Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 1 of 25
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF CALIFORNIA
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`NATURAL GROCERS, et al.,
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`Plaintiffs,
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`v.
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`THOMAS VILSACK, et al.,
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`Defendants.
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`Case No. 20-cv-05151-JD
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`ORDER RE SUMMARY JUDGMENT
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`In 2016, Congress amended the Agricultural Marketing Act of 1946 to enact the first
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`national mandatory bioengineered food disclosure standards. See 7 U.S.C. § 1639 (the disclosure
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`statute). The purpose of the disclosure statute is to establish uniformity in the way that
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`bioengineered food is labeled and described to consumers. Plaintiffs are retail stores that sell
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`natural and organic food products, and organizations engaged in food safety advocacy.
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`Defendants are the United States Department of Agriculture (USDA), the USDA Secretary, and
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`the Administrator of the Agricultural Marketing Service (AMS), which is a USDA agency
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`responsible for the marketing of agricultural commodities, among other programs.
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`Plaintiffs filed a 115-page amended complaint that alleges a number of challenges to the
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`disclosure statute and implementing regulations promulgated by the USDA. Dkt. No. 19. In
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`pertinent part, plaintiffs challenge under the Administrative Procedure Act, 5 U.S.C. § 706 (APA),
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`regulations that: (1) permit a text message disclosure option as an alternative to an electronic or
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`digital link disclosure; (2) require disclosures to use the word “bioengineered”; and (3) exclude
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`highly refined foods that do not contain detectable amounts of modified genetic material.
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`Plaintiffs also say that the word-use regulations restrict their speech in violation of the First and
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`Fifth Amendments to the United States Constitution, and that a provision in the disclosure statute
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`Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 2 of 25
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`preempting state labeling laws for genetically engineered (GE) seeds violates the Tenth
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`Amendment.
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`Plaintiffs filed a motion for summary judgment, Dkt. No. 54, which the government
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`opposed, Dkt. No. 56. The Court granted applications to intervene by the United States Beet
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`Sugar Association, the American Sugarbeet Growers Association, and the American Farm Bureau
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`Federation, see Dkt. Nos. 29, 46, and intervenors filed a consolidated opposition to plaintiffs’
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`summary judgment motion. Dkt. No. 57.
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`Summary judgment is granted in favor of plaintiffs under the APA for the text message
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`disclosure regulation. In all other respects, plaintiffs’ motion is denied.
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`I.
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`THE DISCLOSURE STATUTE
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`BACKGROUND
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`The salient facts are undisputed. In 2016, in response to the adoption of state laws
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`regulating the labeling of GE and genetically modified (GM or GMO) food and seeds, Congress
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`amended the Agricultural Marketing Act of 1946 to establish the first-ever national standard of
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`consumer disclosures for bioengineered foods. AR248811.1 Congress declared that the purpose
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`of the disclosure statute was “to preempt state and local actions that mandate labeling of whether a
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`food or seed is genetically engineered, and establish a mandatory uniform national disclosure
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`standard for human food that is or may be bioengineered.” Id.
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`As used in the disclosure statute, “bioengineering” with respect to a food means a food
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`“(A) that contains genetic material that has been modified through in vitro recombinant
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`deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not otherwise
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`be obtained through conventional breeding or found in nature.” 7 U.S.C. § 1639(1). “Food” takes
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`the definition in 21 U.S.C. § 321(f) of “(1) articles used for food or drink for man or other animals,
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`(2) chewing gum, and (3) articles used for components of any such article.” See 7 U.S.C.
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`§ 1639(2). A “food derived from an animal” may not “be considered a bioengineered food solely
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`because the animal consumed feed” containing bioengineered substances. Id. § 1639b(b)(2)(A).
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`1 All citations to the administrative record (AR) are in Dkt. No. 59.
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`Congress did not specify a threshold of “the amounts of a bioengineered substance” in a food to
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`trigger a bioengineering classification. Id. § 1639b(b)(2)(B).
