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`MEREDITH STEVENSON (CA Bar No. 328712)
`GEORGE KIMBRELL (Pro Hac Vice)
`AMY VAN SAUN (Pro Hac Vice)
`Center for Food Safety
`2009 NE Alberta St., Suite 207
`Portland, OR 97211
`Ph: (971) 271-7372
`Emails: meredith@centerforfoodsafety.org
` gkimbrell@centerforfoodsafety.org
`avansaun@centerforfoodsafety.org
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`Counsel for Plaintiffs
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`THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
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`Case No. 20-5151-JD
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`FIRST AMENDED
`COMPLAINT FOR
`DECLARATORY AND
`EQUITABLE RELIEF
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`NATURAL GROCERS, CITIZENS
`FOR GMO LABELING, LABEL
`GMOS, RURAL VERMONT, GOOD
`EARTH NATURAL FOODS, PUGET
`CONSUMERS CO-OP, NATIONAL
`ORGANIC COALITION, AND
`CENTER FOR FOOD SAFETY
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`
`Plaintiffs,
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`v.
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`SONNY PERDUE, Secretary of the
`United States Department of
`Agriculture; BRUCE SUMMERS,
`Administrator of the Agricultural
`Marketing Service; and the UNITED
`STATES DEPARTMENT OF
`AGRICULTURE,
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`Defendants.
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY AND EQUITABLE RELIEF
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`Case 3:20-cv-05151-JD Document 19 Filed 10/02/20 Page 2 of 118
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`TABLE OF CONTENTS
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`INTRODUCTION AND NATURE OF ACTION ......................................................... 1
`JURISDICTION AND VENUE .................................................................................... 4
`THE PARTIES .............................................................................................................. 5
`LEGAL AUTHORITY ................................................................................................. 12
`GENERAL FACTUAL BACKGROUND .................................................................... 16
`CLAIMS ...................................................................................................................... 24
`I.
`Claim 1: Electronic or Digital Disclosures ........................................... 24
`FIRST CAUSE OF ACTION ...................................................................................... 45
`II. Claim 2: USDA’s Exclusion of Common, Similar Terms ..................... 47
`SECOND CAUSE OF ACTION ................................................................................. 66
`III. Claim 3: Exclusion of “Highly Refined” Bioengineered
`Foods ...................................................................................................... 68
`THIRD CAUSE OF ACTION ..................................................................................... 83
`IV. Claim 4: First Amendment Freedom of Speech ................................... 85
`FOURTH CAUSE OF ACTION ................................................................................. 94
`V. Claim 5: Commandeering ..................................................................... 97
`FIFTH CAUSE OF ACTION .................................................................................... 104
`VI. Claim 6: Void for Vagueness ............................................................... 106
`SIXTH CAUSE OF ACTION .................................................................................... 111
`RELIEF REQUESTED ............................................................................................. 114
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`AMENDED COMPLAINT
`Plaintiffs Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural
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`Vermont, Good Earth Natural Foods, Puget Consumers Co-op, National Organic
`Coalition, and Center for Food Safety, on behalf of themselves and their members
`allege as follows:
`
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`INTRODUCTION AND NATURE OF ACTION
`This case is about ensuring meaningful food product labeling, the
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`public’s right to know how their food is produced, and producers’ and retailers’
`rights to provide it to them. Throughout U.S. history, government mandated food
`and ingredient information has always been the same: on packages and in language
`consumers could understand. This rulemaking is a significant departure from that
`standard.
`Genetically engineered (GE) organisms have been a controversial topic
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`in the public arena since their introduction into the food supply nearly three
`decades ago. Advocates, including plaintiffs, sought their labeling, like the labeling
`mandated by 64 other countries around the world. After several states passed
`labeling laws, Congress finally passed the Bioengineered Food Disclosure Act
`(Disclosure Act) in 2016.
`The U.S. Department of Agriculture (USDA), charged with writing the
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`implementing rules, finished them in 2019. Unfortunately, in its final decision the
`agency fell far short of fulfilling the promise of meaningful labeling of GE foods. In
`fact in many ways the result is in the direct or de facto concealment of these foods
`and avoidance of their labeling.
