Ninth Circuit Decision Foreshadows Major Blow to Prop 65 Acrylamide Claims
By Matthew G. Lawson
On Thursday, March 17, 2022, the Ninth Circuit issued a critical decision in California Chamber of Commerce v. CERT, No. 21-15745 (9th Cir. 2022), reinstating a preliminary injunction against the filing or prosecuting of any new lawsuits to enforce Proposition 65’s warning requirements as applied to acrylamide in food and beverage products. The decision reinstalls a roadblock against future lawsuits and may offer a light at the end of the tunnel for the regulated community by signaling the existence of a valid defense against Proposition 65 claims where the health risks of a chemical remain subject to ongoing debate and disagreement from scientific experts. The decision is a blow against Proposition 65 plaintiffs who had recently succeeded in petitioning the court to grant an emergency stay of the district court’s preliminary injunction pending appeal.
Proposition 65 provides that “[n]o person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer . . . without first giving clear and reasonable warning to such individual…” A chemical is deemed to be “known to the state to cause cancer” if it meets one of three statutory criteria: (1) the state’s qualified experts believe “it has been clearly shown through scientifically valid testing according to generally accepted principals to cause cancer”; (2) “a body considered to be authoritative by such experts has formally identified it as causing cancer”; or (3) “an agency of the state or federal government has formally required it to be labeled or identified as causing cancer.” See Cal. Health & Safety Code § 25249.8(b). Where a consumer product contains such a chemical, the manufacturer or distributor of the product must provide a warning to consumers, unless they can affirmatively show that quantities of the chemical within the product are below certain “safe harbor” levels. Manufacturers that fail to provide a warning notice may be subject to significant civil penalties, often pursuant to claims brought by private plaintiff enforcers.
A particularly controversial chemical on Proposition 65’s list is acrylamide. Unlike many Proposition 65 chemicals, which are often additives or ingredients within a consumer product or food, acrylamide is a substance that forms through a natural chemical reaction between sugars and asparagine, an amino acid, in plant-based foods—including potato and certain grain-based foods. Acrylamide often forms during high-temperature cooking, such as frying, roasting and baking. Acrylamide was added to the Proposition 65 list in 1990 “because studies showed it produced cancer in laboratory rats and mice.” However, this conclusion is not shared by other experts—including the American Cancer Society and National Cancer Institute—who stated that “a large number of epidemiologic studies . . . have found no consistent evidence that dietary acrylamide exposure is associated with the risk of any type of cancer.” Between 2015 and October 2020, the State of California reported that it received almost 1,000 notices of alleged acrylamide violations sent by private enforcers to businesses selling food products in California.
In an effort to strike back against enforcement of Proposition 65’s warning requirements, CalChamber—a nonprofit business association with over 13,000 members, many of whom sell or produce food products that contain acrylamide—filed litigation in California federal district court seeking to vindicate its members’ First Amendment right to not be compelled to place false and misleading acrylamide warnings on their food products. CalChamber’s preliminary injunction motion sought to prohibit parties from “filing and/or prosecuting new lawsuits to enforce the Proposition 65 warning requirement for cancer as applied to acrylamide in food and beverage products.” The Council for Education and Research on Toxics (“CERT”) intervened as a defendant and argued that, as a private enforcer of Proposition 65, an injunction would impose an unconstitutional prior restraint on its First Amendment rights. In Cal. Chamber of Com. v. Becerra, 529 F. Supp. 3d 1099, 1123 (E.D. Cal. 2021), the district court granted CalChamber’s request for preliminary injunction finding that CalChamber was likely to succeed on the merits of its First Amendment Claim. Citing Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985), the district court held that to pass constitutional muster, the warnings compelled by Proposition 65 must “(1) require the disclosure of purely factual and uncontroversial information only, (2) [be] justified and not unduly burdensome, and (3) [be] reasonably related to a substantial government interest.” Because the Attorney General and CERT did not meet their burden to show the warning requirement was lawful under Zauderer, the district court concluded that CalChamber was likely to succeed on the merits of its First Amendment claim and granted the preliminary injunction against new Proposition 65 lawsuits regarding acrylamide. While CERT appealed the preliminary injunction order, the Attorney General did not, and a divided motions panel of the Ninth Circuit granted in part CERT’s motion for an emergency stay of the preliminary injunction pending appeal.
