(San Francisco City and County Super. Ct. Nos. CGC-01-402975 & CGC-04-432394), Trial Judge: Hon. Robert Dondero.
The opinion of the court was delivered by: Reardon, J.
CERTIFIED FOR PUBLICATION
There is no dispute that methylmercury is a reproductive toxin that can harm a developing fetus, and that the primary path for human exposure to methylmercury is consumption of fish. All canned tuna distributed by respondents*fn1 in California contain traces of methylmercury, yet no warnings appear on tuna cans or accompany the sale of canned tuna in this state. This litigation, prosecuted by appellant State of California (State)*fn2 against the Tuna Companies under the authority of Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health & Saf. Code,*fn3 § 25249.5 et seq.), seeks to require the companies to warn pregnant women and women of childbearing age that they are exposed to methylmercury when they consume canned tuna.
Following a six-week bench trial, with a parade of expert witnesses, the trial court handed the Tuna Companies a complete victory. The trial court ruled that the State was not entitled to any of the relief requested, elaborating three distinct and separate bases: (1) Proposition 65, as applied to the Tuna Companies, was preempted because it conflicts with federal law; (2) the amount of methylmercury in canned tuna does not rise to the threshold level that would trigger the warning requirement for this chemical; and (3) virtually all methylmercury is "naturally occurring," and under the governing regulations does not count toward the threshold exposure; therefore the Tuna Companies are exempt from the warning mandates. The State challenges each ruling. We affirm the judgment on the narrow ground that substantial evidence supports the trial court‟s finding that methylmercury in tuna is naturally occurring, thereby removing the Tuna Companies from the reach of Proposition 65.
1. Proposition 65 Regulatory Scheme
Proposition 65, added by voter initiative in 1986, is a "right to know" statute requiring companies that expose consumers to carcinogens or reproductive toxins to provide a warning, subject to specified defenses. Section 25249.6 states 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 or reproductive toxicity without first giving clear and reasonable warning to such individual, except as provided in Section 25249.10."
Proposition 65 directs our Governor to publish a list of chemicals known to the state to cause cancer or reproductive toxicity, and to revise and republish the list annually in light of additional knowledge. (§ 25249.8, subd. (a).) In July 1987, the Governor listed methylmercury as a chemical known to cause reproductive toxicity (Cal. Code Regs., tit. 27, § 27001, subd. (c) (Regs.)), and in May 1996, methylmercury compounds were listed as a chemical known to cause cancer (id., subd. (b)).
The warning mandates do not apply in several important situations. There is no duty to warn if federal law preempts state authority for warning of exposure to a particular chemical. (§ 25249.10, subd. (a).) As well, Proposition 65 warning duties are not implicated if exposure to a listed chemical falls below the threshold level established under statutory and regulatory criteria. The defendant must demonstrate "that the exposure poses no significant risk assuming lifetime exposure at the level in question for substances known to the state to cause cancer, and that the exposure will have no observable effect assuming exposure at one thousand (1,000) times the level in question for substances known to the state to cause reproductive toxicity...." (Id., subd. (c).)
The "no observable effect level," or "NOEL," is a scientific term denoting the maximum dose level at which a chemical is found to have no observable reproductive effect. (Regs., tit. 27, § 25801, subd. (c).) The NOEL is determined through scientific inquiry and assessment as detailed in the framework set forth in the regulations. (Id., §§ 25801, subds. (a), (b)(1), 25803.) In turn, the NOEL is divided by 1,000 to arrive at the maximum allowable dose level (MADL), which is the threshold warning level for a listed chemical. (Regs., tit. 27, § 25801, subd. (b)(1); § 25249.10, subd. (c).)
The procedures for calculating the exposure to a chemical in food start with the quantification of the "chemical concentration of a listed chemical for the exposure in question." (Regs., tit. 27, § 25821, subd. (a).) This concentration is called the " "level in question.‟ " (Ibid.) The level in question is then multiplied by "the reasonably anticipated rate of exposure for an individual" to the food. (Id., subd. (b).) This rate of exposure must be "based on the pattern and duration of exposure that is relevant to the reproductive effect" which formed the basis for listing the chemical as causing reproductive toxicity. (Ibid.) Thus, an "exposure of short duration" is the appropriate frame of reference for a teratogenic chemical. (Ibid.) A teratogen is a chemical that can cause birth defects. Methylmercury is a teratogen and that is why it was listed under Proposition 65.