`There are six claims in this action. First is the issue of how the
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`disclosure is provided under the final rule: electronic or digital forms of labeling,
`also known as Quick Response code (QR code) or “smartphone” labeling. Congress
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`included this potential form of disclosure in the new law, but, recognizing its
`untested nature, made USDA undertake a study of its potential efficacy to
`eventually use it alone as a means of labeling. The study showed undeniably what
`opponents told the agency: (a) it was not realistic to have customers in a grocery
`store use their phone to scan barcodes for dozens of products, and (b) this form of
`disclosure would discriminate against major portions of the population—the poor,
`elderly, rural, and minorities—with lower percentages of smartphone ownership,
`digital expertise, or ability to afford data, or who live in areas in which grocery
`stores do not have internet bandwidth. Defendants’ decision nonetheless to
`greenlight QR codes without other forms of labeling on products was arbitrary and
`capricious and contrary to law, in violation of the Disclosure Act and the
`Administrative Procedure Act (APA).
`Second is the issue of what terminology is permitted. For 25 years, all
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`aspects of the public dialog around GE foods—scientific, policy, market, legislative,
`consumer—have used either “genetically engineered” (GE) or “genetically modified”
`(GMO) to refer to genetically engineered foods.1 Those are terms that all federal
`agencies, including USDA during this very rulemaking, used. They are what the
`public knows, understands, and expects, and what is currently used in the
`marketplace by producers. They are what other countries and U.S. trade partners
`use internationally. And, Congress used the new term “bioengineered” in the Act, at
`the same time, it instructed USDA to also include “any similar term” in its new
`standard. Despite that instruction and the overwhelming support from stakeholders
`to allow continued use of the far more well-known “GE”/ “GMO” terms, in its final
`rule USDA instead excluded “GE” and “GMO,” prohibiting them from use in the on-
`package text or symbol labeling, only allowing use of the term bioengineered. That
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`1 For clarity sake, we will use the term “GE” in this complaint to refer to genetically
`engineered foods.
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`decision was arbitrary and capricious, contrary to the Act’s plain language and the
`APA and failed to fulfill the Act’s fundamental purpose of informing consumers. It is
`antithetical to the Act’s purpose because it will confuse and mislead consumers.
`Third is the issue of what foods are covered (or not covered) under the
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`scope. The vast majority of GE foods are not whole foods but rather highly processed
`foods with GE ingredients like sodas and oils, which by some estimates account for
`over 70% of all GE foods. The Act provided broad scope to USDA to cover all GE
`foods, and the legislative history shows that USDA and Congress made assurances
`that the majority of GE foods—those highly refined GE foods—would be covered.
`Yet in the final rulemaking, USDA decided to exclude highly refined GE foods,
`creating a new extra-statutory limitation. That decision was contrary to the Act and
`the APA, and again failed to fulfill the Act’s core purpose of informing consumers.
`Fourth is the right of improving on the limited and flawed disclosure
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`the rules provide, particularly important given all the problems explained above.
`Manufacturers and retailers have a fundamental First Amendment Right to provide
`truthful commercial information to consumers, and consumers have a right to
`receive it. In this context, manufacturers and retailers have the right to label foods
`as produced through genetic engineering or as genetically engineered. Yet the final
`rule attempts to restrict that right in multiple ways, providing only limited and
`restricted voluntary labeling beyond its narrow scope. Those speech chilling
`restrictions violate the statute’s text and purposes as well as the First Amendment’s
`guarantees.
`Fifth is the issue of states’ rights in regulating seeds and their labeling
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`under the broad preemption provisions in the Act. In general states and political
`subdivisions have a Tenth Amendment Right to regulate their own citizens in the
`absence of federal regulation. In this instance, states and political subdivisions have
`a right to directly and indirectly regulate genetically engineered seed labels,
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`because GE seeds are not included in the scope of the Act, nor are any federal
`standards for their labeling established in the Act or final rule. The Tenth
`Amendment prohibits the federal government from unlawfully “commandeering”
`state government actions. Yet the Act’s overbroad preemption provision prohibits
`states from regulating GE seed labels, unlawfully commandeering state
`governments by ordering them not to pass any seed labeling laws directly or
`indirectly on this topic. It does this without providing any alternative federal
`regulatory scheme for GE seed labeling.
