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United States District Court strikes down USDA rules on genetically engineered crops; court orders APHIS to revise oversight regulations for GE organisms in precedential ruling

December 3, 2024 (press release) –

SAN FRANCISCO—In a precedential victory for food and environmental safety, a federal district court ruledCase 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 1 of 26 1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 NATIONAL FAMILY FARM COALITION Case No. 21-cv-05695-JD et al., 8 Plaintiffs, ORDER RE SUMMARY JUDGMENT 9 v. 10 TOM VILSACK et al., 11 Defendants. 12 13 In 2004, the Animal and Plant Health Inspection Service (APHIS), housed within the U.S. 14 Department of Agriculture (USDA), announced the intention to revisit regulations governing 15 genetically engineered (GE) organisms. APHIS published a notice of proposed rulemaking in 16 2008 that kicked off over a decade of activity and concluded in a final rule the agency adopted in 17 May 2020. Plaintiffs, who are non-profit and public-interest groups organized around concerns 18 for farmers, crops, food safety, and the environment, object to the final rule. In plaintiffs’ view, 19 the final rule effectively abandoned federal government regulation of GE organisms, leaving GE 20 crop developers and agribusinesses to their own devices without adequate safety and other 21 oversight. Plaintiffs ask to set aside the final rule under the Administrative Procedure Act on the 22 ground that APHIS acted arbitrarily and capriciously, and contrary to various federal statutes. See 23 generally Dkt. No. 1. 24 Summary judgment is granted in part to plaintiffs. The rule is vacated and remanded to the 25 agency for further consideration in a manner consistent with this order. 26 27 28 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 2 of 26 1 BACKGROUND 2 I. STATUTORY FRAMEWORK 3 In 1986, the Office of Science and Technology Policy promulgated a Coordinated 4 Framework for the Regulation of Biotechnology, under which regulatory jurisdiction over 5 emerging developments in genetic engineering was delegated to three agencies: (1) the USDA, 6 and specifically APHIS; (2) the Environmental Protection Agency, and (3) the Food and Drug 7 Administration. See Movement of Certain Genetically Engineered Organisms, 85 Fed. Reg. 8 29790, 29790 (May 18, 2020) (codified at 7 C.F.R. §§ 330, 340, & 372). At that time, three 9 federal statutes were the keystones of overseeing our national agricultural resources: the Plant 10 Quarantine Act of 1912 (PQA), Pub. L. No. 62-275, 37 Stat. 315; the Federal Plant Pest Act of 11 1957 (FPPA), Pub. L. No. 85-36, 71 Stat. 31; and the Federal Noxious Weed Act of 1974 12 (FNWA), Pub. L. No. 93-629, 88 Stat. 2148. 13 In 2000, Congress enacted the Plant Protection Act (PPA), Pub. L. No. 106-224, 114 Stat. 14 438, which consolidated the FPPA, PQA, and FNWA into a unitary statutory scheme. The PPA 15 authorizes the Secretary of Agriculture (Secretary), who has delegated her authority to APHIS, see 16 7 C.F.R. §§ 371.1, 371.3, to regulate plant pests and noxious weeds and requires the agency to 17 “facilitate exports, imports, and interstate commerce in agricultural products and other 18 commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to 19 the extent practicable, as determined by the [agency], the risk of dissemination of plant pests or 20 noxious weeds.” 7 U.S.C. § 7701(3). 21 The statute defines a “plant pest” as an organism “that can directly or indirectly injure, 22 cause damage to, or cause disease in any plant or plant product.” Id. at § 7702(14). The 23 movement of “any plant pest” without a “permit” is prohibited, id. at § 7711(a), although the 24 agency may suspend permitting requirements for “specified plant pests . . . if the [agency] finds 25 that a permit . . . is not necessary,” id. at § 7711(c). The PPA defines “noxious weed” as “any 26 plant or plant product that can directly or indirectly injure or cause damage to crops (including 27 nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, 28 navigation, the natural resources of the United States, the public health, or the environment.” Id. 2 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 3 of 26 1 at § 7702(10). The agency is authorized to “prohibit or restrict the . . . movement in interstate 2 commerce of any . . . noxious weed” as “necessary.” Id. at § 7712(a). The statute contemplates 3 permitting requirements for noxious weeds and authorizes the agency to “publish, by regulation, a 4 list of noxious weeds that are prohibited or . . . subject to restrictions.” Id. at § 7712(c), (f). 5 II. REGULATORY BACKDROP 6 APHIS regulates GE plants under 7 C.F.R. § 340. The regulations date back to 1987, 7 when APHIS first imposed a pre-market authorization requirement and other measures for GE 8 plants if the plants were classified as a “plant pest” under the then-controlling FPPA. 85 Fed. Reg. 9 at 29790; see generally Introduction of Organisms and Products Altered or Produced Through 10 Genetic Engineering Which Are Plant Pests or Which There is Reason to Believe Are Plant Pests, 11 52 Fed. Reg. 22892 (June 16, 1987). A GE plant was classified as a “plant pest” if “it [was] 12 created using an organism that is itself a plant pest,” Ctr. for Food Safety v. Vilsack, 718 F.3d 829, 13 835 (9th Cir. 2013), and so the rule covered most GE plants at the time because the predominant 14 engineering technique used plant-pest material to introduce new genetic characteristics to the 15 target plant, see Movement of Certain Genetically Engineered Organisms, 84 Fed. Reg. 26514, 16 26521 (June 6, 2019). Under the part 340 regulations, plant pests could not be moved interstate or 17 introduced into the environment without notification and a permit, and permitting conditions 18 included record-keeping and labeling requirements. See, e.g., Importation, Interstate Movement, 19 and Release into the Environment of Certain Genetically Engineered Organisms, 73 Fed. Reg. 20 60008, 600010-11 (Oct. 9, 2008). The regulatory scheme reflected a presumption of “plant pest 21 risk, until proven otherwise,” due to the means by which genetic material was introduced into the 22 target plant. Dkt. No. 60 at 6. 23 Between 1987 and the start of the rulemaking process at the heart of this lawsuit, the 24 regulations were revised several times to lessen the regulatory burden on some GE plants. See 84 25 Fed. Reg. at 26514. For example, one set of revisions provided that GE-plant developers could 26 introduce or move in interstate commerce certain crop species without obtaining a permit if certain 27 eligibility requirements were met and the developer went through the agency’s notification 28 procedure. See generally Genetically Engineered Organisms and Products; Notification 3 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 4 of 26 1 Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated 2 Status, 58 Fed. Reg. 17044 (Mar. 31, 1993). Other revisions created a process through which GE- 3 plant developers could petition for deregulation from section 340 altogether by submitting to the 4 agency extensive data pertaining to the GE plant’s plant-pest risk. See generally id. 5 In all of the revisions, GE plants were treated as plant pests for regulatory purposes and so 6 were not subject to the permitting or pre-market-authorization requirements that applied to 7 noxious weeds. APHIS regulated, and continues to regulate, noxious weeds under 7 C.F.R. § 360 8 and prohibits the unauthorized movement of any plant designated as a noxious weed by the 9 Secretary of Agriculture. See id. § 360.300. By its own terms, part 360 regulates noxious weeds 10 by taxon, which is defined as “[a]ny grouping within botanical nomenclature, such as family, 11 genus, species, or cultivar.” See 7 C.F.R. §§ 360.100 (defining “taxon”), 360.200, 360.500-01. 12 The result, then, is that a plant’s GE and non-GE counterparts are treated identically for noxious- 13 weed purposes. Cf. id. at § 360.200 n.1. APHIS does not dispute plaintiffs’ statement that, with 14 one minor exception, the agency does not regulate GE plants under section 360. See Dkt. No. 59 15 at 23 n.39; 7 C.F.R. §360.200 (list of plant taxa designated as noxious weeds). 16 III. THE RULEMAKING SAGA 17 The 2020 final rule plaintiffs challenge is the culmination of nearly 15 years of attempts by 18 APHIS to update the part 340 GE-plant regulations. These attempts entailed multiple proposals, 19 permutations, and withdrawals of proposals. A clear map of this winding road is useful for the 20 resolution of this lawsuit. 21 A. CONTEMPLATING AN OVERHAUL 22 The journey began in 2004 when APHIS published a notice of intent to open public 23 comment and begin an environmental impact study of potential changes to section 340, including 24 an expansion of “its regulatory scope beyond genetically engineered organisms that may pose a 25 plant pest risk to include genetically engineered plants that may pose a noxious weed risk.” 26 Environmental Impact Statement; Introduction of Genetically Engineered Organisms, 69 Fed. 27 Reg. 3271, 3272 (Jan. 23, 2004). 28 4 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 5 of 26 1 The USDA’s Office of Inspector General (OIG) encouraged the agency to implement 2 changes and stated in a 2005 audit report that “APHIS has not finished updating its regulations to 3 comply with the Plant Protection Act of 2000,” “which grant[s] new regulatory authority to the 4 Secretary of Agriculture for controlling noxious weeds.” AR 22970.1 The report noted that 5 “APHIS began the process of updating its regulations” in January 2004 when it published the 6 notice of its intent to “prepare an environmental impact statement . . . in connection with potential 7 changes to the regulations[] regarding the movement and release of certain [GE organisms].” Id. 8 APHIS responded by stating that it would soon complete its study and that “[t]he rule will include 9 the provisions of the Plant Protection Act of 2000.” AR 22973. 10 B. CONGRESSIONAL INTERVENTION 11 Before any proposed updates to part 340 were published, some high-profile instances of 12 transgenic contamination (the unintended cross-pollination of non-GE plants with the modified 13 genetic material of GE plants) prompted APHIS to consider additional changes to section 340. 14 See AR 18415, 27050. In 2007, the agency published a report entitled “Lessons Learned and 15 Revisions under Consideration for APHIS’ Biotechnology Framework” that contained suggestions 16 as to how APHIS could “enhance” its GE-plant rules by, inter alia, requiring (1) the “creation and 17 retention of additional records” by GE-plant developers, AR 18415; (2) permit applications to 18 prepare contingency and corrective-action plans for unauthorized releases of GE material, see 19 AR 18416; and (3) “minimum distances” between GE field test sites and nearby fields to avoid 20 inadvertent contamination events, see AR 18417-18. 21 In 2008, Congress passed legislation directing the agency to “take action on each issue 22 identified” in the 2007 report. Food, Conservation, and Energy Act of 2008 (2008 Farm Bill), 23 Pub. L. No. 110-246, 122 Stat. 1651 § 10204 (codified at 7 U.S.C. § 7701 Note). Specifically, 24 Congress mandated that the agency “take actions that are designed to enhance,” inter alia, “the 25 quality and completeness of records . . . the maintenance of identity and control in the event of an 26 unauthorized release . . . [and] corrective actions in the event of an unauthorized release.” Id. at 27 1 28 “AR” references are to the administrative record, which consists of a dozen volumes containing thousands of pages. See Dkt. Nos. 66, 67, 70. 5 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 6 of 26 1 § 10204(b)(1), (3), & (4). Congress also directed the Secretary to “promulgate regulations to 2 improve the management and oversight of articles” regulated under the PPA “as the Secretary 3 considers appropriate.” Id. at § 10204(a)(2). 4 C. RULEMAKING: 2008-2017 5 In 2008, APHIS published a notice of proposed rulemaking (NPRM) for the part 340 6 regulations to consolidate the agency’s noxious-weed authority under the PPA and address the 7 concerns raised in the 2005 OIG audit report and the 2008 Farm Bill. See 73 Fed. Reg. at 60009- 8 11. The NPRM stated that, “[i]n order to best evaluate the risks associated with these GE 9 organisms and regulate them when necessary, APHIS needs to exercise its authorities regarding 10 noxious weeds . . . in addition to its authority regarding plant pests.” Id. at 60011. The NPRM 11 identified the risks with GE organisms it would consider under its noxious-weed authority, 12 including harms to “irrigation, navigation, the natural resources of the United States, the public 13 health, the environment and interests of agriculture.” Id. at 60014. APHIS received a deluge of 14 comments -- more than 88,000 comments in more than 5,500 submissions -- and ultimately 15 withdrew the proposed rule in 2015 so that it could engage in “an open and robust policy 16 dialogue” with key stakeholders. Importation, Interstate Movement, and Release into the 17 Environment of Certain Genetically Engineered Organisms, 80 Fed. Reg. 11598, 11598 (Mar. 4, 18 2015). 19 In 2015, the OIG published another audit report. The report concluded that APHIS had 20 “not implemented the agreed upon corrective actions for 3 of the 28 recommendations from [the] 21 2005 report,” specifically identifying the recommendation to “incorporat[e] additional authority to 22 control noxious weeds.” AR 23027. APHIS responded that it had attempted to revise the rule in 23 2008 but was obligated to work through the enormous number of comments. AR 23040. 24 Two years after the withdrawal, APHIS announced a new proposed rule that was again 25 said to address the concerns raised in the 2008 Farm Bill, the 2005 OIG audit, and the 2015 OIG 26 audit. See Importation, Interstate Movement, and Environmental Release of Certain Genetically 27 Engineered Organisms, 82 Fed. Reg. 7008, 7011-12 (Jan. 19, 2017). Like its predecessor, the 28 2017 proposed rule would evaluate GE plants for noxious-weed risk. Id. at 7010-11. APHIS 6 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 7 of 26 1 stated that the “current regulatory structure, which entails evaluating such plants solely for plant 2 pest risk, is not sufficient to properly identify all risks that these plants present to other plants and 3 plant products.” Id. at 7010. The agency said that part 340’s focus on plant-pest risks had been 4 workable in the past because “most GE plants to date have been agricultural crops, and most 5 agricultural crops are not biologically weeds prior to modification” and most GE plants were 6 created using plant pests and therefore already fell “under APHIS’ regulatory authority.” Id. The 7 agency believed that approach was no longer tenable because “[a]dvances in genetic engineering 8 have . . . made the need to evaluate GE plants for noxious weed risk more pressing.” Id. at 7009. 9 For the noxious-weed regulations already on the books, APHIS said that they suffered from 10 limitations that made them inadequate for GE-crop oversight. Id. at 7009-10. 11 Even so, the 2017 proposal was not necessarily about regulatory maximalism. APHIS 12 proposed to narrow the regulations by exempting some GE plants altogether from part 340 13 regulation. The biggest change in this respect was the proposal to move away from the prior 14 definition of “GE organism,” which the agency believed was both overinclusive and 15 underinclusive for mitigating risk. See id. at 7009, 7015-16. The agency proposed to exempt GE 16 plants “that could otherwise have been produced using traditional breeding techniques or chemical 17 or radiation-based mutagenesis.” Id. at 7015. This was because “GE plants as a class . . . pose no 18 greater plant pest or noxious weed risk than their counterparts developed through conventional 19 breeding techniques.” Id at 7015-16. The agency acknowledged that the potentially exempt plants 20 are not “risk-free,” id. at 7017, and so proposed to exempt such plants from the blanket permitting 21 requirements of part 340 but to simultaneously amend part 330 regulations to permit some 22 oversight of those exempt GE plants that “pose a potential plant pest risk.” Id. at 7016. 23 In contrast to the prior tidal wave of public comment, the 2017 NPRM elicited only 203 24 comments. Even so, APHIS abruptly withdrew the 2017 NPRM in a one-page notice. See 25 Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered 26 Organisms, 82 Fed. Reg. 51582 (Nov. 7, 2017). APHIS represented that commentators had 27 expressed concern that the proposed rule would “hinder[] innovation” and “could result in the 28 7 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 8 of 26 1 creation of two parallel but inconsistent regulatory systems and thus more regulatory uncertainty.” 2 Id. In effect, APHIS ended 2017 back where it started in 2004. 3 D. RULEMAKING: 2019-PRESENT 4 The rulemaking for GE plants went silent until 2019, when APHIS promulgated a third 5 proposal that ultimately was implemented in 2020 as the final rule in question here. See 84 Fed. 6 Reg. 26514; 85 Fed. Reg. 29790. The final rule revised the scope of regulations under part 340 to 7 reflect the fact that APHIS changed its risk assessment of GE plants to focus on the specific trait 8 introduced in the plant and that trait’s potential to pose plant-pest risks in the modified plant. See 9 generally 7 C.F.R. § 340; 84 Fed. Reg. at 26516-17. 10 Although this revision was anticipated to some extent by the changes announced in 2017, 11 the final rule differed from its predecessors in many respects. In salient part, the final rule 12 categorically exempts GE plants created by conventional-breeding techniques. 7 C.F.R. 13 § 340.1(b). But unlike the 2017 proposal, the final rule does not regulate such plants under part 14 330. Id at §§ 330.200, 340.1-3; 85 Fed. Reg. at 29823. The finale rule excludes from regulation 15 under part 340 GE plants with “plant-trait-mechanism of action” combinations that the agency has 16 determined do not pose plant-pest risks. 7 C.F.R. § 340.1(c). A “mechanism of action” is the 17 “biochemical process(es) through which genetic material determines a trait.” Id. at § 340.3. The 18 final rule does not treat noxious weeds as a trigger for part 340 regulation, unlike the 2008 and 19 2017 proposals. 85 Fed. Reg. at 29822. APHIS said that it was not “statutorily obligated to 20 integrate noxious weed authority into a revised part 340” and that it did “not perceive a basis at 21 this time for overhauling part 360 noxious weed regulations, which we believe have functioned 22 well over the years, or establishing alternate regulations in title 7 governing noxious weeds.” Id. 23 APHIS also said that it would “continue [its] current practice of considering the weediness” of GE 24 plants when it considers their plant-pest risks. Id. Lastly, the final rule extends record retention 25 for GE-plant developers from one year to two years without requiring permit applicants to retain 26 or prepare any new types of records. 7 C.F.R. §§ 340.5, 340.6. 27 28 8 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 9 of 26 1 IV. THIS LITIGATION 2 Plaintiffs have sued to rescind the final rule under the Administrative Procedure Act 3 (APA), Pub. L. No. 404-79, 60 Stat. 237 (codified at 5 U.S.C. § 500 et seq.). The complaint 4 named as defendants the Secretary of Agriculture, the Administrator of APHIS, and the USDA 5 and APHIS as agencies.2 Dkt. No. 1 ¶¶ 29-31. The complaint alleged that the final rule 6 contravened various federal statutes and consequently was arbitrary and capricious. Specifically, 7 plaintiffs alleged that, in promulgating the final rule, the agency failed to heed procedural 8 requirements under the Endangered Species Act of 1973 (ESA), Pub. L. No. 93-205, 87 Stat. 884 9 (codified at 16 U.S.C. § 1531 et seq.), and the National Environmental Policy Act (NEPA), Pub. 10 L. No. 91-190, 83 Stat. 852 (1970) (codified at 42 U.S.C. § 4321 et seq.). Dkt. No. 1 ¶¶ 223-47. 11 Plaintiffs also alleged that the final rule failed to implement directives set forth in the 2008 Farm 12 Bill and that the rule violated the PPA. Id. ¶¶ 248-76. And plaintiffs said that portions of the final 13 rule relating to the exemptions unconstitutionally delegated statutory authority to private parties 14 without Congress’s express authorization. Id. ¶¶ 277-86. The complaint seeks declaratory and 15 injunctive relief, most particularly a remand of the rule to the agency with vacatur. Id. ¶¶ 287-300. 16 Early in litigation, the Court granted permissive intervention to two agricultural-industry 17 trade associations, the American Seed Trade Association and the Biotechnology Innovation 18 Organization (intervenors). Dkt. No. 43. Plaintiffs moved for summary judgment as to four of 19 their five claims. See Dkt. No. 59. APHIS opposed as to all claims asserted in the complaint, see 20 Dkt. No. 60, and intervenors filed an opposition raising additional points against plaintiffs’ 21 motion, see Dkt. No. 63. 22 DISCUSSION 23 I. THE PROPER UNIVERSE OF EVIDENCE 24 Before getting to the merits of the motion, some threshold issues require discussion. To 25 start, the parties disagree about the scope of the record properly before the Court. Plaintiffs’ 26 opening brief featured an abundance of materials that are not part of the agency’s administrative 27 2 28 For clarity and ease of reading, the Court refers to the named defendants together as “the agency” or “APHIS,” unless otherwise noted. 9 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 10 of 26 1 record. See generally Dkt. No. 59. The Court declines to consider most of these materials for any 2 purpose beyond determining standing, see Ecological Rts. Found. v. FEMA, 384 F. Supp. 3d 1111, 3 1119 (N.D. Cal. 2019), which is another dispute that will be discussed next. It is well established 4 that, in a suit brought under the APA to review agency action, “the function of the district court is 5 to determine whether or not as a matter of law the evidence in the administrative record permitted 6 the agency to make the decision it did.” Occidental Engineering Co. v. INS, 753 F.2d 766, 769 7 (9th Cir. 1985). There are limited exceptions to that rule, see Lands Council v. Powell, 395 F.3d 8 1019, 1030 (9th Cir. 2005), but plaintiffs give no good reason for applying an exception. 9 Plaintiffs also agreed in a joint status report to the Court that “there will be no need for any motion 10 practice on the scope of the administrative record.” Dkt. No. 55 at 1. Consequently, there is no 11 basis for the Court to consider much of the extra-record materials. 12 The only small exception to this conclusion is for judicial notice of Exhibits A and C of the 13 Wu Declaration. See Dkt. Nos. 59-20, 59-22. The exhibits are simply the 2008 and 2017 NPRMs. 14 The agency broadly objects to all documents attached to that declaration, see Dkt. No. 60 at 11, 15 but the Court does not understand the agency to suggest that the prior proposed versions of the 16 very rule under review cannot be considered. In any event, judicial notice of those exhibits is 17 appropriate. See Fed. R. Ev. 201(b)(2); 44 U.S.C. § 1507 (“The contents of the Federal Register 18 shall be judicially noticed.”). 19 II. ARTICLE III STANDING 20 To litigate in federal court, plaintiffs must “demonstrate standing to sue by alleging the 21 ‘irreducible constitutional minimum’ of (1) an ‘injury in fact’ (2) that is ‘fairly traceable to the 22 challenged conduct of the defendants’ and (3) ‘likely to be redressed by a favorable judicial 23 decision.’” Patel v. Facebook, Inc., 290 F. Supp. 3d 948, 952 (N.D. Cal. 2018) (quoting Spokeo, 24 Inc. v. Robins, 578 U.S. 330, 338 (2016)), aff’d by Patel v. Facebook, Inc., 932 F.3d 1264 (9th Cir. 25 2019). The elements of standing “must be supported in the same way as any other matter on 26 which the plaintiff bears the burden of proof,” Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 27 (1992), and so at summary judgment, “[a] plaintiff . . . must ‘set forth’ by affidavit or other 28 evidence ‘specific facts,’ which for purposes of the summary judgment motion will be taken as 10 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 11 of 26 1 true,” id. (citation omitted), that show a “substantial probability” of standing, Nat’l Fam. Farm 2 Coalition v. EPA, 966 F.3d 893, 908 (9th Cir. 2020) (quotation omitted). 3 APHIS did not challenge plaintiffs’ standing to sue, see Dkt. No. 60, but intervenors say 4 that plaintiffs have not demonstrated standing, Dkt. No. 63 at 4-7. In addition, the Court “has an 5 independent duty to be vigilant about standing.” Natural Grocers v. Vilsack, 627 F. Supp. 3d 6 1130, 1143 (N.D. Cal. 2022) (quotation omitted). 7 The standing challenge is not well taken. In Monsanto Co. v. Geertson Seed Farms, the 8 Supreme Court of the United States held that farmers of non-GE alfalfa had standing to challenge 9 an agency decision to deregulate GE alfalfa where the record established that: (1) the non-GE 10 alfalfa had a “reasonable probability” of being contaminated by gene flow if GE alfalfa was 11 completely deregulated; and (2) gene flow injured those farmers by, inter alia, requiring them to 12 incur costs for preemptive measures to prevent or test for gene flow and ensure supply of non-GE 13 alfalfa seeds. 561 U.S. 139, 153-55 (2010). 14 So too here. Because the only relief sought is injunctive, see Dkt. No. 59 at 29-30, the 15 Court “need not address standing of each plaintiff” at this juncture. Atay v. Cnty. of Maui, 842 16 F.3d 688, 696 (9th Cir. 2016) (quoting Nat’l Ass’n of Optometrists & Opticians LensCrafters, Inc. 17 v. Brown, 567 F.3d 521, 523 (9th Cir. 2009)). The undisputed evidence establishes that: 18 (1) members of the plaintiff organizations, namely Peter Baumer, Darvin Bentlage, and Jonathan 19 Krohn, are organic or non-GE farmers; (2) if the final rule is allowed to deregulate GE plants, the 20 risk that those members’ farms will experience incidents of transgenic contamination increases 21 beyond a “reasonable probability,” see Dkt. No. 59-1 ¶¶ 8, 12, 14-15; Dkt. No. 59-2 at ¶¶ 7, 13, 22 16; Dkt. No. 59-12 at ¶¶ 9, 11-14; and (3) such contamination will harm their non-GE farming 23 operations, see generally, e.g., Dkt. Nos. 59-1, 59-2, 59-12. Specifically, one farmer says that his 24 non-GE farm is near several GE farms, Dkt. No. 59-1 ¶ 7, which will require measures to stave off 25 contamination, see id. ¶ 11, and the others anticipate incurring greater costs for non-GE seeds, see 26 Dkt. No. 59-2 ¶¶ 7, 16; Dkt. No. 59-12 ¶ 12. Such harms were “sufficiently concrete to satisfy the 27 injury-in-fact prong” in Monsanto, 561 U.S. at 155, and the same goes in this lawsuit. 28 11 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 12 of 26 1 “Those harms are readily attributable to APHIS’s deregulation decision,” id., because the 2 paring back of regulatory oversight is what gives rise to the injuries, see Dkt. No. 59-1 ¶¶ 8, 12, 3 14-15; Dkt. No. 59-2 at ¶¶ 7, 13, 16; Dkt. No. 59-12 at ¶¶ 9, 11-14. This is so notwithstanding 4 some evidence that contamination has occurred in the past and may occur in the future irrespective 5 of the regulatory scheme. E.g., Dkt. No. 59-1 ¶¶ 12-13. “[A] plaintiff may sue [a] defendant” so 6 long as that “defendant is at least partially causing the alleged injury.” Nat’l Fam. Farm 7 Coalition, 966 F.3d at 910 (quoting WildEarth Guardians v. U.S. Dep’t of Agric., 795 F.3d 1148, 8 1157 (9th Cir. 2015)). In addition, a judicial order vacating and remanding the challenged rule 9 would alleviate the increased risk of contamination the evidence shows to be posed by certain 10 aspects of the rule. See Idaho Conservation League v. Bonneville Power Admin., 83 F.4th 1182, 11 1191 (9th Cir. 2023). 12 With respect to the organizations, the record establishes that the interests sought to be 13 protected by Center for Food Safety, of which Baumer and Krohn are members, see Dkt. Nos. 59- 14 1, 59-12, and National Family Farm Coalition, for which Bentlage serves as a board member, see 15 Dkt. No. 59-2, are germane to the organizations’ purposes, see Dkt. No. 1 ¶¶ 20-23, and that 16 nothing about the claims asserted or relief requested requires the members’ individual 17 participation in this litigation. See Oregon Advoc. Ctr. v. Mink, 322 F.3d 1101, 1109 (9th Cir. 18 2003) (quoting Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S. 333, 343 (1977)). 19 Consequently, Article III standing to sue has been demonstrated. As a closing observation, 20 intervenors failed to address governing precedent such as Monsanto and Atay. Dkt. No. 63. Why 21 that happened is unknown, but it substantially diluted their argument. 22 III. LEGAL STANDARDS 23 In reviewing agency action other than the interpretation of a statute, the scope of review 24 under the APA is narrow, and “agency action will be upheld unless it is found to be ‘arbitrary, 25 capricious, an abuse of discretion, or otherwise not in accordance with law.’” Natural Grocers, 26 627 F. Supp. 3d at 1142 (quoting 5 U.S.C. § 706(2)(A)). “Agency action is arbitrary and 27 capricious when the agency ‘relie[s] on factors which Congress has not intended it to consider, 28 entirely fail[s] to consider an important aspect of the problem, [or] offer[s] an explanation for its 12 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 13 of 26 1 decision that runs counter to the evidence before the agency.” Ctr. for Biological Diversity v. U.S. 2 Fish and Wildlife Serv., 67 F.4th 1027, 1035 (9th Cir. 2023) (alterations in original) (quoting 3 Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983)). 4 “[T]he Court will not substitute its own judgment for that of the agency” but will “engage 5 in a careful, searching review to ensure that the agency has made a rational analysis and decision 6 on the record before it.” Ecological Rts. Found., 384 F. Supp. 3d at 1119 (quoting Wild Fish 7 Conservancy v. Salazar, 628 F.3d 513, 521 (9th Cir. 2010)). Consequently, the Court “will not 8 ‘rubber-stamp’ agency decisions that are inconsistent with a statutory mandate or that frustrate the 9 congressional policy underlying a statute.” Id. (quoting Natural Res. Def. Council, Inc. v. 10 Pritzker, 828 F.3d 1125, 1139 (9th Cir. 2016)). “The Court’s deference extends to less than stellar 11 work by an agency, so long as its analytical path and reasoning can be reasonably discerned,” 12 Natural Grocers, 627 F. Supp. 3d at 1142 (quotation omitted), although it is still incumbent on 13 agencies to “engage in ‘reasoned decisionmaking,’” Dep’t of Homeland Sec. v. Regents of the 14 Univ. of Cal., 591 U.S. 1, 16 (2020) (quoting Michigan v. EPA, 576 U.S. 743, 750 (2015)), and 15 “articulate a satisfactory explanation for its action including a ‘rational connection between the 16 facts found and the choice made,’” State Farm Mut. Auto. Ins. Co., 463 U.S. at 43 (quoting 17 Burlington Truck Lines v. United States, 371 U.S. 156, 168 (1962)). 18 “Summary judgment is an appropriate procedure for deciding challenges under the APA.” 19 Natural Grocers, 627 F. Supp. 3d at 1142. And a grant of summary judgment is warranted where 20 there is no genuine dispute of material fact and the moving party is entitled to judgment as a 21 matter of law. See Brickman v. Fitbit, Inc., No. 15-cv-02077-JD, 2017 WL 6209307, at *2 (N.D. 22 Cal. Dec. 8, 2017) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986)). “Because this is 23 a record review case, the summary judgment motion will be decided upon a review of the 24 administrative record as it existed at the time of the agency’s decision.” Natural Grocers, 627 25 F. Supp. 3d at 1142 (citing Karuk Tribe of Cal. v. U.S. Forest Serv., 681 F.3d 1006, 1017 (9th Cir. 26 2012) (en banc)). 27 28 13 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 14 of 26 1 IV. NOXIOUS WEEDS 2 The APA review starts with plaintiffs’ challenges to the rule’s assertedly unlawful failure 3 to incorporate the agency’s noxious-weed authority into the part 340 regulations. Plaintiffs first 4 contend that the failure was contrary to the PPA’s statutory mandate and so the final rule must be 5 set aside on that basis. See Dkt. No. 59 at 22-23. 6 The point is not well taken. “Courts must exercise their independent judgment in deciding 7 whether an agency has acted within its statutory authority.” Loper Bright Enterp. v. Raimondo, --- 8 U.S. ---, ---, 144 S. Ct. 2244, 2273 (2024). There is no question that the PPA expanded the 9 definition of noxious weeds, and so the scope of the agency’s regulatory authority as well, 10 see Pub. L. No. 106-224, 114 Stat. 438 § 403(10) (codified at 7 U.S.C. § 7702(10)), nor is there 11 any dispute the statute charges the agency with the responsibility to “facilitate . . . interstate 12 commerce in agricultural products . . . that pose a risk of harboring plant pests or noxious weeds in 13 ways that will reduce . . . the risk of dissemination of plant pests or noxious weeds,” id. at § 402(3) 14 (codified at 7 U.S.C. § 7701(3)). 15 But plaintiffs did not identify any statutory text that “command[s],” Dkt. No. 59 at 22, the 16 agency to discharge that responsibility in a particular way, let alone plaintiffs’ preferred way. 17 Rather, as the agency notes, see Dkt. No. 60 at 16, the statute is replete with language indicating 18 that the way in which that responsibility is to be discharged is within the agency’s discretion. 19 See, e.g., 7 U.S.C. § 7712(a) (“The Secretary may prohibit or restrict the . . . movement in 20 interstate commerce of any . . . noxious weed[.]” (emphasis added)); id. at § 7712(c) (“The 21 Secretary may issue regulations to implement subsection (a)[.]” (emphasis added)). Where a 22 “statute delegates authority to an agency . . . courts must respect the delegation, while ensuring the 23 agency acts within it.” Loper Bright Enterp., --- U.S. at ---, 144 S. Ct. at 2273. 24 Overall, plaintiffs did not establish that the agency exceeded its statutory authority here. 25 Plaintiffs say the agency itself previously interpreted the PPA as imposing a “statutory duty” to 26 add noxious weeds as a trigger for part 340 regulations. See Dkt. No. 59 at 22-23. Even if an 27 agency’s prior interpretations of a statute in rescinded NPRMs carried some persuasive value, 28 which is not at all clear, see Loper Bright Enterp., --- U.S. at ---, 144 S. Ct. at 2259 (citing 14 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 15 of 26 1 Skidmore v. Swift & Co., 323 U.S. 134 (1944)), the statements plaintiffs proffer were the agency’s 2 conclusions at the time about how to exercise its discretion, not interpretations of a statutory 3 directive, see 73 Fed. Reg. at 60011. 4 Plaintiffs next contend that the final rule’s failure to incorporate noxious weeds as a trigger 5 for part 340 regulations was inadequately explained. This challenge fares better. 6 The parties disagree whether the factors for assessing changes in agency policy set forth in 7 FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009), should guide the analysis here. 8 See Dkt. No. 59 at 23; Dkt. No. 60 at 18-19. The Court sees no reason to wade into that dispute 9 and instead takes guidance from the Ninth Circuit’s discussion in Transportation Division of the 10 International Association of Sheet Metal, Air, Rail, & Transportation Workers v. Federal Railroad 11 Administration (Transp. Workers), 988 F.3d 1170 (9th Cir. 2021). 12 In that case, the Federal Railroad Administration (FRA) issued in 2016 a NPRM that 13 proposed “[a] minimum requirement of two crewmembers . . . for all railroad operations.” Id. at 14 1174 (emphasis omitted) (quoting 81 Fed. Reg. 13918, 13918 (Mar. 15, 2016)). After a public 15 hearing and the comments period, the FRA did not act on the NPRM until issuing an order on May 16 29, 2019. See id. The 2019 order withdrew the 2016 NPRM, purported to preempt any state laws 17 regulating the number of crewmembers for train operations, and “provid[ed] notice of [FRA’s] 18 affirmative decision that no regulation of train crew staffing is necessary or appropriate,” id. at 19 1175-77 (quoting 84 Fed. Reg. 24735, 24735 (May 29, 2019)). The Ninth Circuit understood the 20 “real and intended effect” of the 2019 order was to “authorize nationwide one-person train crews 21 and to bar any contrary state regulations.” Id. at 1182. 22 Reviewing the FRA 2019 order for arbitrariness and capriciousness, the court concluded 23 that the record did not support the order’s conclusions and that the agency’s contemporaneous 24 explanation was inadequate. See id. at 1182-84. In pertinent part, the court concluded that the 25 order did not sufficiently address the safety concerns raised by comments on the NPRM because 26 (1) the order “[did] not discuss crew fatigue at all,” despite the FRA’s own research having 27 identified crewmember fatigue as a “critical component” of safety; (2) it failed to consider 28 concerns about the technical challenges posed by passage over mountainous terrain that “FRA had 15 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 16 of 26 1 previously recognized”; and (3) an “assertion that [the agency] has the inherent authority to 2 implicitly preempt state law does not” explain the reason why the agency exercised its authority in 3 the manner it did. Id. at 1183. 4 APHIS’s 2020 final rule suffers from many of the same infirmities. It did not address 5 concerns about the adequacy of APHIS’s “current practice,” 85 Fed. Reg. at 29822, for regulating 6 GE plants and noxious weeds that the agency had “previously recognized.” Transp. Workers, 988 7 F.3d at 1183. The administrative record includes two OIG audit reports from 2005 and 2015 8 which, as APHIS forthrightly acknowledges, contain recommendations “that incorporating the 9 PPA’s expanded definition of noxious weed into the part 340 Rules would be preferable.” Dkt. 10 No. 60 at 19 (citing AR 22970); see also AR 23027, 23037, 23039; 73 Fed. Reg. at 60009. In 11 addition, APHIS discussed at great length in the 2017 NPRM the shortcomings of the current 12 regulatory regime with respect to GE plants and noxious weeds. APHIS stated that the part 360 13 regulations, “while effective, continue to have a significant restriction that limits their applicability 14 to GE organisms: They are predicated on a determination by APHIS that a taxon is a Federal 15 noxious weed.” 82 Fed. Reg. at 7010. This means that part 360 regulations would cover a GE 16 plant only if the taxon to which it belongs is deemed a noxious weed (in other words, only if both 17 a plant’s GE and non-GE counterparts are deemed to be a noxious weed). See 7 C.F.R. 18 §§ 360.200, 360.500-600. APHIS also said that, “in recent years, there has been an increasing 19 diversity of both agronomic and non-agronomic traits engineered in plants. . . . [and] an increased 20 use of plants in genetic engineering that, in their unmodified state, are known to possess weedy 21 traits,” which poses “a correspondingly higher risk that such a plant may be genetically engineered 22 into a noxious weed.” 82 Fed. Reg. at 7010. Finally, APHIS stated that part 340 “is not sufficient 23 to properly identify all risks that these plants present to other plants and plant products,” for 24 potentially harmful “plants may entirely escape regulation” if the GE plant is not engineered using 25 a plant-pest vector or is not itself deemed to be a plant pest. Id. 26 The final rule does not address a single one of these issues. The rule states that APHIS 27 “disagrees with the proposition that [it] is statutorily obligated to integrate noxious weed authority 28 into a revised part 340” and that it instead believes it has discretion to do so. 85 Fed. Reg. at 16 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 17 of 26 1 29822. But APHIS’s “assertion that it has the . . . authority” to make such a decision “does not 2 address why” it chose to make or not make the decision. Transp. Workers, 988 F.3d at 1183. In 3 the final rule, APHIS “recognize[d]” that genetic engineering could introduce traits that increase 4 the weedy aspects of a plant and stated, “[a]ccordingly, [it] would continue [its] current practice of 5 considering the weediness of the unmodified plant and whether the new trait could in any way 6 change the weediness.” 85 Fed. Reg. at 29822. The rule further provides that APHIS would 7 consider “potential effects on the weediness of other plants with which the engineered plant can 8 interbreed” and “whether the plant with the specific trait being evaluated should be considered for 9 regulation pursuant to” the separate part 360 regulations. Id. Statements about maintaining the 10 status quo sidestep the problems with the status quo that APHIS “had previously recognized.” 11 Transp. Workers, 988 F.3d at 1183. The final rule’s silence on this score indicates that APHIS 12 “failed to consider an important aspect of the problem” that the agency itself had identified. State 13 Farm Mut. Auto. Ins. Co., 463 U.S. at 43. 14 It bears mention that the final rule concludes APHIS does not “perceive a basis at this 15 time” for overhauling its noxious-weed regulations because it “believe[s]” those regulations “have 16 functioned well over the years.” 85 Fed. Reg. at 29822. But the agency’s perceptions and beliefs 17 are of little moment when, as here, they are asserted as fiat untethered to a clear and sound 18 analysis. The agency had in hand OIG audit reports the agency understood to suggest that 19 “incorporating the PPA’s expanded definition of noxious weeds into the part 340 Rules would be 20 preferable.” Dkt. No. 60 at 19. Yet the rule does not address the relevant recommendations in 21 those reports. See, e.g., Rancheria v. Jewell, 776 F.3d 706, 714 (9th Cir. 2015) (“An agency’s 22 decision is arbitrary and capricious if it ignores important considerations or relevant evidence on 23 the record.”). 24 Transportation Workers concluded that FRA’s failure to consider crew fatigue in 25 connection to safety in the final order after the NPRM had identified crew fatigue as a “critical 26 component” of safety was arbitrary and capricious. 988 F.3d at 1183. The same conclusion 27 applies here. APHIS’s failure to address the limitations in the part 360 regulations with respect to 28 GE plants that its prior assessments identified as justifying adding noxious weeds as a trigger to 17 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 18 of 26 1 part 340 regulations was arbitrary and capricious. Ignoring concerns the agency had previously 2 recognized is not “reasoned decisionmaking.” Regents of the Univ. of Cal., 591 U.S. at 16 3 (quoting Michigan, 576 U.S. at 750). 4 APHIS tries to get around all this by saying that it was entitled to disagree, and so not 5 follow, the OIG report recommendations because “neither report discusses the noxious weed 6 authority issue in any depth” and both “merely assume, without analysis,” that incorporation is 7 preferable. Dkt. No. 60 at 19. That response might have been adequate if the agency had said it at 8 the time. It did not, and so that reason does not carry the day now. See, e.g., State Farm Mut. 9 Auto. Ins. Co., 463 U.S. at 50 (“[A]n agency’s action must be upheld, if at all, on the basis 10 articulated by the agency itself.”). APHIS says that it was not required to “stay true to the ‘very 11 genesis of the rulemaking history’” in promulgating the final rule and that the final rule need only 12 have been a “logical outgrowth” of the NPRMs with a reasonable explanation. Dkt. No. 60 at 18- 13 20 (emphasis in original). That may be, but those comments do not excuse it from complying with 14 the APA’s basic requirement that agencies articulate the bases of their decisions. See, e.g., 15 Arrington v. Daniels, 516 F.3d 1106, 1112-13 (9th Cir. 2008). 16 V. EXEMPTIONS 17 As a brief overview for the ensuing discussion, the final rule provides exemptions for: (1) 18 GE crops that can be created through conventional-breeding techniques, see 7 C.F.R. § 304.1(b); 19 (2) GE crops with certain “plant-trait MOAs,” see id. § 340.1(c); and (3) GE crops previously 20 determined to fall outside part 340’s scope under the “Am-I-Regulated” (AIR) process, see id. 21 § 340.1(d). Plaintiffs challenge the exemptions as arbitrary and capricious because they were not 22 based on “sound science.” Dkt. No. 59 at 20-22; Dkt. No. 65 at 7-8. Plaintiffs also say that the 23 agency’s decision to not require field test data for still-regulated GE crops was arbitrary and 24 capricious for the same reason. Dkt. No. 59 at 20. 25 APHIS suggests in a footnote that plaintiffs waived any claim that the exemptions are 26 arbitrary and capricious and may only rely on “the PPA’s ‘sound science’ standard.” Dkt. No. 60 27 at 15 n.7. This misconstrues plaintiffs’ challenge. Their theory is that the agency’s failure to 28 ground its decisions on the PPA on “sound science” renders those decisions arbitrary and 18 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 19 of 26 1 capricious. See, e.g., Dkt. No. 1 at 82 ln. 15, ¶¶ 262-70 (alleging that the agency’s “Failure to 2 Base Decisions on Sound Science” is a reason for concluding that the agency’s “decision violated 3 the PPA and the APA as it is” arbitrary and capricious); Dkt. No. 59 at 15. 4 A. THE CONVENTIONAL-BREEDING EXEMPTION 5 Plaintiffs first say that “there is no scientific basis” for the conventional-breeding 6 exemption because the scientific evidence in the record bearing on this point, namely a 2002 study 7 from the National Academy of Sciences (NAS), “specifically rejected this rationale.” Dkt. No. 8 59 at 21 (emphasis in original) (quotation omitted). Charging plaintiffs with cherry picking, 9 APHIS says that the 2002 NAS study also concluded that “the genetic engineering process, per se, 10 presents no new categories of risk compared to conventional breeding.” Dkt. No. 60 at 23 11 (quoting AR 20484). APHIS says that, because conventional breeding poses risks that are 12 “manageable by accepted standards,” according to a 1989 report by the National Research Council 13 (NRC), the GE crops covered by the exemption “are the same in kind as, and do not pose any 14 increased plant pest risks than, the [changes] introduced through conventional breeding,” which 15 “have not led to plant pest risk concerns.” 85 Fed. Reg. at 29792, 29794; see Dkt. No. 60 at 23- 16 24. In the agency’s view, nothing in the record “suggests that the scientific evidence employed 17 was anything but sound.” Dkt. No. 60 at 24. 18 The flaw of this rationale is in the premise -- “the types of traits that can be introduced 19 through conventional breeding have not led to plant pest risk concerns,” 85 Fed. Reg. at 29792 -- 20 and the record with respect that statement. There is no dispute that APHIS relied on the 1989 21 NRC study, which concludes that “[p]lants modified by classical genetic methods are . . . 22 ‘manageable by accepted standards.’” AR 5424. But as plaintiffs state, this was expressly 23 repudiated by other more-recent scientific evidence in the record. The 2002 NAS study 24 acknowledged that “[i]n the 1980s . . . an assumption was made that, even though conventionally 25 bred crops were not considered to be completely risk free, the risks associated with the entire class 26 of crops should be considered ‘acceptable’ to society.” AR 20519. It concluded that “the 27 assumption that all conventionally bred crops have ‘acceptable risks’ is not scientifically justified” 28 19 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 20 of 26 1 and therefore “[t]he risks associated with crop cultivars that have been or could be developed 2 through conventional breeding should not be assumed to be acceptable.” AR 20520-21. 3 “An agency conclusion that is in ‘direct conflict with the conclusion of its own experts’ . . . 4 is arbitrary and capricious.” NRDC, Inc. v. Pritzker, 828 F.3d 1125, 1139 (9th Cir. 2016) (quoting 5 W. Watersheds Proj. v. Kraayenbrink, 632 F.3d 472, 492 (9th Cir. 2011)). Nowhere in the final 6 rule does APHIS acknowledge the conflicting scientific evidence concerning the basis on which 7 the exemption is premised. See 85 Fed. Reg. at 29791-94. That is arbitrary and capricious. See 8 Alaska Oil & Gas Ass’n v. Pritzker, 840 F.3d 671, 679 (9th Cir. 2016). 9 As a closing point, APHIS says that “the whole point of Part 340 has always been to create 10 a special, heightened set of regulations to protect against the potential for increased plant pest 11 risks from certain GE crops -- not to eliminate that risk altogether.” Dkt. No. 60 at 21-22 12 (emphasis in original); see 85 Fed. Reg. at 29794. But that contention still takes the risk from 13 conventionally bred plants as the baseline on which the scope of regulatory oversight should be 14 defined, a premise the 2002 NAS study concluded is “not scientifically justified,” and to this the 15 final rule says nothing. AR 20519-22. This is not to suggest APHIS cannot take this position 16 after reasoned consideration of other evidence or its own expertise, but it must provide an 17 “adequate explanation and support for its determinations.” Ctr. for Biological Diversity, 900 F.3d 18 at 1069 (quoting San Luis & Delta-Mendota Water Auth. v. Jewell, 747 F.3d 581, 625 (9th Cir. 19 2014)). 20 B. PLANT-TRAIT MOA EXEMPTION & FIELD TEST DATA 21 Plaintiffs challenge the rule’s plant-trait MOA exemptions, 7 C.F.R. § 340.1(c), and the 22 portion of the rule that does not require GE-crop developers to submit field test data for regulatory 23 status review, see id. at § 340.4, for the same basic reason: the 2002 NAS study concluded there 24 was “no scientific basis” to forego an “initial review of the interactions between the ‘trait, [specific 25 GE] organism, and the environment” for “any GE crops.” Dkt. No. 59 at 21-22 (quoting 26 AR 20515). Plaintiffs say that is what the final rule does by not requiring field test data and 27 exempting certain plant-trait MOAs. 28 20 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 21 of 26 1 The point is not well taken. The final rule acknowledges comments suggesting that every 2 GE crop should be assessed with “case-by-case analysis and controlled field experiments,” as well 3 as the 2002 NAS study’s conclusion that “genetic engineering [i.e., transformation]” is “‘both a 4 useful and justifiable regulatory trigger’ because ‘there is no scientific basis’” for excluding GE 5 organisms from regulation prior to some initial review. 85 Fed. Reg. at 29797. Right after, the 6 rule states that “APHIS disagrees with these points” “[b]ased on the risk assessments [the agency 7 has] performed in accordance with the petition process over 30 years.” Id. This experience is said 8 to have persuaded APHIS that it is “able to evaluate the plant pest risks associated with a GE 9 organism without field-test data” because “the introduced trait of the GE organism provides the 10 most reliable indicator of the organism’s potential for deleterious effects on plants and plant 11 products” -- a conclusion the rule states is consistent with a 2016 NAS study and the 1989 NRC 12 study. Id. The rule also notes that the 2002 NAS study also observed that “the committee expects 13 that most [GE organisms] will not produce significant actual environmental risks” and then 14 explains why the agency thinks the proposed rule strikes the proper balance in regulatory burden 15 by discriminating between risky and non-risky GE organisms per the 2002 study’s 16 recommendations. Id. 17 Unlike its decision-making for the conventional-breeding exemption, APHIS recognized 18 contrary scientific evidence and explained its disagreement with it based on other scientific 19 evidence, namely its own expertise from three decades’ worth of regulatory analyses. Agencies 20 need not credit every piece of scientific evidence before them, and they are permitted to credit 21 their own experts over others. See Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 22 378 (1989). To reiterate, the Court’s task in an APA review case is to “ensure that the agency has 23 made a rational analysis and decision on the record before it,” not to “substitute its own judgment 24 for that of the agency.” Ecological Rts. Found., 384 F. Supp. 3d at 1119 (quoting Salazar, 628 25 F.3d at 521). Deference to the agency in the exercise of delegated authority in connection with 26 technical matters such as these is appropriate where the record shows that the agency accounted 27 for the relevant evidence and offered an explanation implicating its expertise. See, e.g., Ctr. for 28 Biological Diversity, 900 F.3d at 1067; Ctr. for Food Safety v. Regan, 56 F.4th 648, 666-67 (9th 21 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 22 of 26 1 Cir. 2022). The record indicates that APHIS supported its views with scientific evidence, and 2 plaintiffs make no argument that the rule conflicts with, or is unsupported by, the evidence on 3 which the agency purported to rely or that there was other evidence undermining the conclusions 4 the agency drew from its expertise. 5 C. EXEMPTIONS GENERALLY 6 Plaintiffs make a catch-all argument that there was not a sound scientific basis in the 7 record for creating any exemptions because the 2002 NAS study concluded the mere fact of 8 genetic engineering is a logical and scientifically justifiable trigger for regulation. See Dkt. No. 59 9 at 20-21. For the reasons already discussed, this argument is misdirected. The agency was 10 entitled to credit its own expertise and experience over the study’s conclusions and in fact did so. 11 Plaintiffs develop no further argument challenging the AIR-process exemption under 7 C.F.R. 12 § 340.1(d). 13 VI. OTHER ISSUES 14 Plaintiffs take some shots at other aspects of the final rule. Plaintiffs say the rule is 15 arbitrary and capricious because, “[r]ather than increasing management and oversight, the [final 16 rule] significantly reduces what will be regulated,” Dkt. No. 59 at 27 (emphases in original), and 17 so contravenes the 2008 Farm Bill’s directive to APHIS to “improve the management and 18 oversight of articles regulated under the [PPA].” Pub. L. No. 110-246, 122 Stat. 1651 19 § 10204(a)(2) (codified at 7 U.S.C. § 7701 Note). 20 The argument misses the mark. The statute says that the Secretary of Agriculture “shall as 21 the Secretary considers appropriate, promulgate regulations to improve the management and 22 oversight of articles regulated under the [PPA].” Id. (emphasis added). “Increase” is not a 23 synonym for “improve,” and the plain text of the statute grants the agency the discretion to decide 24 what constitutes improvement and how to go about achieving it. Moreover, the statute does not 25 define what is an “article[] regulated under the [PPA]”; it only directs the Secretary to promulgate 26 regulations, if deemed appropriate, in connection with articles that are so regulated. Id. The fact 27 that the rule does not increase regulatory oversight is not itself a basis for concluding the agency 28 flouted a statutory directive. 22 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 23 of 26 1 Plaintiffs also say the final rule ignores Congress’s directives to the agency to “take action 2 on each issue identified in the document entitled ‘Lessons Learned and Revisions Under 3 Consideration for APHIS[.]’” 122 Stat. 1651 § 10204(a)(1) (codified at 7 U.S.C. § 7701 Note). 4 They point to subsection (b), which specifies that, “[i]n carrying out subsection (a), the Secretary 5 shall take actions that are designed to enhance,” in relevant part, “the quality and completeness of 6 records[,]” “the availability of representative samples[,]” “the maintenance of identity and control 7 in the event of an unauthorized release[,]” and “corrective actions in the event of an unauthorized 8 release[.]” Id. § 10204(b)(1)-(4). 9 It is true the subjects for action identified in the statute track the “list of lessons learned” in 10 the report that APHIS composed in 2007 based on its “LibertyLink investigation and from its 20 11 years of experience in the regulation of biotechnology.” AR 18415, 18419. But the statute does 12 not say that the actions to be taken are the suggestions APHIS explored in the report; the statute 13 instead appears to leave to the agency’s discretion the decision of what action to take on the 14 specified topics. See 122 Stat. 1651 § 10204(a), (b). Nor does it make sense to read subsection 15 (b) as directing the agency to undertake those courses of action suggested in the report given that 16 subsection (c) clearly delineates a series of more specific actions the agency “shall consider” 17 undertaking. Id. § 10204(c). If Congress wanted APHIS to act on the specific proposals, it knew 18 how to say so. Consequently, plaintiffs’ sole argument that the final rule contravenes the 2008 19 Farm Bill because it “utterly fails to carry out the proposed revisions” fails. Dkt. No. 59 at 28. 20 VII. REMEDY 21 Summary judgment is granted to plaintiffs on the PPA-based APA claim. See Dkt. No. 1 22 ¶¶ 248-270. The final rule is remanded to the agency for further proceedings consistent with this 23 order. 24 The remaining question concerns vacatur. “Ordinarily when a regulation is not 25 promulgated in compliance with the APA, the regulation is invalid,” Idaho Farm Bureau Fed. v. 26 Babbitt, 58 F.3d 1392, 1405 (9th Cir. 1995), and so “[r]emand with vacatur is the typical remedy,” 27 Natural Grocers, 627 F. Supp. 3d at 1149 (citing All. for the Wild Rockies v. U.S. Forest Serv., 28 907 F.3d 1105, 1121-22 (9th Cir. 2018)). But the Court may “leave invalid agency action in place 23 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 24 of 26 1 when equity demands that we do so.” Regan, 56 F.4th at 663 (cleaned up) (quoting Pollinator 2 Stewardship Council v. EPA, 806 F.3d 520, 532 (9th Cir. 2015)). The equitable inquiry requires 3 balancing “the seriousness of the agency’s errors against ‘the disruptive consequences of an 4 interim change that may itself be changed.’” Id. (quoting Cal. Cmtys. Against Toxics v. EPA, 688 5 F.3d 989, 992 (9th Cir. 2012)). Weighing the seriousness of an agency’s errors entails assessing 6 “whether the agency would likely be able to offer better reasoning . . . [such that] it could adopt 7 the same rule on remand, or whether such fundamental flaws in the agency’s decision make it 8 unlikely that the same rule would be adopted on remand.” Pollinator Stewardship Council, 806 9 F.3d at 532. 10 APHIS’s errors are significant. For over a decade it believed it should incorporate its 11 noxious-weed authority into its part 340 regulations due to specific concerns APHIS itself 12 identified. The final rule does the opposite without so much as a mention of the concerns 13 identified in the prior NPRMs. This is not an error of a “technical nature.” Nat’l Fam. Farm 14 Coalition, 966 F.3d at 929. The error undergirding the conventional-breeding exemption is also 15 substantial, for the rule ignores scientific evidence suggesting that its premise is without scientific 16 basis. Consequently, it is unclear that APHIS would “adopt the same rule on remand.” Pollinator 17 Stewardship Council, 806 F.3d at 532. 18 APHIS says in a single sentence that the Court “should only vacate any portion of the rule 19 applicable to the error found, and not the entire Rule.” Dkt. No. 60 at 40. The point seems 20 sensible enough as it relates to the conventional-breeding exemption, but how partial vacatur 21 would work as to the noxious-weed error is unexplained by the agency. “The Court does not 22 review a party’s motion papers and offer coaching pointers for a second round of briefs. The 23 burden is on the party to make its case in the first instance, as it sees fit.” In re Google Play Store 24 Antitrust Litig., 556 F. Supp. 3d 1106, 1108 (N.D. Cal. 2021). APHIS provided no good reason 25 for concluding that something beside the normal remedy of complete vacatur is warranted. 26 Turning to the consequences of vacatur, the record is slight. APHIS says that vacatur 27 “would jeopardize the agency’s regulatory work . . . and require a disruptive switch back to the 28 prior regulatory framework[] after years of reliance on the new one.” Dkt. No. 60 at 40. The 24 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 25 of 26 1 jeopardy point is inherent in vacating any regulation, and the agency does not say why that 2 consequence is somehow unusual here. For the disruption comment, APHIS did not point to 3 anything in the record indicating that the ostensible disruption outweighs the seriousness of the 4 rule’s flaws. See Nat’l Fam. Farm Coalition, 966 F.3d at 929-30 (observing “there is evidence of 5 potentially serious disruption if a pesticide that has been registered for over five years can no 6 longer be used”); Ctr. for Food Safety, 56 F.4th at 668 (noting that “vacating the sulfoxaflor 7 registration would disrupt many agricultural sectors, which could cause ‘yield quantity losses’”); 8 see also Idaho Farm Bureau Fed., 58 F.3d at 1405-06 (looking to the record for possible effects of 9 leaving the rule in place). 10 Intervenors did not fill in the gap. They allege harm to farmers, consumers, GE crop 11 developers, and the agricultural sector generally if the final rule is vacated and the pre-2020 12 regime is restored. See Dkt. No. 63 at 7-10. But, despite being agricultural trade associations, id. 13 at 1 n.1, intervenors adduced no evidence to support their concerns. As the record currently 14 stands, there is no non-speculative basis for assessing the degree and gravity of disruption if the 15 challenged rule is vacated. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-251 (1986). 16 All that being true, the Court is mindful that the rule took effect in 2020 and that this area 17 of our national agricultural economy is rapidly developing. See Dkt. No. 80 at 4 (stating that “at 18 least 99 new GE plants have been exempted” since the rule’s adoption in 2020). With respect to 19 GE organisms that have been introduced or moved without a permit or pursuant to streamlined 20 procedures under the final rule, but that would have had to meet more stringent requirements 21 under the pre-2020 regime, “[t]he egg has been scrambled” and retroactive vacatur “seems an 22 invitation to chaos.” Sugar Cane Growers Co-op. of Florida v. Veneman, 289 F.3d 89, 97 (D.C. 23 Cir. 2002). 24 Consequently, the Court concludes that the remedy that best balances the law and that 25 which “equity demands,” Pollinator Stewardship Council, 806 F.3d at 532 (quotation omitted), is 26 vacatur of the final rule as of the date of this order. Plaintiffs themselves recognize that this form 27 of vacatur suffices to return the industry and GE-crop regulation to the status quo ante. See Dkt. 28 No. 59 at 30. 25 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 26 of 26 1 CONCLUSION 2 Summary judgment is granted to plaintiffs on the PPA-based APA claim that it was 3 arbitrary and capricious for APHIS to not incorporate its noxious-weed authority in the final rule 4 and to implement the conventional-breeding exemptions. Summary judgment is granted to the 5 agency on plaintiffs’ sub-delegation claim3 and 2008 Farm Bill-based APA claim. The final rule 6 is vacated as of the date of this order and is remanded to APHIS for reconsideration consistent 7 with this order. The parties are directed to file by January 13, 2025, a joint statement addressing 8 what effect, if any, this order will have on the rule identifying additional GE organisms qualified 9 for exemption. See Movement of Organisms Modified or Produced Through Genetic Engineering; 10 Notice of Additional Modifications Exempt Plants Can Contain, 89 Fed. Reg. 89569 (Nov. 13, 11 2024); Dkt. Nos. 79-80. The parties are also directed to jointly propose a status conference date 12 for the remaining procedural challenges under the ESA and NEPA. 13 IT IS SO ORDERED. 14 Dated: December 2, 2024 15 16 JAMES DONATO 17 United States District Judge 18 19 20 21 22 23 24 25 26 27 3 28 The agency sought summary judgment on this claim, see Dkt. No. 60 at 39, and plaintiffs did not oppose, see Dkt. No. 65. 26 United States District Court Northern District of California today that genetically engineered (GE) organisms must be regulated. The Court's ruling overturns the 2020 rule overhaul by the first Trump administration that had eliminated most government oversight over GE crops, trees, and grasses.

