documents/cancer_guidelines_final_3-25-
`05.pdf.
`The FDCA
`B.
`The FDCA prohibits “misbranding” of food products. 21 U.S.C. § 331(a). A food
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`product is misbranded if, among other things, “its labeling is false or misleading in any particular.”
`Id. § 343(a). “Many statements,” including those that are “incomplete” or even “true” can “be
`misleading.” United States v. Watkins, 278 F.3d 961, 967 (9th Cir. 2002).
`The FDCA also regulates the presence of herbicides on foods. The FDCA deems
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`“unsafe foods” to be “adulterated,” 21 U.S.C. § 342(a), and renders their distribution in interstate
`commerce unlawful, id. § 331(b). The statute specifically provides, however, that a food will not
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`be deemed “unsafe” due to the presence of herbicide residue in a quantity within the limits of an
`EPA-established “tolerance for such pesticide chemical residue in or on such food.”
`Id. § 346a(a)(1)(A). In evaluating appropriate tolerances, EPA specifically evaluates the human
`health impact of the presence of an herbicide residue, including potential carcinogenicity.
`Id. § 346a(b)(2)(A)(ii). EPA has set comprehensive tolerances for glyphosate, covering relevant
`U.S. crops and food inputs. 40 C.F.R. § 180.364.
`31. While the FDCA comprehensively regulates permissible herbicide residues in food
`for safety, it also explicitly provides that disclosure of such safe residue amounts to consumers
`purchasing food products is not required. 21 U.S.C. § 343(l), (k). States are barred under the
`FDCA from “prohibit[ing] or penaliz[ing] the production, processing, shipping, or other handling
`of a food because it contains a pesticide residue.” Id. § 346a(n)(4). And States may not “enforce
`any regulatory limit on the level of a pesticide chemical residue that may appear in or on any food
`if, at the time of the application of the pesticide that resulted in such residue, the sale of such food
`with such residue level was lawful” under the FDCA. Id. § 346a(n)(7) (emphasis added).
`FACTUAL BACKGROUND
`Overview Of Glyphosate
`A.
`Glyphosate is a broad-spectrum herbicide that is used to control weeds in a variety
`32.
`of agricultural, residential, aquatic, and other settings. Since it was first introduced in 1974,
`glyphosate has become the world’s most widely used herbicide because it is efficacious,
`economical, and environmentally benign. Glyphosate is marketed under a number of trade names
`and is registered for use as an herbicide in more than 160 countries, including the United States.
`The “environmentally benign” glyphosate has, over the past several decades, substantially
`displaced other herbicides which were perceived to pose environmental, health, or safety risks.
`See Jorge Fernandez-Cornejo et al., U.S. Dep’t of Agric., Pesticide Use in U.S. Agriculture: 21
`1960-2008,
`at
`21
`(May
`2014),
`Selected
`Crops,
`https://www.ers.usda.gov/webdocs/publications/43854/46734_eib124.pdf.
`Glyphosate is approved for use in more than 250 agricultural crop applications in
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`California and elsewhere. It is used on the vast majority of corn, soybean, and canola crops across
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`the United States. It is also widely used on Canadian crops—including oats—and in conjunction
`with the cultivation of wheat, beans, peas, and other crops in many locations. It is also used in
`conjunction with cultivation of almond, citrus, cotton, and other crops in California. Glyphosate-
`based herbicides are particularly desirable in the agricultural setting because of their broad-
`spectrum effectiveness, which allows farmers to control weeds with minimal tilling of soil (a
`practice known as conservation tilling), thereby conserving valuable topsoil, reducing soil
`movement into streams and other surface water, and retaining soil moisture. The scientific
`literature has expressly recognized these environmental benefits of using glyphosate, and has
`explained why these practices are preferable to traditional means of cultivation, which involve
`multiple other potentially significant impacts. See, e.g., Stephen O. Duke & Stephen B. Powles,
`Mini-Review Glyphosate: A Once-in-a-Century Herbicide, 64 Pest Mgmt. Sci. 319, 322 (2008).