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`Congress directed the USDA to implement regulations “with respect to any bioengineered
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`food and any food that may be bioengineered,” and to “establish such requirements and
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`procedures as the [USDA] determines necessary to carry out the standard.” Id. § 1639b(a). The
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`statute mandates that “[a] food may bear a disclosure that the food is bioengineered only in
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`accordance with regulations promulgated by the [USDA] in accordance with this subchapter.” Id.
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`§ 1639b(b)(1).
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`Congress issued a number of specific directives to the USDA for the regulations. Among
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`others, Congress required that a bioengineering disclosure on labels for consumers take the form
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`of “a text, symbol, or electronic or digital link,” with the “disclosure option to be selected by the
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`food manufacturer.” Id. § 1639b(b)(2)(D). It required that the electronic or digital link be
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`accompanied by “on-package language” indicating that the link provides access to food
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`information, along with “a telephone number that provides access to the bioengineering
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`disclosure.” Id. § 1639b(d)(1), (4).
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`The disclosure statute also directed the USDA to “conduct a study to identify potential
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`technological challenges that may impact whether consumers would have access to the
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`bioengineering disclosure through electronic or digital disclosure methods.” Id. § 1639b(c)(1). If
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`the study determined “that consumers, while shopping, would not have sufficient access to the
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`bioengineering disclosure through electronic or digital disclosure methods,” the USDA was to
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`“provide additional and comparable options to access the bioengineering disclosure.” Id.
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`§ 1639b(c)(4).
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`In addition to the consumer disclosure elements, the statute contains a section that
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`preempts state labeling laws for GE food and seeds. This section declares that “[n]o State or a
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`political subdivision of a State may directly or indirectly establish under any authority or continue
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`in effect as to any food or seed in interstate commerce any requirement relating to the labeling of
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`whether a food (including food served in a restaurant or similar establishment) or seed is
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`genetically engineered (which shall include such other similar terms as determined by the
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`[USDA]) or was developed or produced using genetic engineering, including any requirement for
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`claims that a food or seed is or contains an ingredient that was developed or produced using
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`genetic engineering.” Id. § 1639i(b). Plaintiffs acknowledged in a reply brief that the preemption
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`provision properly regulates private actors with respect to food labeling, but they challenge
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`preemption with respect to seed labeling. Dkt. No. 58 at 18-19.
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`II.
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`THE DISCLOSURE REGULATIONS
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`The USDA delegated to AMS the task of formulating regulations responsive to Congress’s
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`directives. 83 Fed. Reg. at 65814. To that end, AMS posted 30 questions for public comment on
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`its website in June 2017, and received over 112,000 responses. AR282-90; 83 Fed. Reg. at 19860.
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`In May 2018, AMS published a notice of proposed rulemaking, and received approximately
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`14,000 comments. 83 Fed. Reg. at 19860, 65814. AMS published the final regulations in
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`December 2018, with a mandatory compliance date of January 1, 2022. Id. at 65814; 7 C.F.R.
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`§ 66.1.
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`The regulations apply to a “regulated entity,” which is defined as “the food manufacturer,
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`importer, or retailer that is responsible for making bioengineered food disclosures under
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`§ 66.100(a).” 7 C.F.R. § 66.1. A manufacturer or importer is responsible for disclosures for foods
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`that are “packaged prior to receipt by a retailer.” Id. § 66.100(a)(1). A retailer is responsible for
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`foods the retailer packages itself, or sells in bulk. Id. § 66.100(a)(2). The retailer plaintiffs,
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`Natural Grocers, Good Earth Natural Foods, and Puget Consumers Co-op, are regulated entities to
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`the extent they package or sell food in bulk in their stores. See id.
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`A.
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`The Electronic Disclosure Study
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`AMS hired Deloitte Consulting to conduct the study on the accessibility of the electronic
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`disclosure mandated by Section 1639b(c)(1) of the statute. See AR250043-118. The study found
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`that “key technological challenges,” including a lack of technical knowledge and a lack of
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`infrastructure, “prevented nearly all participants from obtaining the information through electronic
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`or digital disclosure methods.” AR250046. It also found that the telephone numbers
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`accompanying the electronic disclosure “do not provide a viable means of accessing the
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`bioengineering disclosure.” AR250091. The study recommended “on-package identification,”
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`Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 5 of 25
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`such as “a landline-enabled bioengineering disclosure” with “24-hour disclosure information via
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`an automated recording,” and “a text message alternative for consumers who have access to a
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`mobile phone.” AR250111.