"This is a critical victory on behalf of farmers, the planet, and scientific integrity," said George Kimbrell, legal director for the lead plaintiff Center for Food Safety, and counsel in the case. "USDA tried to hand over its job to Monsanto and the pesticide industry and the Court held that capitulation contrary to both law and science."

The ruling is a rebuke of the first Trump administration's efforts to practically eliminate oversight of novel GE technology and instead let industry self-regulate. Previously, nearly all GE plants went through agency approval before experimental planting and again before any commercial use. Center for Food Safety and allies sued USDA in 2021 to reverse this rollback, arguingCase 3:21-cv-05695 Document 1 Filed 07/26/21 Page 1 of 91 1 GEORGE KIMBRELL (Pro Hac Vice pending) AUDREY LEONARD (Pro Hac Vice pending) 2 AMY VAN SAUN (Pro Hac Vice pending) MEREDITH STEVENSON (CA Bar No. 328712) 3 Center for Food Safety 303 Sacramento Street, 2nd Floor 4 San Francisco, CA 94111 Phone: (415) 826-2770 5 Emails: gkimbrell@centerforfoodsafety.org aleonard@centerforfoodsafety.org 6 avansaun@centerforfoodsafety.org mstevenson@centerforfoodsafety.org 7 Counsel for Plaintiffs 8 9 10 THE UNITED STATES DISTRICT COURT 11 FOR THE NORTHERN DISTRICT OF CALIFORNIA 12 13 NATIONAL FAMILY FARM ) Case No. 21-5695 COALITION, CENTER FOR FOOD ) 14 SAFETY, PESTICIDE ACTION ) NETWORK NORTH AMERICA, ) COMPLAINT FOR 15 CENTER FOR ENVIRONMENTAL ) DECLARATORY AND 16 HEALTH, FRIENDS OF THE EARTH, ) EQUITABLE RELIEF and, CENTER FOR BIOLOGICAL ) 17 DIVERSITY, ) ) 18 Plaintiffs, ) 19 ) v. ) 20 ) TOM VILSACK, in his official capacity ) 21 as Secretary of the United States ) 22 Department of Agriculture, KEVIN ) SHEA, in his official capacity as ) 23 Administrator of the Animal and Plant ) Health Inspection Service, the ) 24 UNITED STATES DEPARTMENT OF ) 25 AGRICULTURE, and ANIMAL AND ) PLANT HEALTH INSPECTION ) 26 SERVICES, ) ) 27 Defendants. ) 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 2 of 91 1 TABLE OF CONTENTS 2 3 INTRODUCTION AND NATURE OF ACTION…………………………………….…… 1 4 JURISDICTION AND VENUE………………………………………………………………5 5 PARTIES…………………………………………………………………………………...……5 6 LEGAL AUTHORITY……………………………………………………………………..…..9 7 FACTUAL ALLEGATIONS…………………………………………………………….…..20 8 I. GE ORGANISMS IN THE U.S…………………………………………..………20 9 Contamination Harms……………………………………………………….22 10 A Pesticide-Promoting System………………………………………...……25 11 Other GE Harms………………………………………………………….…..34 12 II. PROCEDURAL HISTORY………………………………………………………40 13 The Prior Regulations…………………………………………………….….41 14 New Authority: The Plant Protection Act…………………………...……44 15 The Long Road to New PPA Implementing Regulations……………….45 16 The Final Rule…………………………………………………………...……56 17 Major Problems with the Final Rule………………………………..……..61 18 Effects of the Decision on Endangered Species and their Habitats…..67 19 Harm to Plaintiffs…………………………………………………………….69 20 CLAIMS FOR RELIEF…………………………………………………………………..…..74 21 FIRST CAUSE OF ACTION: VIOLATION OF ESA……………………………74 22 SECOND CAUSE OF ACTION: VIOLATION OF NEPA AND APA…….…..78 23 THIRD CAUSE OF ACTION: VIOLATION OF PPA AND APA…………..….80 24 FOURTH CAUSE OF ACTION: VIOLATION OF THE 2008 FARM BILL…84 25 FIFTH CAUSE OF ACTION: UNCONSTITUTIONAL SUB-DELEGATION 26 OF STATUTORY AUTHORITY…………………………………………………....85 27 RELIEF REQUESTED…………………………………………………………………..…..87 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF i CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 3 of 91 1 Plaintiffs National Family Farm Coalition, Center for Food Safety, Pesticide 2 Action Network North America, Center for Environmental Health, Friends of the 3 Earth, and Center for Biological Diversity (collectively, Plaintiffs) on behalf of 4 themselves and their members, allege as follows: 5 INTRODUCTION AND NATURE OF ACTION 6 1. This case is about whether or not both experimental and 7 commercialized genetically engineered (GE) organisms will remain regulated by the 8 federal government, or if they will now effectively be left to the devices of their 9 manufacturers, to experiment, plant, and sell them as they self-interestedly see fit, 10 without any further oversight by the U.S. Department of Agriculture (USDA), 11 regardless of their agronomic risks to U.S. agriculture or their environmental risks 12 to soils, waterways, native ecosystems, and endangered species. 13 2. For over twenty-five years, USDA has been charged with overseeing a 14 significant range of genetically engineered organisms, from experimental GE crops, 15 grasses, and tree species to GE commodity crops. And twenty-five years of evidence 16 shows that GE crops carry significant adverse agricultural environmental risks, 17 including but not limited to: transgenic contamination1 (gene flow from GE crops to 18 related conventional or organic cultivars or wild species); significant increases in 19 herbicide use from genetically engineered herbicide-resistant crop systems, which 20 are the vast majority of all GE crops; and the proliferation of “superweeds”— 21 resistant to these herbicides. 22 3. Accordingly, among other things, during that time USDA had to 23 approve, or “deregulate” a specific GE crop variety before it could be 24 commercialized. And, before an experimental GE crop could be open-air field tested, 25 26 1 The term “transgenic” is used synonymously with “genetically engineered” or “GE” 27 in this complaint, even though technically GE is the broader term, as it 28 encompasses techniques that introduce genes native to the recipient species, or directly manipulate an organism’s genes (e.g. gene editing). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 1 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 4 of 91 1 USDA had to approve such an experiment and oversee it. These actions required, 2 among other things, the submission of data by the GE crop proponent, public notice 3 and comment, and approval under USDA’s GE crop regulations, 7 C.F.R. Part 340, 4 as well as analysis under the National Environmental Policy Act (NEPA) and the 5 Endangered Species Act (ESA). Stakeholders disagreed about the rigor of USDA’s 6 oversight of GE crops, but oversight it was. 7 4. After nearly two decades of proposed rules, withdrawals, stakeholder 8 comments, and government audit reports, the agency announced proposed new GE 9 crop regulations in 2019. However in a radical departure from previous rule 10 iterations, the third proposed rule, among other changes, failed to invoke USDA’s 11 noxious weed authority under the Plant Protection Act. Nor did it explain its 12 departure from years of detailed environmental analyses and proposed rules which 13 insisted upon the necessity of incorporating this authority to forestall the harms of 14 GE organisms to U.S. agriculture and the environment. 15 5. Last year, the Trump administration’s final rule amending 7 C.F.R. 16 Part 340 fundamentally altered that regulatory system. Going forward and 17 indefinitely, GE organisms will no longer be subject to USDA oversight and 18 approval before open-air experiments and before commercial sale and planting. 19 Since there will no longer be a USDA final agency approval action under the 20 Administrative Procedure Act (APA), there will not be any analysis or transparency 21 under NEPA or the ESA of GE crops’ agricultural or environmental risks. In effect, 22 USDA has attempted to get out of the regulation business entirely in this area. 23 6. In so doing, USDA unconstitutionally delegated its own duties to 24 protect farmers and the environment to GE crop developers. It also violated the 25 statute it is supposed to be implementing in this area, the Plant Protection Act 26 (PPA), as well as NEPA, the ESA, the APA, and the 2008 Farm Bill, which 27 supplemented the PPA by requiring new protections for GE crop open-air 28 experiments. In fact, as explained later, this final decision is made worse when COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 2 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 5 of 91 1 shown against the long procedural history of this rulemaking: started in 2004 and 2 long intended to effectuate Congressional intent to improve USDA’s oversight, not 3 eliminate it. For all of these reasons, the Court should vacate and remand the final 4 rule. 5 7. More specifically, this case challenges USDA’s final rule on “Movement 6 of Certain Genetically Engineered Organisms,” 7 CFR Parts 340 and 372. 7 8. Plaintiffs National Family Farm Coalition, Center for Food Safety, 8 Pesticide Action Network North America, Center for Environmental Health, 9 Friends of the Earth, and Center for Biological Diversity, on behalf of their 10 adversely affected members, challenge Defendants’ May 18, 2020 final rule 11 amending those rules, to remove oversight for GE organisms. The final rule violates 12 the PPA, NEPA, ESA, APA, the 2008 Farm Bill’s GE crop provisions, the 13 Constitution, and is arbitrary, capricious, and contrary to law. 14 9. First, the final rule fails to comply with the ESA because USDA did 15 not undertake the required ESA Section 7 consultation process with the expert 16 Wildlife Services before taking action that may affect listed species and/or their 17 designated critical habitat. The experimental and commercial planting of GE 18 organisms without individual agency approvals allows GE organisms to be released 19 into the environment without individual assessments. The wholesale exemption of 20 many future GE organisms such as GE grasses, trees, and other plants, and the 21 overall relaxation of these regulations has the potential to affect—and likely cause 22 significant harm to—many broad categories of endangered species and their 23 habitat, including endangered plants, insects, birds, and mammals. USDA was 24 required to undertake consultation to understand the effects of its decision on 25 endangered species and their critical habitats and to protect against those effects. 26 10. Second, the final rule fails to comply with NEPA’s mandates, our basic 27 environmental charter, for multiple reasons, including that USDA did not explore 28 reasonable alternatives that would be more protective to the environment than its COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 3 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 6 of 91 1 chosen action, did not adequately analyze direct, indirect, and cumulative impacts, 2 and improperly relied on voluntary mitigation measures from private entities. 3 11. Third, the final rule fails to comply with the PPA’s mandates because 4 it does not implement a full half of USDA’s statutory authority—its noxious weed 5 authority—to fulfill its responsibility to mitigate noxious weed harms of GE 6 organisms, despite the overdue implementation of that PPA authority being a major 7 reason for this rulemaking in the first place. It also violates the PPA’s requirement 8 that USDA’s decisions be based on sound science. 9 12. Fourth, the final rule fails to comply with the 2008 Farm Bill, which 10 included specific new strengthening mandates for GE crop experiments because 11 already too lax USDA oversight had caused contamination and market rejection 12 harm to U.S. farmers. Yet, by creating broad exemption categories and instituting a 13 self-determination scheme, USDA failed to implement the Farm Bill’s 14 requirements, instead opting for less oversight, not more. 15 13. Fifth and finally, the rulemaking violates the Constitution and the 16 separation of powers principles by placing agency authority in the hands of self- 17 interested private parties without retaining oversight. Because the new rules give 18 private entities carte blanche to “self-determine” their own products’ regulation 19 without any future oversight from USDA (or the courts), USDA has 20 unconstitutionally sub-delegated its own regulatory duties to private industry. 21 14. Accordingly, Plaintiffs ask this Court to: (1) declare that USDA’s final 22 rule for the regulation of GE organisms is arbitrary, capricious, and in violation of 23 the, ESA, NEPA, APA, PPA, the 2008 Farm Bill, and the Constitution; (2) vacate 24 the May 18, 2020 final rule; (3) order USDA to implement its noxious weed 25 authority under the PPA and (4) order USDA to undertake ESA consultation and 26 further NEPA analysis before promulgating new, meaningful GE organisms in 27 accordance with the controlling statutes according to a court-mandated schedule. 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 4 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 7 of 91 1 JURISDICTION AND VENUE 2 15. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 3 1331 (federal question) and 28 U.S.C. § 1346 (United States as Defendant). 4 16. Plaintiffs have a right to bring this action pursuant to the APA, 5 5 U.S.C. § 702. 6 17. The relief requested is specifically authorized pursuant to 5 U.S.C. § 7 706(2)(A) (holding unlawful and setting aside agency actions that are arbitrary, 8 capricious, or otherwise not in accordance with law) and 28 U.S.C. §§ 2201-02 9 (declaratory and equitable relief). An actual controversy exists between the parties 10 within the meaning of 28 U.S.C. § 2201. 11 18. The Court has jurisdiction to review USDA’s failure to consult with the 12 Services under the citizen suit provision of the ESA, 16 U.S.C. §1540(g)(1), which 13 provides that the “district courts shall have jurisdiction . . . to enforce any such 14 provision or regulation” of the ESA. As required by the ESA, Plaintiffs provided 15 sixty days’ notice of their intent to sue by the letter sent to USDA and the Services 16 on July 28, 2020.2 USDA has not remedied the violations set out in that sixty-day 17 notice. See id. § 1540(g)(2)(A). 18 19. Venue properly lives in this Court pursuant to 28 U.S.C. § 1391(e) 19 because one or more of the Plaintiffs reside in this District. 20 PARTIES 21 Plaintiffs 22 20. Plaintiff Center for Food Safety (CFS) brings this action on behalf of 23 itself and its members. CFS is a public interest, non-profit, membership 24 organization that has offices in San Francisco, CA; Portland, OR; and Washington, 25 26 2 See Center for Food Safety, Sixty-Day Notice of Intent to Sue APHIS Pursuant to 27 the Endangered Species Act (July 28, 2020), 28 https://www.centerforfoodsafety.org/files/2020-07-28-aphis-60-day-notice-letter- final_79309.pdf. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 5 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 8 of 91 1 D.C. CFS represents over 950,000 members, from every state in the country. 2 USDA’s failure to meet the statutory and constitutional requirements outlined 3 above and below has adversely affected CFS and its members. 4 21. CFS’s fundamental mission is to empower people, support farmers, and 5 protect the earth from the harmful impacts of industrial agriculture. CFS is a 6 recognized national leader on the issue of GE crops and other GE organisms, and 7 has worked to improve their regulation and address their impacts continuously 8 since the organization’s inception in 1997. 9 22. For over two decades, CFS has been the leading U.S. public interest 10 organization working on the issue of agricultural biotechnology, a pillar of the 11 current industrial agriculture system. Part of CFS’s mission is to ensure that GE 12 organisms that could adversely affect public health, agriculture, and the 13 environment are properly regulated. CFS has a major program area specific to GE 14 organism oversight, and numerous staff members—scientific, policy, campaign, and 15 legal—whose work encompasses the topic. CFS staff members are recognized 16 experts in the field and are intimately familiar with the issue of GE foods, their 17 inadequate oversight, their risks, and their adverse impacts. 18 23. In accordance with its organizational missions to reduce harms caused 19 by industrial agriculture and champion transparency throughout the food 20 production system, CFS has long been committed to establishing meaningful GE 21 regulations. CFS has worked on dozens of individual GE crop, grass, and tree issues 22 over the past several decades, submitting comments to the agency and when 23 necessary engaging in public interest litigation. Specific to this case on the Part 340 24 rules themselves, starting in 2004, CFS submitted comments on behalf of its 25 members for each iteration of the proposed rules and environmental analyses at 26 issue here and has submitted multiple Freedom of Information Act requests to 27 USDA regarding the rulemaking. For many years, CFS has spearheaded 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 6 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 9 of 91 1 nationwide grassroots efforts to inform consumers around the country about GE 2 foods, and the effects of GE organisms on the environment. 3 24. Pesticide Action Network North America (PANNA) is a nonprofit 4 organization that works with farmers, farmworkers, and rural communities to 5 address the health and economic burdens that pesticide and biotech corporations 6 have put on those communities. With the goal of creating a just, thriving food 7 system, PANNA links local and international consumer, labor, health, environment, 8 and agriculture groups to an international citizens’ action network, challenging the 9 global proliferation of pesticides and defending basic rights to health and 10 environmental quality. PANNA has long worked on the issue of GE organism 11 oversight, in particular because of the intertwined nature of GE seeds and 12 pesticides, since the vast majority of GE crops are engineered to tolerate pesticide 13 applications. This program work has included work on numerous specific GE crops 14 as well as this rulemaking process. 15 25. Center for Environmental Health (CEH) is a nonprofit organization 16 that works with communities, consumers, workers, government, and the private 17 sector to keep people safe from unnatural and malicious chemicals by insisting that 18 laws and policies protect people from harm. CEH advances environmental health 19 and justice for the greater good by encouraging business and government 20 decisionmakers to heed the early warnings of science. As part of its broader mission, 21 CEH has worked on the issue of improving GE crop oversight, acknowledging the 22 many associated environmental and public health hazards, and the need for 23 continuous vigilance to protect people’s health and avoid future environmental 24 harm. 25 26. Friends of the Earth (FOE) is a nonprofit organization that engages in 26 advocacy, legal, political, and organizing work to fight for a healthier and more just 27 world. Implementing its overarching mission, FOE has had a longstanding flagship 28 program advocating for precautionary assessment and oversight of organisms COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 7 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 10 of 91 1 derived from genetic engineering by federal regulators. FOE has actively led efforts 2 to address negative biodiversity and public health impacts from newer forms of 3 genetically engineered organisms, including synthetic biology, RNA interference, 4 and gene editing. FOE works with frontline communities potentially impacted by 5 genetic engineering applications, FOE’s membership, farmers, and federal 6 government agencies to address the need for precautionary regulation and robust 7 oversight of all genetic engineering. 8 27. Center for Biological Diversity (CBD) is a nonprofit organization that 9 works through science, law, and creative media to secure a future for all species, 10 with a focus on protecting the lands, waters, and climate that species need to 11 survive. Increasingly, imperiled butterfly and native bee species require 12 Endangered Species Act listing, and numerous species are already listed, because of 13 harm caused to them from industrial agriculture. This includes pesticides and 14 pesticide-resistant GE crop systems. As such CBD has a flagship program on 15 environmental health, which protects biodiversity and human health from toxic 16 substances, specifically including pesticides. Since the vast majority of GE crop 17 systems are engineered to resist (and thus promote) pesticides, CBD’s 18 environmental health program also works on these GE crop systems and their 19 adverse impacts. 20 28. The National Family Farm Coalition (NFFC) is a nonprofit 21 organization that represents 30 grassroots farm, ranch, fishing, and rural advocacy 22 organizations across 42 states to policy- and decision-makers in the nation’s capital. 23 NFFC champions vibrant rural communities in which growers and workers are paid 24 fairly and can live with dignity; diversity in social, racial, cultural, agrarian, and 25 economic realms; and democratic, community-based control of and responsibility for 26 ecological resources and practices, including seeds, land, and water. Since the 27 1990s, the coalition has opposed the proliferation of GE crops, particularly those 28 that resist chemical pesticides. In particular, growers lament the loss of heirloom or COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 8 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 11 of 91 1 hybrid seed varieties for planting due to seed company closures and cross- 2 pollination between GE and non-GE crops, and the pesticide drift that harms or 3 destroys native plants, wildlife, environmental resources, and human health. 4 Defendants 5 29. Defendant Tom Vilsack is sued in his official capacity as USDA 6 Secretary. As Secretary, Mr. Vilsack has the ultimate responsibility for USDA’s 7 activities and policies and for the implementation of GE organism regulations. 8 30. Defendant Kevin Shea is sued in his official capacity as the 9 Administrator of USDA’s Animal and Plant Health Inspection Service (APHIS). 10 APHIS administers programs at USDA related to GE organisms. As Administrator, 11 Mr. Shea has the ultimate responsibility for APHIS’s activities and policies, 12 including the GE organism regulations. 13 31. Defendant USDA is a federal agency of the U.S. with a mission to 14 provide leadership on food, agriculture, natural resources, and related issues based 15 on sound public policy, the best available science, and efficient management. USDA, 16 including APHIS, is the Agency responsible for the implementation of GE organism 17 regulations. 18 LEGAL AUTHORITY 19 I. CONSTUTIONAL 20 32. Congress delegated to USDA the responsibility of protecting 21 agriculture, the economy, and the environment from plant pest and noxious weed 22 harms through the PPA. 23 33. The Constitution delegates “all legislative powers” “in a Congress of 24 the United States.” Art. I, § 1. Federal agency officials “may not subdelegate [their 25 decisionmaking authority] to outside entities—private or sovereign—absent 26 affirmative evidence of authority to do so.” U.S. Telecom Ass’n v. F.C.C., 359 F.3d 27 554, 566 (D.C. Cir. 2004). 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 9 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 12 of 91 1 34. The reason for this is clear: when an agency “shifts to another party 2 ‘almost the entire determination of whether a specific statutory requirement . . . has 3 been satisfied,’ or . . . abdicates its ‘final reviewing authority,’” then “lines of 4 accountability may blur, undermining an important democratic check on 5 government decision-making.” Fund for Animals v. Kempthorne, 538 F.3d 124, 132 6 (2d Cir. 2008); see also Nat’l Ass’n of Regulatory Util. Comm’rs v. F.C.C., 737 F.2d 7 1095, 1143 n.41 (D.C. Cir. 1984) (a key purpose of prohibiting delegation to private 8 entities is preventing “the harm done thereby to principles of political 9 accountability.”). 10 35. This is also because, while agencies are charged with acting in the 11 public interest, “outside parties . . . might not ‘share the agency’s national vision 12 and perspective.’” Fund for Animals, 538 F.3d at 132 (quoting U.S. Telecom Ass’n, 13 359 F.3d at 566). 14 36. Taken together, Article III and VI of the Constitution stand for the 15 concept of judicial review. Article III grants the federal judiciary power to make 16 judgements in all cases pertaining to the Constitution, statutes, and treaties of the 17 United States. Art. III, § 2. Article VI allows federal courts of law to use their 18 judicial power to protect and defend the authority of the Constitution against acts of 19 the government that violate or contradict it, and states that federal governments 20 are bound to support the Constitution. Art. VI. 21 37. Because judicial review flows from final agency action, when an agency 22 unlawfully sub-delegates its statutory authority to private entities, it thereby 23 prevents judicial review of the decision. 24 II. PLANT PROTECTION ACT OF 2000 25 38. Under the PPA, USDA has the responsibility to prevent plant pest 26 risks and noxious weed risks, both of which are broadly defined agricultural and 27 environmental harms. The PPA defines “plant pest” harms broadly, as organisms 28 with the potential to injure or cause disease or damage, directly or indirectly, in or COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 10 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 13 of 91 1 to any plant or part of a plant. 7 U.S.C. § 7702(14). A “noxious weed” harm is 2 defined even broader, to be “any plant or plant product that can directly or 3 indirectly injure or damage crops, livestock, natural resources, public health, the 4 environment, or other interests of agriculture.” Id. § 7702(10). 5 39. In enacting the PPA, Congress found that “biological control is often a 6 desirable, low-risk means of ridding crops and other plants of plant pests and 7 noxious weeds, and its use should be facilitated by [USDA] whenever feasible.” Id. § 8 7702(2). 9 40. Congress realized the threats certain plants could pose. It specifically 10 found that “export markets could be severely impacted by the introduction or spread 11 of plant pests or noxious weeds into or within the United States,” id. § 7701(6), and 12 that “the unregulated movement of plant pests, noxious weeds, plants, certain 13 biological control organisms, plant products, and articles capable of harboring plant 14 pests or noxious weeds could present an unacceptable risk of introducing or 15 spreading plant pests or noxious weeds.” Id. § 7701(7). 16 41. Congress also noted that the existence of “a plant pest or noxious weed 17 new to or not known to be widely prevalent in or distributed within and throughout 18 the United States could constitute a threat to crops and other plants or plant 19 products of the United States and burden interstate commerce or foreign 20 commerce.” Id. § 7701(8). 21 42. As such, Congress found that “all plant pests, noxious weeds, plants, 22 plant products, articles capable of harboring plant pests or noxious weeds regulated 23 under [the PPA] are in or affect interstate commerce or foreign commerce.” Id. § 24 7701(9). 25 43. The PPA gives USDA a multiplicity of statutory tools with which to 26 prevent plant pest and noxious weed harms. Id. § 7701(3); id. § 7702(10), (14); id. §§ 27 7714, 7733, 7731, 7735, 7721. The goals of the PPA include “protection of the 28 agriculture, environment, and economy of the United States” from these broadly COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 11 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 14 of 91 1 defined harms. Id. § 7701(1). The goals also include facilitation of “exports, imports, 2 and interstate commerce in agricultural products” by reducing the risks caused by 3 any plant pest or noxious weed harms. Id. § 7701(3), 7701(6). 4 44. Predominately, the PPA allows USDA to issue regulations to “prohibit 5 or restrict the importation, entry, exportation, or movement in interstate commerce 6 of any plant, plant product, biological control organism, noxious weed, article, or 7 means of conveyance” in order to “prevent the introduction in to the United States 8 or the dissemination of a plant pest or noxious weed within the United States.” Id. § 9 7712(c), (a). 10 45. In exercising the PPA’s authority, the USDA must make all decisions 11 “based on sound science.” Id. § 7701(4).3 12 III. 2008 FARM BILL 13 46. Every five years, Congress passes an omnibus, multiyear agricultural 14 and food policy bill called the farm bill. 15 47. The 2008 Farm Bill directives required USDA to “promulgate 16 regulations to improve the management and oversight of articles regulated under 17 the Plant Protection Act,” including the oversight and management of GE crop field- 18 testing within eighteen months of the bill’s June 18, 2008 enactment date.4 19 48. These regulations were to address and correct nine problem areas 20 identified by USDA in a report it published following the agency’s investigation into 21 a GE rice field trial contamination episode that severely damaged U.S. rice export 22 23 24 3 Under Executive Order 13990, agency decision making “must be guided by the best science” and agencies are obligated to “immediately review . . . actions 25 during the last 4 years that conflict with these important national objectives.” Executive Order on Protecting Public Health and the Environment and 26 Restoring Science to Tackle the Climate Crisis, 86 Fed. Reg. 7037 (Jan. 25, 27 2021). 4 28 Food, Conservation, and Energy Act of 2008, Pub. L. No. 110-246, Tit. X § 10204(a)(2). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 12 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 15 of 91 1 markets. This document is entitled, LESSONS LEARNED AND REVISIONS UNDER 2 CONSIDERATION FOR APHIS’ BIOTECHNOLOGY FRAMEWORK (“LESSONS LEARNED”). 3 49. While preparing the report, the agency took the opportunity to review 4 the lessons it learned from its investigation as part of an initiative to explore 5 revisions to its biotechnology regulations in 7 C.F.R. Part 340. Section 10204 of the 6 2008 Farm Bill entitled Regulations to Improve Management and Oversight of 7 Certain Regulated Articles, codified the LESSONS LEARNED report by incorporation. 8 50. The LESSONS LEARNED report enumerates considerations to enhance 9 the agency’s regulatory framework and include, but are not limited to, the following: 10 (1) Additional recordkeeping requirements 11 (2) Regulatory revisions to improve availability of physical samples 12 (3) Mandated procedures for unauthorized release events 13 (4) Mandated corrective actions for unauthorized release events 14 (5) Enhanced agency protocols for conducting molecular forensics after 15 unauthorized release 16 (6) Required maintenance of contractual relationships for access during later 17 investigations 18 (7) Ensuring the use of the latest science for isolation as a confinement tool 19 (8) Improving quality management systems to manage research effectively 20 (9) Using permits to store important documents and other information 21 related to the permit and notification processes 22 51. The 2008 Farm Bill states that within eighteen months of enactment, 23 USDA “shall – (1) take action on each issue identified in the document entitled 24 ‘Lessons Learned and Revisions under Consideration for APHIS’ Biotechnology 25 Framework.’” 26 52. The APA states that a reviewing court “shall” interpret statutes and 27 “compel agency action unlawfully withheld or unreasonably delayed.” 5 U.S.C. § 28 706(1). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 13 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 16 of 91 1 IV. NATIONAL ENVIRONMENTAL POLICY ACT 53. NEPA is our “national charter for protection of the environment.” 40 2 C.F.R. § 1500.1(a). Its purpose is to “promote efforts which will prevent or eliminate 3 damage to the environment.” 42 U.S.C. § 4321. 4 54. When enacting NEPA, Congress expressed great concern for the 5 “profound impact of man’s activity on the interrelations of all components of the 6 natural environment, particularly the profound influences of . . . new and expanding 7 technological advances. . . .” 42 U.S.C. § 4331(a). Congress was specifically wary of 8 “[a] growing technological power which is far outstripping man’s capacity to 9 understand and ability to control its impact on the environment.” S. Rep. No. 91- 10 296, 91st Cong., 1st Sess., at 6, 1969 U.S. Code Con. & Admin. News 1969. 11 55. Regulations promulgated by the Council on Environmental Quality 12 (CEQ) implement NEPA and govern USDA’s decision making.5 See 40 C.F.R. §§ 13 1500-1508; 21 C.F.R., Part 25. Agencies like USDA also have their own NEPA 14 regulations, applying the controlling CEQ regulations but specific to their own 15 agency actions. See 7 C.F.R. § 372. 16 56. The twin pillars of NEPA are the requirements that agencies (1) 17 carefully evaluate the environmental impacts of proposed actions before 18 undertaking the action, and (2) fully advise the public of the potential impacts of 19 those actions, and of alternatives. NEPA requires federal agencies to fully consider 20 and disclose the environmental consequences of an agency action before proceeding 21 22 5 CEQ issued new implementing regulations for NEPA in July, 2020. 85 Fed. Reg. 23 43,304 (July 16, 2020). The revised regulations apply to NEPA processes begun 24 after the September 14, 2020 effective date. The Part 340 regulations were finalized before September 2020, and thus are subject to the old regulations and 25 relevant case law. Additionally, the current administration is in the process of walking back the Trump Administration’s NEPA regulations. As such, the 26 implementation of those regulations is delayed, and additional rulemaking is 27 forthcoming. See Deadline for Agencies to Propose Updates to National Environmental Policy Act Procedures, 86 Fed. Reg. 34,154 (June 29, 2021). 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 14 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 17 of 91 1 with the action—to take a “hard look.” 42 U.S.C. § 4332(2)(C); 40 C.F.R. §§ 1501.2, 2 1501.4, 1502.5. An agency’s evaluation of environmental consequences must be 3 based on “accurate scientific” information of “high quality.” 40 C.F.R. § 1500.1(b). If 4 there are not sufficient data available, the agency must follow the requisite 5 procedure for addressing or evaluating the impacts in view of incomplete or 6 unavailable information. Id. § 1502.22. 7 57. NEPA requires federal agencies to prepare an environmental impact 8 statement (EIS) for all “major Federal actions significantly affecting the quality of 9 the human environment. 42 U.S.C. § 4332(2)(C); 40 C.F.R. § 1501.4. Major federal 10 actions “include new and continuing activities, including projects and programs . . . 11 conducted, regulated, or approved by Federal agencies; new or revised agency rules, 12 regulations, plans, policies, or procedures[.]” 40 C.F.R. § 1508.1(q)(2). 13 58. In determining whether an action “significantly” affects the 14 environment, the agency must analyze significance in several contexts “such as 15 society as a whole (human, national), the affected region, the affected interests, and 16 the locality.” Id. § 1508.27(a). Determining the significance of an action also 17 requires the agency to consider the intensity of the impact by evaluating factors 18 enumerated at 40 C.F.R. § 1508.27(b). 19 59. An EIS must “serve as the means of assessing the environmental 20 impact of proposed agency actions, rather than justifying decisions already made. 21 Id. § 1502.2(g). “To the fullest extent possible, agencies shall prepare draft 22 environmental impact statements concurrently with and integrated with 23 environmental impact analyses and related surveys and studies required by . . . the 24 Endangered Species Act of 1973.” Id. § 1502.25(a). 25 60. In a NEPA analysis, the federal agency must identify the direct, 26 indirect, and cumulative impacts of the proposed action, consider alternative actions 27 and their impacts, and identify all irreversible and irretrievable commitments of 28 resources associated with the proposed action. 42 U.S.C. § 4332(2)(C); 40 C.F.R. §§ COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 15 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 18 of 91 1 1508.7, 1508.8, 1502.14. Direct effects are those “which are caused by the action and 2 occur at the same time and place.” 40 C.F.R. § 1508.8(a). Indirect effects are “caused 3 by the action and are later in time or farther removed in the distance, but are still 4 reasonably foreseeable.” Id. 1508.8(b). Cumulative impacts are impacts from “past, 5 present and reasonably foreseeable future actions regardless of what agency 6 (Federal or non-Federal) or person undertakes such other actions.” Id. § 1508.7. 7 “Cumulative impacts can result from individually minor but collectively significant 8 actions taking place over a period of time.” Id. “Effects” or “impacts” (synonymous) 9 include “ecological (such as the effects on natural resources and on the components, 10 structures, and functioning of affected ecosystems), aesthetic, historic, cultural, 11 economic, social, or health, whether direct, indirect, or cumulative.” Id. § 1508.8. 12 61. NEPA also requires agencies to evaluate economic or social and 13 natural or physical environmental effects that are interrelated. Id. § 1508.14. 14 62. NEPA requires agencies to consider “alternatives to the proposed 15 action.” 42 U.S.C. § 4332(2)(C)(iii) & (E); 40 C.F.R. § 1502.14. The analysis of 16 alternatives is the “heart” of the NEPA process and must provide for “a clear basis 17 for choice among options by the decisionmaker and the public.” 40 C.F.R. § 1502.14. 18 63. NEPA also requires agencies to disclose and analyze measure to 19 mitigate the impacts of proposed actions. Id. §§ 1502.14(f), 1502.16(h). An agency’s 20 analysis of mitigation measures must be reasonably complete in order to properly 21 evaluate the severity of the adverse effects of an agency’s proposed action prior to 22 the agency making a final decision. 23 64. Agencies may conduct NEPA review on a broader “programmatic” level 24 to assess the environmental impacts of “policies, plans, programs, or projects for 25 which subsequent actions will be implemented” based on a programmatic EIS 26 (PEIS). Id. § 1502.4(b) (“Environmental impact statements may be prepared, and 27 are sometimes required, for broad Federal actions such as the adoption of new 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 16 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 19 of 91 1 agency programs or regulations”). PEIS’s are subject to “the same regulations and 2 guidance that apply to non-programmatic NEPA reviews.”6 3 65. NEPA requires that an agency incorporate its environmental analysis 4 into its decision-making process. “NEPA’s purpose is not to generate paperwork— 5 even excellent paperwork—but to foster excellent action.” Id. §1500.1(c); see also id. 6 (“Ultimately . . . it is not better documents but better decisions that count.”); id. § 7 1502.1 (“primary purpose” of an EIS is to “serve as an action-forcing device to insure 8 that the policies and goals defined in the Act are infused into the ongoing programs 9 and actions of the Federal Government. . . . An environmental impact statement is 10 more than a disclosure document. It shall be used by Federal officials in conjunction 11 with other relevant material to plan actions and make decisions.”). 12 V. ENDANGERED SPECIES ACT 13 66. When a species is listed as threatened or endangered under the ESA, 14 section 7(a)(2) of the Act requires that all federal agencies “insure” that their 15 actions “are not likely to jeopardize the continued existence of any endangered 16 species or threatened species or result in the destruction or adverse modification of” 17 their critical habitat. 16 U.S.C. § 1536(a)(2). The “institutionalized caution” 18 embodied in the ESA requires federal agencies to give the benefit of the doubt to 19 listed species and places the burden of risk and uncertainty on the proposed action.7 20 67. The Act establishes an interagency consultation process to assist 21 federal agencies in complying with their substantive section 7(a)(2) duty to guard 22 against jeopardy to listed species or destruction or adverse modification of critical 23 habitat. Under section 7(a)(2), federal agencies must consult with the appropriate 24 expert fish and wildlife agency to determine whether their actions well jeopardize 25 26 6 CEQ, Guidance: Effective Use of Programmatic NEPA Reviews 7 (Dec. 18, 2014), 27 https://obamawhitehouse.archives.gov/sites/default/files/docs/effective_use_of_pr ogrammatic_nepa_reviews_final_dec2014_searchable.pdf. 28 7 H.R. Rep. No. 93-412, pp. 4-5 (1973). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 17 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 20 of 91 1 any listed species’ survival or adversely modify designated critical habitat and, if so, 2 to identify ways to modify the action to avoid that result. See 50 C.F.R. § 402.14. 3 The National Marine Fisheries Service is the expert fish and wildlife agency with 4 respect to most anadromous and marine species and the Fish and Wildlife Service 5 (collectively, the Services) is the expert agency with respect to many terrestrial and 6 freshwater species. 7 68. The Services have adopted joint regulations governing the section 8 7(a)(2) consultation process. Under the joint regulations, a federal agency must 9 initiate a section 7(a)(2) consultation with the expert agencies whenever it 10 undertakes an “action” that “may affect” a listed species or critical habitat. 50 11 C.F.R. § 402.14(a). The threshold for a “may affect” determination and the required 12 ESA section 7(a)(2) is low. See 51 Fed. Reg. 19,926, 19,949 (June 3, 1986) (“Any 13 possible effect, whether beneficial, benign, adverse, or of an undetermined 14 character, triggers the formal consultation requirement.”). See also FWS, 15 Endangered Species Consultation Handbook at 3-13, 4-26 (1998). An agency is 16 relieved of the obligation to consult only if the action will have “no effect” on listed 17 species or designated critical habitat. 18 69. The joint regulations broadly define the scope of agency actions subject 19 to ESA section 7(a)(2) mandates to encompass “all activities or programs of any 20 kind authorized, funded, or carried out, in whole or in part by Federal agencies,” 21 including the promulgation of regulations and granting licenses. 50 C.F.R. § 402.02 22 (definition of “action”). 23 70. Under the ESA, “action area” is broadly defined as “all areas to be 24 affected directly or indirectly by the federal action and not merely the immediate 25 area involved in the action.” Id. § 402.02. The potential “effects” of an agency action 26 that an agency must consider are similarly broad and include both “direct” and 27 “indirect” effects of the action and all activities “interrelated or interdependent” 28 with that action. Id. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 18 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 21 of 91 1 71. In insuring that any action is not likely to jeopardize a listed species or 2 result in the adverse modification of critical habitat, the ESA requires every agency 3 to use only the best scientific and commercial data available at every step in the 4 process. 16 U.S.C. § 1536(a)(2); 50 C.F.R. § 402.14(g)(8). 5 72. If an agency determines that its action “may affect” but is not likely to 6 adversely affect” a listed species or its critical habitat, ESA regulations permit 7 “informal consultation,” in which there is no requirement for a biological opinion, so 8 long as the expert service concurs in writing with the “not likely to adversely affect” 9 determination. 50 C.F.R. § 402.13. If the service does not concur in the “not likely to 10 adversely affect” determination or if the action agency determines that the action is 11 “likely to adversely affect” the listed species, the agencies must engage in “formal 12 consultation.” Id. §§ 402.12; 402.14(a), (b). 13 73. Formal consultation “is a process between the Service and the Federal 14 agency that commences with the Federal agency’s written request for consultation 15 under section 7(a)(2) of the Act and concludes with the Service’s issuance of the 16 biological opinion under section 7(b)(3) of the Act.” Id. § 402.02. 17 74. Compliance with the procedural provisions of the ESA—identifying the 18 likely effects of the action through the consultation process—is integral to 19 compliance with the substantive requirements of the Act. Under the statutory 20 framework, federal actions that “may affect” a listed species or critical habitat may 21 not proceed unless and until the federal agency ensures, through completion of the 22 consultation process, that the action is not likely to cause jeopardy or adverse 23 modification of critical habitat. 16 U.S.C. § 1536(a); 50 C.F.R. §§ 402.14; 402.13; see 24 also 16 U.S.C. § 1536(d). 25 75. The ESA mandates that agencies use the “best scientific and 26 commercial data available” in fulfilling the above requirements. 6 U.S.C. § 27 1536(a)(2). 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 19 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 22 of 91 1 VI. ADMINISTRATIVE PROCEDURE ACT 76. The APA grants a right of judicial review to “[a] person suffering legal 2 wrong because of agency action, or adversely aggrieved by agency action. . . .” 5 3 U.S.C. § 702. 4 77. Under the APA, a court must “hold unlawful and set aside agency 5 action . . . found to be . . . arbitrary, capricious, an abuse of discretion, or otherwise 6 not in accordance with the law. . . .” Id. § 706(2)(A). An agency action is “arbitrary 7 and capricious if the agency has relied on factors which Congress has not intended 8 it to consider, entirely failed to consider an important aspect of the problem, offered 9 an explanation for its decision that runs counter to the evidence before the agency, 10 or is so implausible that it could not be ascribed to a difference in view or the 11 product of agency expertise.” Motor Vehicles Mfrs. Assoc. v. State Farm Mut. Auto. 12 Ins. Co., 463 U.S. 29, 43 (1983). 13 78. “[A]n agency changing its course by rescinding a rule is obligated to 14 supply a reasoned analysis for the change beyond that which may be required when 15 an agency does not act in the first instance.” Id. at 42. 16 79. Under the APA, a court must also “hold unlawful and set aside” any 17 agency action taken that is “in excess of statutory jurisdiction, authority, or 18 limitations, or short of statutory right.” 5 U.S.C. § 706(2)(C). 19 80. Finally, under the APA, a court shall also “hold unlawful and set 20 aside” any agency action that was promulgated “without observance of procedure 21 required by law.” Id. § 706(2)(D). 22 FACTUAL ALLEGATIONS 23 24 I. GE ORGANISMS IN THE U.S. 25 81. The first GE crops were approved in the U.S. in the 1990s. Now, the 26 genetic engineering of organisms looms as one of the greatest and most intractable 27 environmental and agricultural challenges of the 21st century. 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 20 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 23 of 91 1 82. By taking genetic material from one organism and inserting it into the 2 permanent genetic code of another, or manipulating plant DNA via gene editing, 3 the biotechnology industry has created an astounding number of organisms that are 4 not produced by nature or traditional breeding practices.8 These creations are now 5 being patented and released into our environment and food supply at an alarming 6 rate. The vast majority of U.S. commodity crops—corn, soybeans, and cotton—are 7 genetically engineered. It is estimated that upwards of 75% of processed foods on 8 supermarket shelves contain GE ingredients. 