`Glyphosate-based herbicides are also widely used—including by municipal,
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`county, and California government agencies—to control vegetation in utility right-of-ways, along
`roadsides and railways, in aquatic environments, in residential home and garden settings, and to
`reduce the risk associated with the rapid spread of wildfires. In addition, glyphosate-based
`herbicides are used by wildlife organizations to protect and restore wildlife habitats threatened by
`invasive, non-native vegetation. For example, a glyphosate-based herbicide is used to control
`arundo donax (giant reed) in central California’s river valleys; arundo donax is a highly invasive
`weed that threatens California’s riparian ecosystems by competing with native species, such as
`willows, for water.
`For many applications, glyphosate is the most effective and reliable weed control
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`option. Indeed, very few herbicides other than glyphosate are approved by EPA for use in aquatic
`environments.
`Glyphosate Has Been Widely Recognized To Be Non-Carcinogenic
`B.
`Glyphosate has been recognized as a safe herbicide for over 40 years by EPA,
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`regulators across the globe, and even OEHHA. Because of its immense popularity, glyphosate is
`one of the most extensively studied herbicides in the world and has been subject to hundreds of
`safety studies by the world’s most prominent and authoritative sources.
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`
`
`Glyphosate was first registered in the United States as an herbicide in 1974. In
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`1991, EPA conducted a peer review of glyphosate under FIFRA and, in 1993, approved the
`renewal of its registration. At the time EPA concluded that:
`
`Several chronic toxicity/carcinogenicity studies . . . resulted in no effects
`based on the parameters examined, or resulted in findings that glyphosate
`was not carcinogenic in the study. In June 1991, EPA classified glyphosate
`as a Group E oncogen—one that shows evidence of non-carcinogenicity for
`humans—based on the lack of convincing evidence of carcinogenicity in
`adequate studies.
`
`EPA, Reregistration Eligibility Decision (RED): Glyphosate, EPA-738-F-93-011, at 2 (1993).
`EPA has reaffirmed this conclusion more recently. In relevant part:
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`
`[In 2014], EPA reviewed over 55 epidemiological studies conducted on the
`possible cancer and non-cancer effects of glyphosate. Our review
`concluded that this body of research does not provide evidence to show that
`glyphosate causes cancer and it does not warrant any change in EPA’s
`cancer classification for glyphosate.
`
`Statement of Carissa Cyran, Chem. Review Mgr., EPA Office of Pesticide Programs (2015).
`This view of glyphosate’s safety is widely shared by the international community.
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`In 2002, for instance, the Health and Consumer Protection Directorate-General of the European
`Commission conducted a review of glyphosate for its re-registration for use in Europe and likewise
`concluded there was “[n]o evidence of carcinogenicity.” Health & Consumer Prot. Directorate –
`Gen., European Comm’n, Report for the Active Substance Glyphosate, Directive 6511/VI/99, at
`12 (Jan. 21, 2002). The same agency reaffirmed that conclusion on July 11, 2016.
`Germany’s Federal Institute for Risk Assessment—BfR—also recently reviewed
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`glyphosate. In December 2013 it submitted a glyphosate Renewal Assessment Report to the
`European Food Safety Authority recommending re-approval of glyphosate for use in Europe. The
`Report was revised in 2014 and again in 2015 in response to comments, and in it BfR concluded
`that glyphosate was “unlikely to pose a carcinogenic risk in humans.” See BfR, Renewal
`Assessment Report and Proposed Decision – Volume 1, at 35 (Mar. 31, 2015). More emphatically,
`BfR found that:
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`In epidemiological studies in humans, there was no evidence of
`carcinogenicity and there were no effects on fertility, reproduction and
`development or of neurotoxicity that might be attributed to glyphosate.
`
`Id. at 36.
`The European Food Safety Authority (EFSA) concurred with BfR’s assessment. It
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`evaluated BfR’s findings and “concluded that glyphosate is unlikely to pose