At trial, a defendant can secure the protection of the exposure exemption by establishing (1) the NOEL; (2) the level of exposure in question, and ultimately that the level of exposure was 1,000 times below the NOEL. (§ 25249.10, subd. (c); Regs., tit. 27, §§ 25801, subds. (a), (b)(1), (c), 25803; Consumer Cause, Inc. v. SmileCare (2001) 91 Cal.App.4th 454, 469.)
Further, the duty to warn before exposing any person to a listed chemical also escapes activation to the extent a listed chemical is naturally occurring in the food. (Regs., tit. 27, § 25501, subd. (a).) Human consumption of a food is not an " "exposure‟ " under Proposition 65 if a defendant can show that the targeted chemical is naturally occurring in food. (Ibid.) A chemical is naturally occurring only to the extent it does not result from known human activity. (Id., subd. (a)(3).) Thus, where a food contains a chemical which is "in part naturally occurring and in part added as a result of known human activity," only the portion attributable to human activity counts toward the exposure. (Ibid.) Finally, to come within the "naturally occurring" rubric, a defendant must prove that the chemical "is a natural constituent of a food" or "is present in a food solely as a result of absorption or accumulation of the chemical which is naturally present in the environment in which the food is raised, or grown, or obtained...." (Id., subd. (a)(1).)
Proposition 65 thus requires clear and reasonable warnings absent an exemption under section 25249.10, or a determination that the listed chemical is naturally occurring. The method chosen to convey the warning must "be reasonably calculated... to make the warning message available to the individual prior to exposure." (Regs., tit. 27, § 25601.) In addition, the "message must clearly communicate that the chemical in question is known to the state to cause cancer, or birth defects or other reproductive harm." (Ibid.)
Warnings may be provided using one or more of the following methods: labeling; identification of the product at the retail outlet through shelf labeling, signs, menus, or a combination of these methods; a system of signs, public advertising identifying such system and toll-free information services, or other system that provides clear and reasonable warnings. (Regs., tit. 27, § 25603.1, subds. (a), (b), (d).) Warnings provided by labeling or displayed at a retail outlet must be prominently placed or displayed "with such conspicuousness, as compared with other words, statements, designs, or devices in the label, labeling or display as to render it likely to be read and understood by an ordinary individual under customary conditions of purchase or use." (Id., subd. (c).)
The Regulations describe "safe harbor" warning messages that are deemed to meet the clear and reasonable standard. (Regs., tit. 27, § 25603.2, subd. (a); Dowhal v. SmithKline Beecham Consumer Healthcare (2004) 32 Cal.4th 910, 918.) The "safe harbor" warning message for a reproductive toxin in a consumer product is this: "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm." (Regs., tit. 27, § 25603.2, subd. (a)2.)
2. Methylmercury; Methylmercury in Fish
Methylmercury is a potent neurotoxic agent that can cause harm to a developing fetus. The effects of severe methylmercury poisoning in a fetus include mental retardation, cerebral palsy, small brain size and severe sensory deficits and motor effects. As well, there is evidence that exposure to methylmercury at lower levels affects development of the brain.
Fish is a low calorie source of protein and omega-3 fatty acids and thus is an important component of a healthy diet, but most fish contains methylmercury and some may contain higher levels than others. Omega-3 fatty acids are important in enhancing the growth and development of fetuses. Thus, there is tension between the benefits of consuming fish and the risk of mercury exposure. This tension is borne out by a recent nutritional study involving 135 mother/infant pairs in Massachusetts published by the National Institute of Environmental Health Sciences. Results from the study suggested "that maternal fish consumption during pregnancy may benefit offspring cognition in infancy, but that exposure to higher levels of mercury has adverse effects on child cognition." The researcher recommended that women continue to consume fish during pregnancy, but that they seek out varieties with lower levels of mercury.
Tuna contains methylmercury. The Tuna Companies have stipulated that they have known since at least 1998 that all the canned and packaged tuna products they distribute in California contain detectable traces of methylmercury, and have never provided Proposition 65 warnings on their tuna products.