9 83. All GE crops are developed using imprecise techniques that are known 10 to produce unpredictable and unintended effects, which can have adverse health 11 impacts.9 In some cases, this can lead to large-scale mutations in crop genomes.10 12 According to the U.S. Food and Drug Administration, the unintended effects of 13 genetic engineering include increased levels of plant toxicants, creation of novel 14 toxins or allergens, and nutritional deficits.11 15 84. Further, independent scientists are prohibited from conducting risk 16 assessments of GE materials used in food products due to industry restrictions on 17 research of those materials.12 There are no long-term or epidemiological studies in 18 19 20 8 Allison Snow, Genetic Engineering: Unnatural Selection, 424 NATURE 619 (2003), 21 http://goo.gl/Fn6hs3. 9 Inst. of Med. & Nat’l Research Counsel of the Nat’l Acads., Safety of Genetically 22 Engineered Foods: Approaches to Assessing Unintended Health Effects, 64, 65 n. 23 3 (2004), http://goo.gl/g9AuE1. 10 Allison K. Wilson et al., Transformation-Induced Mutations in Transgenic Plants: 24 Analysis and Biosafety Implications, 23 BIOTECH. & GENETIC ENG’G REV. 209-234 25 (2006), http://goo.gl/JtDyk8. 11 FDA, Statement of Policy: Foods Derived From New Plant Varieties; Notice, 57 26 Fed. Reg. 22,984, 22,986-87 (May 29, 1992). 27 12 Emily Waltz, Under Wraps, 27 NATURE BIOTECH 880, 880-82 (2009); Andrew 28 Pollack, Crop Scientists Say Biotechnology Seed Companies Are Thwarting Research, N.Y. TIMES (Feb. 19, 2009), http://goo.gl/Nz7tWu. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 21 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 24 of 91 1 the U.S. that have examined the safety of human consumption of GE foods, despite 2 scientific recommendations for post-market surveillance. 3 85. GE organisms pose a range of risks to public health, the environment, 4 and the interests of agriculture—risks attributable to both genetic engineering per 5 se, and the ends to which the organism is engineered. The great majority of GE 6 organisms to date are GE plants, particularly GE crops. Some of these risks are 7 summarized below. 8 Contamination Harms 9 86. GE crops cause substantial harms via transgenic contamination, which 10 occurs when a GE plant disperses its pollen to cross-pollinate a crop or wild plant of 11 the same or closely related species through wind, insect pollinators, or when it 12 disperses its seed to propagate itself in a new area. Time and time again, 13 experimental and commercialized GE plants have shown their ability to escape 14 confinement and contaminate conventional crops and wild relatives, or colonize wild 15 places.13 GE contamination is a living pollution that can propagate itself via gene 16 flow. 17 87. Transgenic contamination of conventional or organic crops has cost 18 U.S. farmers billions of dollars in market losses, as food companies, grain traders, 19 and export markets have rejected contaminated supplies.14 USDA’s current decision 20 21 13 Carey Gillam, U.S. Organic Food Industry Fears GMO Contamination, REUTERS 22 (Mar. 12, 2008), https://www.reuters.com/article/us-biotech-crops-contamination- 23 idUSN1216250820080312. 14 Michelle Marvier & Rene C. Van Acker, Can Crop Transgenes Be Kept on a 24 Leash?, 3 FRONTIERS ECOLOGY & ENV’T 99, 100-01 (2005), 25 https://www.centerforfoodsafety.org/files/can-crop-transgenes-be-kept-on- aleash_82326.pdf; Andrew Harris, Bayer Agrees to Pay $750 Million to End 26 Lawsuits Over Gene-Modified Rice, BLOOMBERG (July 2, 2011), http://goo.gl/ymErOa; K.L. Hewlett, The Economic Impacts of GM 27 Contamination Incidents on the Organic Sector (2008), http://goo.gl/jf2F5E; 28 Stuart Smyth et al., Liabilities & Economics of Transgenic Crops, 20 NATURE COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 22 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 25 of 91 1 to deregulate most GE crops stands in sharp contrast to most of the rest of the 2 world; before the current rule, too lax U.S. oversight lead to market harm: foreign 3 markets with restrictions on GE foods have rejected imports of U.S. crops and shut 4 down export markets when GE contamination was discovered.15 Some foreign 5 markets are choosing to purchase agricultural products from countries other than 6 the U.S. due to GE-contaminated supplies. 7 88. To give just a few examples:16 Field trials of an experimental, GE- 8 herbicide resistant rice known as LibertyLink601 led to contamination of 30% of 9 U.S. long-grain rice supplies in 2006 and 2007, resulting in massive export market 10 rejection of contaminated shipments, and huge losses estimated at up to $1.3 billion 11 to 11,000 American rice farmers and others in the rice food chain. It took farmers 12 five years of class action damages litigation to obtain only partial compensation,17 13 and led Congress to add a new mandate in the 2008 Farm Bill, requiring USDA to 14 improve its GE experiment oversight, see infra. 15 89. More recently, USDA deregulated a GE corn known as MIR 162, and 16 its developer Syngenta began selling seed to farmers for unregulated cultivation, 17 even though China, a major buyer of U.S. corn, had not approved it for import. 18 BIOTECH. 537 (2002), https://www.centerforfoodsafety.org/files/liabilities-and- 19 economics-of-transgeniccrops_82369.pdf. 20 15 Tom Polansek, China Rejections of GMO U.S. Corn Cost up to $2.9 Billion, REUTERS (Apr. 16, 2014), https://www.reuters.com/article/syngenta-corn- 21 costs/chinarejections-of-gmo-u-s-corn-cost-up-to-2-9-bln-group- 22 idUSL2N0N82DF20140416. 16 23 U.S. GAO, GENETICALLY ENGINEERED CROPS (Nov. 2008), https://www.gao.gov/assets/gao-09-60.pdf (GAO report giving contamination 24 incident examples); Andrew Pollack, Lax Oversight Found in Tests of Gene- Altered Crops, N.Y. TIMES (Jan. 3, 2006), 25 https://www.nytimes.com/2006/01/03/science/lax-oversight-found-in-tests-of- 26 genealtered-crops.html. 17 Harris & Beasley, Bayer Will Pay $750 Million to Settle Gene-Modified Rice Suits, 27 BLOOMBERG (July 1, 2011), https://www.bloomberg.com/news/articles/2011-07- 28 01/bayer-to-pay-750-million-to-end-lawsuits-over-genetically-modified-rice. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 23 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 26 of 91 1 Chinese testing detected this GE corn in American shipments, and rejected 1 2 million tons, wreaking havoc on the U.S. corn trade.18 The National Grain & Feed 3 Association estimates overall losses at $6.3 billion, and China began importing corn 4 from Brazil in response—a major setback for the U.S. corn industry.19 5 90. In another instance, Monsanto’s GE “Roundup Ready” alfalfa was 6 found contaminating alfalfa seed fields and lots in 63 different contamination 7 events in California and other western states from 2006 to 2009.20 Feral GE alfalfa 8 was also widely detected near alfalfa seed production fields in California, Idaho, and 9 Washington in 2011 and 2012.21 Thus, it is not surprising that GE alfalfa was found 10 contaminating conventional alfalfa supplies, jeopardizing annual American exports 11 of roughly $200 million worth of this valuable commodity to nations that reject the 12 GE contaminant.22 Transgenic contamination of seed is particularly insidious, 13 14 15 18 Nick McCain, Syngenta Agrees to Pay $1.5B Over Modified Corn Seeds, 16 COURTHOUSE NEWS SERV. (Mar. 13, 2018), https://www.courthousenews.com/syngenta-agrees-to-pay-1-5b-over-modified- 17 corn-seeds/. 18 19 Megan Durisin & Jeff Wilson, U.S. Grain Losses Seen up to 6.3 Billion on China Ban, BLOOMBERG (Apr. 16, 2014), https://www.bloomberg.com/news/articles/2014- 19 04-16/u-s-group-says-losses-may-be-6-3-billion-on-china-corn. 20 20 Final Environmental Impact Statement on Roundup Ready Alfalfa, USDA APHIS, Dec. 2010, Appendix V, V-64 to V-65; Cal/West Seeds Newsletter, Winter 21 Issue 2010; “Roundup Ready Contamination of Feral Alfalfa,” report and affidavit by Phil Geertson, May 28, 2009. 22 21 Stephanie L. Greene et al., Occurrence of Transgenic Feral Alfalfa (Medicago 23 sativa subsp. sativa L.) in Alfalfa Seed Production Areas in the United States, 10 PLOS ONE 12 (Dec. 2015), 24 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0143296. 22 25 Jesse Newman, China’s Hard Line on Biotech Burns U.S. Hay, WALL ST. J. (Dec. 15, 2014), https://www.wsj.com/articles/u-s-hay-exports-to-china-shrivel-up- 26 1418598477; AP, Genetically Modified Alfalfa Confirmed in Washington Test Sample, OREGON LIVE (Sept. 13, 2013), 27 https://www.oregonlive.com/business/2013/09/genetically_modified_alfalfa_c.htm 28 l. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 24 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 27 of 91 1 because farmers who plant what they believe is pure seed line are unwittingly 2 propagating the GE contaminant throughout the alfalfa production system. 3 91. Repeated GMO contamination incidents in other U.S. crops have cost 4 farmers literally billions23 over the past decade in rejected sales,24 lost exports,25 5 and closed agricultural markets, with new episodes26 “cropping” up regularly.27 6 A Pesticide-Promoting System 7 92. The last twenty-five years of use has also proved that GE crops are a 8 key pillar of inherently unsustainable industrial agriculture, and cause significant 9 adverse environmental impacts. Contrary to the industry’s hype about various 10 potential public good uses for GE crops, in reality the overwhelming majority of 11 commercial GE crops are created and marketed by pesticide companies to survive 12 direct application of plant-killing pesticides (herbicides), produce insecticidal toxins 13 in their tissues, or both.28 14 15 23 Harris & Beasley, Bayer Will Pay $750 Million to Settle Gene-Modified Rice Suits, 16 BLOOMBERG (July 1, 2011), https://www.bloomberg.com/news/articles/2011-07- 01/bayer-to-pay-750-million-to-end-lawsuits-over-genetically-modified-rice. 17 24 Carey Gillam, U.S. Organic Food Industry Fears GMO Contamination, REUTERS 18 (Mar. 12, 2008) https://www.reuters.com/article/us-biotech-crops-contamination- idUSN1216250820080312. 19 25 Jesse Newman, China’s Hard Line on Biotech Burns U.S. Hay, WALL ST. J. (Dec. 20 15, 2014), https://www.wsj.com/articles/u-s-hay-exports-to-china-shrivel-up- 1418598477. 21 26 Tom Polansek, China Rejections of GMO U.S. Corn Cost up to $2.8 Billion: Group, 22 REUTERS (Apr. 16, 2014), https://www.reuters.com/article/us-syngenta-corn- costs-idUSBREA3F20P20140416. 23 27 Steven Mufson, Unapproved Genetically Modified Wheat from Monsanto Found in 24 Oregon Field, WASHINGTON POST (May 30, 2013), https://www.washingtonpost.com/business/economy/unapproved-genetically- 25 modified-wheat-from-monsanto-found-in-oregon-field/2013/05/30/93fe7abe-c95e- 26 11e2-8da7-d274bc611a47_story.html. 28 Jung, C., et al., Recent Developments in Genome Editing and Applications in 27 Plant Breeding, 137 PLANT BREEDING 1-9 (2017); Kaskey, J., BASF to Crank Up 28 R&D ‘Two Gears’ With Bayer Seeds, Next CEO Says, BLOOMBERG TECH. (Apr. 12, COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 25 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 28 of 91 1 93. The well-established impacts of GE crops (and their companion 2 pesticides) are widespread and dire. Reliance on these pesticide-promoting GE crop 3 systems has caused a number of harms, including widespread pollution of our 4 waterways and ecosystems,29 injury to beneficial insects such as pollinators,30 and 5 harm to soil health.31 6 94. The great majority of corn, soybeans, cotton, canola, and sugar beets 7 grown in the U.S. are GE herbicide-resistant varieties that have dramatically 8 increased use of these weed-killing chemicals and the overall pesticide output into 9 our environment.32 Herbicide-resistant seeds and their companion herbicides are 10 marketed together as a crop system. It is estimated that GE corn, soybeans, and 11 12 13 14 2018), https://www.bloomberg.com/news/articles/2018-04-12/basf-to-crank-up-r- 15 d-two-gears-with-bayer-seeds-next-ceo-says. 29 Feng-Chih Chang et al., Occurrence and Fate of the Herbicide Glyphosate and its 16 Degradate Aminomethylphosphonic Acid in the Atmosphere, 30 ENV’T 17 TOXICOLOGY & CHEMISTRY 548, 548-50 (2011), http://goo.gl/bZZTve; Richard H. Coupe et al., Fate and Transport of Glyphosate and Aminomethylphosphonic 18 Acid in Surface Waters of Agricultural Basins, 68 PEST. MGMT. SCI. 16, 16-17 (2012), http://goo.gl/WSvHO2. 19 30 Richard Coniff, Tracking the Causes of Sharp Decline of the Monarch Butterfly, 20 YALE ENV’T 360 (Apr. 1, 2013), http://goo.gl/EBCU33; J.M. Pleasants & K.S. Oberhauser, Milkweed Loss in Agricultural Fields Because of Herbicide Use: 21 Effect on the Monarch Butterfly Population, 6 INSECT CONSERVATION AND 22 DIVERSITY, 135-144 (2013), http://home.cc.umanitoba.ca/~frist/PLNT4600/biodiversity/icad196.pdf. 23 31 Robert J. Kremer, Soil and Environmental Health After Twenty Years of Intensive 24 Use of Glyphosate, 6 ADV. PLANTS AGRIC. RES. 00224 (2017). 32 25 See William Neuman & Andrew Pollack, Farmers Cope with Roundup-Resistant Weeds, N.Y. TIMES (May 3, 2010), http:// 26 www.nytimes.com/2010/05/04/business/energy-environment/04weed.html?_ r=1&pagewanted=all (“Today, Roundup Ready crops account for about 90 27 percent of the soybeans and 70 percent of the corn and cotton grown in the 28 United States.”). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 26 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 29 of 91 1 cotton alone have led to a 527 million pound increase in herbicide use over the first 2 sixteen years of their cultivation, from 1996 to 2011.33 3 95. The first generation of Monsanto’s “Roundup Ready” crops, resistant to 4 the pesticide glyphosate, have transformed glyphosate from a minor agricultural 5 pesticide to by far the most intensively and extensively sprayed weed killer in the 6 country, with 280 million pounds applied to nearly 300 million acres of farmland, 7 annually.34 8 96. Glyphosate-containing Roundup formulations are extremely toxic to 9 tadpoles and frogs, and likely have contributed to the worldwide decline in frog 10 populations.35 Glyphosate is also harmful to organisms beneficial to agriculture. For 11 instance, glyphosate is toxic to Bradyrhizobium japonicum, an important nitrogen- 12 fixing symbiont that colonizes soybean roots, due to sensitivity of its EPSPS enzyme 13 to inhibition by glyphosate.36 Suppression of this important symbiont is likely 14 related to the finding that glyphosate application to glyphosate-resistant soybeans 15 reduces foliar nitrogen content, seed nitrogen content, biomass and yields, 16 especially under conditions of water stress, early application of glyphosate, and high 17 application rates.37 18 19 33 Charles M. Benbrook, Impacts of Genetically Engineered Crops on Pesticide Use in 20 the U.S. – the First Sixteen Years, 24 ENV’T SCI. EUR. 1, 3 (2012), 21 https://enveurope.springeropen.com/articles/10.1186/2190-4715-24-24. 34 EPA, Glyphosate: Response to Comments, Usage, and Benefits. Biological and 22 Economic Analysis Division 13 (Apr. 18, 2019), EPA-HQ-OPP-2009-0361-2342. 23 35 Rick A. Relyea, The Lethal Impact of Roundup on Aquatic and Terrestrial Amphibians, 15 ECOLOGICAL ADAPTIONS 1118, 1120-23 (2005), 24 http://goo.gl/ZjYiHG. 25 36 Zablotowicz, R.M. and K.N. Reddy, Nitrogenase Activity, Nitrogen Content, and Yield Responses to Gyphosate in Glyphosate-Resistant Soybean, CROP 26 PROTECTION 26: 370-376 (2007). 27 37 Zablotowicz et al. (2007), op. cit.; King, C.A., L.C. Purcell and E.D. Vories, Plant 28 growth and Nitrogenase Activity of Gyphosate-Tolerant Soybean in Response to Foliar Glyphosate Applications, AGRON. J. 93: 179-186 (2001). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 27 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 30 of 91 1 97. GE glyphosate-resistant crop systems were not introduced with the 2 intention of harming N-fixing symbionts, but as noted above can do so. A second 3 example also illustrates this point: the genetic engineering of Arctic apple to resist 4 browning (the intended purpose) involved the silencing of a family of genes that 5 generate enzymes that are critical to plant defense against disease and insect pests 6 in some plants. Thus, their silencing may well have the unintended effect of 7 rendering Artic apple trees more susceptible to disease or insect pests, creating 8 plant pest risks. This is true even though the engineering of the Arctic apple trees 9 was not intended to make them more susceptible to pest attack. 10 98. Glyphosate sprayed over the top of Roundup Ready crop systems has 11 nearly eradicated the common milkweed from farm fields in the Midwest, thereby 12 contributing to the dramatic, quarter-century decline in Monarch butterflies that 13 critically depend on milkweed for survival; Monarchs have consequently been 14 driven so near to extinction that in December 2020 the U.S. Fish and Wildlife 15 Service (FWS) found that their listing under the ESA was “warranted” and that 16 they will be listed in coming years, only precluded by more immediate species 17 currently.38 18 99. The massive use of glyphosate has had substantial adverse impacts on 19 human health. The World Health Organization’s International Agency for Research 20 on Cancer concluded that glyphosate is “probably carcinogenic to humans,”39 based 21 in part on epidemiology studies showing increased risk of the cancer non-Hodgkin 22 23 38 Petition to Protect the Monarch Butterfly Under the Endangered Species Act (Aug. 24 26, 2014) https://www.centerforfoodsafety.org/files/monarch-esa-petition- final_61585.pdf; 79 Fed. Reg. 78,775 (Dec. 31, 2014) (finding listing may be 25 warranted); 85 Fed. Reg. 81,813 (Dec. 17, 2020) (finding listing is warranted but 26 precluded; to be listed by 2024). 39 World Health Organization, IARC Monographs Volume 112: Evaluation of Five 27 Organophosphate Insecticides and Herbicides (Mar. 20, 2015), 28 http://goo.gl/KRhWNX. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 28 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 31 of 91 1 lymphoma among farmers who used glyphosate formulations. In three lawsuits 2 against Monsanto, juries ruled that use of Roundup and other glyphosate 3 formulations contributed to the development of non-Hodgkin lymphoma in 4 California users of these products.40 The amount of glyphosate permitted in the food 5 supply has increased dramatically since the 1980s. To take one prominent example, 6 the Environmental Protection Agency (EPA) has raised the amount of glyphosate 7 residue permitted on wheat grain from 0.1 part per million (ppm) in 1983,41 to 5 8 ppm in 1993,42 and to 30 ppm in 2008,43 a 300-fold increase. A growing number of 9 registrant and independent studies indicate that long-term glyphosate exposure 10 11 12 13 14 15 16 17 18 40 Burger & Bellon, Bayer to Pay up to $10.9 Billion to Settle Bulk of Roundup 19 Weedkiller Cancer Lawsuits, REUTERS (June 24, 2020), 20 https://www.reuters.com/article/us-bayerlitigation-settlement/bayer-to-pay-up- to-10-9-billion-to-settle-bulk-of-roundupweedkiller-cancer-lawsuits- 21 idUSKBN23V2NP. 22 41 EPA, Glyphosate (Roundup) on Wheat; PP#3F2809; Reg. #524-308; Winnie Teeters, Ph.D., Toxicology Branch (Mar. 3, 1983). 23 42 EPA, Reregistration Eligibility Decision (RED): Glyphosate, EPA 738-R-93-014, 24 (Sept. 1993), https://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/red_PC- 25 417300_1-Sep-93.pdf. 26 43 Benfluralin, Carbaryl, Diazinon, Dicrotophos, Fluometuron, Formetanate Hydrochloride, Glyphosate, Metolachlor, Napropamide, Norflurazon, Pyrazon, 27 and Tau-Fluvalinate; Proposed Tolerance Actions; Proposed Rule, 73 Fed. Reg. 28 29,456, 29,643 (May 21, 2008). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 29 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 32 of 91 1 poses risks to the liver,44 kidney,45 and reproductive system.46 These are serious 2 health impacts that fall disproportionately on farmers, farmworkers, and other 3 users of glyphosate herbicides. 4 100. Herbicide-resistant GE crop systems also foster rapid emergence of 5 “superweeds” immune to the GE crop’s companion herbicide(s). Weeds resistant to 6 glyphosate, virtually unknown through the mid-1990s, evolved in epidemic fashion 7 with the massive use of glyphosate accompanying widespread planting of Roundup 8 Ready crops, and now infest at least 120 million acres—nearly 40% of the nation’s 9 cultivated cropland (see Fig. 1).47 Efforts to control these resistant weeds involve 10 spraying increasingly toxic herbicides and soil-eroding tillage operations, imposing 11 12 13 44 14 Robin Mesnage et al., Multiomics Reveal Non-Alcoholic Fatty Liver Disease in Rats Following Chronic Exposure to an Ultra-Low Dose of Roundup Herbicide, 7 15 SCI. REPORTS 39,328 (2017), https://www.nature.com/articles/srep39328; see also Paul J. Mills et al., Glyphosate Excretion is Associated With Steatohepatitis and 16 Advanced Liver Fibrosis in Patients with Fatty Liver Disease, 18 CLINICAL 17 GASTROENTEROLOGY AND HEPATOLOGY 741-743 (2019). 45 EPA, Addendum to Pathology Report for a Three-Generation Reproduction Study 18 in Rats with Glyphosate, R.D. #374 (July 21, 1982), 19 https://archive.epa.gov/pesticides/chemicalsearch/chemical/foia/web/pdf/103601/1 03601-135.pdf; Gabriel A. Dedeke et al., Comnparative Assessment on 20 Mechanism Underlying Renal Toxicity of Commercial Formulation of Roundup Herbicide and Glyphosate Alone in Male Albino Rat, 37 INT’L J. OF TOXICOLOGY 21 285-295 (2018). 22 46 R.M Romano et al., Prepubertal Exposure to Commercial Formulation of the 23 Herbicide Glyphosate Alters Testosterone Levels and Testicular Morphology, 84 ARCHIVES OF TOXICOLOGY 309-317 (2010); Folarin O. Owagobriaye et al., 24 Reproductive Toxicity of Roundup Herbicide Exposure in Male Albino Rat, 69 EXPERIMENTAL AND TOXICOLOGIC PATHOLOGY 461-468 (2017). 25 47 K. Fraser, Glyphosate Resistant Weeds – Intensifying (Jan. 25, 2013) STRATUS AG 26 RESEARCH, http://www.stratusresearch.com/newsroom/glyphosate-resistant- weeds-intensifying/; J. Pucci, The War Against Weeds Evolves in 2018 (Mar. 20, 27 2018) CROPLIFE, https://www.croplife.com/crop-inputs/the-war-against-weeds- 28 evolves-in-2018/. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 30 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 33 of 91 1 huge costs on farmers and the environment.48 Because herbicide-resistant weeds 2 can spread, they also impact growers who played no role in their development. 3 4 5 6 7 8 9 10 11 12 13 14 15 Figure 1 16 101. Glyphosate-resistant weeds have also driven widespread introduction 17 of a second generation of GE crops, resistant to additional toxic herbicides like 18 dicamba or 2,4-D as well as to glyphosate.49 The number of discrete herbicide- 19 resistance traits ratchets up as the overuse of weedkillers characteristic of these 20 crop systems selects for further weed resistance. These GE crop systems facilitate 21 the use of cocktails of multiple different herbicides, sprayed at increased frequency 22 23 48 David Mortensen et al., Navigating a Critical Juncture for Sustainable Weed 24 Management, 62 BIOSCIENCE 75-84 (2012), http://goo.gl/RxZVM2; Scott Kilman, Superweed Outbreak Triggers Arms Race, WALL ST. J. (June 4, 2010), 25 http://goo.gl/Fcolxd. 26 49 David Mortensen et al., Navigating a Critical Juncture for Sustainable Weed Management, 62 BIOSCIENCE 75-84 (2012), http://goo.gl/RxZVM2; Brandon Keim, 27 New Generation of GM Crops Put Agriculture in a ‘Crisis Situation,’ WIRED 28 (Sept. 25, 2014), http://goo.gl/ejbTLF. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 31 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 34 of 91 1 and greater volume than has ever been possible before. Accordingly, per-acre use of 2 herbicides in soybeans has doubled since the GE crop era began, from 1.2 to 2.4 3 pounds per acre annually (see Fig. 2).50 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Figure 2 18 102. Besides increasing the amount of weedkiller that is sprayed, herbicide- 19 resistant crop systems also shift applications to later in the growing season, when 20 more plants are vulnerable to damage from direct contact with spray or from drift. 21 Through these different pathways, GE crop systems have caused immeasurable 22 harm to a wide spectrum of wild plants that are important to hundreds of 23 pollinators and endangered species, not to mention farmers’ crops. 24 25 50 Agricultural Chemical Usage: Field Crops, U.S. Dept. of Agriculture, National 26 Agricultural Statistics Service, selected years from 1994 to 2020, https://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Chemical_Use/. 27 “Selected years” because herbicide usage on soybeans was not reported every 28 year. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 32 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 35 of 91 1 103. Use of dicamba has skyrocketed since widespread introduction of 2 dicamba-resistant soybeans and cotton in 2017 (see Fig. 3)51. Notorious for its 3 volatility, dicamba has caused rampant drift damage to all manner of crops across 4 millions of acres, resulting in huge economic losses to farmers.52 Additionally, 5 dicamba damage to wild flowering plants has robbed bees of nectar and pollen 6 resources, causing huge drops in beekeepers’ honey production in several states, 7 with likely impacts on other pollinators as well. Dicamba drifting from GE crop 8 fields where it is sprayed has also damaged millions of trees throughout the 9 Midwest and South, has forced soybean farmers to buy dicamba-resistant seeds for 10 protection from drift, and torn apart the fabric of rural communities by inciting 11 strife between farmers who spray it and others whose crops and residential plants 12 incur damage.53 These herbicidal impacts are direct, indirect, interrelated, and 13 interdependent impacts of these GE crops. 14 15 16 17 18 19 20 21 22 23 51 Fig. 3 was created using data from the following documents: EPA, Over-The- Top Dicamba Products for Genetically Modified Cotton and Soybeans: Benefits 24 and Impacts at 5 (Oct. 31, 2018); EPA, Assessment of the Benefits 25 of Dicamba Use in Genetically Modified, Dicamba-Tolerant Soybean Production at 11, Table 3b (Oct. 26, 2020); EPA, Assessment of the Benefits of Dicamba Use 26 in Genetically Modified, Dicamba-Tolerant Cotton Production at 11, Table 3b (Oct. 26, 2020). 27 52 Nat’l Family Farm Coal. v. EPA, 960 F.3d 1120, 1123, 1135 (9th Cir. 2020). 28 53 Id. at 1143. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 33 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 36 of 91 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Figure 3 15 Other GE Harms 16 104. The most well-known and well-established adverse environmental and 17 agricultural impacts of GE crop systems are transgenic contamination, increased 18 use of pesticides, and the creation of the superweeds epidemic. But they are not 19 alone. 20 105. For example, GE crops not only promote rapid emergence of herbicide- 21 resistant weeds, but in some cases can actually be weeds themselves. For instance, 22 plants can be endowed with traits that increase their fitness, such as their ability to 23 persist and propagate, in both agricultural and non-agricultural contexts. 24 Herbicide-resistant GE crop volunteers, which sprout from grain left in the field 25 after the previous season’s harvest, may well persist in farm fields due to the 26 difficulty, cost or inability to control them, while GE grasses may spread far beyond 27 a field’s boundaries to become established in the wild, which contributes to 28 displacement of native vegetation. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 34 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 37 of 91 1 106. To give one example, in the mid-2000s, USDA permitted open-air field 2 trials of a GE “Roundup Ready” bentgrass proposed for golf courses and lawns. 3 Public interest organizations successfully challenged the legality of the field trials, 4 with the Court holding that USDA had failed to comply NEPA and the PPA in 5 approving them.54 During that litigation, EPA scientists found that the GE grass 6 had escaped the trial, cross-pollinated with wild varieties, and contaminated a 7 protected national grassland over twelve miles away.55 Despite continued and 8 longstanding eradication efforts by the Scotts Company and USDA, the feral GE 9 bentgrass populations continue to be found in the wild years later by farmers in 10 eastern Oregon and western Idaho.56 11 107. When USDA entered into ESA Section 7 consultation on the GE 12 bentgrass, FWS found in a 2010 Biological Opinion that if it was ever 13 commercialized, the GE grass would escape, spread, and edge-out native species 14 and take over their habitat, becoming impossible to eradicate—likely causing the 15 extinction of at least three endangered species (two endangered plants and a 16 17 54 Int’l Ctr. for Tech. Assessment v. Johanns, 473 F. Supp. 2d 9, 28 (D.D.C. 2007). 18 55 Christopher Doering, Scotts to Pay $500,000 Fine Over Biotech Bentgrass, 19 REUTERS (Nov. 7, 2007), https://www.reuters.com/article/us-scotts-usda- 20 idUSN2643698720071127; Andrew Pollack, Genes from Engineered Grass Spread for Miles, Study Finds, N.Y. TIMES (Sept. 21, 2004), 21 https://www.nytimes.com/2004/09/21/business/genes-from-engineered-grass- spread-for-miles-study-finds.html?_r=1; Jay R. Reichman et al., Establishment of 22 Transgenic Herbicide-Resistant Creeping Bentgrass (Agrostis solonifera L.) in 23 Nonagronomic Habitats, 15 MOLECULAR ECOLOGY 4243, 4245 (2006). 56 GMO Bentgrass Found in Eastern Oregon, CAPITAL PRESS (Nov. 9, 2010), 24 https://www.capitalpress.com/state/oregon/gmo-bentgrass-found-in-eastern- 25 oregon/article_ae4be0b2-98bd-56a2-badf-193236d2342c.html; Mitch Lies, Coba Presses Scotts for Bentgrass Plan, CAPITAL PRESS (Feb. 10, 2011), 26 http://www.capitalpress.com/oregon/ml-coba-letter-021111; Mitch Lies, Feds Mum on GMO Spread, CAPITAL PRESS, 27 https://www.capitalpress.com/ag_sectors/feds-mum-on-gmo- 28 spread/article_734706ac-8b5a-578c-8551-9576c32a6368.html. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 35 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 38 of 91 1 butterfly, the Fender Blue Butterfly), and potentially imperiling dozens more 2 endangered species.57 3 108. In another example, in the summer of 2010, two scientists from the 4 University of Arkansas sampled feral canola plants growing along the roadside in 5 North Dakota. They found that 80% of the plants they tested carried GE herbicide- 6 resistance traits, illustrating widespread gene flow from cultivated GE canola fields 7 and the establishment of these GE plants in the wild.58 8 109. To provide another type of risk example, some GE crops are engineered 9 as “biofactories” for experimental production of pharmaceutical compounds, such as 10 insulin, which are extracted from the plant’s grain or leaf tissue. While these have 11 not yet been commercialized, GE pharmaceutical crops could contaminate food crops 12 by cross-pollination or other avenues, posing potential threats to human health and 13 wildlife from consumption of the experimental pharmaceutical. Such contamination 14 episodes have already occurred, even from limited field trials.59 Pharmaceutical 15 crop contamination also results in economic losses because contaminated supplies 16 cannot be used for food production.60 17 18 57 FWS, BiOp on Roundup Ready Bentgrass, 19 http://www.centerforfoodsafety.org/files/fws-biop-on-rr-bentgrass- 20 deregulation_received-via-foia_2011_49385.pdf 58 Meredith Schafer et al., Presentation of Results, Evidence for the Establishment 21 and Persistence of Genetically Modified Canola Populations in the U.S. (Aug. 6, 22 2010); Meredith Schafer et al., Evidence for the Establishment and Persistence of Genetically Modified Canola Populations in the U.S., 6 PUB. LIB. SCI. ONE 1, 2 23 (2011); Andrew Pollack, Canola, Pushed by Genetics, Moves into Uncharted Territories, N.Y. TIMES, (Aug. 9, 2010) 24 http://www.nytimes.com/2010/08/10/science/10canola.html. 25 59 GAO, Genetically Engineered Crops: Agencies are Proposing Changes to Improve 26 Oversight, but Could Take Additional Steps to Enhance Coordination and Monitoring, Appendix VII (2008). 27 60 Karen Charman, Down on the Biopharm, IN THESE TIMES (Feb. 13, 2003), 28 https://inthesetimes.com/article/down-on-the-biopharm. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 36 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 39 of 91 1 110. Other GE plants are engineered to produce industrial enzymes, either 2 for extraction as with pharmaceutical plants, or for use embedded in the crop’s 3 grain. For instance, a GE corn grown exclusively for ethanol production contains 4 ultra-high levels of an enzyme, amylase, that helps transform corn starch into 5 ethanol.61 USDA deregulated the GE corn in 2011 despite the likelihood it would 6 contaminate food-grade corn, degrade the quality of tainted corn products, and 7 potentially trigger allergies.62 The corn did in fact contaminate white corn in 8 Nebraska years later, triggering market losses for affected farmers, while tainted 9 corn flour was reportedly ruined, with some people falling ill from eating products 10 made from it.63 As with pharmaceutical-producing GE crops, those engineered to 11 express industrial enzymes pose economic, environmental, and food safety risks. 12 111. In one type of gene editing process, where genes are inserted to give an 13 organism a particular trait, it is possible for several functional genes to be inserted 14 at once, resulting in extensive changes to the genome. These changes could make 15 the genome almost unrecognizable compared to the original organism, and fall 16 within the scope of “synthetic biology.”64 This has already been achieved in bacteria 17 18 61 Union of Concerned Scientists, Comments to USDA APHIS on Draft Environmental Assessment and Preliminary Decision to Deregulate Syngenta’s 19 Genetically Engineered Ethanol Corn (July 6, 2009). 20 62 Ken Roseboro, StarLink 2: Approval of GM Biofuel Corn Threatens Food Supply, THE ORGANIC & NON-GMO REPORT (Mar. 1, 2011), https://non- 21 gmoreport.com/articles/march2011/gmbiofuelcornthreatensfoodsupply.php. 22 63 Ken Roseboro, GMO-Ethanol Corn Contamination Raises Concerns About Another 23 “StarLink” Disaster, THE ORGANIC & NON-GMO REPORT (Feb. 22, 2017), http://non-gmoreport.com/articles/gmo-ethanol-corn-contamination-raises- 24 concerns-another-starlink-disaster/. 64 25 FRIENDS OF THE EARTH & ETC GROUP, GMOS 2.0: SYNTHETIC BIOLOGY: A GUIDE TO PROTECTING NATURAL PRODUCTS (2017), https://1bps6437gg8c169i0y1drtgz- 26 wpengine.netdna-ssl.com/wp- content/uploads/2017/12/SynbioFreeCompanyGuide.pdf; European Network of 27 Scientists for Social and Environmental Responsibility, Products of New Genetic 28 Modification Techniques Should be Strictly Regulated as GMOs (2018), COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 37 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 40 of 91 1 and yeast, and shows that even small edits through gene editing can result in 2 significant changes.65 3 112. Gene editing techniques have also facilitated the possibility of “gene 4 drives,” which use a few gene-edited individuals to spread new genes through the 5 entire population of a species.66 This mechanism that the new genes will be 6 inherited by each offspring in the next generation, rather than the expected half in 7 normal inheritance.67 This means that genetic changes in a population are likely to 8 persist for longer periods of time, even permanently. Scientists are already warning 9 that the consequences of gene drives could be severe, including adverse 10 environmental outcomes and harmful effects on vegetable crops.68 These newer 11 types of future genetically engineered organisms would also fall under USDA’s new 12 regulatory regime (or now lack thereof). 13 113. GE trees under USDA’s purview present their own unique risks 14 separate and apart from GE plants. Trees are long-lived and can reproduce over 15 Secretariat of the Convention on Biological Diversity, Synthetic Biology, CBD 16 Technical Series no. 82, Montreal (2015), https://www.cbd.int/ts/cbd-ts-82-en.pdf. 65 17 Bao, Z., et al., Genome-Scale Engineering of Saccharomyces Cerevisiae with Single-Nucleotide Precision, 36 NATURE BIOTECHNOLOGY 505-508 (2018); Garst, 18 A.D., et al., Genome-Wide Mapping of Mutations at Single-Nucleotide Resolution for Protein, Metabolic and Genome Engineering, 35 NATURE BIOTECHNOLOGY 48- 19 55 (2017). 20 66 FRIENDS OF THE EARTH, GENE-EDITED ORGANISMS IN AGRICULTURE: RISKS AND UNEXPECTED CONSEQUENCES 14 (2018), https://1bps6437gg8c169i0y1drtgz- 21 wpengine.netdna-ssl.com/wp- 22 content/uploads/2018/09/FOE_GenomeEditingAgReport_final.pdf; NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE, GENE DRIVES ON THE 23 HORIZON: ADVANCING SCIENCE, NAVIGATING UNCERTAINTY, AND ALIGNING RESEARCH WITH PUBLIC VALUES, National Academies Press, Washington, D.C. 24 (2016), https://www.nap.edu/download/23405. 25 67 NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE, GENE DRIVES ON 26 THE HORIZON: ADVANCING SCIENCE, NAVIGATING UNCERTAINTY, AND ALIGNING RESEARCH WITH PUBLIC VALUES, National Academies Press, Washington, D.C. 27 (2016), https://www.nap.edu/download/23405. 68 28 Id. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 38 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 41 of 91 1 great distances via wind, water, and animals, raising even more significant and 2 different in kind risks from contamination, including contamination of forests and 3 wild relatives.69 4 114. Trees are a key species comprising forest ecosystems that regulate air 5 quality, stabilize climate, preserve water quality and abundance, and harbor much 6 of the world’s biodiversity, including endangered species. These essential functions 7 of forests are threatened by GE trees, which will mainly be designed to increase 8 profitability of industrial tree plantations.70 9 115. For example, plantations of proposed but never deregulated “freeze- 10 tolerant” GE eucalyptus trees previously tested in USDA-permitted field trials 11 could cause broad, long-term ecosystem changes, such as increased fire risks, and 12 water table depletion. This alteration would allow the trees to grow in areas they 13 could not survive naturally, at growth rates that are much faster than pine 14 populations in the southeastern U.S.71 Eucalyptus plantations are extremely water- 15 intensive and could exacerbate water scarcity if grown in new regions.72 16 116. Finally, juxtaposed against these facts, the U.S. public is discovering 17 that the industry’s hype about GE foods is false: despite billions of dollars in 18 research and two decades of commercialization, no GE crops are commercially 19 produced to increase yields, reduce world hunger, or mitigate the climate crisis.73 20 69 21 CENTER FOR FOOD SAFETY, GENETICALLY ENGINEERED TREES: THE NEW FRONTIER OF BIOTECHNOLOGY 8 (2013), 22 http://www.centerforfoodsafety.org/files/ge_trees_2016_93322.pdf. 70 23 Id. at 5. 71 Id. at 31. 24 72 Id. at 40. 25 73 Doug Gurian-Sherman, Union of Concerned Scientists, Failure to Yield: 26 Evaluating the Performance of Genetically Engineered Crops, at 1-5 (Apr. 2009), https://www.ucsusa.org/resources/failure-yield-evaluating-performance- 27 geneticallyengineered-crops; Jack A. Heinemann, Reply to Comment on 28 Sustainability and Innovation in Staple Crop Production in the US Midwest, 12 INT’L J. OF AG. SUSTAINABILITY 387-390 (2014), http://goo.gl/GruWvv. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 39 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 42 of 91 1 Rather, the commercial reality is that agrochemical companies have largely 2 succeeded in engineering these crops to be resistant to the companies’ own 3 products—pesticides—in order to reap huge profits. 4 II. PROCEDURAL HISTORY 5 117. The final Part 340 regulations challenged in this case are the first 6 comprehensive revision of USDA’s GE organism regulations since 1987, when they 7 were established under the Federal Plant Pest Act, a precursor statute to the PPA 8 of 2000. 9 118. In the U.S., no single overarching law or federal agency oversees 10 biotechnology. Instead, the U.S. government oversees its products using a mosaic of 11 laws, implemented by several agencies, pursuant to executive order known as the 12 Coordinated Framework for the Regulation of Biotechnology.74 These agencies are 13 mainly USDA, EPA, and the Food & Drug Administration (FDA). FDA is charged 14 with vetting the safety of GE foods, as well as oversight of GE animals. EPA 15 oversees GE plants that are engineered to themselves act as pesticides by producing 16 pesticidal substances, as well as GE microbes. And USDA regulates GE plants, 17 whether food or feed, as well as GE trees and grasses, overseeing their field trials 18 and granting permission for unregulated commercial cultivation (or at least, it used 19 to do so).75 20 119. Because the U.S. lacked a biotechnology-specific law, the coordinated 21 framework called for these agencies to apply their existing statutes, using existing 22 definitions and authorities to promulgate regulations and oversee transgenic 23 products. FDA was to classify GE food ingredients as “food additives” under the 24 25 26 74 Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 27 (June 26, 1986). 75 28 See infra paragraphs 120-121. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 40 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 43 of 91 1 Federal Food Drug and Cosmetic Act.76 EPA was to regulate the pesticidal 2 substances expressed in transgenic plants as “pesticides” under the Federal 3 Insecticide, Fungicide, and Rodenticide Act.77 Transgenic microorganisms would be 4 regulated by EPA as “toxic chemicals” under the Toxic Substances Control Act.78 5 Transgenic animals would be regulated by FDA as “new animal drugs.”79 And most 6 relevant here and as discussed below, USDA would oversee all other transgenic 7 plants as “plant pests” under the former Plant Pest Act. 8 The Prior Regulations 9 120. Accordingly, the prior USDA Part 340 regulations governed outdoor 10 planting of GE organisms whose development involved the use of plant pest 11 organisms.80 As a practical reality, that covered virtually all GE plants,81 because 12 bacteria and viruses that infect plants—plant pests—and DNA derived from them 13 were invariably needed to successfully engineer the GE plant to express the desired 14 trait. For instance, a soil bacterium known as Agrobacterium, which naturally 15 infects plants, has been repurposed through genetic engineering to “infect” plants 16 with genetic material that lends the GE plant the desired trait(s), most commonly 17 18 76 Id. at 23,304; 21 U.S.C. § 301 et seq. 19 77 Plant-Incorporated Protectants (Formerly Plant Pesticides), Supplemental Proposal, 66 Fed. Reg. 37,855-69 (July 19, 2001); 7 U.S.C. § 136 et seq. 20 78 40 C.F.R. § 725. 21 79 See Inst. for Fisheries Res. v. USDA, 499 F. Supp. 3d 657, 663 (N.D. Cal. 2020). 22 80 A plant pest is defined as “[a]ny living stage (including active and dormant forms) 23 of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof; 24 viruses; or any organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or indirectly injure or cause 25 disease or damage in or to any plants or parts thereof, or any processed, 26 manufactured, or other products of plants.” 40 C.F.R § 340.1. 81 The vast majority of GE organisms under USDA jurisdiction belong to the plant 27 kingdom, and include crops like corn, soybeans, and cotton as well as grasses 28 and trees. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 41 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 44 of 91 1 herbicide-resistance. On this basis, USDA regulated GE crops during field testing 2 and prior to commercialization, as presumptive “plant pests.” 3 121. Because of their presumptive status as plant pests, outdoor field trial 4 experiments of GE plants required permits issued by USDA.82 The ultimate goal of 5 permitting was containment: to prevent the GE plant from propagating itself 6 outside the field trial plot via seed escape or cross-pollination. To this end, USDA 7 permits would require measures like no-plant buffer zones around the GE crop test 8 plots, and mandated crop destruction at the end of field trials.83 9 122. In 1993, a streamlined system was introduced in which developers 10 could submit “notification” to USDA of upcoming GE crop field trials, to which 11 USDA would respond with “acknowledgement.”84 By 2004, 97% of field trials were 12 conducted under notification, versus only 3% under the more rigorous permit 13 system.85 14 123. Each permit or notification was limited to only one crop, but often 15 encompassed: (1) several to dozens of genetic modifications, (2) multiple field tests 16 in several to dozens of states, conducted on (3) anywhere from fractions of an acre to 17 thousands of acres.86 GE organism field tests were conducted under more than 18 19 82 40 C.F.R. § 340.4 (2003). 20 83 Id. § 340.3; see USDA OFFICE OF INSPECTOR GENERAL, AUDIT REPORT: ANIMAL AND 21 PLANT HEALTH INSPECTION SERVICE CONTROLS OVER ISSUANCE OF GENETICALLY ENGINEERED ORGANISM RELEASE PERMITS 44 (2005) (finding that applicants did 22 not destroy remaining GE crops appropriately). 23 84 USDA OFFICE OF INSPECTOR GENERAL, AUDIT REPORT: ANIMAL AND PLANT HEALTH INSPECTION SERVICE CONTROLS OVER ISSUANCE OF GENETICALLY ENGINEERED 24 ORGANISM RELEASE PERMITS 2 (2005). 25 85 Id. 26 86 USDA, Biotechnology Regulatory Services Interstate/Release and Release Permits and Notifications, 27 https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications- 28 petitions/sa_permits/status-update/release-permits. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 42 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 45 of 91 1 20,000 notifications and permits from the 1980s until this year, when the new 2 regulations took effect.87 3 124. The terms “movement” in the PPA and “introduce” in Part 340 have 4 been defined broadly and among other definitions, refer to the act of releasing 5 regulated articles into the environment.88 The old regulations defined “release into 6 the environment” as “the use of a regulated article outside the constraints of 7 physical confinement that are found in a laboratory, contained in a greenhouse, or a 8 fermenter or other contained structure.89 The regulations, therefore, apply 9 specifically to the field-testing of GE plants. 10 125. The old regulations also provided a pathway to commercial approval 11 and sale of GE crops, called deregulation.90 The developer would submit a petition 12 to USDA containing voluminous information about the GE crop, including 13 molecular characterization, and years of field trial data it had collected. USDA 14 would assess this information to determine whether or not the GE crop posed “a 15 greater plant pest risk than the unmodified organism from which it was derived.”91 16 “Plant pest risk” was defined in broad terms, and included GE plant characteristics 17 involving susceptibility to diseases or pests, weediness, changes to plant 18 metabolism, and GE plant-induced changes in agricultural or cultivation practices, 19 among others. USDA would then conduct a Plant Pest Risk Assessment and 20 invariably concluded that the GE crop did not pose a plant pest risk, based on 21 extremely narrow criteria, and grant a determination of nonregulated status, which 22 87 USDA, Permitting and the Regulatory Process / Check Status (last visited July 6, 23 2021), https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits- 24 notifications-petitions/check-status. 