Cal. Chamber of Commerce v. Becerra

529 F.Supp.3d 1099

CALIFORNIA CHAMBER OF COMMERCE, Plaintiff,

v.Xavier BECERRA in his official capacity as Attorney General of the State of California, Defendant.

No. 2:19-cv-02019-KJM-EFB

United States District Court, E.D. California.

Signed March 29, 2021

Filed March 30, 2021

Trenton H. Norris, David Barnes, Samuel Zachary Fayne, Sarah Esmaili, Arnold & Porter Kaye Scholer LLP, San Francisco, CA, for Plaintiff.

Joshua Robert Purtle, California Department of Justice, Harrison M. Pollak, Laura Zuckerman, California Attorney General's Office, Oakland, CA, for Defendant.

ORDER

Kimberly J. Mueller, CHIEF UNITED STATES DISTRICT JUDGE The California Chamber of Commerce contends California has compelled businesses to display misleading warnings about the dangers of acrylamide, a carcinogen. It seeks a preliminary injunction barring the California Attorney General and anyone else from filing new lawsuits against businesses that do not display the warning.

The Council for Education and Research on Toxics, or "CERT," joins the State as a defendant in this case. CERT is an intervening nonprofit organization that often files lawsuits against businesses that do not display warnings about acrylamide. CERT moves for summary judgment against the Chamber of Commerce. It argues its right to prosecute private enforcement actions is protected by the First Amendment.

The court held a hearing by videoconference on December 11, 2020. Trenton Norris and S. Zachary Fayne appeared for the Chamber of Commerce. Joshua Purtle and Harrison Pollak appeared for the State. Raphael Metzger and Scott Brust appeared for CERT. As explained in this order, the Chamber of Commerce's motion is granted, and CERT's motion is denied . The State has not shown that the cancer warnings it requires are purely factual and uncontroversial. Nor has it shown that Proposition 65 imposes no undue burden on those who would provide a more carefully worded warning. CERT, for its part, has not shown it is entitled to judgment as a matter of law.

I. BACKGROUND

Acrylamide is a toxic chemical. It is produced industrially for use in plastics, grouts, water treatment products, and cosmetics. See, e.g. , U.S. Food & Drug Admin., "Acrylamide Questions and Answers" (Sept. 25, 2019), Norris Decl. Ex. E, ECF No. 95-7.¹ It is also found in cigarette smoke. Id. And in 2002, it was detected in food. Maier Decl. at 16 ¶ 44, ECF No. 95-24,² Solomon Decl. ¶ 18, ECF No. 101-1.³

Although acrylamide was first detected in food in 2002, it has likely always been a part of many foods. See Acrylamide Questions & Answers, supra. Sometimes it occurs naturally. Maier Decl. ¶ 44. Often, however, it forms as a result of a reaction between sugars and the amino acid asparagine, which naturally occur in many foods. See Acrylamide Questions & Answers, supra. Roasting, baking, frying, or otherwise cooking food at a high temperature appears to cause acrylamide to form, whether at home or at industrial scale. Id. ; Solomon Decl. ¶ 18; Letter from Lester Crawford, Deputy Comm'r, U.S. Food & Drug Admin. at 2 (July 14, 2003), Norris Decl. Ex. G, ECF No. 95-9.

Acrylamide is most commonly found in foods made from plants. See Acrylamide Questions & Answers, supra. Dairy products, meat, and fish do not usually contain acrylamide after they are cooked at high temperatures, and when acrylamide is found in these foods, it forms at lower levels. Id. 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. Solomon Decl. ¶ 19 (citing Eileen Abt et al., "Acrylamide Levels and Dietary Exposure from Foods in the United States, An Update Based on 2011-2015 Data," 36 Food Additive Contamination Part A 1475–90 (July 18, 2019)). Coffee also contains acrylamide, see id., as do almonds, olives, and asparagus, Maier Decl. at 16 ¶ 44; Nat'l Cancer Institute, "Acrylamide and Cancer Risk" (Dec. 5, 2017).⁴

For decades, experiments have shown that when mice and rats eat or drink food or water containing acrylamide, they develop cancerous tumors in many parts of their bodies, including in their lungs, stomachs, skin, brains, and reproductive organs. See Solomon Decl. ¶ 33 (citing, among other materials, Keith A. Johnson, et al., "Chronic Toxicity and Oncogenicity Study on Acrylamide Incorporated in the Drinking Water of Fischer 344 Rats," 85 Toxicology & Applied Pharmacology 154–68 (Sept. 15, 1986)). The greater the quantity of acrylamide the animals ingest, the more cancer is found in the tested group. Id. ¶ 34.