`Sixth, and alternatively to the arguments raised above is the issue of
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`providing sufficient notice to regulated entities and political jurisdictions regarding
`both permissible labeling terms and state/local laws under the new federal
`regulatory scheme. Regulated entities have a Fifth Amendment Right to clear, plain
`standards that provide sufficient notice regarding what is permissible to avoid
`USDA enforcement actions. In this context, the final rule contradicts itself and the
`Act with regards to permissible terminology to be used on food labels. Further, the
`Act and final rule also fail to set clear standards for what is permissible state and
`local GE seed labeling. These unclear standards are void for vagueness in violation
`of the Fifth Amendment.
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`JURISDICTION AND VENUE
`10. This action arises under the U.S. Constitution and laws of the United
`States, including the Administrative Procedure Act (APA). Jurisdiction is conferred
`on this Court pursuant to 28 U.S.C. §§ 1331, 1343, & 1346.
`11. Plaintiffs have a right to bring this action pursuant to the APA, 5
`U.S.C. § 702.
`12. This Court has authority to grant declaratory and equitable relief
`herein requested pursuant to 5 U.S.C. § 706(2) (setting aside agency action that is
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with
`law) and 28 U.S.C. §§ 2201–2202, and Rules 57 and 65 of the Federal Rules of Civil
`Procedure.
`13. An actual controversy exists between the parties within the meaning of
`28 U.S.C. § 2201 (declaratory judgments).
`14. Venue is proper in the U.S. District Court for the Northern District of
`California pursuant to 28 U.S.C. § 1391(e).
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`THE PARTIES
`
`Plaintiffs
`15. Plaintiff Center for Food Safety (CFS) brings this action on behalf of
`itself and its members. CFS is a public interest, non-profit, membership
`organization that has offices in San Francisco, CA; Portland, OR; and Washington,
`D.C. CFS represents over 950,000 members, from every state in the country. The
`Disclosure Act and USDA’s final rule implementing it adversely affect CFS and its
`members.
`16. CFS’s mission is to empower people, support farmers, and protect the
`environment from the harms of industrial agriculture. A large part of that mission
`is championing transparency in the food system and preserving informed consumer
`choice. For that reason a major CFS program area has always been improving food
`labeling and protecting the consumers’ right to know what’s in their food and what
`they feed their families.
`17. For over two decades CFS has worked to ensure that GE organisms
`that could adversely affect public health, agriculture, and the environment are
`adequately labeled and properly regulated. CFS has a major program area specific
`to GE organism oversight, and numerous staff members—scientific, policy,
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`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`campaign, and legal—whose work encompasses the topic. CFS staff members are
`recognized experts in the field and are intimately familiar with the issue of GE
`foods, their inadequate oversight, their risks, and their adverse impacts.
`18. As part of both of these missions and programs, CFS has long been
`committed to securing mandatory GE food labeling across the country. To that end
`CFS has worked closely with dozens of state legislatures and leaders in U.S.
`Congress on GE food issues and GE food labeling legislation. For example, in 2011,
`CFS drafted and filed a rulemaking petition with the Food and Drug
`Administration (FDA), on behalf of over 650 companies and organizations, calling
`on FDA to require the mandatory labeling of all GE foods, which garnered over 1.4
`million individual public comments in support. In the void of federal leadership, in
`2012-2016, several states stepped in to protect the public’s right to know, and to
`that end, CFS also assisted in the successful passage of several state labeling laws,
`including the passage of state GE labeling laws in Vermont, Connecticut, and
`Maine.