88 7 U.S.C. § 7702(9) and 7 C.F.R. § 340.1. 25 89 7 C.F.R. § 340.1. The new regulations simplify this definition, but the meaning 26 remains the same. 27 90 See 58 Fed. Reg. 17,044-59. 91 28 40 C.F.R. § 340.6. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 43 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 46 of 91 1 authorized unregulated commercial cultivation of the GE crop.92 It would also 2 perform an analysis of the broader environmental effects pursuant to NEPA. 3 126. The 1987 regulations were issued under the authority of the Federal 4 Plant Pest Act of 1957 and Plant Quarantine Act of 1912. At that time, USDA’s 5 authority to regulate noxious weeds came from the Federal Noxious Weed act of 6 1974, which limited USDA’s noxious weed authority to plant that were of foreign 7 origin and new to the U.S. Most GE plants during that era were modified crops that 8 were already present in the U.S., meaning USDA did not have authority to regulate 9 them. 10 New Authority: The Plant Protection Act 11 127. In 2000, Congress subsumed the Plant Pest Act and Noxious Weed Act 12 into the Plant Protection Act (PPA).93 In doing so, Congress provided USDA with 13 powerful new authority to regulate GE organisms not only as potential plant pests, 14 but for the noxious weed risks they may pose. The PPA’s broadened definition of 15 noxious weed is: “Any plant or plant product that can directly or indirectly injure or 16 cause damage to crops (including nursery stock or plant products), livestock, 17 poultry, or other interests of agriculture, irrigation, navigation, the natural 18 resources of the United States, the public health, or the environment.”94 The PPA 19 gives USDA explicit authority to issue regulations regarding noxious weeds.95 20 128. Under the PPA, USDA has the responsibility to prevent plant pest 21 risks and noxious weed risks, both of which are broadly defined agricultural and 22 23 24 92 USDA has granted nonregulated status to 133 GE plants from the early 1990s to June 26, 2021, and has never denied a petition for nonregulated status (though 25 some have been withdrawn by the crop developer). 26 93 7 U.S.C. §§ 7701-7786. 27 94 Id. § 7702(10). 95 28 Id. § 7712(c). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 44 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 47 of 91 1 environmental harms. USDA has a multiplicity of statutory tools with which to 2 prevent those harms.96 3 129. However, it took USDA 20 years to finally update its Part 340 4 regulations. Up until the very final rule, the impetus of this entire process was to 5 implement its new broader authority over GE organisms. In the meantime, USDA 6 continued to operate under its older, pre-PPA regulations, which only regulated GE 7 organisms for plant pest risks. 8 130. In 2002, the National Academy of Sciences recommended the use of 9 genetic engineering (i.e. “transformation”) as “both a useful and logically justifiable 10 regulatory trigger” because “there is no scientific basis” on which to exclude GE 11 organisms from regulatory review prior to evaluation of data on the interactions 12 between “trait, organism and environment.”97 13 131. Over the past two decades, USDA repeatedly acknowledged the need to 14 implement its PPA noxious weed authority to address a wide variety of risks posed 15 by GE organisms that it does not regard as plant pest risks, and thus have not been 16 addressed under the plant pest regulatory framework. USDA accordingly made 17 repeated attempts to implement its noxious weed authority, as described below, but 18 ultimately abandoned this path in the final rule. 19 The Long Road to New PPA Implementing Regulations 20 132. USDA first proposed updating its regulations to implement its noxious 21 weed authority over 15 years ago, in 2004.98 In this EIS scoping notice, the agency 22 took the first step towards implementing its noxious weed authority for GE 23 organisms, suggesting that its noxious weed authority could be used to regulate GE 24 plants that produce experimental pharmaceutical and industrial compounds, as 25 96 Id. § 7701(3); id. §§ 7702(10), (14); id. §§ 7714, 7733, 7731, 7735, 7721, 7714. 26 97 National Academy of Sciences, NRC, ENVIRONMENTAL EFFECTS OF TRANSGENIC 27 PLANTS 79 (2002). 98 28 See Environmental Impact Statement; Introduction of Genetically Engineered Organisms, 69 Fed. Reg. 3271 (Jan. 23, 2004). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 45 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 48 of 91 1 well as nonviable GE plant material. USDA also suggested it would regulate GE 2 biological control organisms. 3 133. Some Plaintiffs and many other interested parties participated in 4 public comment on the 2004 scoping notice, urging USDA to broaden its regulatory 5 scope to include noxious weed risks. Particularly, Plaintiffs emphasized that stress 6 tolerance genes can increase the fitness of GE plants and wild relatives they 7 interbreed with, creating possible noxious weed risks associated with their potential 8 to spread into natural areas and displace other species. 9 134. In 2005, USDA’s Office of Inspector General (OIG) released an audit 10 report on USDA’s oversight of GE organisms.99 The OIG report found numerous 11 grave deficiencies in inspection, enforcement, and transparency, and concluded that 12 USDA’s existing regulations were inadequate: “APHIS’ current regulations, policies, 13 and procedures do not go far enough to ensure the safe introduction of agricultural 14 biotechnology.”100 Specifically, the report noted that USDA still needed to update its 15 regulations to comply with the PPA and reflect the PPA’s noxious weed authority, 16 and made a formal recommendation to this effect.101 17 135. In 2007, USDA released a draft PEIS analyzing the potential 18 environmental impacts resulting from potential revisions to its Part 340 19 regulations. The 2007 PEIS was the eventual result of the process begun with 20 USDA’s 2004 scoping notice. The agency found that historically, it has only used its 21 22 99 OIGs were created by Congress as “independent and objective units” charged with conducting and supervising audits and investigations into the programs and 23 operations of agencies. OIGs are to “provide leadership and coordination and recommend policies” to agencies and keep “Congress fully and currently 24 informed about problems and deficiencies” in agency programs. Inspector 25 General Act of 1978, Pub. L. No. 95-452 § 2. 100 26 USDA OFFICE OF INSPECTOR GENERAL, AUDIT REPORT: ANIMAL AND PLANT HEALTH INSPECTION SERVICE CONTROLS OVER ISSUANCE OF GENETICALLY 27 ENGINEERED ORGANISM RELEASE PERMITS at iv (2005). 101 28 Id. at 8, 11. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 46 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 49 of 91 1 plant pest authority as a basis for GE regulation but that the PPA “redefined 2 authorities and responsibilities for the agency.”102 As such, USDA preliminarily 3 determined that it would broaden its regulatory scope to include GE plants that 4 could pose a noxious weed risk. USDA acknowledged that, “[g]iven the rapid 5 advances in biotechnology, the present scope of regulations may not be of sufficient 6 breadth to cover the full range of GE organisms and the full range of potential 7 agricultural and environmental risks posed by these organisms.”103 8 136. Specifically, USDA made a preliminary determination to increase 9 oversight of GE organisms by utilizing the PPA’s noxious weed authority, which 10 would allow for a broader consideration of risks.104 Again, USDA referenced as an 11 example the need to regulate GE plants that produce pharmaceutical or industrial 12 compounds that could pose human health or environmental risks. More generally, 13 USDA found that “it is possible for a plant to be genetically engineered with genes 14 that might give the plant the characteristics of a noxious weed, and APHIS wants 15 the ability to ask not only whether a GE organism is a plant pest, but also whether 16 a GE plant may be considered a noxious weed.”105 17 137. USDA acknowledged that its noxious weed authority would allow it to 18 “look at the broadest range of possible impacts resulting from releasing [a GE] plant 19 in the environment.”106 The agency recognized that plants can be engineered with 20 genes to increase fitness, and the risk that such a plant would become invasive in 21 the wild. Additionally, USDA was particularly interested in using the noxious weed 22 23 102 24 USDA, INTRODUCTION OF GENETICALLY ENGINEERED ORGANISMS: DRAFT PROGRAMMATIC ENVIRONMENTAL IMPACT STATEMENT at v (2007). 25 103 Id. 26 104 Id. at ix. 27 105 Id. at 21. 106 28 Id. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 47 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 50 of 91 1 provision to consider public health effects of GE plants.107 Invoking its noxious weed 2 authority would allow USDA to regulate for these risks because the definition of 3 “noxious weed” is broader than that for a “plant pest.” For instance, plant pests are 4 defined as living, while the definition of noxious weeds includes both plants and 5 non-living “plant products.” 6 138. The 2007 draft PEIS also shows the agency’s concern with the 7 proliferation of herbicide-resistant weeds. It recognized that herbicide-resistant 8 transgenes in GE crops could pass to weeds, creating problems for farmers who 9 must cope with herbicide-resistant weeds.108 USDA also acknowledged the 10 environmental costs of this problem, noting that individuals would be forced to use 11 higher toxicity or persistent herbicides to control these new weed variations.109 12 139. Finally, the draft PEIS acknowledged that approvals of petitions for 13 nonregulated status (permitting unrestricted planting), could have effects on 14 threatened or endangered species. It found that USDA must determine which listed 15 species would come into contact with a deregulated plant, and whether contact 16 would affect the species or its habitat.110 If so, USDA would need to consult with the 17 expert services. 18 140. In June 2008, Congress passed the 2008 Farm Bill, which set 19 agricultural policy for a period of five years. The 2008 Farm Bill directives required 20 USDA to “promulgate regulations to improve the management and oversight of 21 articles regulated under the Plant Protection Act,” including the oversight and 22 management of GE crop field-testing.111 This Congressional action was prompted by 23 107 24 Id. 108 Id. at 120-21. 25 109 Id. at 121. 26 110 Id. at 177-78. 27 111 Food, Conservation, and Energy Act of 2008, Pub. L. No. 110-246, Tit. X § 28 10204(a)(2). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 48 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 51 of 91 1 the disastrous LibertyLink rice contamination incidents discussed above,112 and the 2 dire need for the agency to establish better confinement, monitoring and record- 3 keeping procedures. After the LibertyLink rice incidents, USDA conducted an 4 investigation and issued a LESSONS LEARNED report with a list of considerations to 5 enhance its regulatory framework.113 The 2008 Farm Bill required USDA to take 6 action on each of the issues identified in that document, many of which focused on 7 field-trial containment and documentation. 8 141. A 2008 Government Accountability Office study analyzed the more 9 impactful of numerous contamination episodes from field trials of GE organisms in 10 the preceding decade, concluding that “the ease with which genetic material from 11 crops can be spread makes future releases likely,” and recommended that USDA 12 address the unintended release of GE organisms and coordinate strategies for post- 13 commercialization monitoring.114 14 First Proposed Rule 15 142. USDA issued its first proposed rule later in 2008, in which it 16 recognized that new regulations were necessary to apply the PPA and more 17 effectively regulate GE organisms.115 In the proposed rule, USDA found that “it is 18 appropriate to align the regulations with both the plant pest and the noxious weed 19 authorities of the PPA,” for many of the same reasons it indicated in the 2007 20 21 112 See supra paragraph 88. 22 113 USDA, LESSONS LEARNED AND REVISIONS UNDER CONSIDERATION FOR APHIS’ 23 BIOTECHNOLOGY FRAMEWORK 2007, https://www.aphis.usda.gov/biotechnology/downloads/supportingdocs/LessonsLea 24 rned10-2007.pdf. 25 114 U.S. GAO, GENETICALLY ENGINEERED CROPS (Nov. 2008), 26 https://www.gao.gov/assets/gao-09-60.pdf. 115 See Importation, Interstate Movement, and Release Into the Environment of 27 Certain Genetically Engineered Organisms; Proposed Rule, 73 Fed. Reg. 60,007 28 (Oct. 9, 2008). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 49 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 52 of 91 1 PEIS.116 Particularly, it explained that “with the increasing diversity of both 2 agronomic and non-agronomic traits being engineered into plants it is appropriate 3 to place regulatory controls upon GE plants proportionate to the likelihood that 4 they may present a noxious weed risk until the potential risk can be appropriately 5 evaluated.”117 6 143. Here, USDA also recognized Congress’s new mandate for it and 7 proposed to implement changes that would “reflect provisions of the 2008 Farm Bill 8 recently enacted,” and aligned its proposal with recommendations from the 2005 9 OIG audit.118 10 144. The 2008 proposed rule noted that most of the public comments on the 11 draft PEIS urged USDA to expand its scope to include noxious weeds, and that even 12 though the agency can technically assess “weediness” in relation to a GE plant’s 13 plant pest potential, that trait is “more properly a noxious weed risk characteristic 14 than a plant pest one.” Accordingly, “the proposed revision of the regulations will 15 more clearly align the regulations with the plant pest and noxious weed risk 16 pursuant to the PPA.”119 17 145. The agency solicited public comment on the proposed rule for over 18 eight months and received over 88,300 comments from stakeholders. During that 19 time, USDA held public meetings with stakeholders to discuss the regulation of GE 20 organisms. There, USDA discussed the “goal of incorporating the noxious weed 21 authority” of the PPA into Part 340, and indicated that its “current thinking” was to 22 revise the regulations to incorporate that authority.120 23 116 24 Id. at 60,011. 117 Id. at 60,014. 25 118 Id. at 60,007. 26 119 Id. at 60,029. 27 120 USDA, Issue Paper 2: Incorporation of the Plant Protection Act Noxious Weed 28 Provisions (Apr. 28, 2009). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 50 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 53 of 91 1 146. However after taking no action for nearly 7 years to finalize the rule, 2 in 2015, USDA instead withdrew the 2008 proposed rule, announcing a new plan for 3 further “stakeholder engagement.”121 4 147. Later in 2015, USDA’s OIG released another audit report on USDA’s 5 regulation of GE organisms and internal management controls. The 2015 report 6 again criticized USDA for not implementing its additional authority to control 7 noxious weeds and recommended that the agency implement the corrective actions 8 it agreed upon in the previous 2005 assessment. This included a commitment to 9 updating its regulations and “incorporating additional authority to control noxious 10 weeds.”122 USDA’s response to the audit agreed with OIG’s recommendations and 11 committed to proposing revised Part 340 regulations. 12 Second Proposed Rule 13 148. In January 2017, USDA published a second proposed rule.123 In line 14 with OIG’s recommendations and its previous proposals, USDA again proposed to 15 invoke and implement its PPA noxious weed authority in the revised Part 340 16 regulations. As its basis for the proposed rule, the agency stated that its past 17 evaluations had provided evidence that most genetic engineering techniques do not 18 result in GE organisms that present plant pest risks. Additionally, USDA explained 19 that genetic engineering techniques have been developed that could create GE 20 organisms with plant pest risks without falling into the scope of regulation.124 21 22 121 Importation, Interstate Movement, and Release Into the Environment of Certain 23 Genetically Engineered Organisms; Proposed Rule; Withdrawal, 80 Fed. Reg. 11,598 (Mar. 4, 2015). 24 122 USDA, OFFICE OF INSPECTOR GENERAL, CONTROLS OVER APHIS’ INTRODUCTION 25 OF GENETICALLY ENGINEERED ORGANISMS 7 (Sept. 2015). 123 26 Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms; Proposed Rule, 82 Fed. Reg. 7008 (Jan. 19, 27 2017). 124 28 Id. at 7009. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 51 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 54 of 91 1 149. An entire section of the proposed rule discusses the OIG audits and the 2 2008 Farm Bill and their influence on the agency’s approach to its new regulations. 3 Specifically, it references the need to minimize “dissemination” from field trials.125 4 150. The 2017 proposed rule admitted that USDA’s “current regulatory 5 structure, which entails evaluating such plants solely for plant pest risk, is not 6 sufficient to properly identify all risks that these plants present to other plants and 7 plant products.”126 In fact, under that scheme, USDA found that “such plants may 8 entirely escape regulation.” Therefore, USDA found it “both appropriate and 9 necessary to begin to evaluate GE plants for noxious weed risk.”127 10 151. Along with the 2017 proposed rule, USDA released yet another draft 11 PEIS on the environmental impacts of revising the Part 340 regulations. This 12 document shows the agency’s commitment to invoking its noxious weed authority 13 and further elaborates on the importance of doing so. It cites the 2015 OIG report’s 14 recommendation to incorporate its authority to control noxious weeds, noting that, 15 “[a]mong the recommendations provided [to] APHIS in the 2015 audit report, OIG 16 stated that APHIS needed to revise its regulations (7 CFR part 340) to consolidate 17 all requirements for conducting field tests of regulated material in order to 18 minimize the inadvertent release of GE material; . . . and that APHIS update its 19 regulations to incorporate the provisions of the Plant Protection Act of 2000, to 20 specifically include incorporation of authority to control noxious weeds. APHIS 21 agreed with these recommendations (USDA-OIG 2015), and has, as part of 22 implementing the recommendations, issued proposed revisions for 7 CFR part 23 340.”128 24 125 Id. at 7011. 25 126 Id. at 7010. 26 127 Id. 27 128 USDA, REVISIONS TO USDA-APHIS 7 CFR PART 340 REGULATIONS GOVERNING 28 THE IMPORTATION, INTERSTATE MOVEMENT, AND ENVIRONMENTAL RELEASE OF COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 52 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 55 of 91 1 152. The agency further explained that, “[b]ecause noxious weed risk has 2 become an important aspect of the regulation of GE plants, and the fact that it is 3 more scientifically and legally justified to consider weed risk under noxious weed 4 authority rather than under the plant pest authority, APHIS considers it both 5 appropriate and necessary to incorporate the noxious weed authority provided [to] 6 APHIS under the PPA, and to begin to evaluate GE plants for noxious weed risk.”129 7 153. USDA also found that increasing diversity and number of traits in GE 8 crops necessitated the application of its noxious weed authority.130 9 154. In comparing the proposed regulations to the “No Action” alternative, 10 USDA found that the “No Action alternative does not provide for sufficient 11 incorporation of recommendations by USDA OIG audits,” and that providing 12 regulatory oversight for noxious weed risks would “reduce[] the potential risks to 13 physical and biological resources,” providing environmental protections that could 14 not be realized under the status quo.131 15 155. Finally, as it did in its 2007 environmental analysis, USDA 16 acknowledged that the agency would need to make determinations regarding 17 individual deregulation decisions’ effects on threatened or endangered species and 18 critical habitat.132 19 20 21 22 23 24 GENETICALLY ENGINEERED ORGANISMS: DRAFT PROGRAMMATIC ENVIRONMENTAL IMPACT STATEMENT at ES-2 (2017). 25 129 Id. at ES-4 (emphasis added). 26 130 Id. at 1-4 to 1-5. 27 131 Id. at ES-8. 132 28 Id. at ES-35 to ES-36. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 53 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 56 of 91 1 156. However rather than proceed to a final rule, in November 2017, USDA 2 withdrew the second proposed rule, once again claiming it needed to deliberate 3 further on its revision of the Part 340 regulations.133 4 Third Proposed Rule 5 157. In June 2019, USDA published yet another proposed rule, and an 6 accompanying draft PEIS.134 The PEIS rejected an alternative that would 7 incorporate USDA’s noxious weed authority and mitigate GE contamination and 8 resulting economic harm. Rather than analyzing this as a true alternative, USDA 9 glossed over the option without conducting a cost-benefit analysis, which would 10 reveal benefits that would protect farmers. USDA failed to fully evaluate this 11 alternative, included in the section, “Alternatives Considered But Dismissed from 12 Further Consideration.”135 13 158. In contrast to prior iterations, in the third proposed rule, among other 14 changes, USDA failed to invoke the PPA’s noxious weed authority. Nor did it 15 provide any explanation for its radical departure from 15 years of detailed 16 environmental analyses, prior proposed rules, and OIG mandates, all of which 17 insisted upon the necessity of incorporating USDA’s noxious weed authority to 18 forestall the harms of GE organisms—harms not captured by USDA’s plant pest 19 authority. 20 21 22 133 Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms; Proposed Rule; Withdrawal, 82 Fed. Reg. 23 51,582 (Nov. 7, 2017). 24 134 Movement of Genetically Engineered Organisms; Proposed Rule, 84 Fed. Reg. 26,514 (June 6, 2019). 25 135 USDA, REVISIONS TO USDA-APHIS 7 CFR PART 340 REGULATIONS GOVERNING 26 THE IMPORTATION, INTERSTATE MOVEMENT, AND ENVIRONMENTAL RELEASE OF CERTAIN GENETICALLY ENGINEERED ORGANISMS: DRAFT PROGRAMMATIC 27 ENVIRONMENTAL IMPACT STATEMENT at 2-20 to 2-24 (May 2019), 28 https://www.aphis.usda.gov/brs/pdf/340_proposedrule_draftEIS_2019.pdf. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 54 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 57 of 91 1 159. Instead, USDA proposed a bevy of exemptions, whereby a host of GE 2 organisms that purportedly could have been developed via traditional breeding 3 techniques escape regulation altogether. These exemptions were not based in 4 science, but rather were crafted to comply with a statement made by then-Secretary 5 of Agriculture, Sonny Perdue on March 28, 2018.136 Other GE organisms were 6 excluded if USDA had previously cleared a GE plant with the same plant-trait- 7 mechanism of action combination. These exemptions replaced USDA’s former 8 system of assessing each and every unique GE plant—known as an “event”—under 9 its purview, which was based in part on the unintended, unpredictable, and 10 potentially hazardous changes that occur with any GE technique. 11 160. Also prominent in the third proposed rule was the great leeway given 12 to companies to “self-determine” whether or not their GE crops even met either of 13 the above broad exemption categories, which would allow potentially risky crops to 14 be planted without USDA’s consent or knowledge. 15 161. Due to these changes and others, as Plaintiffs explained in its 16 comments, the proposed rule represented the “opposite of regulation” because, 17 instead of exercising its broad PPA authority to regulate GE crops and provide 18 better regulatory oversight, developers of GE technologies will have free rein to self- 19 determine whether or not their GE experiments should be subject to regulations, 20 and the vast majority of GE plants would be exempted from any meaningful 21 regulatory oversight.137 Moreover, Plaintiffs explained that the proposed rule would 22 allow these GE plants to be commercialized and planted without any regulation or 23 24 136 Secretary Perdue Issues USDA Statement on Plant Breeding Innovation, USDA, Mar. 28, 2018, https://www.usda.gov/media/press-releases/2018/03/28/secretary- 25 perdue-issues-usda-statement-plant-breeding-innovation; Movement of Genetically Engineered Organisms; Proposed Rule, 84 Fed. Reg. 26,519 (June 6, 26 2019). 27 137 Center for Food Safety, Comments on Proposed Rule on Movement of Certain 28 Genetically Engineered Organisms, 7 CFR Parts 340 and 372, Docket No. APHIS-2018-0034. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 55 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 58 of 91 1 monitoring based only on a streamlined review that does not capture the myriad of 2 biological, agricultural, socioeconomic, and environmental harms of new GE 3 technologies, falling woefully short of USDA’s duties to prevent noxious weed risks 4 and plant pest harms under the PPA. 5 The Final Rule 6 162. USDA published the final rule in May 2020, codifying these hugely 7 problematic changes, with only minor changes from the proposed rule.138 Under the 8 final rule, USDA exempts numerous GE organisms from being subject to any 9 regulation at all.139 The final rule also excludes from regulation those GE plants 10 with plant-trait-mechanism of action combinations that have previously been 11 exempted after a cursory regulatory status review, and allows GE plant developers 12 to self-determine whether regulations apply to their products.140 The major changes 13 from the old regulatory regime are a dramatically reduced scope of regulation, 14 empowerment of crop developers to make their own regulatory determinations, and 15 a far weaker assessment of non-exempted GE plants made in the absence of real- 16 world data. The overriding rationale for these changes is to provide “regulatory 17 relief” to crop developers.141 18 163. USDA reduces its scope of regulation in two major ways. First, in 19 compliance with a brief 2018 statement by former Secretary of Agriculture Sonny 20 Perdue, USDA exempts from regulation plants that were developed with GE 21 technology, but purportedly could have been developed by conventional breeding 22 methods,142 as well as plants that have a plant-trait mechanism of action 23 138 24 Movement of Certain Genetically Engineered Organisms; Final Rule, 85 Fed. Reg. 29,790 (May 18, 2020). 25 139 Id. at 29,791. 26 140 Id. at 29,798. 27 141 Id. at 29,791. 142 28 7 C.F.R. § 340(b)(4). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 56 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 59 of 91 1 combination that is the same as in a plant USDA has previously exempted from 2 regulation.143 Second, it allows GE developers to make exemption determinations 3 for their experiments without consultation or approval from USDA.144 4 Exemptions 5 164. The three initial exemption classes carved out to comply with Perdue’s 6 statement are GE plants resulting from: (1) Intentional DNA strand breakage, 7 followed by cellular repair of the break without a provided template;145 (2) A single 8 base pair substitution; and (3) Introduction of a gene from the plant’s gene pool, or 9 modification of a gene to correspond to a gene variant present in the gene pool.146 10 USDA also incorporated a mechanism by which it can create new exemptions on the 11 same grounds, initiated by it or by other parties,147 and recently proposed three 12 additional exemption classes.148 13 165. This exemption rationale—“if it could have been developed via 14 conventional breeding”—is not grounded in science. USDA concedes that “there is 15 no universally applicable, sharp delineation between what is and what is not 16 possible to achieve with traditional breeding methods.”149 Judgments as to whether 17 18 143 Id. § 340.1(c)(1). 19 144 85 Fed. Reg. at 29,798-99. 20 145 This exemption was expanded from that in the proposed rule, and includes GE 21 plants in which DNA segments of “any size” have been deleted, as well as DNA insertions or combinations of both deletions and insertions, as effected by 22 cellular repair mechanisms in the absence of a provided repair template. Id. at 29,791, 29,794. 23 146 7 C.F.R. § 340.1(b)(1)-(3). 24 147 Id. § 340.1(b)(4). 25 148 USDA, Movement of Organisms Modified or Produced Through Genetic 26 Engineering; Notice of Exemptions, 86 Fed. Reg. 37,988 (July 19, 2021). 149 84 Fed. Reg. at 26,519. Moreover, the “traditional” or “conventional” breeding 27 methods USDA cites in support of all six exemption classes are highly disruptive 28 mutagenesis techniques, little used today, whereby radiation or chemicals are COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 57 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 60 of 91 1 some facsimile of an existing GE plant could have been generated via conventional 2 techniques are not informative regarding whether or not it poses risks cognizable 3 under the PPA, and thus are not legitimate grounds for exemption. 4 166. A GE plant is also exempted from regulation if USDA has previously 5 determined that a GE plant of the same species, with the same plant trait 6 (observable characteristic of an organism) and same mechanism of action (the 7 biochemical process(es) through which genetic material determines a trait) is 8 unregulated.150 However, two GE plants that share the same plant-trait-mechanism 9 of action combination may nonetheless pose different direct and indirect risks under 10 the PPA. 11 167. These and likely future exemptions mean a growing class of GE plants 12 can be grown experimentally and commercially without any regulatory review. In 13 contrast, the old rule captured all GE organisms initially, provided plant pests were 14 involved in their development (as nearly all were). 15 Self-Determination & Data Requirements 16 168. GE plant developers are empowered to make these critical exemption 17 decisions or self-determinations entirely on their own, as a regulatory relief 18 measure, without consulting USDA or USDA approval.151 In contrast, under the old 19 regulations, any GE plant classified as a regulated article could only be grown 20 outdoors in field tests with use of gene confinement measures under authorizations 21 issued by USDA, either under the notification or permit system.152 And, in order to 22 23 24 used to induce large-scale, random and mostly deleterious mutations in crop genomes. 85 Fed. Reg. at 29,794; 86 Fed. Reg. 37,988-89. 25 150 7 C.F.R. § 340.4. See also id. § 340.3 for definitions of trait and mechanism of 26 action. 27 151 85 Fed. Reg. at 29,798-99 (May 18, 2020). 152 28 7 C.F.R. §§ 340.3, 340.4 (2003). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 58 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 61 of 91 1 be commercialized, a plant had to be “deregulated” by USDA through a formal 2 approval process.153 3 169. Now, while a developer may request “confirmation” from USDA that a 4 GE plant is exempted,154 it is not required to do so. 5 170. With no obligation to seek USDA’s approval or even consult USDA, 6 developers are free to field test and commercialize exempted GE plants anytime, 7 anywhere, entirely without USDA’s awareness. With no obligation to practice 8 containment, neighboring farmers are at risk of GE contamination. 9 171. GE plants that are not exempted in these ways would normally 10 undergo a regulatory status review, for which developers submit genetic sequence 11 information on their engineered plant’s modification to USDA.155 However this 12 status review requires “much less information” than the old deregulation process, 13 which required submission of a petition containing “information regarding a broad 14 range of possible harms.”156 15 172. For example, the old deregulation process required data from all field 16 tests,157 while the new regulatory status review requires neither laboratory nor 17 field-test data, and thereby reduces “a developer’s data submission burden.”158 18 173. The lack of real-world data on a GE plant’s characteristics and effects 19 during cultivation makes it likely that USDA will miss many harms caused by GE 20 21 22 23 153 See 58 Fed. Reg. 17,044-59. 24 154 7 C.F.R. § 340.1(e). 25 155 85 Fed. Reg. at 29,808-09. 26 156 Id. at 29,808. 27 157 7 C.F.R. § 340.6 (2003). 158 28 85 Fed. Reg. at 29,808. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 59 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 62 of 91 1 crops that are cognizable under the PPA, and does not heed the recommendations of 2 the National Academy of Sciences for GE plant regulation.159 3 174. USDA states that real-world information typically does not influence 4 deregulation decisions,160 but this is because, in the past and in the new 5 regulations, it has narrowly construed its plant pest authority, and now refuses to 6 implement its noxious weed authority. The risks posed by GE organisms that USDA 7 once acknowledged required the noxious weed authority to address are also the kind 8 for which high-quality, real-world field-test data are essential. 9 175. Under the old rule’s petition process, developers would submit a 10 petition requesting an agency determination of non-regulated status, and USDA 11 would hold notice and comment, review the individual GE organism under the PPA 12 as well as NEPA, and make a final agency approval determination, that was 13 subsequently subject to judicial review.161 The new regulatory status review does 14 not involve notice and comment or culminate in a judicially reviewable decision.162 15 This portion of the new rule took effect on April 5, 2021. 16 176. Now, in those few cases in which the regulatory status review does not 17 clear a GE plant of posing a plant pest risk, it could still be grown under a 18 permit.163 Developers can also request a permit to grow a GE plant in lieu of a 19 regulatory status review.164 20 21 159 NATIONAL ACADEMY OF SCIENCES, NRC, ENVIRONMENTAL EFFECTS OF TRANSGENIC 22 PLANTS 79 (2002). 23 160 85 Fed. Reg. at 29,797. 24 161 7 C.F.R. § 340.5(c)(2) (2003); id. § 372.5(b)(4) (2014). 25 162 See 85 Fed. Reg. at 29,791. 163 7 C.F.R. § 340.4(b)(3)(iii). 26 164 USDA, Secure Rule Regulatory Changes: About the Secure Rule, Determining 27 Regulatory Status for GE Plants/Organisms, 28 https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/biotech-rule- revision/secure-rule/secure-reg-changes (last updated June 12, 2020). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 60 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 63 of 91 1 Major Problems with the Final Rule 2 177. First, under USDA’s new deregulatory regime, a growing number of 3 experimental GE crops will no longer be regulated for confinement, even at the field 4 trial stage. That is, in sharp contrast to the prior regulations, GE crop experiments 5 will no longer be regulated under the PPA or analyzed under NEPA or the ESA. 6 This will result in high risks of transgenic contamination, leading to market 7 rejection of contaminated food supplies, and attendant economic losses to farmers, 8 food companies, and others in the food supply chain. In some cases, transgenic 9 contamination will compromise the safety and quality of the contaminated food. 10 178. One example that bodes ill for the future is the GE industrial crop, 11 Enogen corn, which is meant exclusively for production of ethanol for biofuels use. 12 Enogen produces high levels of a bacteria-derived enzyme that initiates the process 13 of converting corn starch to ethanol. Even low-level contamination of food-grade 14 corn with Enogen degrades the agricultural quality of the corn by converting 15 starches to sugars, rendering it potentially unfit for food use. USDA deregulated 16 Enogen corn over the strong objections of major corn commodity and public interest 17 groups on the strength of assurances from Syngenta, its developer, that it would be 18 managed in a “closed loop” production system that would prevent contamination of 19 food-grade corn.165 Despite these assurances, Enogen has widely contaminated 20 white corn in Nebraska, resulting in substantial losses to white corn growers. Corn 21 22 23 165 Ken Roseboro, StarLink 2: Approval of GM Biofuel Corn Threatens Food Supply, 24 THE ORGANIC & NON-GMO REPORT (Mar. 1, 2011), https://non- 25 gmoreport.com/articles/march2011/gmbiofuelcornthreatensfoodsupply.php; see also Comments to USDA APHIS on Environmental Assessment for the 26 Determination of Syngenta Seeds, Inc. Alpha-Amylase Maize Event 3272, Center for Food Safety (Jan. 20, 2009), 27 https://www.centerforfoodsafety.org/files/cfs_comments_on_biofuel_corn_1-20- 28 09.pdf. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 61 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 64 of 91 1 flour contaminated with Enogen was detected in California and reportedly made 2 some people sick.166 3 179. GE crops that would evade regulation entirely under the plant-trait- 4 mechanism of action exemption include hypothetical new versions of GE crops that 5 have caused enormous harm to U.S. agriculture. 6 180. For instance, the GE herbicide-resistant rice contamination debacle 7 that triggered losses of over $1 billion to the rice industry involved gene flow from 8 an experimental rice variety grown in field tests authorized by USDA.167 Because 9 USDA subsequently deregulated this line,168 it or a new GE rice variety with the 10 same trait and mechanism of action could be grown today, with absolutely no gene 11 confinement and without even notifying USDA,169 sharply increasing the risks of 12 another costly transgenic contamination catastrophe. 13 181. A similar situation exists with GE herbicide-resistant flax, approved in 14 Canada in 1998 and deregulated by USDA in 1999.170 Despite being de-registered in 15 16 17 166 18 Ken Roseboro, GMO-ethanol Corn Contamination Raises Concerns About Another “StarLink” Disaster, THE ORGANIC & NON-GMO REPORT (Feb. 22, 2017), 19 https://non-gmoreport.com/articles/gmo-ethanol-corn-contamination-raises- concerns-another-starlink-disaster/. 20 167 See supra paragraph 88. 21 168 ANIMAL AND PLANT HEALTH INSPECTION SERVICE, USDA, FINDING OF NO 22 SIGNIFICANT IMPACT: EXTENSION OF NONREGULATED STATUS TO RICE LINE LLRICE601 (Nov. 24, 2006). 23 169 7 C.F.R. § 340.1(c)(2). See also Plant-Trait-Mechanism of Action (MOA) 24 combinations that have been determined by APHIS not to require regulation under 7 CFR Part 340, 25 https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications- 26 petitions/confirmations/moa/moa-table. 170 University of Saskatchewan, Availability of Determination of Nonregulated 27 Status for Flax Genetically Engineered for Tolerance to Soil Residues of 28 Sulfonylurea Herbicides, 64 Fed. Reg. 28,794-95 (May 27, 1999). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 62 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 65 of 91 1 Canada in 2001 over concerns it could disrupt exports,171 this GE flax somehow 2 turned up in shipments to Europe in 2009, triggering massive rejection of Canadian 3 flaxseed, a development that “threatened the very existence of the [Canadian flax] 4 industry.”172 It took six years to flush most of this GE contaminant from the flax 5 seed supply, but only after estimated losses to Canadian flax growers of $29.1 6 million.173 A new GE flax variety with the same trait and mechanism of action 7 combination could be grown today in the U.S., without notifying the USDA or 8 making any effort to prevent contamination. 9 182. Even in less drastic circumstances, as discussed above, transgenic 10 contamination can have significant financial consequences to farmers and U.S. 11 agricultural markets domestic and export that are sensitive to contamination, as 12 shown time and time again.174 13 183. Gene flow from a GE plant to natural areas can also have serious 14 adverse environmental impacts, as discussed above with regard to GE bentgrass.175 15 184. In contrast, implementation of its noxious weed authority would 16 permit USDA to forestall or mitigate these harms, since unlike its plant pest 17 authority, which applies only to living organisms, noxious weeds encompass “plant 18 products” that would include unwanted GE plant material that contaminates a food 19 supply, or invades natural areas via movement of seeds or pollen. 20 21 22 171 R. Kamchen, Flax on the Road to Recovery in a Post-Triffid World, COUNTRY 23 GUIDE (Mar. 31, 2016) https://www.country-guide.ca/crops/flax-on-the-road-to- 24 recovery-in-a-post-triffid-world/. 172 Flax Council of Canada, Flax: 2009-2015 the Triffid Years, 23(1) (2015), 25 https://flaxcouncil.ca/wp-content/uploads/2015/07/Flax-focus-July-2015LR.pdf. 26 173 Canadian Biotechnology Action Network, Flax: GM Contamination Crisis, https://cban.ca/gmos/products/not-on-the-market/flax/. 27 174 See supra paragraphs 87-91. 28 175 See supra paragraphs 106-107. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 63 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 66 of 91 1 185. Because permits only apply to those GE crops where the developer opts 2 to apply for a permit, or those few that USDA determines carry plant pest risks on 3 extremely narrow grounds, the regulations result in permits for only a minority of 4 previously-regulated GE plant field trials. The practical effect of exempting GE 5 plants from regulation is to permit experimental varieties to be grown in field tests 6 without gene confinement, and often without reporting to or oversight by USDA. 7 This will have dramatically negative effects in terms of harm to farmers, markets, 8 and the environment from GE escapes and contamination. 9 186. Additionally, because of these rampant exemptions from regulation, 10 the final rule also fails to implement the requirements from the 2008 Farm Bill for 11 regulation and oversight of GE crop field-tests, to prevent contamination episodes. 12 The final rule’s only reference to the 2008 Farm Bill mandates is a conclusory 13 statement that the new regulations will provide the agency with “sufficient 14 information to monitor compliance with its regulations and maintain effective 15 oversight of regulated GE organisms, in accordance with provisions of the 2008 16 Farm Bill [and 2015 OIG report].” However, by completely exempting broad 17 categories from regulation and allowing developers to self-determine regulatory 18 status, USDA misses the entire point of these requirements, opting instead for 19 surface-level changes that apply only to the select few “regulated” articles in the 20 scheme. 21 187. Second, in refusing to implement its noxious weed authority, USDA 22 also rejects a critical tool in the fight against the growing epidemic of herbicide- 23 resistant weeds generated by the cultivation of herbicide-resistant GE crops. Weeds 24 immune to glyphosate from the first generation of GE crops are legion, while weeds 25 that have developed in the second generation of GE crops are rapidly fostering 26 additional resistance to dicamba. The remarkable rise in weeds resistant to 27 multiple herbicides—leading to still more herbicide use and resistance—will only 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 64 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 67 of 91 1 accelerate without USDA action to check these often noxious weeds, which burden 2 farmers with increased costs while degrading the environment. 3 188. Another indirect cost of GE herbicide-resistant crops is indirect and 4 intertwined herbicidal drift damage, which is tremendously increased by the late- 5 season herbicide use pattern characteristic of GE crop systems. USDA’s regulations 6 do not account for the fact that the minutia of genetic modifications can trigger 7 huge and adverse changes in real-world farming practice that it has the power to 8 address and cannot continue to ignore. Two decades of experience with GE crop 9 systems now show that they have dramatically increased the overall output of 10 pesticides into the environment, including in new “over the top” spraying ways, at 11 new times of the year, all leading to dramatic environmental harms.176 USDA’s new 12 rules ignore this cost and will worsen it by removing oversight and approval 13 completely. 14 189. Third, the lack of noxious weed regulations will also hamstring USDA 15 from regulating GE crops that themselves might become weeds. Crops like 16 switchgrass, genetically engineered for potential uses such as biofuels or feedstock, 17 are already quite weedy in their unmodified forms, but could become far more 18 invasive and difficult to control with GE traits that improve fitness. GE crop 19 volunteers (plants sprouting from seed left unharvested the prior season) may also 20 become weeds, particularly if they are endowed with herbicide-resistance traits that 21 render them more difficult and costly to control. Indeed, USDA recently received a 22 petition to deregulate corn genetically engineered to withstand five different 23 herbicides, volunteers of which would be quite troublesome and even noxious 24 weeds.177 25 176 26 See supra paragraphs 93-103. 177 See USDA-APHIS, Bayer; Notice of Intent to Prepare an Environmental Impact 27 Statement for Determination of Nonregulated Status for Maize Developed Using 28 Genetic Engineering for Dicamba, Glufosinate, Quizalofop, and 2,4- COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 65 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 68 of 91 1 190. Fourth, the elimination of the petition for nonregulated status process 2 means no GE organism will receive the degree of scrutiny it deserves. For instance, 3 GE crops will be commercialized without consideration of field trial data and 4 observations, which informed deregulation decisions under the old regulations. 5 USDA’s substitute process, the regulatory status review, largely eschews any 6 consideration of the direct and indirect agricultural and environmental impacts of 7 GE crops, impacts that could be addressed if USDA were to properly implement its 8 noxious weed authority to regulate GE organisms. 9 191. USDA’s failure to do so—despite this being the overriding goal of the 10 regulatory revision process since it began in 2004—represents an abdication of its 11 statutory duty to provide meaningful oversight of GE organisms. 12 192. Fifth, in the “self-determination” scheme, there is no opportunity for 13 the agency to conduct ESA and NEPA analyses, as it formerly had in the old 14 deregulation context, to determine whether cultivation of the GE crop affects 15 endangered species or their habitat. It will likewise be impossible to challenge and 16 receive judicial review, absent later decisions or analyses. In other words, should 17 future adverse environmental and agronomic harms flow from USDA’s regulatory 18 abdication, in many cases there will be no agency action to challenge and no judicial 19 review to remedy those harms to farmers and the environment. 