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`Based on the study, AMS concluded that “consumers would not have sufficient access to
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`the bioengineering disclosure through electronic or digital means under ordinary shopping
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`conditions at this time.” 83 Fed. Reg. at 65828. To improve consumer access to the
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`bioengineering information, and to satisfy Congress’s directive to “provide additional and
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`comparable options to access the bioengineering disclosure,” 7 U.S.C. § 1639b(c)(4), AMS
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`created a fourth disclosure option of text messaging separate from the electronic disclosure
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`method. 83 Fed. Reg. at 65828-29; 7 C.F.R. §§ 66.100(b)(4), 66.108.
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`The final regulations provide that regulated entities can comply with the disclosure
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`requirement by adding one of the following to a food label: (i) the statement “Bioengineered
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`food” or “Contains a bioengineered food ingredient” (the text disclosure); (ii) a symbol that says
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`“bioengineered” (the symbol disclosure); (iii) an electronic or digital disclosure link and
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`accompanying text (the electronic disclosure); or (iv) text message instructions (the text message
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`disclosure). Id. §§ 66.100(b)(1)-(4), 66.102, 66.104, 66.106, 66.108. 2
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`For the electronic disclosure, a food label must have an electronic or digital link printed on
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`the label, and the link must be accompanied by the statement “Scan here for more food
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`information” and “Call [1-000-000-0000] for more food information.” Id. § 66.106. The link
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`must connect directly to a product information page that includes the text disclosure or the symbol
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`disclosure, and the page must exclude marketing and promotional information. Id. § 66.106(b).
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`For the text message disclosure, a food label must say “Text [command word] to [number]
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`for bioengineered food information.” Id. § 66.108(a). The number must send “an immediate
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`response to the consumer’s mobile device” with the text disclosure or the symbol disclosure, and
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`the response must not contain any marketing or promotional information. Id. § 66.108(a)-(c).
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`2 The regulations also provide alternative disclosure options for small food manufacturers and for
`small packages pursuant to 7 U.S.C. §§ 1639b(2)(E), (F). 7 C.F.R. §§ 66.110, 66.112.
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`Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 6 of 25
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`B. Mandatory Disclosure Terminology
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`In the notice of proposed rulemaking, AMS proposed the use of the term “bioengineered”
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`in all disclosures because the “statutory term, ‘bioengineering,’ adequately describes food
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`products of the technology that Congress intended to be within the scope of the [regulations].” 83
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`Fed. Reg. at 19871. The statute itself did not require the use of any particular words.
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`A number of commenters objected to this proposal, and said the disclosure language
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`should include GE or GMO because those terms are better understood by consumers. See id. at
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`65851-52. Some commenters suggested that disclosures should include “may be bioengineered,”
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`but others said that would be confusing. Id. at 65827, 65852.
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`After reviewing the comments, AMS decided to require “bioengineered” in all disclosures.
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`Id. at 65827, 65852-53; 7 C.F.R. §§ 66.100-66.108. The agency declined to use “may be
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`bioengineered” as vague and likely to be confusing. 83 Fed. Reg. at 65827, 65852. AMS was a
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`bit more ambivalent about GE or GMO, but “ultimately determined that bioengineering and
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`bioengineered food accurately reflected the scope of disclosure and the products and potential
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`technology at issue.” Id. at 65837. In the view of AMS, GE or GMO might “create
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`inconsistencies with the preemption provisions or muddy the scope of disclosure,” and limiting
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`mandatory disclosure language to bioengineered would provide “disclosure consistency” and
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`minimize “marketplace confusion.” Id. at 65837, 65851.