`19. CFS takes a multi-faceted approach in pursuing its mission, utilizing
`legal, political, and grassroots strategies, including public and policymaker
`education, outreach, and campaigning. For instance, CFS disseminates a wide array
`of informational materials to government agencies, lawmakers, nonprofits, and the
`general public regarding the adverse effects of industrial food production—such as
`genetically engineered agricultural products and pesticides—on human health, the
`environment, and farmers and on the transparency of the food system. These
`educational and informational materials include, but are not limited to, news
`articles, videos, and other multimedia, policy reports, white papers, legal briefs,
`press releases, newsletters, product guides, action alerts, and fact sheets. One
`example is the book Your Right to Know: Genetic Engineering and the Secret
`Changes in Your Food (Earth Aware Press, 2007).
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`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`20. Plaintiff Rural Vermont is a 501(c)(3) nonprofit organization founded
`in 1985 and based in Montpelier, Vermont. Rural Vermont is a grassroots
`membership organization that has worked for 35 years to bring the voices of the
`people who are affected by public policy decisions into the process of creating public
`policy. Its mission is to lead the resurgence of community-scale agriculture, through
`education, advocacy, and organizing.
`21. From 2011 to 2016, Rural Vermont was a founder and leading member
`of the “Vermont Right to Know GMOs” Coalition. The Coalition led the grassroots
`effort that resulted in the successful passage of the first law in the United States
`that required the labeling of food produced through genetic engineering. That effort
`brought over 10,000 citizens into the legislative campaign as well as built a
`supporting coalition of scores of farms, food producers, restaurants, food co-ops,
`schools and other businesses and organizations who supported Vermonters’ right to
`know how their food is produced.
`22. Plaintiff Citizens for GMO Labeling is a nonprofit organization
`based in Connecticut with a mission of working across the country to pass state
`legislation to require the labeling of genetically engineered foods. In 2013
`Connecticut passed one of the first GMO labeling laws. However, it required other
`states to pass similar laws prior to taking effect. From 2013-2016, Citizens for GMO
`Labeling provided support to over thirty state-based campaigns to label genetically
`engineered foods and helped pass similar labeling laws in other states.
`23. While working to pass these laws, staff members were located in MA
`and RI and board members in CT, PA, MA, NJ, RI, and NY. The organization
`testified at state legislative hearings in NH, MA, and RI. In 2015 it hosted an
`advocate training for 80 GMO labeling advocates from states including, CT, MA,
`NJ, RI, PA, NH, VT, ME, NY, CA, ID, WA, AZ, FL, CO, HA, IA, MI, IL, NC, VA,
`DC, OR, NV, OH, DE, MD and GA. The organization’s entire budget went toward
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`passing these state level GMO laws and protecting the laws that CT, VT, and ME
`passed.
`24. The Disclosure Act preempted all current and future state labeling
`laws, and did so far beyond the scope and substance of what the law offered the
`public. In doing so it undid all the work the organization had undertaken prior to its
`passage and made it impossible to continue that work absent judicial review.
`25. Plaintiff Label GMOs is a California-based nonprofit organization
`that spearheaded California Prop 37 (2012), a state ballot initiative to require the
`mandatory labeling of genetically engineered food. Prop 37 was the first major
`state-wide effort at GMO labeling, and was narrowly defeated (51%-49%) after
`opponents of disclosure broke the state record for spending in their opposition to it
`($44 million). However Prop 37 galvanized a grassroots movement across the
`United States for the mandatory labeling of genetically engineered food, and
`inspired and sent off a chain of aligned future ballot initiatives in Washington
`(2013) and Oregon (2014) as well as state legislative efforts, including those that
`eventually passed into law in Vermont, Connecticut, and Maine. All of those
`disclosure laws and efforts were substantially identical. Label GMOs also worked to
`pass Senate Bill 1381 (2014) and other California legislative GMO labeling efforts
`prior to the preemption of those efforts by the 2016 Disclosure Act.
`26. Plaintiff Good Earth Natural Foods is an independent natural and
`organic grocer based in Marin, California since 1969. Good Earth is committed to
`advocating for a healthier and more sustainable food system. Historically Good
`Earth was one of the original pioneers and creators of the organic farming
`standards and labeling, at the state level and then at the federal level, and has
`since that time worked to ensure the organic standard retains its original integrity.