20 193. In its previous environmental analyses, and again in the final PEIS, 21 USDA avoided ESA analysis at the programmatic level, claiming it would 22 undertake them at the individual project level. However, with broad exemptions 23 and “self-determination,” the agency plays no role in deregulation and thus has no 24 opportunity to conduct the required inquiries. Neither will the limited number of 25 GE plants that initially fall under USDA’s purview be adequately regulated, as the 26 27 Dichlorophenoxyacetic Acid Resistance, With Tissue-Specific Glyphosate 28 Resistance Facilitating the Production of Hybrid Maize Seed, 86 Fed. Reg. 34,714 (June 30, 2021). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 66 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 69 of 91 1 regulatory status review is a superficial document-based evaluation that fails to 2 adequately vet GE plants for the risks they may pose. 3 194. For future GE crops that fall under the new exemptions, there will be 4 no NEPA or ESA analysis done. And for those few GE crops that still go thru the 5 new regulatory review process, at best it is entirely unclear whether any NEPA or 6 ESA analyses will be done or required. 7 Effects of the Decision on Endangered Species and their Habitats 8 195. Endangered species and their critical habitats will likely face the 9 effects of adverse environmental impacts from the deregulation of GE organisms, 10 including, but not limited to: transgenic contamination; significant increases in 11 herbicide use in GE herbicide-resistant crop systems; and the proliferation of weeds 12 resistant to these herbicides. 13 196. Transgenic contamination: When gene flow from GE crops to non-GE 14 crops and wild species occurs, the GE-contaminated plants can establish themselves 15 or colonize in wild places—similar to the effect of invasive species. GE organisms 16 could infest habitat for endangered species and critical habitat, and may 17 outcompete the endangered species, or native plants and animals essential to the 18 species, or otherwise adversely modify the habitat. They might also transfer 19 different genetic traits, such as weediness or pesticide resistance traits. GE traits 20 like insect resistance, herbicide resistance, or stress tolerance traits can increase 21 the hardiness, weediness, plant pest potential, and/or competitive ability of the GE 22 plant that escapes cultivation into wild places, or of the wild relative to which the 23 GE plant transfers its trait(s) via cross-pollination.178 GE plants engineered to 24 25 26 178 See supra paragraphs 106-107 for the GE creeping bentgrass example. Future 27 GE grasses and other GE plants will present similar risks, but because of the 28 2020 regulatory revision, will now undergo even less regulation, or be entirely exempted. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 67 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 70 of 91 1 produce experimental pharmaceutical or industrial compounds could have direct 2 adverse impacts on organisms that come into contact with or consume them. 3 197. Herbicide-Resistant Crop Systems: Herbicides used with herbicide- 4 resistant crops kill different spectra of plants, and used in combinations leave few if 5 any plants unscathed. By facilitating increased and later-season use of an 6 increasing array of herbicides, on a massive geographic application footprint of 7 millions of acres, GE crop systems pose unprecedented threats to listed plants and 8 critical habitats for listed species, including through spray drift, volatilization, and 9 runoff, harming wild plants and contaminating waterways and soils. 10 198. These landscapes cover literally hundreds of endangered species at 11 risk from future GE crops’ agricultural use. 12 199. Examples of threatened or endangered species that are potentially put 13 at risk by the dicamba-resistant soybean and cotton systems include but are not 14 limited to Mead’s milkweed, dwarf-flowered heartleaf, green pitcherplant, Texas 15 prairie dawn-flower, the Indiana bat, Karner blue butterfly, whooping crane, rusty 16 patched bumble bee, Southwestern willow flycatcher, yellow-billed cuckoo, and 17 Chiricahua leopard frog. 18 200. GE Trees: Future GE trees approved under USDA’s new rules present 19 their own unique endangered species risks. Trees are a key species comprising 20 ecosystems that regulate air quality, stabilize climate, preserve water quality and 21 abundance, and harbor much of the world’s biodiversity, including endangered 22 species. These essential functions of forests are threatened by GE trees, which will 23 mainly be designed to increase profitability of industrial tree plantations. 24 Significant endangered species issues were raised by the first proposed GE forest 25 tree, which has still not been commercially approved. Because trees are long-lived 26 and can reproduce over long distances, there are significant concerns about GE 27 contamination of forests and wild relatives and the associated impacts on 28 endangered species and habitat. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 68 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 71 of 91 1 201. USDA acknowledged that “individual decisions made during 2 implementation of the revised regulation could potentially impact T&E species[.]”179 3 However it still erroneously determined that its final rule decision would have “No 4 Effect” on any of hundreds of endangered species or their habitat across the U.S. 5 near and around U.S. farmland. USDA claims that individual decisions under the 6 regulations will receive ESA analysis, but this will not occur for any “decisions” 7 made through self-determination. 8 Harm to Plaintiffs 9 202. Plaintiffs and their members have been and continue to be injured by 10 the Part 340 regulations and USDA’s failure to adequately regulate GE organisms. 11 203. Plaintiffs’ organizational purposes are adversely affected by USDA’s 12 action, which prevents Plaintiffs from obtaining access to information about new 13 GE organisms which are “self-determined” to be exempt from regulation, that they 14 would use to more effectively advocate for public health, food safety, and the 15 environment. But for USDA’s actions, Plaintiffs would not have to spend as much of 16 their resources seeking basic information about GE organism exemptions, and could 17 direct these resources to other priorities. 18 204. The Court can craft equitable relief that will redress Plaintiffs’ 19 informational and organizational injuries. 20 205. Plaintiffs’ members are injured because, among other things, the Part 21 340 regulations have allowed potentially unsafe GE organisms to be tested in open 22 air experiments and in the market and environment without any oversight or 23 approval. 24 25 26 179 USDA, REVISIONS TO USDA-APHIS 7 CFR PART 340 REGULATIONS GOVERNING 27 THE IMPORTATION, INTERSTATE MOVEMENT, AND ENVIRONMENTAL RELEASE OF 28 CERTAIN GENETICALLY ENGINEERED ORGANISMS: FINAL PROGRAMMATIC ENVIRONMENTAL IMPACT STATEMENT 7-8 (May 2020). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 69 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 72 of 91 1 Farmers 2 206. Plaintiffs’ members comprise thousands of individuals, many of whom 3 are farmers who now experience an increased risk of GE-contamination of their 4 crops, and the corresponding economic loss from the inability to sell contaminated 5 crops on the market. The lack of GE crop regulation burdens them even if they are 6 not contaminated, because they have to take additional cost and resource measures 7 to try and avoid such contamination, such as buffer zones, DNA testing of their 8 crops, or declining to plant some crops because of the risks of cross-pollination. 9 These farmers sell their crops to GE-sensitive export and domestic markets and risk 10 the loss of those markets based on contamination or perceived increased risk of 11 contamination. These farmers also include organic farmers, who are harmed by 12 increases in pesticide use that go hand in hand with the expansion of GE crops. 13 Those farmers now face increased risk of herbicide drift and damage to crops, as 14 well as the loss of organic certifications and ability to sell their product in the 15 organic market. 16 207. Many of Plaintiffs’ farmer members grow vulnerable crops, such as 17 tomatoes, grapes, and conventional soybeans, which are at risk of pesticide drift 18 harms due to GE crop systems. Other Plaintiff members are gardeners that also 19 grow vegetables, fruits, herbs, native and ornamental plants, trees, shrubs, and 20 other plants that are at risk of pesticide drift damage. These members enjoy the 21 benefits of pollinators, birds, and other wildlife that rely on vulnerable plants for 22 food, nesting, or breeding. They are at risk of pesticide drift damage to their crops, 23 hedgerows, gardens, and surrounding ecologically important flora. 24 208. GE crop systems promote the use of types, quantities, and 25 combinations of pesticide, which have already caused unprecedented damage to 26 farmers and gardeners’ crops and plants across millions of acres. Some of Plaintiffs’ 27 members include farmers and gardeners who live and grow crops that have already 28 been damaged by drift caused by pesticide application to GE crops, and USDA’s COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 70 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 73 of 91 1 regulations will make it more likely that Plaintiffs’ farmer and gardener members 2 who cultivate crops near areas of pesticide application will suffer crop or land use 3 damage. 4 209. Such members may have to adjust their planting season, impose costly 5 measures such as buffer strips, or forego the planting of certain crops, in order to 6 try to reduce the negative impacts of pesticide drift onto their crops. The livelihoods 7 and economic interests of Plaintiffs’ members who cultivate and farm such crops are 8 injured by the final rule. 9 210. Plaintiffs’ farmer members are also injured by the anti-competitive, 10 monopolistic impacts of the final rule to the seed market. The final rule increases 11 the likelihood of contamination of non-GE crops. Contamination could mean loss of 12 heirloom varieties and an inability to sell their crops in their preferred markets, 13 thus loss of revenues. 14 211. GE crop systems are responsible for a superweed epidemic that harms 15 Plaintiffs’ farmer members, as these herbicide-resistant weeds are extremely 16 difficult and costly to control and spread beyond the boundaries of where pesticides 17 are initially sprayed. Many of Plaintiffs’ members are organic farmers who do not 18 use herbicides to control weeds on their farms, and in order to maintain organic 19 certification must implement more expensive measures for weed control to fight 20 increasingly stubborn weeds driven by GE crop systems that promote the overuse of 21 pesticides. 22 Consumers 23 212. Many of Plaintiffs’ members regularly and purposefully consume non- 24 GE foods and are exposed to an increased risk of harm as a result of consuming GE- 25 contaminated products due to the decreased regulation of GE organisms. This 26 includes the potential contamination of the food supply by experimental GE 27 plantings, or “biopharma” crops engineered with drugs like insulin. 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 71 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 74 of 91 1 Conservationists 2 213. Plaintiffs’ members are people with strong interests in environmental 3 conservation because of their aesthetic, recreational, vocational, spiritual, and 4 personal stakes in the protection of the environment from the adverse impacts of 5 GE organisms and increased pesticide usage. Those members are deeply invested in 6 the environment remaining inhabitable for many species of animals, plants, and 7 trees. The proliferation of GE crops and other plants will harm wild plants, trees, 8 animals, insects, and their native habitats, injuring Plaintiffs’ members’ 9 recreational and aesthetic interests. The intensive use of pesticides on GE pesticide- 10 resistant crops compromises Plaintiffs’ members’ ability to use and enjoy the 11 ecosystems that maintain biodiversity and protect sensitive species. 12 214. USDA’s regulatory scheme will continue to cause an increase in the 13 release of GE organisms without appropriate regulatory oversight and proper 14 evaluation of direct and indirect environmental harms. 15 215. Plaintiffs’ members are concerned about the adverse impacts to the 16 environment and to wild plants and trees from exposure to rogue GE organisms, as 17 well as adverse impacts to insects, birds, and other animals whose habitat is 18 harmed by the release of GE organisms into the wild. They are also concerned about 19 the effects of increased pesticide use in GE crop systems, and their effects on water 20 quality and human health, particularly to children and farmworkers. They live and 21 regularly hike and recreate around areas where new GE crops may be grown and 22 sprayed. 23 216. A great number of Plaintiffs’ members are concerned about the rapid 24 decline of pollinators and endangered or threatened species, and their personal, 25 professional, spiritual, aesthetic and recreational interests are harmed by the loss of 26 these species due to GE crop systems. 27 217. An increase in GE organisms creates an increased risk of escape and 28 harm to threatened or endangered plants or species habitat through spread of GE COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 72 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 75 of 91 1 crops or traits to wild relatives. Because of USDA’s final rule, these species and 2 habitats are also at an increased risk of exposure to pesticide drift from use on GE 3 crops. Plaintiffs’ conservationist members are concerned about the survival of these 4 species and their personal, professional, spiritual, aesthetic, and recreational 5 interests are harmed by these species’ decline. 6 Procedural Injuries 7 218. This is both a substantive and procedural case and Plaintiffs’ concrete 8 harms illustrated above are also closely tied to procedural injuries from USDA’s 9 action. Namely, Plaintiffs’ members are injured by USDA’s failure to comply with 10 the procedural requirements of NEPA and the ESA. By failing to adequately 11 analyze and assess the environmental impacts of the final rule, USDA prevented 12 Plaintiffs’ members from being fully informed and able to participate in agency 13 decisionmaking. 14 219. Similarly, by jumping to a “no effect” determination and failing to 15 undertake the required consultation with the expert wildlife agencies, Plaintiffs’ 16 members are deprived of the ability to understand the effects of the final rule on 17 threatened and endangered species and their habitats. 18 220. Also, because of the exemption and self-determination scheme in the 19 final rule, Plaintiffs’ members will not have the opportunity to review or comment 20 on future individual-level NEPA or ESA analyses. 21 Constitutional Injuries 22 221. Finally, Plaintiffs’ members are injured by USDA’s unlawful sub- 23 delegation of its PPA responsibilities to private entities. Not only are Plaintiffs’ 24 members deprived of judicial review because sub-delegation eliminates the agency 25 action necessary to bring a challenge, but Plaintiffs’ members are also harmed by 26 the lack of any transparency and process for future individual GE crop approvals. 27 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 73 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 76 of 91 1 222. These injuries are actual, concrete, ongoing, and particularized, and 2 monetary damages cannot redress them. The requested relief will redress these 3 injuries. 4 CLAIMS FOR RELIEF 5 FIRST CAUSE OF ACTION 6 VIOLATION OF ESA: 7 FAILURE TO CONSULT/ARBITRARY AND CAPRICIOUS “NO EFFECT” DETERMINATION 8 223. Section 7(a)(2) of the ESA prohibits agency actions that jeopardize the 9 survival of listed species or that destroy or adversely modify their critical habitat. 10 16 U.S.C. § 1536(a)(2). To assist in complying with this duty, federal agencies, like 11 USDA, must consult with the expert Services whenever they take an action that 12 “may affect” a listed species or the species’ critical habitat. Id.; 50 C.F.R. § 13 402.14(a). 14 224. The ESA and its implementing regulations broadly define agency 15 action. 50 C.F.R. §§ 402.02; 402.03. USDA’s promulgation of new GE organism 16 regulations at issue in this case constitute “agency action” under ESA section 17 7(a)(2). Id. 18 225. Under the ESA, agency actions that “may affect” a listed species or 19 critical habitat may not proceed unless and until the federal agency first ensures, 20 through completion of the consultation process, that the action is not likely to cause 21 jeopardy or adverse modification of critical habitat. 16 U.S.C. § 1536(a), (d); 50 22 C.F.R. §§ 402.14; 402.13. The threshold for a “may affect” determination and the 23 required ESA section 7(a)(2) consultation is low. See 51 Fed. Reg. 19,926, 19,949 24 (June 3, 1986) (“Any possible effect, whether beneficial, benign, adverse or of an 25 undetermined character, triggers the formal consultation requirement.”). 26 226. USDA committed both procedural and substantive violations of the 27 ESA. First, by issuing new Part 340 regulations, USDA has taken action that “may 28 affect” listed species without consulting the expert Services, in violation of the ESA. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 74 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 77 of 91 1 227. As explained at length above, the final rule considerably weakens 2 regulation of GE organisms in several respects, among other things by entirely 3 exempting a majority of future GE plants from any oversight or approval process. 4 This wholesale exemption of future GE organisms such as GE plants, grasses, and 5 trees, and relaxing of already weak regulation on the rest that will result from the 6 new regulations may affect, and likely will cause significant harm, to many broad 7 categories of endangered species and their habitats. 8 228. GE crops carry significant adverse environmental impacts, including 9 but not limited to transgenic contamination; significant increases in herbicide uses 10 in GE herbicide-resistant crop systems; and the proliferation of weeds resistant to 11 these herbicides. Examples of these risks to endangered species are numerous.180 12 229. Because USDA acknowledged that decisions made under the revised 13 regulations “could potentially impact T&E species,”181 yet went on to make a “No 14 Effect” determination for the final rule, the agency failed to meet the ESA’s 15 requirements. 16 230. “Could potentially impact” is synonymous with “may affect,” triggering 17 the consultation requirement. The agency’s reliance on consultation at project-level 18 actions rings hollow. Under the new regulatory framework, developers may self- 19 determine wither a GE plant is exempt from regulation. Thus for many future 20 commercial and experimental GE crops, will be no other future agency action to 21 trigger ESA analysis and protections. And for other USDA actions with regard to 22 GE crops, at best it is far from clear that there will be any further consultation duty 23 for any future individual actions in this scheme. 24 25 180 See supra paragraphs 195-200. 26 181 USDA, REVISIONS TO USDA-APHIS 7 CFR PART 340 REGULATIONS GOVERNING 27 THE IMPORTATION, INTERSTATE MOVEMENT, AND ENVIRONMENTAL RELEASE OF 28 CERTAIN GENETICALLY ENGINEERED ORGANISMS: FINAL PROGRAMMATIC ENVIRONMENTAL IMPACT STATEMENT 7-8 (May 2020). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 75 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 78 of 91 1 231. Accordingly, USDA has violated the ESA by finalizing the new Part 2 340 regulations without first completing consultation with the expert Services 3 regarding an action that “may affect” listed species and/or their critical habitat. 4 USDA’s failure to consult with the Services to insure that its action is not likely to 5 jeopardize endangered or threatened species or adversely modify their critical 6 habitat violates the ESA, 16 U.S.C. § 1536(a)(2), its implementing regulations; and 7 the APA, 5 U.S.C. §§ 701-706. 8 232. Second, USDA also violated the ESA’s mandate to use the “best 9 scientific and commercial data available,” an independent mandate of Section 7. 16 10 U.S.C. § 1536(a)(2). 11 233. In complying with Section 7, agencies must “give the benefit of the 12 doubt to the species.” 182 13 234. First, USDA violated the best scientific data mandate by not using any 14 scientific data to make its “no effect” determination in the PEIS, instead claiming 15 that analyses would be done later, at the individual level. However, with exemption 16 and self-determination, there will be not later action to review to determine effects 17 on endangered species or critical habitat. This, coupled with the lack of any 18 scientific analysis rendered USDA’s “no effect” determination arbitrary and 19 capricious, and contrary to the best scientific data mandate. 20 235. Second, USDA ignored the recommendation of a National Academy of 21 Science committee, which conducted an exhaustive review of USDA plant regulation 22 and recommended that USDA regulate all GE plants because those that did not 23 involve use of plant pests could also cause harm to public health or the 24 25 26 27 182 H.R. Conf. Rep. No. 96-697, 96th Cong., 1st Sess. 12, reprinted in 1979 U.S. Code 28 Cong. & Admin. News 2572, 2576. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 76 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 79 of 91 1 environment, and because there is no scientific basis on which to forecast which 2 ones might pose risk.183 3 236. Next, in order to be scientifically sound, the definition of genetic 4 engineering must be robust and include all methods that use in vitro manipulation 5 of nucleic acids and proteins to alter genetic material or its expression, including 6 methods on the horizon, so the regulations are inclusive and durable. Based on this 7 proper definition, all GE organisms should begin and stay regulated and not be 8 eligible for commercialization absent USDA analysis, affirmative approval, and 9 continued monitoring conditions. The National Academies of Sciences, Engineering, 10 and Medicine recently produced reports using a suitably inclusive definition of 11 genetic engineering that USDA should have used to capture all GE organisms for 12 assessment and regulation: 13 Genetic engineering means the introduction or change of DNA, RNA, or 14 proteins by human manipulation to effect a change in an organism’s genome 15 or epigenome; where genome means the complete sequence of the DNA in an 16 organism, and epigenome means the physical factors affecting the expression 17 of genes without affecting the actual DNA sequence of the genome.184 18 237. Finally, the final rule violates the ESA’s best scientific data mandate 19 by ending petitions for deregulation and replacing it with a regulatory scheme that 20 would end regulated status for the vast majority of GE organisms. This is not 21 grounded in the best scientific data available. An agency needs adequate data to 22 assess risks, and the streamlined regulatory review process dramatically narrows 23 data requirements. USDA must regulate and assess each GE organism on an 24 25 183 NATIONAL ACADEMY OF SCIENCES, NRC, ENVIRONMENTAL EFFECTS OF TRANSGENIC 26 PLANTS 79 (2002). 27 184 NATIONAL ACADEMIES OF SCIENCE, ENGINEERING, AND MEDICINE, GENETICALLY 28 ENGINEERED CROPS: EXPERIENCES AND PROSPECTS 36, Glossary at 384-88 (2016), available at http://www.nap.edu/24605. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 77 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 80 of 91 1 individual basis, and must include an assessment of their actual direct and indirect 2 harms. 3 SECOND CAUSE OF ACTION 4 VIOLATION OF NEPA AND APA 5 238. Plaintiffs re-allege, as if fully set forth, each and every allegation set 6 forth in paragraphs 1 through 237 of this Complaint. 7 239. NEPA is our “basic national charter for protection of the environment.” 8 40 C.F.R. § 1500.1(a). 9 240. NEPA requires all federal agencies to prepare a “detailed statement” 10 that discusses the environmental effects of, and reasonable alternatives to, all 11 “major federal actions significantly affecting the quality of the human 12 environment,” commonly known as an EIS. 42 U.S.C. § 4332(2)(C). Major federal 13 actions include “new or revised agency rules,” as here. 40 C.F.R. § 1508. 14 241. The environmental effects that must be considered in an EIS include 15 “indirect effects, which are caused by the action and are later in time or farther 16 removed in distance, but are still reasonably foreseeable,” as well as direct and 17 cumulative effects. Id. §§ 1508.7; 1508.8; 1508.27(b)(7). The purpose of an EIS is to 18 inform decision-makers and the public of the significant environmental impacts of 19 the proposed action, means to mitigate those impacts, and reasonable alternatives 20 that will have lesser environmental impacts. 21 242. NEPA and its implementing regulations require an agency to 22 “[r]igorously explore and objectively evaluate all reasonable alternatives.” 40 C.F.R. 23 § 1502.14(a). See also 42 U.S.C. § 4332(C), (E); 40 C.F.R. § 1508.25. 24 243. NEPA requires federal agencies to use high quality, accurate scientific 25 information and ensure the scientific integrity of the analysis in an EIS. See id. §§ 26 1500.1(b); 1502.24. 27 244. Here, Defendants failed to undertake the required analysis in the final 28 PEIS and violated NEPA in the following ways: COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 78 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 81 of 91 1 2 1. USDA improperly cabined its purpose and need for the revised regulations to, among other things, exclude its authority to prevent or 3 mitigate noxious weed risks. 4 2. USDA failed to consider reasonable alternatives, 40 C.F.R. § 5 1502.14, that would be more protective to agriculture and the environment by only considering the “Preferred Alternative” and “No 6 Action Alternative.” Among other things, USDA arbitrarily failed to consider alternatives that would prevent or limit the future 7 proliferation of herbicide-resistant “superweeds” or the future 8 occurrences of transgenic contamination from GE organisms. 9 3. USDA failed to analyze the direct and indirect, id. § 1502.1, of the Preferred Alternative in the final PEIS, including and especially the 10 effects of exempting broad categories of GE plants from any future 11 oversight. Other direct and indirect that USDA failed to rigorously analyze and consider include impacts to agricultural land use, impacts 12 from climate change, impacts from increased pesticide use, and impacts from gene flow or transgenic contamination. 13 14 4. USDA also violated NEPA’s cumulative impact requirements. Id. § 1508.25(c)(3). Rather than analyze the cumulative impacts of the 15 regulations on various environmental (and other) resources when combined with past, present, and reasonably foreseeable impacts to 16 those resources, USDA merely concluded that there are no reasonably 17 foreseeable impacts of a cumulative nature that could result from authorized field testing of GE organisms. 18 5. USDA also violated NEPA’s mitigation requirements. Robertson v. 19 Methow Valley Citizens Council, 490 U.S. 332, 351 (1989). USDA 20 improperly relies on the agricultural biotechnology industry’s “best interests” and “stewardship” efforts to self-regulate GE experimental 21 and commercial organisms as mitigation measures, creating an improper baseline for USDA’s analysis of the regulations and their 22 impacts. 23 6. For any and all of these reasons, USDA failed to take the required 24 “hard look” at the effects of its action. Metcalf v. Daley, 214 F.3d 1135, 1142 (9th Cir. 2000). 25 245. Finally, the NEPA regulations allow agencies to establish “categorical 26 exclusions,” which are categories of actions “which do not individually or 27 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 79 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 82 of 91 1 cumulatively have a significant effect on the human environment” and therefore do 2 not require environmental analysis under NEPA. 40 C.F.R § 1507.3. 3 246. USDA’s revisions to the agency’s implementing NEPA regulations 4 under 40 C.F.R Part 372, included in the final rule challenged here, include a 5 categorical exclusion for field trials as “research and development activities.” 7 6 C.F.R. § 372.5(c). Given past incidences of escape and tremendous harm from field 7 trials, and the likelihood of future episodes, it is arbitrary and capricious for USDA 8 to categorically exempt field trials from NEPA analysis. 9 247. Defendants’ failure to prepare an adequate PEIS and comply with 10 NEPA, in connection with the final rule, violates NEPA and its implementing 11 regulations and is “arbitrary, capricious, an abuse of discretion, or otherwise not in 12 accordance with law” in violation of the APA. 5 U.S.C. § 706(2)(A). 13 14 THIRD CAUSE OF ACTION VIOLATION OF PPA AND APA 15 248. Plaintiffs re-allege, as if fully set forth, each and every allegation set 16 forth in paragraphs 1 through 247 of this Complaint. 17 249. USDA violated the PPA in two ways: (1) by failing to apply its 18 authority to regulate GE crops for noxious weed harms and (2) by failing to base its 19 regulations in “sound science.” 20 Failure to Incorporate Noxious Weed Authority 21 250. In 2000, Congress provided USDA broader, more robust authority with 22 the passage of the PPA. Specifically, the PPA provides USDA the authority to not 23 just address the plant pest harms of GE crops, but also the noxious weed harms 24 they may cause. 25 251. Noxious weed harms are very broadly defined, to include “damage to 26 crops (including nursery stock or plant products), livestock, poultry, or other 27 interests of agriculture, irrigation, navigation, the natural resources of the United 28 States, the public health, or the environment.” 7 U.S.C. § 7702(10). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 80 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 83 of 91 1 252. USDA is charged with implementing the PPA’s purpose to “protect[] 2 the agriculture, environment, and economy of the United States.” Id. § 7701(1). In 3 enacting the PPA, Congress found that “the detection, control, suppression, 4 prevention, or retardation of the spread of plant pests or noxious weeds is 5 necessary” to fulfill this purpose. Id. 6 253. Because Congress was specifically concerned about “the unregulated 7 movement of plant pests, [and] noxious weeds,” USDA has an obligation to regulate 8 GE organisms that fall under those categories. 9 254. USDA has not met its statutory obligations by failing to implement 10 half of its PPA authority—the noxious weed authority—to regulate GE organisms 11 and capture the full range of risks they present. 12 255. Throughout the Part 340 rulemaking, USDA acknowledged that the 13 main reason for the new revisions to the 1996 Part 340 rules was to bring them in 14 compliance and make them consistent with the PPA’s new statutory authority. 15 256. Repeatedly, USDA in prior proposed rules and supporting 16 documentation concluded that it should apply its noxious weed authority and to do 17 so was necessary to fulfill its duties in overseeing GE crops. 18 257. In the 2008 and 2017 proposed rules and accompanying decision 19 documents, USDA recognized the duty to implement its noxious weed authority in 20 order to reach all potential risks these organisms present. In fact, USDA found that 21 “it is more scientifically and legally justified to consider weed risk under the noxious 22 weed authority rather than under the plant pest authority.”185 23 258. Yet in the final rule, USDA’s about-face reversal of the entire 15 years 24 prior of rulemaking is mostly unexplained. Nowhere in the final rule itself or record 25 26 185 USDA, REVISIONS TO USDA-APHIS 7 CFR PART 340 REGULATIONS GOVERNING 27 THE IMPORTATION, INTERSTATE MOVEMENT, AND ENVIRONMENTAL RELEASE OF 28 GENETICALLY ENGINEERED ORGANISMS: DRAFT PROGRAMMATIC ENVIRONMENTAL IMPACT STATEMENT at ES-4 (2017). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 81 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 84 of 91 1 of decision does USDA explain why it decided to not apply the noxious weed 2 authority and integrate it into its Part 340 regulations. 3 259. In the response to comments, USDA said only that it now believes it 4 can fully regulate for weediness risks using only the plant pest authority, a reversal 5 from its prior proposed rules and contrary to the 2005 and 2015 OIG audit reports. 6 85 Fed. Reg. 29,822. 7 260. An agency “must examine the relevant data and articulate a 8 satisfaction for its action including a ‘rational connection between the facts found 9 and the choice made.’” Motor Vehicle Mfrs. Ass’n, Inc. v. State Farm Mut. Auto. Ins. 10 Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck Lines v. United States, 371 11 U.S. 156, 168 (1962)). 12 261. This explanation is not sufficient, nor is it legally or scientifically 13 sound. The final rule is arbitrary, capricious, and contrary to law, and violates the 14 PPA and APA. 15 Failure to Base Decisions on Sound Science 16 262. The PPA mandates that all USDA decisions under the PPA that 17 “decisions affecting imports, exports, and interstate movement of products 18 regulated under [the PPA] shall be based on sound science.” 7 U.S.C. § 7701(4). The 19 Part 340 regulations affect the imports, exports, and interstate movement of GE 20 organisms through the PPA’s authority, and therefore must be based on sound 21 science. 22 263. The final rule is contrary to the PPA’s core “sound science” mandate in 23 multiple ways. First, it is contrary to sound science for USDA to exempt broad 24 categories of GE plants from regulation entirely, based on the purported ability to 25 generate such GE plants through conventional breeding methods. Because each GE 26 plant is a unique event, which carries both intended modifications as well as its own 27 array of off-target mutations, it is impossible to re-create the exact result by 28 conventional means. Additionally, the similarity of a GE plant to a conventionally COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 82 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 85 of 91 1 bred plant says nothing about the GE plant’s potential plant pest or noxious weed 2 harms under the PPA. USDA grounded these exemptions, and hence a major part of 3 its new rule, not on any scientific principle, but rather on an unscientific statement 4 by a former Secretary of Agriculture intent upon weakening or eliminating 5 regulation of GE crops. 6 264. Neither is it consistent with sound science to exempt from regulation 7 one GE plant based on prior deregulation of a second GE plant with the same plant- 8 trait-mechanism of action combination, because additional factors such as pattern 9 and level of gene expression in various plant tissues may differ between the two and 10 render one—but not the other—a plant pest or noxious weed risk. 11 265. Instead, USDA must use genetic engineering, broadly defined, as the 12 trigger for regulation. This approach would follow the recommendation of a 13 National Academy of Sciences committee, which determined that USDA should 14 regulate all GE plants because there is no scientific basis on which to forecast which 15 ones might pose a risk to public health and the environment. USDA chose to 16 disregard this recommendation to follow sound science, in favor of its deregulatory 17 scheme that does not achieve the purpose of the statute. 18 266. Alternatively and at a minimum, it was contrary to sound science for 19 the agency to completely exempt many future GE crops and GE crop experiments 20 from any oversight. 21 267. Second, USDA’s decision not to invoke its noxious weed authority 22 under the PPA is also not based in sound science. The agency itself admitted in its 23 previous proposed rules that using this authority is the most scientifically sound 24 course of action to address a broader range of risks presented by new GE 25 experiments. Applying that authority would have provided the agency the sounder 26 footing it needed for regulation, as the agency previously acknowledged. 27 268. Third, it is contrary to sound science to base regulatory status 28 assessments overwhelmingly on the minutia of the genetic modification itself, at the COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 83 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 86 of 91 1 molecular level, vis-à-vis an unmodified crop, while ignoring the significant changes 2 in agricultural practice that the genetic modification often triggers—changes that 3 can have enormously adverse impacts, such as the herbicide-resistant weed 4 epidemic and rampant herbicidal drift damage ensuing from the insertion of 5 herbicide-resistance genes into crops. 6 269. The PPA specifies that USDA is to protect “the agriculture, 7 environment, and economy of the United States,” Id. § 7701(1), and must make 8 decisions based on sound science in doing so. By refusing to implement half of its 9 authority and setting up a deregulatory exemption scheme, USDA does not even 10 attempt to meet these protective goals. USDA purposely created regulatory holes 11 and has abdicated its duty to protect American agriculture, the economy, and the 12 environment through its regulation of GE organisms. 13 270. For all these reasons, USDA’s decision violated the PPA and the APA 14 as it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance 15 with law” in violation of the APA. 5 U.S.C. § 706(2)(A). 16 FOURTH CAUSE OF ACTION 17 VIOLATION OF THE 2008 FARM BILL: 18 FAILURE TO IMPLEMENT REQUIRED OVERSIGHT OF GE ORGANISMS 19 271. Plaintiffs re-allege, as if fully set forth, each and every allegation set 20 forth in paragraphs 1 through 270 of this Complaint. 21 272. The 2008 Farm Bill directives required USDA to “promulgate 22 regulations to improve the management and oversight of articles regulated under 23 the Plant Protection Act,” including the oversight and management of GE crop field- 24 testing.186 25 26 27 186 28 Food, Conservation, and Energy Act of 2008, Pub. L. No. 110-246, Tit. X § 10204(a)(2). COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 84 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 87 of 91 1 273. The 2008 Farm Bill also required USDA to take action on each of nine 2 problem areas in its LESSONS LEARNED document, detailing inadequacies in 3 reporting and field-test containment. 4 274. In the final rule, USDA fails to implement the 2008 Farm Bill’s 5 requirements. The 2008 Farm Bill expressly directs USDA to strengthen its 6 regulation of GE crop field trials to forestall GE contamination events. Instead, 7 USDA ended the notification process and replaced it with a system where, in many 8 cases, field trials will occur completely without USDA’s knowledge or approval. 9 275. By instituting a scheme of deregulation through exemption and self- 10 determination, USDA violated the 2008 Farm Bill’s mandate to act on each of the 11 nine issues identified in its LESSONS LEARNED document in response to its 12 investigation of the massive rice contamination episode. 13 276. For all these reason the final rule violated the 2008 Farm Bill and the 14 APA as it is “arbitrary, capricious, an abuse of discretion, or otherwise not in 15 accordance with law” in violation of the APA. 5 U.S.C. § 706(2)(A). 16 17 FIFTH CAUSE OF ACTION UNCONSTITUTIONAL SUB-DELEGATION 18 OF STATUTORY AUTHORITY 19 277. Plaintiffs re-allege, as if fully set forth, each and every allegation set 20 forth in paragraphs 1 through 276 of this Complaint. 21 278. The Constitution delegates “all legislative powers” “in a Congress of 22 the United States.” Art. I, § 1. Federal agency officials “may not subdelegate [their 23 decisionmaking authority] to outside entities—private or sovereign—absent 24 affirmative evidence of authority to do so.” U.S. Telecom Ass’n v. F.C.C., 359 F.3d 25 554, 566 (D.C. Cir. 2004). 26 279. The Part 340 final rule allows future decisions regarding the 27 regulatory status of GE organisms, including GE crops but also GE trees and 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 85 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 88 of 91 1 grasses, their experimentation and commercialization, to be made by private parties 2 (developers) without USDA oversight or knowledge. 3 280. In the Part 340 regulations, USDA has sub-delegated to private, self- 4 interested parties the responsibility given to it by Congress to “facilitate exports, 5 imports, and interstate commerce in agricultural products and other commodities 6 that pose a risk of harboring plant pests or noxious weeds in ways that will reduce . 7 . . the dissemination of plant pests or noxious weeds.” 7 U.S.C. § 7701(3). 8 281. USDA’s abdication of responsibility with regard to determining the 9 regulatory status of GE organisms prevents the agency from carrying out its duties 10 under the PPA to protect “the agriculture, environment, and economy of the United 11 States.” Id. § 7701(1). Nothing in the PPA states that USDA may sub-delegate to 12 regulated entities these responsibilities. 13 282. Because Congress did not expressly authorize it the regulations’ sub- 14 delegation of authority for regulatory status determinations is flatly impermissible. 15 “A general delegation of decision-making authority to a federal administrative 16 agency does not, in the ordinary course of things, include the power to subdelegate 17 that authority beyond federal subordinates.” U.S. Telecom Ass’n, 359 F.3d at 566. 18 The key purpose of prohibiting delegation to private entities is preventing “the 19 harm done thereby to principles of political accountability.” Nat’l Ass’n of 20 Regulatory Util. Comm’rs v. F.C.C., 737 F.2d 1095, 1143 n.41 (D.C. Cir. 1984). Sub- 21 delegations that render agency oversight “neither timely, nor assured” cannot 22 stand. U.S. Telecom Ass’n, 359 F.3d at 567. 23 283. The self-determination aspect of the final rule allow developers to 24 determine regulatory status without notifying USDA. See 7 C.F.R. § 340.1(e) 25 (“Developers may request confirmation from APHIS that a plant is not within the 26 scope of this part.” (emphasis added)); 85 Fed. Reg. 29,798-99 (discussing the self- 27 determination aspect of the regulations). The existence of a voluntary confirmation 28 process does not guarantee transparency or agency review. COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 86 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 89 of 91 1 284. This sub-delegation eliminates USDA oversight, public accountability, 2 and judicial review—all constitutional necessities. The result is a complete erosion 3 of the PPA’s structure and purpose with respect to protecting agriculture and the 4 environment. 5 285. USDA has foreclosed from judicial review actions it is required to carry 6 out, undermining the constitutional balance between the federal branches. The 7 system of separated powers and checks and balances established in the Constitution 8 was regarded by the Framers as “a self-executing safeguard against the 9 encroachment or aggrandizement of one branch at the expense of the other.” 10 Buckley v. Valeo, 424 U.S. 1, 122 (1976). 11 286. The Part 340 regulations offend core precepts of democratic 12 accountability for agency actions, contradict the language and goals of the PPA, 13 impede USDA from doing its job, and permit self-interested private parties to be the 14 guardians of GE organisms. As such, the regulations violate the doctrine against 15 sub-delegation and the separation of powers principle by placing agency authority 16 in the hands of self-interested entities without retaining oversight. 17 18 RELIEF REQUESTED 19 WHEREFORE, the Plaintiffs respectfully request that the Court: 20 287. Adjudge and declare that USDA’s failure to undertake ESA 21 consultation with the expert services prior to finalizing its Part 340 regulations is 22 contrary to the ESA and constitutes a violation of the ESA and APA. 23 288. Adjudge and declare that USDA’s PEIS is inadequate, in violation of 24 NEPA and the APA. 25 289. Adjudge and declare that USDA’s final rule unlawfully fails to 26 implement its noxious weed authority under the PPA and fails to fulfill its mandate 27 to promulgate regulations based on sound science, in violation of the PPA and APA. 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 87 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 90 of 91 1 290. Adjudge and declare that USDA’s final rule unlawfully fails to 2 implement the requirements of the 2008 Farm Bill to provide more oversight of GE 3 organism field testing and recordkeeping, and constitutes a violation of the 2008 4 Farm Bill and APA. 5 291. Adjudge and declare that USDA’s final rule unlawfully sub-delegates 6 agency decision making to private entities, and constitutes a violation of the 7 Constitution. 8 292. Set aside or vacate the final rule based on Defendants’ violations of the 9 ESA and APA. 10 293. Set aside or vacate the final rule based on Defendants’ violations of 11 NEPA and the APA. 12 294. Set aside or vacate the final rule based on Defendants’ violations of the 13 PPA and APA. 14 295. Set aside or vacate the final rule based on Defendants’ violations of the 15 2008 Farm Bill and APA. 16 296. Set aside or vacate the final rule based on Defendants’ violation of the 17 Constitution and separation of powers principles. 18 297. Order USDA to finalize and issue meaningful GE regulations that 19 comply with these statutes as soon as reasonably practicable, according to a Court- 20 ordered timeline, or, in the alternative, order USDA to initiate ESA consultation 21 with the expert services; 22 298. Retain jurisdiction of this action to ensure compliance with its decree; 23 299. Award Plaintiffs their fees, costs, expenses, and disbursements, 24 including reasonable attorneys’ fees, associated with this litigation under the Equal 25 Access to Justice Act, 28 U.S.C. § 2412; and 26 300. Grant such further and additional relief as the Court deems just and 27 proper. 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 88 CASE NO. 21-5695 Case 3:21-cv-05695 Document 1 Filed 07/26/21 Page 91 of 91 1 Respectfully submitted this 26th day of July, 2021, in San Francisco, California. 2 3 4 MEREDITH STEVENSON (CA Bar No. 5 328712) GEORGE KIMBRELL (Pro Hac Vice 6 pending) AUDREY LEONARD (Pro Hac Vice pending) 7 AMY VAN SAUN (Pro Hac Vice pending) Center for Food Safety 8 303 Sacramento Street, 2nd Floor San Francisco, CA 94111 9 Phone: (415) 826-2770 Emails: gkimbrell@centerforfoodsafety.org 10 aleonard@centerforfoodsafety.org avansaun@centerforfoodsafety.org 11 mstevenson@centerforfoodsafety.org 12 13 Counsel for Plaintiffs 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF 89 CASE NO. 21-5695 that the rule change violated numerous environmental laws, including the Endangered Species Act, the National Environmental Policy Act, and the Plant Protection Act. Today, the Court held that the regulations violate the Plant Protection Act and the Administrative Procedure Act.