The authority of the federal government to regulate food and food products is anchored in the power of Congress to regulate interstate commerce. (U.S. Const., art. I, § 8, cl. 3.) This authority finds expression in the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 301 et seq.), which prohibits the transmission in interstate commerce of any food that is adulterated or misbranded (id., § 331(a), (c)). The Food and Drug Administration (FDA) is entrusted with administering the Act, with authority to promulgate regulations for enforcement of its provisions and conduct hearings, examinations and investigations. (Id., §§ 371, 372.) This includes the authority to regulate food labeling, with jurisdiction over labeling of food that is false or misleading in any particular. (Id., §§ 331(a)-(c), 371(a), 343(a).)
The FDA is specifically empowered to regulate the appropriate level of an unavoidable "added" poisonous or deleterious substance in any food by (1) establishing formal tolerances and regulatory limits by regulation, and (2) setting an action level administratively to define a level of contamination at which a food may be deemed adulterated. (21 U.S.C. § 346; 21 C.F.R. § 109.4(a)-(c) (2008).) As well, the FDA is empowered to establish regulations to identify and list foods containing naturally occurring poisonous or deleterious substances which will be considered adulterated under the Act. (21 C.F.R. § 109.4(d).)*fn4 Among the criteria for establishing a tolerance for an added poisonous or deleterious substance in food is that the tolerance "is sufficient for the protection of the public health, taking into account the extent to which the presence of the substance cannot be avoided and the other ways in which the consumer may be affected by the same or related poisonous or deleterious substances." (Id., § 109.6(b)(2.) An action level for an added poisonous or deleterious substance in food may be established at a level at which the food is deemed to be adulterated. (Id., § 109.6(d).)
In 1979, the FDA determined that an action level limiting the amount of mercury residues permitted in fish and other aquatic animals to 1.0 part per million provided adequate protection to consumers. (44 Fed. Reg. 3990, 3992-3993 (Jan. 19, 1979).) Since the mid-1990s, the FDA has issued advisories on the subject of methylmercury in fish. Most recently, in March 2004 the FDA, in conjunction with the Environmental Protection Agency (EPA), promulgated an advisory entitled "What You Need to Know About Mercury in Fish and Shellfish" (the 2004 Advisory).
The 2004 Advisory extols the benefits of fish and shellfish to a healthy diet, noting that these foods contain high quality protein, are low in saturated fat and contain omega-3 fatty acids. However, it also points out that fish and shellfish contain traces of mercury, and some such foods contain higher levels that may harm an unborn baby or a young child‟s developing nervous system. The 2004 Advisory recommends that the target group, consisting of women who might become pregnant, nursing mothers, pregnant women and young children, "[e]at up to 12 ounces (2 average meals) a week of a variety of fish and shellfish that are lower in mercury." Further, it identifies "canned light tuna" as one source that is low in mercury, and notes that "albacore ("white‟) tuna has more mercury than canned light tuna." Therefore, when choosing the two meals of fish and shellfish, the 2004 Advisory cautions that the consumer may eat up to six ounces or one average meal of albacore tuna per week.
In 2004, the State sued the Tuna Companies for injunctive relief and penalties, asserting violations of Proposition 65 and the unfair competition law (UCL).*fn5 The complaints asserted that the companies distribute and sell canned tuna products in California without providing a clear and reasonable warning that the products contain methylmercury, a chemical known to the State to cause reproductive harm.
At the close of the 24-day bench trial, the superior court issued a 118-page proposed decision to which the State objected. The trial court overruled all but one of the numerous objections, adopted the tentative decision with a minor modification, and issued a further ruling explaining some of its reasoning and conclusions. Ultimately, the court entered judgment dismissing the UCL cause of action and decreeing that the Tuna Companies are not required to provide any Proposition 65 warnings on their tuna products sold in California, or to pay any penalties.
The trial court first ruled that any Proposition 65 compliant warning would frustrate the purpose and objectives of the FDA‟s carefully considered federal approach to advising consumers of both the benefits and possible risks of eating fish; the Tuna Companies could not comply with both federal law and Proposition 65; and thus Proposition 65 as applied to the Tuna Companies in this action was preempted by federal law. ...