Monday, January 23, 2023

bioengineering disclosures mostly survive APA, First Amendment attack

Natural Grocers v. Vilsack, --- F.Supp.3d ----, 2022 WL 4227248, No. 20-cv-05151-JD (N.D. Cal. Sept. 13, 2022)

An appeal has been filed in this case upholding USDA regulations promulgated to deal with bioengineering disclosures. Congress declared that the purpose of the disclosure statute was “to preempt state and local actions that mandate labeling of whether a food or seed is genetically engineered, and establish a mandatory uniform national disclosure standard for human food that is or may be bioengineered.”

Plaintiffs, retail stores that sell natural and organic food products, and organizations engaged in food safety advocacy, challenged the disclosure statute and implementing regulations promulgated by the USDA. They objected under the APA to regulations that: (1) permit a text message disclosure option as an alternative to an electronic or digital link disclosure; (2) require disclosures to use the word “bioengineered”; and (3) exclude highly refined foods that do not contain detectable amounts of modified genetic material. They also alleged that the word-use regulations restricted their speech in violation of the First and Fifth Amendments to, and preemption of state labeling laws for genetically engineered (GE) seeds violates the Tenth Amendment. I’ll focus on the First Amendment, but the court did grant summary judgment to plaintiffs under the APA for the text message disclosure regulation.

Congress required that a bioengineering disclosure on labels for consumers take the form of “a text, symbol, or electronic or digital link,” with the “disclosure option to be selected by the food manufacturer.” It required that the electronic or digital link be accompanied by “on-package language” indicating that the link provides access to food information, along with “a telephone number that provides access to the bioengineering disclosure.” If a statutorily required study determined “that consumers, while shopping, would not have sufficient access to the bioengineering disclosure through electronic or digital disclosure methods,” the USDA was to “provide additional and comparable options to access the bioengineering disclosure.” The resulting Deloitte study found that “key technological challenges,” including a lack of technical knowledge and a lack of infrastructure, “prevented nearly all participants from obtaining the information through electronic or digital disclosure methods.” It also found that the telephone numbers accompanying the electronic disclosure “do not provide a viable means of accessing the bioengineering disclosure.” The study recommended “on-package identification,” such as “a landline-enabled bioengineering disclosure” with “24-hour disclosure information via an automated recording,” and “a text message alternative for consumers who have access to a mobile phone.” The regulations thus created a fourth disclosure option of text messaging separate from the electronic disclosure method.

Note that Congress contemplated that some options for disclosure wouldn’t necessarily need to involve putting “bioengineered” on the package, if they had an electronic or digital disclosure link offering “more food information”; the text message disclosure would say “Text [command word] to [number] for bioengineered food information.” But the regs required “bioengineered” in all disclosures because the “statutory term, ‘bioengineering,’ adequately describes food products of the technology that Congress intended to be within the scope of the [regulations].” The agency rejected GE or GMO as alternatives, which might “create inconsistencies with the preemption provisions or muddy the scope of disclosure,” and limiting mandatory disclosure language to bioengineered would provide “disclosure consistency” and minimize “marketplace confusion.” However, “regulated entities are perfectly free to make additional statements about bioengineered foods so long as they are consistent with federal laws generally.”

The regs defined bioengineering to exclude highly refined foods which had undetectable modified genetic material even if they were produced from bioengineered crops. They adopted a “List of Bioengineered Foods,” which are crops and food ingredients presumed to be bioengineered. “A highly refined food produced with a listed item as an ingredient is presumed to require disclosure, and would be exempted only if the regulated entity proved that the product is not bioengineered.” This is likely overinclusive, and the regs state that many highly refined foods may not require a bioengineering disclosure even with the use of a listed ingredient because “the refining process removes the genetic material so that it can no longer be detected. If the genetic material is not detected, then it is not possible to conclude that the food product or ingredient contains modified genetic material.”

The plaintiffs didn’t challenge the mandatory disclaimer language, but only argued that they were forbidden from using additional terms like GE or GMO. The court disagreed with them that the regs did any such thing. The “whole purpose of the disclosure statute” was “the use of standardized language to ensure that consumers get the same baseline information about bioengineered food irrespective of where they buy it, or from whom. After that, plaintiffs are perfectly free to speak their minds in any manner they choose.” The regs were quite clear: “[N]othing in the final rule prohibits regulated entities from providing additional statements or other claims regarding bioengineered foods and bioengineered food ingredients, so long as such statements are consistent with all other applicable laws and regulations.” Indeed, plaintiffs lacked a well-founded fear of enforcement for using GE, GMO, or any other words above and beyond the mandatory disclosure terminology and didn’t have standing to challenge the statute or regulations on First or Fifth Amendment grounds.

So too with plaintiffs’ objection to a provision that prohibits labeling meat or dairy products as bioengineered solely because the products were derived from livestock fed GE feed; they didn’t demonstrate concrete plans to use a “bioengineered” label on any meat or dairy products. Nor did they have concrete plans to use “may be bioengineered,” another phrase rejected by the regs as confusing.

On the APA challenge, the court concluded that the “decision to provide a separate text message disclosure option did nothing to fix the problem of inaccessible electronic disclosures.” The additional disclosure option didn’t change that a regulated entity could simply choose the standalone electronic disclosure option, even though the study showed it wouldn’t be accessible to many consumers.

APA challenges to the mandated use of “bioengineered” failed, however.

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