Tuesday, August 10, 2021

CA's Prop 65 warning unconstitutional for acrylamide warnings for being scientifically overcertain

California Chamber of Commerce v. Becerra, 2021 WL 1193829, No. 2:19-cv-02019-KJM-EFB (E.D. Cal. Mar. 30, 2021)

California allegedly compelled businesses to display misleading warnings about the dangers of acrylamide, a carcinogen. The Council for Education and Research on Toxics (CERT) intervened because it often files lawsuits against businesses that do not display warnings about acrylamide.

The court granted an injunction against the law because genuine scientific dispute over the harms to humans of acrylamide meant that the disclosure was not “purely factual and uncontroversial,” so not ok under Zauderer, and the state didn’t meet its burden under any higher standard.

Acrylamide is a toxic chemical first detected in food in 2002, but not newly there. It often forms as a result of a reaction between sugars and the amino acid asparagine, which naturally occur in many foods. Roasting, baking, frying, or otherwise cooking food at a high temperature appears to cause acrylamide to form, whether at home or at industrial scale. According to the U.S. Food & Drug Administration (FDA), the foods that contribute the most acrylamide to the American diet are baked and fried starchy foods like french fries, chips, crackers, donuts, pancakes, and toast. Coffee also contains acrylamide, as do almonds, olives, and asparagus.

It's well established that acrylamide increases cancer in animals; more acrylamide means more cancer. The studies do use very high doses, not real-world doses. “[M]any public health authorities have concluded that exposure to acrylamide probably increases the risk of cancer in people.” Some researchers—some with ties to the food/beverage industries—think that rats and mice react differently to acrylamide. And for obvious ethical reasons, there aren’t clinical human studies, though in vitro human cell studies suggest that acrylamide causes DNA changes that are known to cause breaks and mutations in chromosomes, which can in turn cause cancer; in the International Agency for Research on Cancer (IARC) database of 1,600 human tumor genomes, about one third of the tumor genomes could be connected to acrylamide. “This may mean that a large portion of human cancer is connected to acrylamide exposure.” However, dozens of epidemiological studies have failed to find a connection. This may simply be because food diary studies are unreliable, especially given the ubiquity and uniformity of acrylamide exposure—plus, the effects may not surface for decades, so a short-term study won’t be helpful.

It is thus unsurprising that, despite their conclusions about “probable” or “likely” links to cancer, government authorities haven’t urged people to avoid acrylamide-containing foods, though the FDA has offered guidance to reduce consumption. “At the end of the day, however, because acrylamide is found in so many foods, it is probably impossible to avoid it completely. The FDA advises Americans not to attempt removing fried, roasted, and baked foods from their diets.” California public health authorities specifically decided not to warn against acrylamide exposure in coffee; the State found “inverse associations—decreasing risk with increasing coffee consumption—for [some] human cancers.”

But non-coffee sources remain subject to the warning requirements of California's Safe Drinking Water and Toxic Enforcement Act of 1986, more commonly known as “Proposition 65.” Businesses must not knowingly or intentionally expose people to chemicals “known to the state to cause cancer or reproductive toxicity” without a “prior clear and reasonable warning.”   A chemical “must be listed even if it is known to be carcinogenic or a reproductive toxin only in animals.”

Regulations require warnings to name the chemical and to be displayed “prominently,” “with such conspicuousness” that they are “likely to be seen, read, and understood by an ordinary individual.” A warning may include more information than this, but only if the addition “identifies the source of the exposure or provides information on how to avoid or reduce exposure.” There is a safe harbor warning: “Consuming this product can expose you to [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65warnings.ca.gov/food.”

California has settled cases by allowing more nuanced warnings: in potato chip litigation, it allowed the warning to say the chips “contain acrylamide, a substance identified as causing cancer under California's Proposition 65.” The warning further explained that foods other than chips contain acrylamide and that acrylamide is not added to these foods, but rather is “created when these and certain other foods are browned,” and that the “FDA has not advised people to stop eating potato crisps and/or potato chips...or any foods containing acrylamide as a result of cooking.”

Proposition 65 allows for exceptions, as with coffee; under the regulations, 0.2 micrograms/day poses no significant risk and needs no warning, and higher levels of exposure are permitted when “chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbial contamination”; and the law grants businesses an affirmative defense if they can prove the alleged exposure “poses no significant risk assuming lifetime exposure at the level in question,” but the court concluded that these paths were too risky to be a defense to the First Amendment claim.