`Later Good Earth helped start the Non-GMO project and its Non-GMO verified
`label. In 2011, Good Earth launched its own in-store labeling of products, including
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`locally produced and non-GMO verified. In 2012, Good Earth supported Prop 37, the
`California Right to Know GMO labeling initiative. Good Earth is committed to full
`transparency for its customers, including ensuring that foods produced with genetic
`engineering are labeled as such.
` Plaintiff Puget Consumers Co-op, which operates stores under the
`27.
`tradename “PCC Community Markets,” is the nation’s largest community-owned
`food market based in Seattle, Washington. Founded in 1953 and with an active
`membership of just over 80,000 households, PCC operates 14 stores in the Puget
`Sound area and is a Certified Organic retailer.
`28. PCC aims to create a cooperative, sustainable environment in which
`sustainable and organic supply chains thrive. A critical part of that work includes
`increasing transparency for consumers on how their food is grown and raised and
`what is in their food. To that end, PCC has been a dedicated advocate of GMO
`labeling and supporter of GMO absence certification programs, such as Certified
`USDA Organic and Non-GMO Project Verified.
`29. As far back as in 2000, PCC members wrote over 12,000 letters to
`Congress in support of GMO transparency in foods. In 2012-2013, PCC led the effort
`for statewide GMO labeling as a steering committee member for I-522, the People’s
`Right to Know Genetically Engineered Food Act. Although the ballot initiative was
`narrowly defeated by record spending, it helped build the momentum for labeling
`transparency nationwide and the successful passage of other state labeling laws.
`In 2011, PCC pledged to label all GMO items in its stores by 2018. In 2016-2018,
`PCC undertook substantial planning and actions to complete this pledge, including
`after the passage of the 2016 Disclosure Act. However, the final USDA rules forced
`PCC to shelve its store labeling plans because of the speech restrictions created by
`the disclosure scheme, legal uncertainty from its lack of clarity, and potential
`consumer confusion.
`
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`30. Plaintiff Natural Grocers is a Colorado-based specialty retailer of
`natural, organic groceries, body care products and dietary supplements since 1955,
`currently operating 157 stores in 20 states. Natural Grocers is committed to
`educating communities on nutrition and providing only natural and organic
`products that meet high standards for ecological sustainability. As part of these
`efforts, all Natural Grocers brand products are organic or non-GMO if organic is not
`available, and Natural Grocers sells only certified organic produce. Across all stores,
`Natural Grocers carries over 9,000 Non-GMO Project Verified products and over
`10,000 organic grocery products.
`31. Natural Grocers has long been a supporter of GMO labeling at both the
`state and federal level. In 2014, Natural Grocers supported the Right to Know
`Colorado Proposition 105 to label GMO foods and hosted Proposition 105 petition
`gatherers in all of its 34 Colorado stores. Natural Grocers is committed to providing
`transparency for its customers and consistently posts information on GMOs on its
`website to assist its customers in avoiding GMO products.
`32. Plaintiff National Organic Coalition (NOC) is a national alliance of
`organizations representing farmers, seed producers and distributors, ranchers,
`environmentalists, consumers, retailers, and other companies involved in organic
`food production and the organic label. NOC seeks to advance organic food and
`agriculture and ensure a united voice for organic integrity, to maximize the multiple
`health, environmental, and economic benefits that only organic agriculture affords.
`Organic food production prohibits genetic engineering, and as part of its mission
`NOC advocates for transparent labeling of genetically engineered foods and seeds.
`33. On behalf of NOC’s members, including organic farmers, food
`producers, and retailers of all sizes, as well as consumers and environmental
`groups, NOC brings together diverse organic stakeholders to share information and
`create opportunities, offers government agencies and Congress innovative policy
`
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`solutions to challenging issues, and engages the wider organic community to
`advocate on its own behalf. NOC members testify at federal government hearings
`and agency meetings across the U.S. regarding organic issues and have participated
`in discussions regarding GE contamination of organic crops, prohibitions in organic
`for next-generation GMOs, and GMO labeling.
`34. NOC has long sought to keep GMOs out of organic production and has
`advocated for strong enforceable regulations for a uniform national GE labeling
`standard. In 2018, NOC submitted public comments on the proposed GE labeling
`rule, urging the USDA to create a meaningful disclosure standard for GE foods.