On Thursday, the Ninth Circuit issued its final decision on the merits of the preliminary injunction, and affirmed the district court’s original decision. Citing to the existence of “robust disagreement by reputable scientific sources,” the Ninth Circuit held that the district court did not abuse its discretion by concluding that the acrylamide warning was “controversial.” Similarly, the Ninth Circuit agreed with the district court’s conclusions that a Proposition 65 warning for acrylamide would mislead consumers because “[a] reasonable person might think that they would consume a product that California knows will increase their risk for cancer … Such a consumer would be misled by the warning because the State of California does not know if acrylamide causes cancer in humans.” Finally, the appellate court found that the record supported the conclusion that Proposition 65’s “enforcement regime creates a heavy litigation burden on manufacturers who use alternative warnings.” Specifically, the appellate court reasoned that upon receipt of a Proposition 65 notice of violation, “a business must communicate to consumers a disparaging health warning about food containing acrylamide that is unsupported by science, or face the significant risk of an enforcement action under Proposition 65.” For these reasons, the Ninth Circuit found that the preliminary injunction was warranted and removed the emergency stay against its enforcement.
While the immediate impact of the Ninth Circuit’s decision is limited to new lawsuits regarding Proposition 65 warning requirements for acrylamide, the Ninth Circuit’s holding could be viewed as its own warning sign to plaintiffs who seek to enforce Proposition 65 requirements where the science supporting the harmful effects of a chemical remains in dispute. It remains to be seen whether the Ninth Circuit’s holding will spur the CalChamber or other similarly situated groups to raise similar defenses in future cases.
New PFAS Additions to the Proposition 65 List
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
Over the past week, several new per- and polyfluoroalkyl substances (PFAS) have been added to California’s Proposition 65 list. In March 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) selected perfluorooctane sulfonate (PFOS) and its salt and transformation and degradation precursors for evaluation by California’s Carcinogenic Identification Committee (CIC). OEHHA also selected perfluoronanoic acid (PFNA) and perfluoroundecanoic acid (PFDA) for evaluation by California’s Reproductive Toxicant Identification Committee (DARTIC).
Several industry groups submitted comments in opposition to adding these PFAS chemicals to the Proposition 65 lists. For example, even though PFOS has been voluntarily phased out of production in the United States, the American Chemistry Council opposed listing PFOS as a carcinogen under Proposition 65, claiming that the available data doesn’t support a conclusion that PFOS presents a carcinogenic risk to humans.
Notwithstanding this industry opposition, on December 6, 2021, the CIC voted 8-2 with one abstention to add perfluorooctane sulfonate (PFOS) and its salt and transformation and degradation precursors to the Proposition 65 list of chemicals known to the State of California as causing cancer. It is important to note that PFOS had previously been on the Proposition 65 list due to its alleged reproductive toxicity.
On December 14, 2021, DARTIC voted to add PNFA to the Proposition 65 list of reproductive toxicants. However, DARTIC did not add PFDA to the list of reproductive toxicants. DARTIC relied in part on a recent assessment prepared by OEHHA that evaluated the reproductive effects of both PFNA and PFDA.
Unlike PFAS, these particular PFAS chemicals have not been phased out and are used as processing aids in fluoropolymer manufacturing as well as in certain cosmetic products. As such, the inclusion of these chemicals on the Proposition 65 list will trigger new warning obligations.
Once a chemical is added to the Proposition 65 list, companies have one year to provide the requisite Proposition 65 warnings and companies that fail to provide these warning are often the target of “claims” by private party Proposition 65 enforcers. It should also be noted that OEHHA has yet to develop “safe harbor” levels for any of these PFAS chemical and so any exposure to these PFAS chemicals will require a Proposition 65 warning.
These particular PFAS chemicals are commonly found in firefighting foam, stain-resistant fabrics, and food packaging. Companies that distribute and sell these types of products in California would be well served to evaluate whether their products contain any of these chemicals and take steps to either eliminate these chemicals from their products or ensure that the products have the requisite Proposition 65 warnings in the next year.
We will continue to provide updates regarding Proposition 65 at the Corporate Environmental Lawyer blog.
California Federal District Court Grants Preliminary Injunction in Proposition 65 Acrylamide Case
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On the heels of a 2020 decision in National Association of Wheat Growers, et al. v. Becerra that barred the State of California from requiring Proposition 65 warnings for glyphosate-based pesticides because those warnings violated the First Amendment, another California District Court has thrown up a First Amendment roadblock for Proposition 65 claims relating to acrylamide in food and beverage products. As explained in more detail below, on March 29, 2021, the District Court granted a preliminary injunction in favor of the California Chamber of Commerce (Chamber) barring future State and private party Proposition 65 lawsuits alleging a failure to warn of acrylamide in food and beverage products.