Here, the only safe path—the safe-harbor warning—would be: “Consuming this product can expose you to acrylamide, which is ...known to the State of California to cause cancer. For more information go to www.P65warnings.ca.gov/food.” First, by “asserting vaguely” that consumption could expose the consumer to acrylamide, a chemical most people have likely never heard of, “the warning implies incorrectly that acrylamide is an additive or ingredient.” And the warning required consumers to make several leaps—that it meant that animals get cancer more often when they consume doses hundreds of times larger than the amounts in the food, that scientists presume (absent other evidence) this means cancer in people, and that therefore the chemical is “known” to cause cancer in humans. (Necessary implication!) “People who read the safe harbor warning will probably believe that eating the food increases their personal risk of cancer.” There was indeed some evidence for that, but the epidemiological studies didn’t find it, and “California has also decided that coffee, one of the most common sources of acrylamide, actually reduces the risk of some cancers.”

Thus: “the safe harbor warning is controversial because it elevates one side of a legitimately unresolved scientific debate about whether eating foods and drinks containing acrylamide increases the risk of cancer.”

The state couldn’t adopt private definitions of what it means for California to “know” that acrylamide causes cancer, “or by showing the warning contains no affirmative falsehoods. Statements are not necessarily factual and uncontroversial just because they are technically true.”

The court commented that these problems could have been avoided by allowing businesses to explain that acrylamide forms naturally when some foods are prepared; that California has listed acrylamide as a chemical that “probably” causes cancer or is a “likely” carcinogen or that the chemical causes cancer in laboratory animals; and that acrylamide is commonly found in many foods and that neither the federal government nor California has advised people to cut acrylamide from their diets. Although this was okayed in the potato chip litigation, it wasn’t obviously available to others without litigation, based on the statute and the regulations. On the current record, the court agreed that “only the safe harbor warning is actually useable in practice,” and the state couldn’t “ ‘put the burden on commercial speakers to draft a warning that both protects their right not to speak and complies with Proposition 65.’ If the seas beyond the safe harbor are so perilous that no one risks a voyage, then the State has either compelled speech that is not purely factual, or its regulations impose an undue burden.”

This case was distinguishable from the earlier CTIA cellphone radiation warning case in three ways: First, the CTIA warning only “hinted” at potential dangers, for example by referring vaguely to “safety,” but “its text was a purely factual summary of federal regulation about radio frequency radiation.” This wasn’t even argued to be “controversial as a result of disagreement about whether radio-frequency radiation can be dangerous to cell phone users.” But the truth of whether acrylamide is “known to cause cancer” is “the subject of controversy,” even if it wasn’t a political or moral controversy.

Second, CTIA involved an unchallenged federal mandatory disclosure of the same information; the ordinance at issue just required more prominence. Here, “[n]o regulatory or public health authority has advised against consuming foods with acrylamide.” [… That’s not what this disclosure says either.]

Third, the ordinance in CTIA allowed businesses to add information, whereas “Proposition 65 does not permit businesses to add information to the required warning at their discretion, and thus prevents them from explaining their views on the true dangers of acrylamide in food.”

Since Zauderer didn’t apply, it also flunked Central Hudson and any higher standard of scrutiny. “There is no question that protecting the health and safety of consumers is a substantial government interest.”   But at this stage of the litigation, the required warning likely does not “directly advance” that interest and is “more extensive than necessary” because it misleadingly implied that the science about the risks of food-borne acrylamide was settled. The state could also fund scientific research and pursue public awareness campaigns to further its interest. “Regulators could also modify safe harbor warnings to eliminate inaccuracies and controversial statements.”

The court cautioned that it was not invalidating “existing consent decrees, settlements, or other agreements. For example, this order does not permit businesses that have already agreed to display a certain warning do take those warnings down, and businesses that have agreed to reformulate their products to reduce acrylamide content are not permitted by this order to breach those agreements.” And the court noted the risk of misinterpretation or misuse of this injunction to attack warnings about other carcinogens and reproductive toxins. “California has a substantial and likely compelling interest in protecting people from exposure to dangerous chemicals, including chemicals that have been shown to cause cancer or reproductive harm in experimental animals, even if epidemiological evidence is inconclusive.” But at this stage, the court granted the preliminary injunction.

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