The Court's decisionCase 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 1 of 26 1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 NATIONAL FAMILY FARM COALITION Case No. 21-cv-05695-JD et al., 8 Plaintiffs, ORDER RE SUMMARY JUDGMENT 9 v. 10 TOM VILSACK et al., 11 Defendants. 12 13 In 2004, the Animal and Plant Health Inspection Service (APHIS), housed within the U.S. 14 Department of Agriculture (USDA), announced the intention to revisit regulations governing 15 genetically engineered (GE) organisms. APHIS published a notice of proposed rulemaking in 16 2008 that kicked off over a decade of activity and concluded in a final rule the agency adopted in 17 May 2020. Plaintiffs, who are non-profit and public-interest groups organized around concerns 18 for farmers, crops, food safety, and the environment, object to the final rule. In plaintiffs’ view, 19 the final rule effectively abandoned federal government regulation of GE organisms, leaving GE 20 crop developers and agribusinesses to their own devices without adequate safety and other 21 oversight. Plaintiffs ask to set aside the final rule under the Administrative Procedure Act on the 22 ground that APHIS acted arbitrarily and capriciously, and contrary to various federal statutes. See 23 generally Dkt. No. 1. 24 Summary judgment is granted in part to plaintiffs. The rule is vacated and remanded to the 25 agency for further consideration in a manner consistent with this order. 26 27 28 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 2 of 26 1 BACKGROUND 2 I. STATUTORY FRAMEWORK 3 In 1986, the Office of Science and Technology Policy promulgated a Coordinated 4 Framework for the Regulation of Biotechnology, under which regulatory jurisdiction over 5 emerging developments in genetic engineering was delegated to three agencies: (1) the USDA, 6 and specifically APHIS; (2) the Environmental Protection Agency, and (3) the Food and Drug 7 Administration. See Movement of Certain Genetically Engineered Organisms, 85 Fed. Reg. 8 29790, 29790 (May 18, 2020) (codified at 7 C.F.R. §§ 330, 340, & 372). At that time, three 9 federal statutes were the keystones of overseeing our national agricultural resources: the Plant 10 Quarantine Act of 1912 (PQA), Pub. L. No. 62-275, 37 Stat. 315; the Federal Plant Pest Act of 11 1957 (FPPA), Pub. L. No. 85-36, 71 Stat. 31; and the Federal Noxious Weed Act of 1974 12 (FNWA), Pub. L. No. 93-629, 88 Stat. 2148. 13 In 2000, Congress enacted the Plant Protection Act (PPA), Pub. L. No. 106-224, 114 Stat. 14 438, which consolidated the FPPA, PQA, and FNWA into a unitary statutory scheme. The PPA 15 authorizes the Secretary of Agriculture (Secretary), who has delegated her authority to APHIS, see 16 7 C.F.R. §§ 371.1, 371.3, to regulate plant pests and noxious weeds and requires the agency to 17 “facilitate exports, imports, and interstate commerce in agricultural products and other 18 commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to 19 the extent practicable, as determined by the [agency], the risk of dissemination of plant pests or 20 noxious weeds.” 7 U.S.C. § 7701(3). 21 The statute defines a “plant pest” as an organism “that can directly or indirectly injure, 22 cause damage to, or cause disease in any plant or plant product.” Id. at § 7702(14). The 23 movement of “any plant pest” without a “permit” is prohibited, id. at § 7711(a), although the 24 agency may suspend permitting requirements for “specified plant pests . . . if the [agency] finds 25 that a permit . . . is not necessary,” id. at § 7711(c). The PPA defines “noxious weed” as “any 26 plant or plant product that can directly or indirectly injure or cause damage to crops (including 27 nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, 28 navigation, the natural resources of the United States, the public health, or the environment.” Id. 2 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 3 of 26 1 at § 7702(10). The agency is authorized to “prohibit or restrict the . . . movement in interstate 2 commerce of any . . . noxious weed” as “necessary.” Id. at § 7712(a). The statute contemplates 3 permitting requirements for noxious weeds and authorizes the agency to “publish, by regulation, a 4 list of noxious weeds that are prohibited or . . . subject to restrictions.” Id. at § 7712(c), (f). 5 II. REGULATORY BACKDROP 6 APHIS regulates GE plants under 7 C.F.R. § 340. The regulations date back to 1987, 7 when APHIS first imposed a pre-market authorization requirement and other measures for GE 8 plants if the plants were classified as a “plant pest” under the then-controlling FPPA. 85 Fed. Reg. 9 at 29790; see generally Introduction of Organisms and Products Altered or Produced Through 10 Genetic Engineering Which Are Plant Pests or Which There is Reason to Believe Are Plant Pests, 11 52 Fed. Reg. 22892 (June 16, 1987). A GE plant was classified as a “plant pest” if “it [was] 12 created using an organism that is itself a plant pest,” Ctr. for Food Safety v. Vilsack, 718 F.3d 829, 13 835 (9th Cir. 2013), and so the rule covered most GE plants at the time because the predominant 14 engineering technique used plant-pest material to introduce new genetic characteristics to the 15 target plant, see Movement of Certain Genetically Engineered Organisms, 84 Fed. Reg. 26514, 16 26521 (June 6, 2019). Under the part 340 regulations, plant pests could not be moved interstate or 17 introduced into the environment without notification and a permit, and permitting conditions 18 included record-keeping and labeling requirements. See, e.g., Importation, Interstate Movement, 19 and Release into the Environment of Certain Genetically Engineered Organisms, 73 Fed. Reg. 20 60008, 600010-11 (Oct. 9, 2008). The regulatory scheme reflected a presumption of “plant pest 21 risk, until proven otherwise,” due to the means by which genetic material was introduced into the 22 target plant. Dkt. No. 60 at 6. 23 Between 1987 and the start of the rulemaking process at the heart of this lawsuit, the 24 regulations were revised several times to lessen the regulatory burden on some GE plants. See 84 25 Fed. Reg. at 26514. For example, one set of revisions provided that GE-plant developers could 26 introduce or move in interstate commerce certain crop species without obtaining a permit if certain 27 eligibility requirements were met and the developer went through the agency’s notification 28 procedure. See generally Genetically Engineered Organisms and Products; Notification 3 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 4 of 26 1 Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated 2 Status, 58 Fed. Reg. 17044 (Mar. 31, 1993). Other revisions created a process through which GE- 3 plant developers could petition for deregulation from section 340 altogether by submitting to the 4 agency extensive data pertaining to the GE plant’s plant-pest risk. See generally id. 5 In all of the revisions, GE plants were treated as plant pests for regulatory purposes and so 6 were not subject to the permitting or pre-market-authorization requirements that applied to 7 noxious weeds. APHIS regulated, and continues to regulate, noxious weeds under 7 C.F.R. § 360 8 and prohibits the unauthorized movement of any plant designated as a noxious weed by the 9 Secretary of Agriculture. See id. § 360.300. By its own terms, part 360 regulates noxious weeds 10 by taxon, which is defined as “[a]ny grouping within botanical nomenclature, such as family, 11 genus, species, or cultivar.” See 7 C.F.R. §§ 360.100 (defining “taxon”), 360.200, 360.500-01. 12 The result, then, is that a plant’s GE and non-GE counterparts are treated identically for noxious- 13 weed purposes. Cf. id. at § 360.200 n.1. APHIS does not dispute plaintiffs’ statement that, with 14 one minor exception, the agency does not regulate GE plants under section 360. See Dkt. No. 59 15 at 23 n.39; 7 C.F.R. §360.200 (list of plant taxa designated as noxious weeds). 16 III. THE RULEMAKING SAGA 17 The 2020 final rule plaintiffs challenge is the culmination of nearly 15 years of attempts by 18 APHIS to update the part 340 GE-plant regulations. These attempts entailed multiple proposals, 19 permutations, and withdrawals of proposals. A clear map of this winding road is useful for the 20 resolution of this lawsuit. 21 A. CONTEMPLATING AN OVERHAUL 22 The journey began in 2004 when APHIS published a notice of intent to open public 23 comment and begin an environmental impact study of potential changes to section 340, including 24 an expansion of “its regulatory scope beyond genetically engineered organisms that may pose a 25 plant pest risk to include genetically engineered plants that may pose a noxious weed risk.” 26 Environmental Impact Statement; Introduction of Genetically Engineered Organisms, 69 Fed. 27 Reg. 3271, 3272 (Jan. 23, 2004). 28 4 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 5 of 26 1 The USDA’s Office of Inspector General (OIG) encouraged the agency to implement 2 changes and stated in a 2005 audit report that “APHIS has not finished updating its regulations to 3 comply with the Plant Protection Act of 2000,” “which grant[s] new regulatory authority to the 4 Secretary of Agriculture for controlling noxious weeds.” AR 22970.1 The report noted that 5 “APHIS began the process of updating its regulations” in January 2004 when it published the 6 notice of its intent to “prepare an environmental impact statement . . . in connection with potential 7 changes to the regulations[] regarding the movement and release of certain [GE organisms].” Id. 8 APHIS responded by stating that it would soon complete its study and that “[t]he rule will include 9 the provisions of the Plant Protection Act of 2000.” AR 22973. 10 B. CONGRESSIONAL INTERVENTION 11 Before any proposed updates to part 340 were published, some high-profile instances of 12 transgenic contamination (the unintended cross-pollination of non-GE plants with the modified 13 genetic material of GE plants) prompted APHIS to consider additional changes to section 340. 14 See AR 18415, 27050. In 2007, the agency published a report entitled “Lessons Learned and 15 Revisions under Consideration for APHIS’ Biotechnology Framework” that contained suggestions 16 as to how APHIS could “enhance” its GE-plant rules by, inter alia, requiring (1) the “creation and 17 retention of additional records” by GE-plant developers, AR 18415; (2) permit applications to 18 prepare contingency and corrective-action plans for unauthorized releases of GE material, see 19 AR 18416; and (3) “minimum distances” between GE field test sites and nearby fields to avoid 20 inadvertent contamination events, see AR 18417-18. 21 In 2008, Congress passed legislation directing the agency to “take action on each issue 22 identified” in the 2007 report. Food, Conservation, and Energy Act of 2008 (2008 Farm Bill), 23 Pub. L. No. 110-246, 122 Stat. 1651 § 10204 (codified at 7 U.S.C. § 7701 Note). Specifically, 24 Congress mandated that the agency “take actions that are designed to enhance,” inter alia, “the 25 quality and completeness of records . . . the maintenance of identity and control in the event of an 26 unauthorized release . . . [and] corrective actions in the event of an unauthorized release.” Id. at 27 1 28 “AR” references are to the administrative record, which consists of a dozen volumes containing thousands of pages. See Dkt. Nos. 66, 67, 70. 5 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 6 of 26 1 § 10204(b)(1), (3), & (4). Congress also directed the Secretary to “promulgate regulations to 2 improve the management and oversight of articles” regulated under the PPA “as the Secretary 3 considers appropriate.” Id. at § 10204(a)(2). 4 C. RULEMAKING: 2008-2017 5 In 2008, APHIS published a notice of proposed rulemaking (NPRM) for the part 340 6 regulations to consolidate the agency’s noxious-weed authority under the PPA and address the 7 concerns raised in the 2005 OIG audit report and the 2008 Farm Bill. See 73 Fed. Reg. at 60009- 8 11. The NPRM stated that, “[i]n order to best evaluate the risks associated with these GE 9 organisms and regulate them when necessary, APHIS needs to exercise its authorities regarding 10 noxious weeds . . . in addition to its authority regarding plant pests.” Id. at 60011. The NPRM 11 identified the risks with GE organisms it would consider under its noxious-weed authority, 12 including harms to “irrigation, navigation, the natural resources of the United States, the public 13 health, the environment and interests of agriculture.” Id. at 60014. APHIS received a deluge of 14 comments -- more than 88,000 comments in more than 5,500 submissions -- and ultimately 15 withdrew the proposed rule in 2015 so that it could engage in “an open and robust policy 16 dialogue” with key stakeholders. Importation, Interstate Movement, and Release into the 17 Environment of Certain Genetically Engineered Organisms, 80 Fed. Reg. 11598, 11598 (Mar. 4, 18 2015). 19 In 2015, the OIG published another audit report. The report concluded that APHIS had 20 “not implemented the agreed upon corrective actions for 3 of the 28 recommendations from [the] 21 2005 report,” specifically identifying the recommendation to “incorporat[e] additional authority to 22 control noxious weeds.” AR 23027. APHIS responded that it had attempted to revise the rule in 23 2008 but was obligated to work through the enormous number of comments. AR 23040. 24 Two years after the withdrawal, APHIS announced a new proposed rule that was again 25 said to address the concerns raised in the 2008 Farm Bill, the 2005 OIG audit, and the 2015 OIG 26 audit. See Importation, Interstate Movement, and Environmental Release of Certain Genetically 27 Engineered Organisms, 82 Fed. Reg. 7008, 7011-12 (Jan. 19, 2017). Like its predecessor, the 28 2017 proposed rule would evaluate GE plants for noxious-weed risk. Id. at 7010-11. APHIS 6 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 7 of 26 1 stated that the “current regulatory structure, which entails evaluating such plants solely for plant 2 pest risk, is not sufficient to properly identify all risks that these plants present to other plants and 3 plant products.” Id. at 7010. The agency said that part 340’s focus on plant-pest risks had been 4 workable in the past because “most GE plants to date have been agricultural crops, and most 5 agricultural crops are not biologically weeds prior to modification” and most GE plants were 6 created using plant pests and therefore already fell “under APHIS’ regulatory authority.” Id. The 7 agency believed that approach was no longer tenable because “[a]dvances in genetic engineering 8 have . . . made the need to evaluate GE plants for noxious weed risk more pressing.” Id. at 7009. 9 For the noxious-weed regulations already on the books, APHIS said that they suffered from 10 limitations that made them inadequate for GE-crop oversight. Id. at 7009-10. 11 Even so, the 2017 proposal was not necessarily about regulatory maximalism. APHIS 12 proposed to narrow the regulations by exempting some GE plants altogether from part 340 13 regulation. The biggest change in this respect was the proposal to move away from the prior 14 definition of “GE organism,” which the agency believed was both overinclusive and 15 underinclusive for mitigating risk. See id. at 7009, 7015-16. The agency proposed to exempt GE 16 plants “that could otherwise have been produced using traditional breeding techniques or chemical 17 or radiation-based mutagenesis.” Id. at 7015. This was because “GE plants as a class . . . pose no 18 greater plant pest or noxious weed risk than their counterparts developed through conventional 19 breeding techniques.” Id at 7015-16. The agency acknowledged that the potentially exempt plants 20 are not “risk-free,” id. at 7017, and so proposed to exempt such plants from the blanket permitting 21 requirements of part 340 but to simultaneously amend part 330 regulations to permit some 22 oversight of those exempt GE plants that “pose a potential plant pest risk.” Id. at 7016. 23 In contrast to the prior tidal wave of public comment, the 2017 NPRM elicited only 203 24 comments. Even so, APHIS abruptly withdrew the 2017 NPRM in a one-page notice. See 25 Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered 26 Organisms, 82 Fed. Reg. 51582 (Nov. 7, 2017). APHIS represented that commentators had 27 expressed concern that the proposed rule would “hinder[] innovation” and “could result in the 28 7 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 8 of 26 1 creation of two parallel but inconsistent regulatory systems and thus more regulatory uncertainty.” 2 Id. In effect, APHIS ended 2017 back where it started in 2004. 3 D. RULEMAKING: 2019-PRESENT 4 The rulemaking for GE plants went silent until 2019, when APHIS promulgated a third 5 proposal that ultimately was implemented in 2020 as the final rule in question here. See 84 Fed. 6 Reg. 26514; 85 Fed. Reg. 29790. The final rule revised the scope of regulations under part 340 to 7 reflect the fact that APHIS changed its risk assessment of GE plants to focus on the specific trait 8 introduced in the plant and that trait’s potential to pose plant-pest risks in the modified plant. See 9 generally 7 C.F.R. § 340; 84 Fed. Reg. at 26516-17. 10 Although this revision was anticipated to some extent by the changes announced in 2017, 11 the final rule differed from its predecessors in many respects. In salient part, the final rule 12 categorically exempts GE plants created by conventional-breeding techniques. 7 C.F.R. 13 § 340.1(b). But unlike the 2017 proposal, the final rule does not regulate such plants under part 14 330. Id at §§ 330.200, 340.1-3; 85 Fed. Reg. at 29823. The finale rule excludes from regulation 15 under part 340 GE plants with “plant-trait-mechanism of action” combinations that the agency has 16 determined do not pose plant-pest risks. 7 C.F.R. § 340.1(c). A “mechanism of action” is the 17 “biochemical process(es) through which genetic material determines a trait.” Id. at § 340.3. The 18 final rule does not treat noxious weeds as a trigger for part 340 regulation, unlike the 2008 and 19 2017 proposals. 85 Fed. Reg. at 29822. APHIS said that it was not “statutorily obligated to 20 integrate noxious weed authority into a revised part 340” and that it did “not perceive a basis at 21 this time for overhauling part 360 noxious weed regulations, which we believe have functioned 22 well over the years, or establishing alternate regulations in title 7 governing noxious weeds.” Id. 23 APHIS also said that it would “continue [its] current practice of considering the weediness” of GE 24 plants when it considers their plant-pest risks. Id. Lastly, the final rule extends record retention 25 for GE-plant developers from one year to two years without requiring permit applicants to retain 26 or prepare any new types of records. 7 C.F.R. §§ 340.5, 340.6. 27 28 8 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 9 of 26 1 IV. THIS LITIGATION 2 Plaintiffs have sued to rescind the final rule under the Administrative Procedure Act 3 (APA), Pub. L. No. 404-79, 60 Stat. 237 (codified at 5 U.S.C. § 500 et seq.). The complaint 4 named as defendants the Secretary of Agriculture, the Administrator of APHIS, and the USDA 5 and APHIS as agencies.2 Dkt. No. 1 ¶¶ 29-31. The complaint alleged that the final rule 6 contravened various federal statutes and consequently was arbitrary and capricious. Specifically, 7 plaintiffs alleged that, in promulgating the final rule, the agency failed to heed procedural 8 requirements under the Endangered Species Act of 1973 (ESA), Pub. L. No. 93-205, 87 Stat. 884 9 (codified at 16 U.S.C. § 1531 et seq.), and the National Environmental Policy Act (NEPA), Pub. 10 L. No. 91-190, 83 Stat. 852 (1970) (codified at 42 U.S.C. § 4321 et seq.). Dkt. No. 1 ¶¶ 223-47. 11 Plaintiffs also alleged that the final rule failed to implement directives set forth in the 2008 Farm 12 Bill and that the rule violated the PPA. Id. ¶¶ 248-76. And plaintiffs said that portions of the final 13 rule relating to the exemptions unconstitutionally delegated statutory authority to private parties 14 without Congress’s express authorization. Id. ¶¶ 277-86. The complaint seeks declaratory and 15 injunctive relief, most particularly a remand of the rule to the agency with vacatur. Id. ¶¶ 287-300. 16 Early in litigation, the Court granted permissive intervention to two agricultural-industry 17 trade associations, the American Seed Trade Association and the Biotechnology Innovation 18 Organization (intervenors). Dkt. No. 43. Plaintiffs moved for summary judgment as to four of 19 their five claims. See Dkt. No. 59. APHIS opposed as to all claims asserted in the complaint, see 20 Dkt. No. 60, and intervenors filed an opposition raising additional points against plaintiffs’ 21 motion, see Dkt. No. 63. 22 DISCUSSION 23 I. THE PROPER UNIVERSE OF EVIDENCE 24 Before getting to the merits of the motion, some threshold issues require discussion. To 25 start, the parties disagree about the scope of the record properly before the Court. Plaintiffs’ 26 opening brief featured an abundance of materials that are not part of the agency’s administrative 27 2 28 For clarity and ease of reading, the Court refers to the named defendants together as “the agency” or “APHIS,” unless otherwise noted. 9 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 10 of 26 1 record. See generally Dkt. No. 59. The Court declines to consider most of these materials for any 2 purpose beyond determining standing, see Ecological Rts. Found. v. FEMA, 384 F. Supp. 3d 1111, 3 1119 (N.D. Cal. 2019), which is another dispute that will be discussed next. It is well established 4 that, in a suit brought under the APA to review agency action, “the function of the district court is 5 to determine whether or not as a matter of law the evidence in the administrative record permitted 6 the agency to make the decision it did.” Occidental Engineering Co. v. INS, 753 F.2d 766, 769 7 (9th Cir. 1985). There are limited exceptions to that rule, see Lands Council v. Powell, 395 F.3d 8 1019, 1030 (9th Cir. 2005), but plaintiffs give no good reason for applying an exception. 9 Plaintiffs also agreed in a joint status report to the Court that “there will be no need for any motion 10 practice on the scope of the administrative record.” Dkt. No. 55 at 1. Consequently, there is no 11 basis for the Court to consider much of the extra-record materials. 12 The only small exception to this conclusion is for judicial notice of Exhibits A and C of the 13 Wu Declaration. See Dkt. Nos. 59-20, 59-22. The exhibits are simply the 2008 and 2017 NPRMs. 14 The agency broadly objects to all documents attached to that declaration, see Dkt. No. 60 at 11, 15 but the Court does not understand the agency to suggest that the prior proposed versions of the 16 very rule under review cannot be considered. In any event, judicial notice of those exhibits is 17 appropriate. See Fed. R. Ev. 201(b)(2); 44 U.S.C. § 1507 (“The contents of the Federal Register 18 shall be judicially noticed.”). 19 II. ARTICLE III STANDING 20 To litigate in federal court, plaintiffs must “demonstrate standing to sue by alleging the 21 ‘irreducible constitutional minimum’ of (1) an ‘injury in fact’ (2) that is ‘fairly traceable to the 22 challenged conduct of the defendants’ and (3) ‘likely to be redressed by a favorable judicial 23 decision.’” Patel v. Facebook, Inc., 290 F. Supp. 3d 948, 952 (N.D. Cal. 2018) (quoting Spokeo, 24 Inc. v. Robins, 578 U.S. 330, 338 (2016)), aff’d by Patel v. Facebook, Inc., 932 F.3d 1264 (9th Cir. 25 2019). The elements of standing “must be supported in the same way as any other matter on 26 which the plaintiff bears the burden of proof,” Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 27 (1992), and so at summary judgment, “[a] plaintiff . . . must ‘set forth’ by affidavit or other 28 evidence ‘specific facts,’ which for purposes of the summary judgment motion will be taken as 10 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 11 of 26 1 true,” id. (citation omitted), that show a “substantial probability” of standing, Nat’l Fam. Farm 2 Coalition v. EPA, 966 F.3d 893, 908 (9th Cir. 2020) (quotation omitted). 3 APHIS did not challenge plaintiffs’ standing to sue, see Dkt. No. 60, but intervenors say 4 that plaintiffs have not demonstrated standing, Dkt. No. 63 at 4-7. In addition, the Court “has an 5 independent duty to be vigilant about standing.” Natural Grocers v. Vilsack, 627 F. Supp. 3d 6 1130, 1143 (N.D. Cal. 2022) (quotation omitted). 7 The standing challenge is not well taken. In Monsanto Co. v. Geertson Seed Farms, the 8 Supreme Court of the United States held that farmers of non-GE alfalfa had standing to challenge 9 an agency decision to deregulate GE alfalfa where the record established that: (1) the non-GE 10 alfalfa had a “reasonable probability” of being contaminated by gene flow if GE alfalfa was 11 completely deregulated; and (2) gene flow injured those farmers by, inter alia, requiring them to 12 incur costs for preemptive measures to prevent or test for gene flow and ensure supply of non-GE 13 alfalfa seeds. 561 U.S. 139, 153-55 (2010). 14 So too here. Because the only relief sought is injunctive, see Dkt. No. 59 at 29-30, the 15 Court “need not address standing of each plaintiff” at this juncture. Atay v. Cnty. of Maui, 842 16 F.3d 688, 696 (9th Cir. 2016) (quoting Nat’l Ass’n of Optometrists & Opticians LensCrafters, Inc. 17 v. Brown, 567 F.3d 521, 523 (9th Cir. 2009)). The undisputed evidence establishes that: 18 (1) members of the plaintiff organizations, namely Peter Baumer, Darvin Bentlage, and Jonathan 19 Krohn, are organic or non-GE farmers; (2) if the final rule is allowed to deregulate GE plants, the 20 risk that those members’ farms will experience incidents of transgenic contamination increases 21 beyond a “reasonable probability,” see Dkt. No. 59-1 ¶¶ 8, 12, 14-15; Dkt. No. 59-2 at ¶¶ 7, 13, 22 16; Dkt. No. 59-12 at ¶¶ 9, 11-14; and (3) such contamination will harm their non-GE farming 23 operations, see generally, e.g., Dkt. Nos. 59-1, 59-2, 59-12. Specifically, one farmer says that his 24 non-GE farm is near several GE farms, Dkt. No. 59-1 ¶ 7, which will require measures to stave off 25 contamination, see id. ¶ 11, and the others anticipate incurring greater costs for non-GE seeds, see 26 Dkt. No. 59-2 ¶¶ 7, 16; Dkt. No. 59-12 ¶ 12. Such harms were “sufficiently concrete to satisfy the 27 injury-in-fact prong” in Monsanto, 561 U.S. at 155, and the same goes in this lawsuit. 28 11 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 12 of 26 1 “Those harms are readily attributable to APHIS’s deregulation decision,” id., because the 2 paring back of regulatory oversight is what gives rise to the injuries, see Dkt. No. 59-1 ¶¶ 8, 12, 3 14-15; Dkt. No. 59-2 at ¶¶ 7, 13, 16; Dkt. No. 59-12 at ¶¶ 9, 11-14. This is so notwithstanding 4 some evidence that contamination has occurred in the past and may occur in the future irrespective 5 of the regulatory scheme. E.g., Dkt. No. 59-1 ¶¶ 12-13. “[A] plaintiff may sue [a] defendant” so 6 long as that “defendant is at least partially causing the alleged injury.” Nat’l Fam. Farm 7 Coalition, 966 F.3d at 910 (quoting WildEarth Guardians v. U.S. Dep’t of Agric., 795 F.3d 1148, 8 1157 (9th Cir. 2015)). In addition, a judicial order vacating and remanding the challenged rule 9 would alleviate the increased risk of contamination the evidence shows to be posed by certain 10 aspects of the rule. See Idaho Conservation League v. Bonneville Power Admin., 83 F.4th 1182, 11 1191 (9th Cir. 2023). 12 With respect to the organizations, the record establishes that the interests sought to be 13 protected by Center for Food Safety, of which Baumer and Krohn are members, see Dkt. Nos. 59- 14 1, 59-12, and National Family Farm Coalition, for which Bentlage serves as a board member, see 15 Dkt. No. 59-2, are germane to the organizations’ purposes, see Dkt. No. 1 ¶¶ 20-23, and that 16 nothing about the claims asserted or relief requested requires the members’ individual 17 participation in this litigation. See Oregon Advoc. Ctr. v. Mink, 322 F.3d 1101, 1109 (9th Cir. 18 2003) (quoting Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S. 333, 343 (1977)). 19 Consequently, Article III standing to sue has been demonstrated. As a closing observation, 20 intervenors failed to address governing precedent such as Monsanto and Atay. Dkt. No. 63. Why 21 that happened is unknown, but it substantially diluted their argument. 22 III. LEGAL STANDARDS 23 In reviewing agency action other than the interpretation of a statute, the scope of review 24 under the APA is narrow, and “agency action will be upheld unless it is found to be ‘arbitrary, 25 capricious, an abuse of discretion, or otherwise not in accordance with law.’” Natural Grocers, 26 627 F. Supp. 3d at 1142 (quoting 5 U.S.C. § 706(2)(A)). “Agency action is arbitrary and 27 capricious when the agency ‘relie[s] on factors which Congress has not intended it to consider, 28 entirely fail[s] to consider an important aspect of the problem, [or] offer[s] an explanation for its 12 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 13 of 26 1 decision that runs counter to the evidence before the agency.” Ctr. for Biological Diversity v. U.S. 2 Fish and Wildlife Serv., 67 F.4th 1027, 1035 (9th Cir. 2023) (alterations in original) (quoting 3 Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983)). 4 “[T]he Court will not substitute its own judgment for that of the agency” but will “engage 5 in a careful, searching review to ensure that the agency has made a rational analysis and decision 6 on the record before it.” Ecological Rts. Found., 384 F. Supp. 3d at 1119 (quoting Wild Fish 7 Conservancy v. Salazar, 628 F.3d 513, 521 (9th Cir. 2010)). Consequently, the Court “will not 8 ‘rubber-stamp’ agency decisions that are inconsistent with a statutory mandate or that frustrate the 9 congressional policy underlying a statute.” Id. (quoting Natural Res. Def. Council, Inc. v. 10 Pritzker, 828 F.3d 1125, 1139 (9th Cir. 2016)). “The Court’s deference extends to less than stellar 11 work by an agency, so long as its analytical path and reasoning can be reasonably discerned,” 12 Natural Grocers, 627 F. Supp. 3d at 1142 (quotation omitted), although it is still incumbent on 13 agencies to “engage in ‘reasoned decisionmaking,’” Dep’t of Homeland Sec. v. Regents of the 14 Univ. of Cal., 591 U.S. 1, 16 (2020) (quoting Michigan v. EPA, 576 U.S. 743, 750 (2015)), and 15 “articulate a satisfactory explanation for its action including a ‘rational connection between the 16 facts found and the choice made,’” State Farm Mut. Auto. Ins. Co., 463 U.S. at 43 (quoting 17 Burlington Truck Lines v. United States, 371 U.S. 156, 168 (1962)). 18 “Summary judgment is an appropriate procedure for deciding challenges under the APA.” 19 Natural Grocers, 627 F. Supp. 3d at 1142. And a grant of summary judgment is warranted where 20 there is no genuine dispute of material fact and the moving party is entitled to judgment as a 21 matter of law. See Brickman v. Fitbit, Inc., No. 15-cv-02077-JD, 2017 WL 6209307, at *2 (N.D. 22 Cal. Dec. 8, 2017) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986)). “Because this is 23 a record review case, the summary judgment motion will be decided upon a review of the 24 administrative record as it existed at the time of the agency’s decision.” Natural Grocers, 627 25 F. Supp. 3d at 1142 (citing Karuk Tribe of Cal. v. U.S. Forest Serv., 681 F.3d 1006, 1017 (9th Cir. 26 2012) (en banc)). 27 28 13 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 14 of 26 1 IV. NOXIOUS WEEDS 2 The APA review starts with plaintiffs’ challenges to the rule’s assertedly unlawful failure 3 to incorporate the agency’s noxious-weed authority into the part 340 regulations. Plaintiffs first 4 contend that the failure was contrary to the PPA’s statutory mandate and so the final rule must be 5 set aside on that basis. See Dkt. No. 59 at 22-23. 