The Chamber filed its lawsuit in October 2019 alleging that because the State did not “know” that eating food with acrylamide causes cancer in people, Proposition 65 violated the First Amendment because it mandated that businesses place warnings on food and beverage products stating that acrylamide is known to the State to cause cancer. The Council for Education and Research on Toxics (CERT)--a nonprofit organization that frequently files private party Proposition 65 lawsuits--intervened in the matter.
The Chamber requested a preliminary injunction to bar the State and any private litigant from filing new lawsuits to enforce Proposition 65 against businesses that do not warn consumers that acrylamide in food is “known to the State of California to cause cancer”. Both the State and CERT opposed the request for a preliminary injunction, arguing that the Chamber had not met its burden. CERT also argued that the preliminary injunction would be an unconstitutional prior restraint on its First Amendment right to bring Proposition 65 enforcement claims.
The Court quickly dismissed CERT’s unconstitutional restraint argument noting that if the Chamber is correct that Proposition 65 lawsuits targeting acrylamide are violative of the First Amendment, then the lawsuit has an illegal objective and therefore can be enjoined without violating the First Amendment. In considering whether the Chamber was likely to succeed on the merits of the complaint, the Court then proceeded to examine the Proposition 65 safe harbor warning which states as follows: “Consuming this product can expose you to [acrylamide], which is … known to the State of California to cause cancer.” After examining the scientific evidence presented to the Court, the Court found that the State had not shown that this warning was purely factual and uncontroversial.
Although the Court acknowledged that high exposure animal studies showed an increased incidence of cancer, dozens of epidemiological studies had failed to tie human cancer to a diet of food containing acrylamide. After considering the competing expert testimony, the Court concluded that the “safe harbor warning is controversial because it elevates one side of a legitimately unresolved scientific debate about whether eating goods and drinks containing acrylamide increases risk of cancer.” The Court recognized California’s substantial government interest in protecting the health and safety of consumers but concluded that at this stage of the litigation, the Chamber had shown that the Proposition 65 warning that the State demands does not directly advance that interest and is more extensive than necessary.
Finally, in evaluating whether the Chamber had demonstrated that it would suffer irreparable harm, the Court acknowledged the significant increase in Proposition 65 acrylamide pre-litigation notices and lawsuits over the past several years. As the Court noted, irreparable harm is relatively easy to establish in a First Amendment case like this and this burden was met by the Chamber. As such, the Court granted the Chamber's request for a preliminary injunction.
Again, it is important to note that this is just a preliminary injunction that bars future State and private party Proposition 65 acrylamide lawsuits while the case proceeds on the merits. However, this decision, along with the 2020 Wheat Growers decision noted above, may evidence a willingness on the part of California courts to give serious credence to First Amendment challenges to Proposition 65 warning requirements and may represent a light at the end of the Proposition 65 tunnel for entities that sell food and beverage products in California (and this time, it may not be the light from a train).
OEHHA Proposes Additional Safe Harbor Levels for Cooked or Heat-Processed Foods Containing Proposition 65 Chemicals
By Matthew G. Lawson
On Tuesday, August 4, 2020, the California Environmental Protection Agency Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Proposed Rulemaking to adopt amendments to the regulations implementing the Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65”). Specifically, OEHHA is proposing to amend Title 27 of the California Code of Regulations, by adopting a new Section 25505, to address listed chemicals formed by cooking or heat processing foods. The proposed amendments, if adopted, would provide new, specific “safe harbor” levels for Proposition 65 listed chemicals that are caused by cooking or heat processing in certain food groups. Manufacturers and sellers of these food products in California could then rely on these levels to demonstrate that their products do not require a consumer warning label under Proposition 65.