`NOC member organizations unanimously oppose the final rule and remain
`committed to establishing a meaningful, fully transparent, and easily accessible
`food labeling system.
`
`Defendants
`35. Defendant Sonny Perdue is sued in his official capacity as USDA
`Secretary. As Secretary, Mr. Perdue has the ultimate responsibility for USDA’s
`implementation of the Disclosure Act.
`36. Defendant Bruce Summers is sued in his official capacity as
`Administrator of the Agricultural Marketing Service (AMS), an agency of the
`United States Department of Agriculture. The AMS administers programs at USDA
`related to the marketing of food and agricultural products. As Administrator, Mr.
`Summers has ultimate responsibility for AMS’s implementation of the Disclosure
`Act.
`
`37. Defendant United States Department of Agriculture is a federal
`agency of the U.S., which is charged with acquiring and providing to the people of
`the United States useful information on subjects connected with, among other
`things, agriculture and food labeling. As relevant here, USDA, including AMS, is
`
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`CASE NO. 20-5151-JD
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`the Agency that Congress made responsible for the implementation of the
`Disclosure Act, including its implementing regulations.
`
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`LEGAL AUTHORITY
`UNITED STATES CONSTITUTION
`38. The First Amendment states that “Congress shall make no law . . .
`abridging the freedom of speech. . . .” U.S. Const., Amend. I.
`39. The Tenth Amendment of the Constitution provides that “The powers
`not delegated to the United States by the Constitution, nor prohibited by it to the
`States, are reserved to the States respectively, or to the people.” U.S. Const.,
`Amend. X.
`40. The Fifth Amendment of the Constitution states that “. . . no person
`shall . . . be deprived of life, liberty, or property, without due process of law.” U.S.
`Const., Amend. V.
`
`ADMINISTRATIVE PROCEDURE ACT
`41. The Administrative Procedure Act (APA) provides that “[a] person
`suffering legal wrong because of agency action, or adversely affected or aggrieved by
`agency action within the meaning of a relevant statute, is entitled to judicial review
`thereof.” 5 U.S.C. § 702.
`42. The definition of agency action within this statute “includes the whole
`or a part of an agency rule, order, license, sanction, relief, or the equivalent or
`denial thereof, or failure to act.” Id. § 551(13).
`43. The APA instructs that reviewing courts “shall . . . hold unlawful and
`set aside agency action, findings, and conclusions found to be . . . arbitrary,
`capricious, an abuse of discretion, or otherwise not in accordance with law . . . [or]
`contrary to constitutional right, power, privilege, or immunity.” Id. § 706(2)(A).
`
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`CASE NO. 20-5151-JD
`FIRST AMENDED COMPLAINT FOR DECLARATORY & EQUITABLE RELIEF
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`44. Under the APA’s standard of review, the Court evaluates whether the
`agency “examine[d] the relevant data and articulate[d] a satisfactory explanation
`for its action including a rational connection between the facts found and the choice
`made.” Motor Vehicle Mfrs. Ass’n of U.S. v. State Farm Mut. Auto. Ins. Co., 463 U.S.
`29, 43 (1983). An action is arbitrary and capricious if the agency “has relied on
`factors which Congress has not intended it to consider, entirely failed to consider an
`important aspect of the problem, offered an explanation for its decision that runs
`counter to the evidence before the agency, or is so implausible that it could not be
`ascribed to a difference in view or the product of agency expertise.” Id. at 43.
`
`THE BIOENGINEERED FOOD DISCLOSURE ACT
`45. The purpose of the Disclosure Act is to “establish a national mandatory
`bioengineered food disclosure standard with respect to any bioengineered food and
`any food that may be bioengineered” within two years following its enactment. 7
`U.S.C. § 1639b(a).
`46. Bioengineering and any similar term is defined to be food “(A) that
`contains genetic material that has been modified through in vitro recombinant
`deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could
`not otherwise be obtained through conventional breeding or found in nature.” 7
`U.S.C. § 1639(1).
`47. While the Act generally uses the term, “bioeng

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