Administering toxic chemicals to people is, of course, highly unethical, so the most powerful and reliable clinical tools for testing the effects of food-borne acrylamide, such as double-blind clinical trials, are impossible. See Lipworth Decl. ¶ 17,⁵ ECF No. 95-20; see also Michael D. Green, et al., Reference Guide on Epidemiology, in Federal Judicial Center Reference Manual on Scientific Evidence at 555 (3d ed. 2011). Animal studies are the main source of data for assessing whether chemicals are safe or dangerous to people. See, e.g. , Solomon Decl. ¶ 24. Public health authorities commonly rely on them. See, e.g. , id. ¶¶ 27–28. As a result of these experiments, many public health authorities have concluded that exposure to acrylamide probably increases the risk of cancer in people. See id. ¶¶ 37–40. The U.S. National Toxicology Program, for example, has said that acrylamide is "reasonably anticipated to be a human carcinogen." See id. ¶ 37; U.S. Dep't of Health & Human Servs. Nat'l Toxicology Program, Report on Carcinogens, "Acrylamide" (12th ed. 2011).⁶ The U.S. Environmental Protection Agency has found that acrylamide is "likely to be carcinogenic in humans." Solomon Decl. ¶ 39; U.S. Envt'l Protection Agency, Acrylamide Integrated Risk Assessment (Mar. 22, 2010).⁷ And a World Health Organization (WHO) committee that includes representatives from the FDA has concluded that acrylamide is carcinogenic. Solomon Decl. ¶ 20; J. Agric. Org. & Expert Comm. on Food Additives, "Evaluation of Certain Contaminants in Food" (Feb. 16–25, 2010).⁸

Animal experiments have limitations. When researchers study the effects of a chemical on animals in a laboratory, they must frequently use very large doses to compensate for small study groups and limited timeframes, and these doses usually do not approximate a person's real-world exposure. See Solomon Decl. ¶ 26; Maier Decl. ¶¶ 78–83, 87; see supra note 1, "Survey Data." According to an expert retained by the Chamber of Commerce, a person would have to eat more than ninety large bags of potato chips every day to consume an equivalent dose of acrylamide. See Maier Decl. ¶ 82. Some researchers also believe that rats and mice react differently to acrylamide. See id. ¶ 58. Acrylamide changes to glycidamide when it is broken down in the body, and glycidamide reacts more potently with DNA to cause cancer. See id. ; see also Solomon Decl. ¶¶ 43–44, 48. Mice and rats may metabolize acrylamide into glycidamide more efficiently than people, so they may be more sensitive to acrylamide. See Maier Decl. ¶ 58. The National Cancer Institute offers similar cautions about animal experiments. See supra Acrylamide and Cancer Risk ("[T]oxicology studies have shown that humans and rodents not only absorb acrylamide at different rates, they metabolize it differently as well."). Some of the studies of acrylamide were authored by researchers with financial connections to the food and beverage industries, however, and many experts disagree with their conclusions. See Solomon Decl. ¶¶ 49–58.

Experiments on animals are not the only tool researchers can use to evaluate the danger of acrylamide for people. For example, researchers can and have exposed human cells to acrylamide and glycidamide in a laboratory setting. See id. ¶ 44; U.S. Envt'l Protection Agency, "Toxicology Review of Acrylamide" at 168 (Mar. 2010), Purtle Decl. Ex. G, ECF No. 101-11. They observed that these chemicals react with human DNA and may become permanently attached. See Solomon Decl. ¶ 44. These attachments are called "adducts," and they are known to cause breaks and mutations in chromosomes, id. , which can in turn cause cancer if the damaged cells proliferate, id. ¶ 59.

Researchers have also found that glycidamide leaves a unique genetic signature when it causes mutations in human cells. See id. ¶ 64 (citing Maria Zhivagui et al., "Experimental and Pan-Cancer Genome Analyses Reveal Widespread Contribution of Acrylamide Exposure to Carcinogenesis in Humans," 29 Genome Res. 521–31 (Apr. 2019)). The International Agency for Research on Cancer (IARC) maintains a database of 1,600 human tumor genomes, and scientific researchers scanned that database to see how many tumor genomes could be matched with the unique glycidamide signature. See id. According to the scientists who published the results of this analysis, about one third of the tumor genomes could be connected to glycidamide and thus to acrylamide. See Zhivagui, supra , Abstract; see also Solomon Decl. ¶ 64. This may mean that a large portion of human cancer is connected to acrylamide exposure. See Solomon Decl. ¶ 64.

Epidemiology also offers well-known statistical tools for investigating whether people are at greater risk of cancer as a result of acrylamide exposure. See Lipworth Decl. ¶ 31. Epidemiologists can, for example, collect data about human consumption of foods that contain relatively high amounts of acrylamide. See id. ¶¶ 19, 44; Green, supra , at 557–59. A "food frequency questionnaire" is a common survey tool for that purpose. Researchers ask participants how often they eat or drink various foods and beverages and then categorize the participants by their levels of likely acrylamide consumption. See Lipworth Decl. ¶¶ 44, 46, 48; Solomon Decl. ¶¶ 82–83. If people in low-exposure groups later report lower average cancer...