6 The point is not well taken. “Courts must exercise their independent judgment in deciding 7 whether an agency has acted within its statutory authority.” Loper Bright Enterp. v. Raimondo, --- 8 U.S. ---, ---, 144 S. Ct. 2244, 2273 (2024). There is no question that the PPA expanded the 9 definition of noxious weeds, and so the scope of the agency’s regulatory authority as well, 10 see Pub. L. No. 106-224, 114 Stat. 438 § 403(10) (codified at 7 U.S.C. § 7702(10)), nor is there 11 any dispute the statute charges the agency with the responsibility to “facilitate . . . interstate 12 commerce in agricultural products . . . that pose a risk of harboring plant pests or noxious weeds in 13 ways that will reduce . . . the risk of dissemination of plant pests or noxious weeds,” id. at § 402(3) 14 (codified at 7 U.S.C. § 7701(3)). 15 But plaintiffs did not identify any statutory text that “command[s],” Dkt. No. 59 at 22, the 16 agency to discharge that responsibility in a particular way, let alone plaintiffs’ preferred way. 17 Rather, as the agency notes, see Dkt. No. 60 at 16, the statute is replete with language indicating 18 that the way in which that responsibility is to be discharged is within the agency’s discretion. 19 See, e.g., 7 U.S.C. § 7712(a) (“The Secretary may prohibit or restrict the . . . movement in 20 interstate commerce of any . . . noxious weed[.]” (emphasis added)); id. at § 7712(c) (“The 21 Secretary may issue regulations to implement subsection (a)[.]” (emphasis added)). Where a 22 “statute delegates authority to an agency . . . courts must respect the delegation, while ensuring the 23 agency acts within it.” Loper Bright Enterp., --- U.S. at ---, 144 S. Ct. at 2273. 24 Overall, plaintiffs did not establish that the agency exceeded its statutory authority here. 25 Plaintiffs say the agency itself previously interpreted the PPA as imposing a “statutory duty” to 26 add noxious weeds as a trigger for part 340 regulations. See Dkt. No. 59 at 22-23. Even if an 27 agency’s prior interpretations of a statute in rescinded NPRMs carried some persuasive value, 28 which is not at all clear, see Loper Bright Enterp., --- U.S. at ---, 144 S. Ct. at 2259 (citing 14 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 15 of 26 1 Skidmore v. Swift & Co., 323 U.S. 134 (1944)), the statements plaintiffs proffer were the agency’s 2 conclusions at the time about how to exercise its discretion, not interpretations of a statutory 3 directive, see 73 Fed. Reg. at 60011. 4 Plaintiffs next contend that the final rule’s failure to incorporate noxious weeds as a trigger 5 for part 340 regulations was inadequately explained. This challenge fares better. 6 The parties disagree whether the factors for assessing changes in agency policy set forth in 7 FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009), should guide the analysis here. 8 See Dkt. No. 59 at 23; Dkt. No. 60 at 18-19. The Court sees no reason to wade into that dispute 9 and instead takes guidance from the Ninth Circuit’s discussion in Transportation Division of the 10 International Association of Sheet Metal, Air, Rail, & Transportation Workers v. Federal Railroad 11 Administration (Transp. Workers), 988 F.3d 1170 (9th Cir. 2021). 12 In that case, the Federal Railroad Administration (FRA) issued in 2016 a NPRM that 13 proposed “[a] minimum requirement of two crewmembers . . . for all railroad operations.” Id. at 14 1174 (emphasis omitted) (quoting 81 Fed. Reg. 13918, 13918 (Mar. 15, 2016)). After a public 15 hearing and the comments period, the FRA did not act on the NPRM until issuing an order on May 16 29, 2019. See id. The 2019 order withdrew the 2016 NPRM, purported to preempt any state laws 17 regulating the number of crewmembers for train operations, and “provid[ed] notice of [FRA’s] 18 affirmative decision that no regulation of train crew staffing is necessary or appropriate,” id. at 19 1175-77 (quoting 84 Fed. Reg. 24735, 24735 (May 29, 2019)). The Ninth Circuit understood the 20 “real and intended effect” of the 2019 order was to “authorize nationwide one-person train crews 21 and to bar any contrary state regulations.” Id. at 1182. 22 Reviewing the FRA 2019 order for arbitrariness and capriciousness, the court concluded 23 that the record did not support the order’s conclusions and that the agency’s contemporaneous 24 explanation was inadequate. See id. at 1182-84. In pertinent part, the court concluded that the 25 order did not sufficiently address the safety concerns raised by comments on the NPRM because 26 (1) the order “[did] not discuss crew fatigue at all,” despite the FRA’s own research having 27 identified crewmember fatigue as a “critical component” of safety; (2) it failed to consider 28 concerns about the technical challenges posed by passage over mountainous terrain that “FRA had 15 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 16 of 26 1 previously recognized”; and (3) an “assertion that [the agency] has the inherent authority to 2 implicitly preempt state law does not” explain the reason why the agency exercised its authority in 3 the manner it did. Id. at 1183. 4 APHIS’s 2020 final rule suffers from many of the same infirmities. It did not address 5 concerns about the adequacy of APHIS’s “current practice,” 85 Fed. Reg. at 29822, for regulating 6 GE plants and noxious weeds that the agency had “previously recognized.” Transp. Workers, 988 7 F.3d at 1183. The administrative record includes two OIG audit reports from 2005 and 2015 8 which, as APHIS forthrightly acknowledges, contain recommendations “that incorporating the 9 PPA’s expanded definition of noxious weed into the part 340 Rules would be preferable.” Dkt. 10 No. 60 at 19 (citing AR 22970); see also AR 23027, 23037, 23039; 73 Fed. Reg. at 60009. In 11 addition, APHIS discussed at great length in the 2017 NPRM the shortcomings of the current 12 regulatory regime with respect to GE plants and noxious weeds. APHIS stated that the part 360 13 regulations, “while effective, continue to have a significant restriction that limits their applicability 14 to GE organisms: They are predicated on a determination by APHIS that a taxon is a Federal 15 noxious weed.” 82 Fed. Reg. at 7010. This means that part 360 regulations would cover a GE 16 plant only if the taxon to which it belongs is deemed a noxious weed (in other words, only if both 17 a plant’s GE and non-GE counterparts are deemed to be a noxious weed). See 7 C.F.R. 18 §§ 360.200, 360.500-600. APHIS also said that, “in recent years, there has been an increasing 19 diversity of both agronomic and non-agronomic traits engineered in plants. . . . [and] an increased 20 use of plants in genetic engineering that, in their unmodified state, are known to possess weedy 21 traits,” which poses “a correspondingly higher risk that such a plant may be genetically engineered 22 into a noxious weed.” 82 Fed. Reg. at 7010. Finally, APHIS stated that part 340 “is not sufficient 23 to properly identify all risks that these plants present to other plants and plant products,” for 24 potentially harmful “plants may entirely escape regulation” if the GE plant is not engineered using 25 a plant-pest vector or is not itself deemed to be a plant pest. Id. 26 The final rule does not address a single one of these issues. The rule states that APHIS 27 “disagrees with the proposition that [it] is statutorily obligated to integrate noxious weed authority 28 into a revised part 340” and that it instead believes it has discretion to do so. 85 Fed. Reg. at 16 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 17 of 26 1 29822. But APHIS’s “assertion that it has the . . . authority” to make such a decision “does not 2 address why” it chose to make or not make the decision. Transp. Workers, 988 F.3d at 1183. In 3 the final rule, APHIS “recognize[d]” that genetic engineering could introduce traits that increase 4 the weedy aspects of a plant and stated, “[a]ccordingly, [it] would continue [its] current practice of 5 considering the weediness of the unmodified plant and whether the new trait could in any way 6 change the weediness.” 85 Fed. Reg. at 29822. The rule further provides that APHIS would 7 consider “potential effects on the weediness of other plants with which the engineered plant can 8 interbreed” and “whether the plant with the specific trait being evaluated should be considered for 9 regulation pursuant to” the separate part 360 regulations. Id. Statements about maintaining the 10 status quo sidestep the problems with the status quo that APHIS “had previously recognized.” 11 Transp. Workers, 988 F.3d at 1183. The final rule’s silence on this score indicates that APHIS 12 “failed to consider an important aspect of the problem” that the agency itself had identified. State 13 Farm Mut. Auto. Ins. Co., 463 U.S. at 43. 14 It bears mention that the final rule concludes APHIS does not “perceive a basis at this 15 time” for overhauling its noxious-weed regulations because it “believe[s]” those regulations “have 16 functioned well over the years.” 85 Fed. Reg. at 29822. But the agency’s perceptions and beliefs 17 are of little moment when, as here, they are asserted as fiat untethered to a clear and sound 18 analysis. The agency had in hand OIG audit reports the agency understood to suggest that 19 “incorporating the PPA’s expanded definition of noxious weeds into the part 340 Rules would be 20 preferable.” Dkt. No. 60 at 19. Yet the rule does not address the relevant recommendations in 21 those reports. See, e.g., Rancheria v. Jewell, 776 F.3d 706, 714 (9th Cir. 2015) (“An agency’s 22 decision is arbitrary and capricious if it ignores important considerations or relevant evidence on 23 the record.”). 24 Transportation Workers concluded that FRA’s failure to consider crew fatigue in 25 connection to safety in the final order after the NPRM had identified crew fatigue as a “critical 26 component” of safety was arbitrary and capricious. 988 F.3d at 1183. The same conclusion 27 applies here. APHIS’s failure to address the limitations in the part 360 regulations with respect to 28 GE plants that its prior assessments identified as justifying adding noxious weeds as a trigger to 17 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 18 of 26 1 part 340 regulations was arbitrary and capricious. Ignoring concerns the agency had previously 2 recognized is not “reasoned decisionmaking.” Regents of the Univ. of Cal., 591 U.S. at 16 3 (quoting Michigan, 576 U.S. at 750). 4 APHIS tries to get around all this by saying that it was entitled to disagree, and so not 5 follow, the OIG report recommendations because “neither report discusses the noxious weed 6 authority issue in any depth” and both “merely assume, without analysis,” that incorporation is 7 preferable. Dkt. No. 60 at 19. That response might have been adequate if the agency had said it at 8 the time. It did not, and so that reason does not carry the day now. See, e.g., State Farm Mut. 9 Auto. Ins. Co., 463 U.S. at 50 (“[A]n agency’s action must be upheld, if at all, on the basis 10 articulated by the agency itself.”). APHIS says that it was not required to “stay true to the ‘very 11 genesis of the rulemaking history’” in promulgating the final rule and that the final rule need only 12 have been a “logical outgrowth” of the NPRMs with a reasonable explanation. Dkt. No. 60 at 18- 13 20 (emphasis in original). That may be, but those comments do not excuse it from complying with 14 the APA’s basic requirement that agencies articulate the bases of their decisions. See, e.g., 15 Arrington v. Daniels, 516 F.3d 1106, 1112-13 (9th Cir. 2008). 16 V. EXEMPTIONS 17 As a brief overview for the ensuing discussion, the final rule provides exemptions for: (1) 18 GE crops that can be created through conventional-breeding techniques, see 7 C.F.R. § 304.1(b); 19 (2) GE crops with certain “plant-trait MOAs,” see id. § 340.1(c); and (3) GE crops previously 20 determined to fall outside part 340’s scope under the “Am-I-Regulated” (AIR) process, see id. 21 § 340.1(d). Plaintiffs challenge the exemptions as arbitrary and capricious because they were not 22 based on “sound science.” Dkt. No. 59 at 20-22; Dkt. No. 65 at 7-8. Plaintiffs also say that the 23 agency’s decision to not require field test data for still-regulated GE crops was arbitrary and 24 capricious for the same reason. Dkt. No. 59 at 20. 25 APHIS suggests in a footnote that plaintiffs waived any claim that the exemptions are 26 arbitrary and capricious and may only rely on “the PPA’s ‘sound science’ standard.” Dkt. No. 60 27 at 15 n.7. This misconstrues plaintiffs’ challenge. Their theory is that the agency’s failure to 28 ground its decisions on the PPA on “sound science” renders those decisions arbitrary and 18 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 19 of 26 1 capricious. See, e.g., Dkt. No. 1 at 82 ln. 15, ¶¶ 262-70 (alleging that the agency’s “Failure to 2 Base Decisions on Sound Science” is a reason for concluding that the agency’s “decision violated 3 the PPA and the APA as it is” arbitrary and capricious); Dkt. No. 59 at 15. 4 A. THE CONVENTIONAL-BREEDING EXEMPTION 5 Plaintiffs first say that “there is no scientific basis” for the conventional-breeding 6 exemption because the scientific evidence in the record bearing on this point, namely a 2002 study 7 from the National Academy of Sciences (NAS), “specifically rejected this rationale.” Dkt. No. 8 59 at 21 (emphasis in original) (quotation omitted). Charging plaintiffs with cherry picking, 9 APHIS says that the 2002 NAS study also concluded that “the genetic engineering process, per se, 10 presents no new categories of risk compared to conventional breeding.” Dkt. No. 60 at 23 11 (quoting AR 20484). APHIS says that, because conventional breeding poses risks that are 12 “manageable by accepted standards,” according to a 1989 report by the National Research Council 13 (NRC), the GE crops covered by the exemption “are the same in kind as, and do not pose any 14 increased plant pest risks than, the [changes] introduced through conventional breeding,” which 15 “have not led to plant pest risk concerns.” 85 Fed. Reg. at 29792, 29794; see Dkt. No. 60 at 23- 16 24. In the agency’s view, nothing in the record “suggests that the scientific evidence employed 17 was anything but sound.” Dkt. No. 60 at 24. 18 The flaw of this rationale is in the premise -- “the types of traits that can be introduced 19 through conventional breeding have not led to plant pest risk concerns,” 85 Fed. Reg. at 29792 -- 20 and the record with respect that statement. There is no dispute that APHIS relied on the 1989 21 NRC study, which concludes that “[p]lants modified by classical genetic methods are . . . 22 ‘manageable by accepted standards.’” AR 5424. But as plaintiffs state, this was expressly 23 repudiated by other more-recent scientific evidence in the record. The 2002 NAS study 24 acknowledged that “[i]n the 1980s . . . an assumption was made that, even though conventionally 25 bred crops were not considered to be completely risk free, the risks associated with the entire class 26 of crops should be considered ‘acceptable’ to society.” AR 20519. It concluded that “the 27 assumption that all conventionally bred crops have ‘acceptable risks’ is not scientifically justified” 28 19 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 20 of 26 1 and therefore “[t]he risks associated with crop cultivars that have been or could be developed 2 through conventional breeding should not be assumed to be acceptable.” AR 20520-21. 3 “An agency conclusion that is in ‘direct conflict with the conclusion of its own experts’ . . . 4 is arbitrary and capricious.” NRDC, Inc. v. Pritzker, 828 F.3d 1125, 1139 (9th Cir. 2016) (quoting 5 W. Watersheds Proj. v. Kraayenbrink, 632 F.3d 472, 492 (9th Cir. 2011)). Nowhere in the final 6 rule does APHIS acknowledge the conflicting scientific evidence concerning the basis on which 7 the exemption is premised. See 85 Fed. Reg. at 29791-94. That is arbitrary and capricious. See 8 Alaska Oil & Gas Ass’n v. Pritzker, 840 F.3d 671, 679 (9th Cir. 2016). 9 As a closing point, APHIS says that “the whole point of Part 340 has always been to create 10 a special, heightened set of regulations to protect against the potential for increased plant pest 11 risks from certain GE crops -- not to eliminate that risk altogether.” Dkt. No. 60 at 21-22 12 (emphasis in original); see 85 Fed. Reg. at 29794. But that contention still takes the risk from 13 conventionally bred plants as the baseline on which the scope of regulatory oversight should be 14 defined, a premise the 2002 NAS study concluded is “not scientifically justified,” and to this the 15 final rule says nothing. AR 20519-22. This is not to suggest APHIS cannot take this position 16 after reasoned consideration of other evidence or its own expertise, but it must provide an 17 “adequate explanation and support for its determinations.” Ctr. for Biological Diversity, 900 F.3d 18 at 1069 (quoting San Luis & Delta-Mendota Water Auth. v. Jewell, 747 F.3d 581, 625 (9th Cir. 19 2014)). 20 B. PLANT-TRAIT MOA EXEMPTION & FIELD TEST DATA 21 Plaintiffs challenge the rule’s plant-trait MOA exemptions, 7 C.F.R. § 340.1(c), and the 22 portion of the rule that does not require GE-crop developers to submit field test data for regulatory 23 status review, see id. at § 340.4, for the same basic reason: the 2002 NAS study concluded there 24 was “no scientific basis” to forego an “initial review of the interactions between the ‘trait, [specific 25 GE] organism, and the environment” for “any GE crops.” Dkt. No. 59 at 21-22 (quoting 26 AR 20515). Plaintiffs say that is what the final rule does by not requiring field test data and 27 exempting certain plant-trait MOAs. 28 20 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 21 of 26 1 The point is not well taken. The final rule acknowledges comments suggesting that every 2 GE crop should be assessed with “case-by-case analysis and controlled field experiments,” as well 3 as the 2002 NAS study’s conclusion that “genetic engineering [i.e., transformation]” is “‘both a 4 useful and justifiable regulatory trigger’ because ‘there is no scientific basis’” for excluding GE 5 organisms from regulation prior to some initial review. 85 Fed. Reg. at 29797. Right after, the 6 rule states that “APHIS disagrees with these points” “[b]ased on the risk assessments [the agency 7 has] performed in accordance with the petition process over 30 years.” Id. This experience is said 8 to have persuaded APHIS that it is “able to evaluate the plant pest risks associated with a GE 9 organism without field-test data” because “the introduced trait of the GE organism provides the 10 most reliable indicator of the organism’s potential for deleterious effects on plants and plant 11 products” -- a conclusion the rule states is consistent with a 2016 NAS study and the 1989 NRC 12 study. Id. The rule also notes that the 2002 NAS study also observed that “the committee expects 13 that most [GE organisms] will not produce significant actual environmental risks” and then 14 explains why the agency thinks the proposed rule strikes the proper balance in regulatory burden 15 by discriminating between risky and non-risky GE organisms per the 2002 study’s 16 recommendations. Id. 17 Unlike its decision-making for the conventional-breeding exemption, APHIS recognized 18 contrary scientific evidence and explained its disagreement with it based on other scientific 19 evidence, namely its own expertise from three decades’ worth of regulatory analyses. Agencies 20 need not credit every piece of scientific evidence before them, and they are permitted to credit 21 their own experts over others. See Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 22 378 (1989). To reiterate, the Court’s task in an APA review case is to “ensure that the agency has 23 made a rational analysis and decision on the record before it,” not to “substitute its own judgment 24 for that of the agency.” Ecological Rts. Found., 384 F. Supp. 3d at 1119 (quoting Salazar, 628 25 F.3d at 521). Deference to the agency in the exercise of delegated authority in connection with 26 technical matters such as these is appropriate where the record shows that the agency accounted 27 for the relevant evidence and offered an explanation implicating its expertise. See, e.g., Ctr. for 28 Biological Diversity, 900 F.3d at 1067; Ctr. for Food Safety v. Regan, 56 F.4th 648, 666-67 (9th 21 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 22 of 26 1 Cir. 2022). The record indicates that APHIS supported its views with scientific evidence, and 2 plaintiffs make no argument that the rule conflicts with, or is unsupported by, the evidence on 3 which the agency purported to rely or that there was other evidence undermining the conclusions 4 the agency drew from its expertise. 5 C. EXEMPTIONS GENERALLY 6 Plaintiffs make a catch-all argument that there was not a sound scientific basis in the 7 record for creating any exemptions because the 2002 NAS study concluded the mere fact of 8 genetic engineering is a logical and scientifically justifiable trigger for regulation. See Dkt. No. 59 9 at 20-21. For the reasons already discussed, this argument is misdirected. The agency was 10 entitled to credit its own expertise and experience over the study’s conclusions and in fact did so. 11 Plaintiffs develop no further argument challenging the AIR-process exemption under 7 C.F.R. 12 § 340.1(d). 13 VI. OTHER ISSUES 14 Plaintiffs take some shots at other aspects of the final rule. Plaintiffs say the rule is 15 arbitrary and capricious because, “[r]ather than increasing management and oversight, the [final 16 rule] significantly reduces what will be regulated,” Dkt. No. 59 at 27 (emphases in original), and 17 so contravenes the 2008 Farm Bill’s directive to APHIS to “improve the management and 18 oversight of articles regulated under the [PPA].” Pub. L. No. 110-246, 122 Stat. 1651 19 § 10204(a)(2) (codified at 7 U.S.C. § 7701 Note). 20 The argument misses the mark. The statute says that the Secretary of Agriculture “shall as 21 the Secretary considers appropriate, promulgate regulations to improve the management and 22 oversight of articles regulated under the [PPA].” Id. (emphasis added). “Increase” is not a 23 synonym for “improve,” and the plain text of the statute grants the agency the discretion to decide 24 what constitutes improvement and how to go about achieving it. Moreover, the statute does not 25 define what is an “article[] regulated under the [PPA]”; it only directs the Secretary to promulgate 26 regulations, if deemed appropriate, in connection with articles that are so regulated. Id. The fact 27 that the rule does not increase regulatory oversight is not itself a basis for concluding the agency 28 flouted a statutory directive. 22 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 23 of 26 1 Plaintiffs also say the final rule ignores Congress’s directives to the agency to “take action 2 on each issue identified in the document entitled ‘Lessons Learned and Revisions Under 3 Consideration for APHIS[.]’” 122 Stat. 1651 § 10204(a)(1) (codified at 7 U.S.C. § 7701 Note). 4 They point to subsection (b), which specifies that, “[i]n carrying out subsection (a), the Secretary 5 shall take actions that are designed to enhance,” in relevant part, “the quality and completeness of 6 records[,]” “the availability of representative samples[,]” “the maintenance of identity and control 7 in the event of an unauthorized release[,]” and “corrective actions in the event of an unauthorized 8 release[.]” Id. § 10204(b)(1)-(4). 9 It is true the subjects for action identified in the statute track the “list of lessons learned” in 10 the report that APHIS composed in 2007 based on its “LibertyLink investigation and from its 20 11 years of experience in the regulation of biotechnology.” AR 18415, 18419. But the statute does 12 not say that the actions to be taken are the suggestions APHIS explored in the report; the statute 13 instead appears to leave to the agency’s discretion the decision of what action to take on the 14 specified topics. See 122 Stat. 1651 § 10204(a), (b). Nor does it make sense to read subsection 15 (b) as directing the agency to undertake those courses of action suggested in the report given that 16 subsection (c) clearly delineates a series of more specific actions the agency “shall consider” 17 undertaking. Id. § 10204(c). If Congress wanted APHIS to act on the specific proposals, it knew 18 how to say so. Consequently, plaintiffs’ sole argument that the final rule contravenes the 2008 19 Farm Bill because it “utterly fails to carry out the proposed revisions” fails. Dkt. No. 59 at 28. 20 VII. REMEDY 21 Summary judgment is granted to plaintiffs on the PPA-based APA claim. See Dkt. No. 1 22 ¶¶ 248-270. The final rule is remanded to the agency for further proceedings consistent with this 23 order. 24 The remaining question concerns vacatur. “Ordinarily when a regulation is not 25 promulgated in compliance with the APA, the regulation is invalid,” Idaho Farm Bureau Fed. v. 26 Babbitt, 58 F.3d 1392, 1405 (9th Cir. 1995), and so “[r]emand with vacatur is the typical remedy,” 27 Natural Grocers, 627 F. Supp. 3d at 1149 (citing All. for the Wild Rockies v. U.S. Forest Serv., 28 907 F.3d 1105, 1121-22 (9th Cir. 2018)). But the Court may “leave invalid agency action in place 23 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 24 of 26 1 when equity demands that we do so.” Regan, 56 F.4th at 663 (cleaned up) (quoting Pollinator 2 Stewardship Council v. EPA, 806 F.3d 520, 532 (9th Cir. 2015)). The equitable inquiry requires 3 balancing “the seriousness of the agency’s errors against ‘the disruptive consequences of an 4 interim change that may itself be changed.’” Id. (quoting Cal. Cmtys. Against Toxics v. EPA, 688 5 F.3d 989, 992 (9th Cir. 2012)). Weighing the seriousness of an agency’s errors entails assessing 6 “whether the agency would likely be able to offer better reasoning . . . [such that] it could adopt 7 the same rule on remand, or whether such fundamental flaws in the agency’s decision make it 8 unlikely that the same rule would be adopted on remand.” Pollinator Stewardship Council, 806 9 F.3d at 532. 10 APHIS’s errors are significant. For over a decade it believed it should incorporate its 11 noxious-weed authority into its part 340 regulations due to specific concerns APHIS itself 12 identified. The final rule does the opposite without so much as a mention of the concerns 13 identified in the prior NPRMs. This is not an error of a “technical nature.” Nat’l Fam. Farm 14 Coalition, 966 F.3d at 929. The error undergirding the conventional-breeding exemption is also 15 substantial, for the rule ignores scientific evidence suggesting that its premise is without scientific 16 basis. Consequently, it is unclear that APHIS would “adopt the same rule on remand.” Pollinator 17 Stewardship Council, 806 F.3d at 532. 18 APHIS says in a single sentence that the Court “should only vacate any portion of the rule 19 applicable to the error found, and not the entire Rule.” Dkt. No. 60 at 40. The point seems 20 sensible enough as it relates to the conventional-breeding exemption, but how partial vacatur 21 would work as to the noxious-weed error is unexplained by the agency. “The Court does not 22 review a party’s motion papers and offer coaching pointers for a second round of briefs. The 23 burden is on the party to make its case in the first instance, as it sees fit.” In re Google Play Store 24 Antitrust Litig., 556 F. Supp. 3d 1106, 1108 (N.D. Cal. 2021). APHIS provided no good reason 25 for concluding that something beside the normal remedy of complete vacatur is warranted. 26 Turning to the consequences of vacatur, the record is slight. APHIS says that vacatur 27 “would jeopardize the agency’s regulatory work . . . and require a disruptive switch back to the 28 prior regulatory framework[] after years of reliance on the new one.” Dkt. No. 60 at 40. The 24 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 25 of 26 1 jeopardy point is inherent in vacating any regulation, and the agency does not say why that 2 consequence is somehow unusual here. For the disruption comment, APHIS did not point to 3 anything in the record indicating that the ostensible disruption outweighs the seriousness of the 4 rule’s flaws. See Nat’l Fam. Farm Coalition, 966 F.3d at 929-30 (observing “there is evidence of 5 potentially serious disruption if a pesticide that has been registered for over five years can no 6 longer be used”); Ctr. for Food Safety, 56 F.4th at 668 (noting that “vacating the sulfoxaflor 7 registration would disrupt many agricultural sectors, which could cause ‘yield quantity losses’”); 8 see also Idaho Farm Bureau Fed., 58 F.3d at 1405-06 (looking to the record for possible effects of 9 leaving the rule in place). 10 Intervenors did not fill in the gap. They allege harm to farmers, consumers, GE crop 11 developers, and the agricultural sector generally if the final rule is vacated and the pre-2020 12 regime is restored. See Dkt. No. 63 at 7-10. But, despite being agricultural trade associations, id. 13 at 1 n.1, intervenors adduced no evidence to support their concerns. As the record currently 14 stands, there is no non-speculative basis for assessing the degree and gravity of disruption if the 15 challenged rule is vacated. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-251 (1986). 16 All that being true, the Court is mindful that the rule took effect in 2020 and that this area 17 of our national agricultural economy is rapidly developing. See Dkt. No. 80 at 4 (stating that “at 18 least 99 new GE plants have been exempted” since the rule’s adoption in 2020). With respect to 19 GE organisms that have been introduced or moved without a permit or pursuant to streamlined 20 procedures under the final rule, but that would have had to meet more stringent requirements 21 under the pre-2020 regime, “[t]he egg has been scrambled” and retroactive vacatur “seems an 22 invitation to chaos.” Sugar Cane Growers Co-op. of Florida v. Veneman, 289 F.3d 89, 97 (D.C. 23 Cir. 2002). 24 Consequently, the Court concludes that the remedy that best balances the law and that 25 which “equity demands,” Pollinator Stewardship Council, 806 F.3d at 532 (quotation omitted), is 26 vacatur of the final rule as of the date of this order. Plaintiffs themselves recognize that this form 27 of vacatur suffices to return the industry and GE-crop regulation to the status quo ante. See Dkt. 28 No. 59 at 30. 25 United States District Court Northern District of California Case 3:21-cv-05695-JD Document 81 Filed 12/02/24 Page 26 of 26 1 CONCLUSION 2 Summary judgment is granted to plaintiffs on the PPA-based APA claim that it was 3 arbitrary and capricious for APHIS to not incorporate its noxious-weed authority in the final rule 4 and to implement the conventional-breeding exemptions. Summary judgment is granted to the 5 agency on plaintiffs’ sub-delegation claim3 and 2008 Farm Bill-based APA claim. The final rule 6 is vacated as of the date of this order and is remanded to APHIS for reconsideration consistent 7 with this order. The parties are directed to file by January 13, 2025, a joint statement addressing 8 what effect, if any, this order will have on the rule identifying additional GE organisms qualified 9 for exemption. See Movement of Organisms Modified or Produced Through Genetic Engineering; 10 Notice of Additional Modifications Exempt Plants Can Contain, 89 Fed. Reg. 89569 (Nov. 13, 11 2024); Dkt. Nos. 79-80. The parties are also directed to jointly propose a status conference date 12 for the remaining procedural challenges under the ESA and NEPA. 13 IT IS SO ORDERED. 14 Dated: December 2, 2024 15 16 JAMES DONATO 17 United States District Judge 18 19 20 21 22 23 24 25 26 27 3 28 The agency sought summary judgment on this claim, see Dkt. No. 60 at 39, and plaintiffs did not oppose, see Dkt. No. 65. 26 United States District Court Northern District of California sharply criticized the defendant federal agency for its abrupt reversal after more than a decade of recognizing the harms of novel GE technology. The Court at various points held the agency decision was in "direct conflict with the conclusion of its own experts," and was based on "perception and beliefs" that are merely "asserted as fiat untethered to a clear and sound analysis." Despite USDA's repeated admissions of the need for stronger—not lesser—regulations, the rule unlawfully ignored these concerns of GE crops' risks.