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`AMS took some pains to emphasize that the mandatory disclosure language is intended to
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`be a floor, not a ceiling. As minimum requirements, the text disclosure must say “Bioengineered
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`food” or “Contains a bioengineered food ingredient,” and the symbol disclosure must use the word
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`“BIOENGINEERED.” 7 C.F.R. §§ 66.102(a), 66.104(a). Even so, as detailed in the ensuing First
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`and Fifth Amendment discussion, regulated entities are perfectly free to make additional
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`statements about bioengineered foods so long as they are consistent with federal laws generally.
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`83 Fed. Reg. at 65852; 7 C.F.R. § 66.118; see also Dkt. No. 56 at 28 (government brief
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`acknowledging same).
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`C.
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`Regulatory Definition of “Bioengineering” and Highly Refined Foods
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`In the notice of proposed rulemaking, AMS called for comments on what bioengineered
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`should mean in light of the statutory definition of “bioengineering.” 83 Fed. Reg. at 19862-63; see
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`also 7 U.S.C. § 1639(1). AMS presented two “positions” as options. Position 1 defined
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`“bioengineering” to exclude highly refined food products that might have used genetically
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`modified ingredients, but do not have detectable levels of modified genetic material in the final
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`product sold to consumers. 83 Fed. Reg. at 19862-63. Such ingredients include sugar derived
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`from genetically modified sugar cane and sugar beets, corn starch and corn syrup derived from
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`genetically modified corn, and soybean oil derived from genetically modified soybeans. Id.
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`Position 2 defined bioengineering to include all foods produced using bioengineering technology
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`or genetically modified ingredients, including highly refined products that do not have detectable
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`modified genetic material. Id. at 19863.
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`The position proposals elicited divided comments. Id. at 65833-37. Supporters of Position
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`2 argued that consumers are more concerned about the use of bioengineered crops than whether
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`the products derived from those crops contain detectable modified genetic material. Id. at 65834-
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`35. Proponents of Position 1 stated that scientific studies have demonstrated an absence of
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`modified genetic material in highly refined foods as the result of processing, and expressed
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`concern that mandating disclosure for all refined products would disparage biotechnology and
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`impose undue compliance costs on regulated entities. Id. at 65833, 65836. Critics of Position 1
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`took issue with the detectability point and noted that testing methods would likely improve over
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`time to reveal the presence of previously undetectable modified genetic material. Id. at 65834.
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`The concern is that a detection standard would allow refined foods containing modified genetic
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`material to be sold unwittingly to consumers today.
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`In the final regulations, AMS adopted a modified version of Position 1. It defined
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`bioengineering to exclude foods with undetectable modified genetic material. Id. at 65816-17;
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`7 C.F.R. § 66.1. AMS also created something of a safety net by adopting a “List of Bioengineered
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`Foods,” which are crops and food ingredients presumed to be bioengineered. 7 C.F.R. § 66.6; 83
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`Fed. Reg. at 65826. The current list comprises “[a]lfalfa, apple (ArcticTM varieties), canola, corn,
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`cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple
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`(pink flesh varieties), potato, salmon (AquAdvantage®), soybean, squash (summer), and
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`sugarbeet.” 7 C.F.R. § 66.6. AMS committed to updating the list as warranted on an annual basis.
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`Id. § 66.7. A highly refined food produced with a listed item as an ingredient is presumed to
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`require disclosure, and would be exempted only if the regulated entity proved that the product is
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`not bioengineered. 83 Fed. Reg. at 65818-19, 65826; 7 C.F.R. §§ 66.5, 66.6, 66.9; see also Dkt.
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`No. 56 at 5 (“A crop or food included on the List or a food made from or with an item on the List
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`requires disclosure unless a regulated entity has records demonstrating that its food product is not
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`bioengineered (e.g. is organic or does not contain detectable modified genetic material).”). In
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`sum, AMS determined that highly refined foods would not be subject to the disclosure statute and
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`regulations unless: (1) they had detectable amounts of modified genetic material; or (2) they
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`included ingredients from the presumed bioengineered list and the regulated entity did not prove
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`that the food was not bioengineered.