In general, Proposition 65 requires that parties manufacturing, distributing, or selling consumer products in California provide a “clear and reasonable warning” to the consumer whenever their product may expose the purchaser to a chemical that OEHHA has identified and listed as a carcinogen or reproductive toxin, unless an exception applies. A key exemption to Proposition 65’s warning requirements includes where a consumer product will not exposure a consumer to a listed chemical in quantities above certain OEHHA-designated Safe Harbor Levels. Safe Harbor Levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Proposition 65 and represent the maximum level of exposure to a chemical that has been deemed “safe” by OEHHA. Products that expose consumers to chemicals at or below a designated Safe Harbor Level are not required to provide a warning label or otherwise warn consumers about potential exposure to the listed chemical in their product. Critically, Proposition 65’s warning requirements are almost entirely forced through litigation brought by private party plaintiffs. In 2018 alone, defendants paid over $35 million in settlements to private party plaintiffs, with over 75% going to attorneys’ fees.
Of particular significance to OEHHA’s proposed regulatory amendment is the Proposition 65 listed chemical acrylamide, which can often form in certain plant-based foods during high-temperature cooking processes, such as frying, roasting, or baking. Acrylamide was first added as a Proposition 65 listed chemical in 1990 after studies showed it had the potential to produce cancer in laboratory mice. Acrylamide was additionally listed as a reproductive toxin in February 2011, when OEHHA determined that the chemical could cause reproductive effects in mice. Despite the relatively long period of time Acrylamide has been listed as a Proposition 65 regulated chemical, private party enforcement actions over the chemical have spiked heavily in recent years. In response, on October 7, 2019, the California Chamber of Commerce filed suit in federal court against the California Attorney General, Xavier Becerra, seeking to block enforcement of Proposition 65’s warning requirements for foods containing acrylamide as the result of the normal cooking process. The Chamber’s complaint alleged that more than 461 companies have received Proposition 65 notice of violations “in connection with alleged exposures to acrylamide in their food products over the past three years.” The complaint further noted that the creation of acrylamide is an unavoidable effect of cooking many plant-based foods and that “there is a lack of reliable scientific evidence suggesting a causal relationship between acrylamide in food products and cancer risk in humans.”
OEHHA’s proposed regulatory amendment appears aimed at addressing the specific concerns asserted in the Chamber of Commerce litigation. In its Statement of Reasons for the proposed amendments, OEHHA acknowledge that the regulatory amendment was needed because “some degree of formation of listed chemicals in many foods is unavoidable when the foods are cooked or otherwise processed with heat.” In addition, OEHHA noted that the agency would consider adding additional food groups to the proposed regulations at a later date.
The proposed regulations provide that a Proposition 65 “exposure” does not occur where a listed chemical in a food product “was created by cooking or other heat processing” and “the producer, manufacturer, distributor, or holder of the food has utilized quality control measures that reduce the chemical to the lowest level currently feasible.” In conjunction with this amendment, the amended regulations provide new Safe Harbor maximum concentration levels for listed chemicals in certain cooked or heated foods that are deemed by OEHHA to be the “lowest level currently feasible.” Food products containing a listed chemical at or below the listed levels are not required to provide a warning under Proposition 65. Listed food groups with specific new Safe Harbor Levels covered by the regulation include:
Almonds, roasted, roasted almond butter, and chocolate-covered almonds;
Bread, wheat and non-wheat-based products including loaves, rolls, buns, and baguettes;
Cookies, including animal crackers, thin and crispy cookies, and sandwich wafers;
Potatoes and sweet potato products, including french fried potatoes, sliced chips, and other potato products such as hash browns and potato puffs;
Prune juice, including made from concentrate and non-concentrate; and
Notwithstanding the new proposed Safe Harbor Levels, the last sentence in new Section 25505(a) could still result in Proposition 65 claims. The sentence provides “[i]f a person does not reduce the level of the chemical in a food to the lowest level currently feasible, the resulting exposure must be calculated without regard to the levels set out in subsection (d).” Although this may not have been the intent of OEHHA, this language could be read to allow a Proposition 65 plaintiff to still claim that a manufacturer failed to utilize control measures that reduce the chemicals to the “lowest level currently feasible” even if below the Safe Harbor Level. Hopefully OEHHA will clear up this potential ambiguity in any final rule.
We also note that while the newly proposed amendments may assist many potential defendants, the updated Safe Harbor Levels explicitly will not apply “to parties to an existing court-ordered settlement or final judgment to the extent that such settlement or judgment establishes a concentration of the chemical in a specific product covered in the settlement or judgment.”
OEHHA is currently accepting written comments concerning its proposed regulatory action and intends to close its comment period no later than October 6, 2020. At present, OEHHA has not announced an intended final publication date for the proposed regulations, but the agency has noted that it anticipated its regulatory process may be delayed “due to the COVID-19 emergency.”