As such, the Court found that the rule did not address "a single one of these issues" that the agency itself previously raised. The Court also found that the exemption of GE crops was "repudiated" by the "scientific evidence in the record," specifically the conclusions and recommendations from the National Academies of Science. Finally, concluding that the agency's errors were "significant," the Court struck down the rules based on those violations alone, determining it unnecessary to yet reach the Endangered Species Act and National Environmental Policy Act claims.

The plaintiffs in the case are the National Family Farm Coalition, Pesticide Action Network, Center for Environmental Health, Center for Biological Diversity, and Center for Food Safety, all represented by counsel from the Center for Food Safety.

Additional Background

Now in commercial production for several decades, GE crop systems are well known to cause several significant agricultural and environmental harms. Such harms include organic and conventional crop contamination from GE crops and market closures, significant increase in pesticide use, and the proliferation of pesticide-resistant "superweeds." Because the vast majority of GMOs are engineered to be resistant to weed-killing pesticides, they have dramatically increased the amount of these chemicals sprayed in U.S. agriculture.

These GE herbicide-resistant crop systems have triggered an epidemic of herbicide-immune weeds, which now infest 120 million acres, leading to a toxic spiral of weeds immune to ever more herbicides, and increased spraying of toxic chemical cocktails to kill them. Genetically engineered crops, including rice to alfalfa to corn and many others, have caused farmers billions of dollars in market losses from transgenic contamination of conventional or organic crops, as food companies and foreign markets reject tainted supplies.

USDA has repeatedly acknowledged the need for stronger GE crop regulations since 2000, when Congress enacted the Plant Protection Act, giving the agency broad new authority to prevent agricultural, economic, and environmental harms. After several false starts to implement this new authority beginning in 2004, nearly a decade-and-a-half later, in 2020, the USDA—under the prior Trump administration— reversed course and dramatically weakened its oversight of GE organisms. Instead of strengthening rules that were already anemic, the 2020 revisions either exempts most GE crops from any regulation or subjects them to cursory reviews that sidestep serious analysis of their actual harms.

Statements from Other Plaintiffs on the Decision

"A growing body of science shows that GE crops dramatically escalate toxic herbicide use, causing harm to farmers, rural communities, and biodiversity. USDA needs to urgently prioritize a high standard of oversight for GE organisms to evaluate real risks for people and the environment," said Dana Perls, program manager of Food and Technology at Friends of the Earth, a plaintiff in this case.

"For the past few decades, America's family farms have struggled under the control of the corporate agrochemical industry, making it nearly impossible for farmers to find anything other than patented-GE seed and pesticide technologies," said Jim Goodman, Board President of plaintiff National Family Farm Coalition, a plaintiff in the case. "Today's Court decision is a victory for family farms, consumers, and the environment. If the agrochemical industry is allowed to determine the approval of their patented products, farmers will have no measure of fairness in the seed market."

"This victory is an important step in making sure the GE crops triggering escalating use of harmful pesticides across millions of acres are actually regulated," said Lori Ann Burd, environmental health director at the Center for Biological Diversity, a plaintiff in the case. "We know GE crops engineered to withstand what would otherwise be a fatal dousing of pesticides are playing a major role in driving endangered species like rusty patched bumblebees toward extinction. The extensive harm to wildlife and plants caused by these poisons must be properly studied so we can get adequate protections in place before it's too late."

"Farmers do not want their farming choices to be limited to the reliance on an ever increasing volume of chemical applications onto crops that corporations have engineered precisely for the purpose of locking in the sale of their patented seeds and proprietary pesticides," said Rob Faux, Iowa Farmer and Communications Manager at Pesticide Action & Agroecology Network (PAN) and a plaintiff in the case. "This ruling restores the basic oversight necessary to protect our water, soil, air, and communities from the corporate-driven cycle of pesticide dependence, weed resistance, pest resurgence, and  reliance on ever more hazardous pesticides. That failed corporate model traps farmers on a treadmill that is catastrophic for biodiversity and human health, and it's high time we got off it."

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