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`AMS concluded that this approach would likely be overinclusive. 83 Fed. Reg. at 65826
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`(“While we acknowledge that this framework may result in regulated entities placing a BE
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`disclosure on a food that they do not know with certainty is bioengineered, we believe that it is
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`appropriate to err on the side of disclosure to provide consumers with the fullest information about
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`food that could be bioengineered.”). AMS also concluded that many highly refined foods may not
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`require a bioengineering disclosure even with the use of a listed ingredient because “the refining
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`process removes the genetic material so that it can no longer be detected. If the genetic material is
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`not detected, then it is not possible to conclude that the food product or ingredient contains
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`modified genetic material.” Id. at 65834.
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`III.
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`PLAINTIFFS’ LAWSUIT
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`Plaintiffs filed this lawsuit approximately 18 months after AMS published the final
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`regulations. Dkt. No. 1. The amended complaint alleges that the regulations concerning the text
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`message disclosure, mandatory disclosure terminology, and the definition of bioengineering, are
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`not in accordance with law and are arbitrary and capricious under the Administrative Procedure
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`Act. Dkt. No. 19 ¶¶ 133-42, 205-10, 271-79. Plaintiffs also say that the disclosure statute and the
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`Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 9 of 25
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`regulations violate the First and Fifth Amendments to the Constitution by limiting their freedom to
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`use words other than “bioengineered” in communications with consumers. Id. ¶¶ 317-33, 392-
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`401. To be clear, plaintiffs do not bring a constitutional challenge to the mandatory use of specific
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`words in the standardized disclosures. They object only that the regulations, in their view, do not
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`let them say more. Plaintiffs also contend that the preemption of state labeling laws for GE seeds
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`violates the Tenth Amendment. Id. ¶¶ 361-67.
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`DISCUSSION
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`IV.
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`LEGAL STANDARDS
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`The standard of review for claims brought under the APA is well established. See, e.g.,
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`Ecological Rts. Found. v. FEMA, 384 F. Supp. 3d 1111, 1118-19 (N.D. Cal. 2019). An agency
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`action will be upheld unless it is found to be “arbitrary, capricious, an abuse of discretion, or
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`otherwise not in accordance with law.” 5 U.S C. § 706(2)(A); Defenders of Wildlife v. Zinke, 856
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`F.3d 1248, 1256-57 (9th Cir. 2017). An agency decision is arbitrary and capricious “if the agency
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`relied on factors Congress did not intend it to consider, entirely failed to consider an important
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`aspect of the problem, or offered an explanation that runs counter to the evidence before the
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`agency or is so implausible that it could not be ascribed to a difference in view or the product of
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`agency expertise.” Defenders of Wildlife, 856 F.3d at 1257 (internal quotations omitted). “An
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`agency decision construing a statute is not in violation of the APA where the agency accurately
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`applies an unambiguous statute, or permissibly construes an ambiguous statute, and its conclusion
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`is ‘well supported by substantial evidence in the record.’” Corrigan v. Haaland, 12 F.4th 901, 906
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`(9th Cir. 2021) (internal quotations omitted). “The Court’s deference extends to less than stellar
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`work by an agency, so long as its analytical path and reasoning can be reasonably discerned.”
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`Ecological Rts. Found., 384 F. Supp. 3d at 1119 (citing San Luis & Delta-Mendota Water Auth. v.
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`Jewell, 747 F.3d 581, 627 (9th Cir. 2014)). Neither party here has suggested that the regulations
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`present an issue under the major questions doctrine, and the Court has independently concluded
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`that they do not. See West Virginia v. EPA, 142 S. Ct. 2587, 2609-10 (2022).
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`The Court will not substitute its own judgment for that of the agency, but will “engage in a
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`careful, searching review to ensure that the agency has made a rational analysis and decision on
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`Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 10 of 25
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`the record before it.” Wild Fish Conservancy v. Salazar, 628 F.3d 513, 521 (9th Cir. 2010)
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`(internal quotations omitted). The Court will not “rubber-stamp” agency decisions that are
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`“inconsistent with a statutory mandate or that frustrate the congressional policy underlying a
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`statute.” Nat. Res. Def. Council, Inc. v. Pritzker, 828 F.3d 1125, 1139 (9th Cir. 2016) (internal
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`quotations omitted).
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`Summary judgment is an appropriate procedure for deciding challenges under the APA.
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`See, e.g., Ecological Rts. Found., 384 F. Supp. 3d at 1119. Summary judgment may be granted
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`when there is no genuine issue of material fact and the moving party is entitled to judgment as a
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`matter of law. Brickman v. Fitbit, Inc., No. 3:15-cv-02077-JD, 2017 WL 6209307, at *2 (N.D.
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`Cal. Dec. 8, 2017) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986)). Because this is
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`a record review case, the summary judgment motion will be decided upon a review of the
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`administrative record as it existed at the time of the agency’s decision. Karuk Tribe of Cal. v. U.S.
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`Forest Serv., 681 F.3d 1006, 1017 (9th Cir. 2012) (en banc); Jewell, 747 F.3d at 602 (quoting
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`Camp v. Pitts, 411 U.S. 138, 142 (1973)). In so doing, the Court relies on the portions of the
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`record that the parties have cited and argued. It is not the Court’s task to “scour the record in
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`search of a genuine issue of triable fact.” Keenan v. Allan, 91 F.3d 1275, 1279 (9th Cir. 1996)
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`(internal quotations omitted). Extra-record materials and “post-hoc rationalizations” for or against
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`the agency’s decision will not be considered for the merits of the APA claims. Jewell, 747 F.3d at
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`602-03. Plaintiffs’ declarations, Dkt. Nos. 54-1 to 54-16, are not part of the administrative record
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`and were considered only for purposes of determining plaintiffs’ standing to sue. Ecological Rts.
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`Found., 384 F. Supp. 3d at 1119.
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`V.
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`STANDING
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`As is true in all federal cases, the “case or controversy” requirement of Article III of the
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`Constitution “limits federal courts’ subject matter jurisdiction by requiring, inter alia, that
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`plaintiffs have standing.” Chandler v. State Farm Mut. Auto. Ins., 598 F.3d 1115, 1121 (9th Cir.
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`2010). “[A] plaintiff must demonstrate standing to sue by alleging the ‘irreducible constitutional
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`minimum’ of (1) an ‘injury in fact’ (2) that is ‘fairly traceable to the challenged conduct of the
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`defendants’ and (3) ‘likely to be redressed by a favorable judicial decision.’” Patel v. Facebook
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`Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 11 of 25
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`Inc., 290 F. Supp. 3d 948, 952 (N.D. Cal. 2018) (quoting Spokeo, Inc. v. Robins, 578 U.S. 330,
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`338 (2016)). An injury in fact is demonstrated when the plaintiff has “suffered ‘an invasion of a
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`legally protected interest’ that is ‘concrete and particularized’ and ‘actual or imminent, not
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`conjectural or hypothetical.’” Spokeo, 578 U.S. at 339 (quoting Lujan v. Defenders of Wildlife,
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`504 U.S. 555, 560 (1992)). “Standing is an ongoing inquiry, and ‘[t]he need to satisfy these three
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`[Article III standing] requirements persists throughout the life of the lawsuit.’” Trump v. Twitter,
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`Inc., ___ F. Supp. 3d ___, 2022 WL 1443233, at *7 (N.D. Cal. May 6, 2022) (quoting Lujan, 504
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`U.S. at 560-61). “A plaintiff must establish standing with the ‘manner and degree of evidence
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`required at the successive stages of the litigation.’” Carrico v. City & Cnty. of San Francisco, 656
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`F.3d 1002, 1006 (9th Cir. 2011) (quoting Lujan, 504 U.S. at 561).
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`The government challenges plaintiffs’ standing to sue only with respect to the First and
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`Fifth Amendment claims. See Dkt. No. 56 at 30, 36-37. Even so, “[t]he Court has an independent
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`duty to be vigilant about standing,” Trump, 2022 WL 1443233, at *7, and will determine standing
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`“claim by claim” for the amended complaint. In re Capacitors Antitrust Litig., 154 F. Supp. 3d
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`918, 924 (N.D. Cal. 2015) (citing DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 352 (2006)).
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`A.
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`APA Standing
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`Plaintiffs have demonstrated standing to sue under the APA, and the government does not
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`contend otherwise. The retail store plaintiffs, namely Natural Grocers, Good Earth Natural Foods,
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`and Puget Consumers Co-op, filed multiple declarations attesting to their stake in disclosing
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`information about bioengineered foods to interested consumers, and how the regulations are said
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`to adversely affect the stores. See Dkt. Nos. 54-1, 54-7, 54-9. Several members of the advocacy
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`group plaintiffs, Center for Food Safety, Rural Vermont, Citizens for GMO Labeling, Label
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`GMOs, and National Organic Coalition, filed declarations describing their organizational interests
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`in transparent labeling of bioengineered foods, their individual interests in obtaining information
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`about bioengineered foods, and how the regulations are said to impede those interests by
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`restricting the scope of disclosures. See Dkt. Nos. 54-2, 54-3, 54-4, 54-5, 54-6, 54-11, 54-12, 54-
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`13, 54-14, 54-15, 54-16.
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`These alleged injuries are concrete, fairly traceable to the agency’s conduct, and
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`redressable by the Court, and so they establish constitutional standing for the APA claims.
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`Plaintiffs also have statutory standing under the APA because they fall squarely “within the zone
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`of interests” protected by the disclosure statute. Cetacean Cmty. v. Bush, 386 F.3d 1169, 1177
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`(9th Cir. 2004) (internal quotations omitted).
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`B.
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`First and Fifth Amendment Standing
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`For the constitutional speech claims, plaintiffs who are regulated entities contend that the
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`mandatory terminology regulations muzzle their right to speak freely about bioengineered foods.
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`See Dkt. No. 54 at 24-25; Dkt. No. 58 at 16-17. Several of the plaintiffs, namely the food
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`advocacy groups, are not regulated entities, and suggest that a right to receive information is
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`impaired by the chilling effect on regulated entities. See Dkt. No. 54 at 23 n.40 (“Customers of
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`Plaintiff retailers have standing because when there is a right to disseminate commercial
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`information, their customers have a reciprocal ‘listeners’’ right to receive the information.”). The
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`standing analysis for the regulated entities establishes that they have no reasonable fear of
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`enforcement or restraint, which also vitiates the listener theory.
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`“First Amendment challenges present unique standing considerations.” Italian Colors
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`Restaurant v. Becerra, 878 F.3d 1165, 1171 (9th Cir. 2018) (internal quotations omitted). When,
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`as is alleged here, “a plaintiff has refrained from engaging in expressive activity for fear of
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`prosecution under the challenged statute, such self-censorship is a constitutionally sufficient injury
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`as long as it is based on an actual and well-founded fear that the statute will be enforced.” Barke
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`v. Banks, 25 F.4th 714, 718 (9th Cir. 2022) (internal quotations omitted).
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`Three factors determine whether a plaintiff faces a “credible threat of enforcement.” Id. at
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`718-19. They are: “1) the likelihood that the law will be enforced against the plaintiff; 2) whether
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`the plaintiff has shown, with some degree of concrete detail, that she intends to violate the
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`challenged law; and 3) whether the law even applies to the plaintiff.” Id. at 719 (internal
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`quotations omitted). “[C]laims of future harm lack credibility when the challenged speech
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`restriction by its terms is not applicable to the plaintiffs, or the enforcing authority has disavowed
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`the applicability of the challenged law to the plaintiffs.” Lopez v. Candaele, 630 F.3d 775, 788
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`Case 3:20-cv-05151-JD Document 64 Filed 09/13/22 Page 13 of 25
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`(9th Cir. 2010). The “inquiry into injury-in-fact does not turn on the strength of plaintiffs’
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`concerns about a law, but rather on the credibility of the threat that the challenged law will be
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`enforced against them.” Id. at 792. The same standing rules apply to pre-enforcement plaintiffs
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`who allege vagueness challenges under the Fifth Amendment. Carrico, 656 F.3d at 1006.
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`Plaintiffs’ main speech challenge goes to the use of terms such a