PEOPLE v. TRI-UNION SEAFOODS, LLC







Filed 3/11/09






CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

FIRST APPELLATE DISTRICT

DIVISION FOUR

THE PEOPLE ex rel. EDMUND G. BROWN, JR., as Attorney General, etc., et al., Plaintiffs and Appellants, v. TRI-UNION SEAFOODS, LLC, et al., Defendants and Respondents.

A116792 (San Francisco City and County Super. Ct. Nos. CGC-01-402975, CGC-04-432394)

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[1] 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)[2] against the Tuna Companies under the authority of Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health & Saf. Code,[3] § 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.
I. BACKGROUND
A. Introduction
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.
3. Federal Regulation
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).)[4] 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.
B. Litigation
In 2004, the State sued the Tuna Companies for injunctive relief and penalties, asserting violations of Proposition 65 and the unfair competition law (UCL).[5] 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.
1. Federal Preemption
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. Additionally, the trial court determined that the State’s proposed warnings failed to comply with Proposition 65.
Significant to the trial court’s ruling on federal preemption was a letter sent during the pendency of the action by FDA Commissioner Lester M. Crawford to then-Attorney General Bill Lockyer. The commissioner expressed his opinion that the FDA’s prior regulatory actions preempted the State’s lawsuit. Specifically, he explained that requiring Proposition 65 warnings would frustrate the agency’s carefully nuanced approach “to advising consumers of both the benefits and possible risks of eating fish and shellfish; accordingly federal law preempts these Proposition 65 warnings concerning mercury and mercury compounds in tuna.” The commissioner’s opinion letter relied in part on the 2004 Advisory. The trial court accorded this letter substantial deference.[6]
The trial court’s preemption ruling also leaned heavily on a recent California Supreme Court decision concluding that the FDA’s approach to warnings on nicotine replacement therapy products embodied a nuanced goal that was in conflict with California’s single-minded goal of informing consumers of the products’ risks. (Dowhal v. SmithKline Beecham Consumer Healthcare, supra, 32 Cal.4th at pp. 934-935.) That conflict justified federal preemption in Dowhal. Interestingly, the court located the federal policy in a letter from the FDA responding to and disposing of the plaintiff’s citizen’s petition. This letter, sent during the pendency of the appeal, rejected the plaintiff’s proposed warning and announced that the FDA had adopted a uniform warning to be implemented by the manufacturers. (Id. at p. 927.) The court considered the letter to be a definitive ruling on the subject, and was not dissuaded by the fact that it was not published in the Federal Register. (Id. at pp. 927-928.)
2. Threshold Warning Level
Second, the trial court ruled that the Tuna Companies met their burden of showing that they were exempt from the Proposition 65 warning mandate because the exposure of the average woman of childbearing age and/or pregnant woman to methylmercury in the companies’ products fell below the MADL for the chemical. In the battle of experts at trial, the trial court accepted the MADL of 0.3 micrograms per day advanced by the Tuna Companies’ expert, which was higher than that advocated by the State.
Significantly, the court also adopted the companies’ formula for calculating the concentration of methylmercury per average serving size, which the parties stipulated was 64.4 grams. This formula used a weighted average of methylmercury concentration in both light and albacore canned tuna, weighted according to the percentage of women of childbearing age in California who eat each type. The result was a blended mean concentration of 0.239 to 0.257 micrograms/grams of methylmercury in canned tuna products. The State challenged reliance on the blended mean, arguing for resort to the actual highest concentration of methylmercury in canned tuna to which a woman may be exposed. The argument boiled down to each side’s interpretation of the governing Proposition 65 regulations.
Moreover, the court credited the approach of the Tuna Companies’ expert of dividing the per serving exposure by 60, the average frequency with which women of childbearing age consume canned tuna in California. This calculation yielded an exposure of 0.26 to 0.28 micrograms of methylmercury per day, below the MADL of 0.3 micrograms per day. The State took the position that the law does not permit averaging the exposure to a teratogen like methylmercury. It urged that a single exposure could cause harm, and thus the single day exposure was the proper unit of comparison to the MADL. The court found this calculation inappropriate and concluded that the Regulations do not prohibit averaging the exposure to a reproductive toxin.
3. Naturally Occurring Ruling
Finally, the trial court concluded that the Tuna Companies met their burden of demonstrating that they are exempt from the Proposition 65 warning requirements, finding that “virtually all” methylmercury in canned tuna is naturally occurring and therefore does not count toward the exposure to the chemical.
The court made two rulings concerning the “naturally occurring” issue. First, relying heavily on Nicolle-Wagner v. Deukmejian (1991) 230 Cal.App.3d 652,[7] it interpreted what is now section 25501 of the Regulations as including within the “naturally occurring” rubric those chemicals in food that are the result of both natural and uncontrollable human activity. It is undisputed that the Tuna Companies do not add methylmercury to canned tuna products, and there is no process to remove the chemical from canned tuna.
Next, it accepted the Tuna Companies’ experts whose testimony, taken together, supported the conclusion that methylmercury in tuna is not a product of human activity (pollution) and thus its presence in tuna is naturally occurring. This conclusion derived largely from scientific studies showing that there has been no increase in the amount of methylmercury in ocean fish over the past 100 years despite the rise in atmospheric mercury due to anthropogenic[8] sources.
II. DISCUSSION
The State challenges all three rulings described above. In order to win this appeal, it must defeat each ruling. Ultimately the third ruling frames a substantial evidence question. While reasonable minds could differ on the outcome at the trial level, we view the trial court findings through the filter of the highly deferential substantial evidence test, a test that is difficult to overcome. We uphold the judgment solely on our conclusion that substantial evidence supports the trial court’s finding that methylmercury is naturally occurring in canned tuna.
A. Facts Relevant to the Finding that Methylmercury in Tuna is Naturally Occurring
1. Mercury in the Environment
Mercury is an element on the periodic table found throughout the environment. Inorganic mercury exists in the environment in three oxidation states: elemental mercury, in both liquid and gas forms, and mercury I and mercury II. The primary form of mercury emitted by power plants into the atmosphere is the gaseous form of elemental mercury. Methylmercury is not known to be emitted from power plants.
Mercury comes into the atmosphere from natural sources, e.g., volcanoes and mineralized areas; there is also an anthropogenic contribution from pollution. Once in the atmosphere, mercury can be readily dispersed and enter the oceans and other aquatic systems through atmospheric deposition. There is a global cycling of mercury whereby elemental mercury emits into the atmosphere, is oxidized into ionic mercury (mercury II), and becomes more soluble in water, falling on the earth and oceans as rain. Mercury that is deposited terrestrially can leach from watersheds and enter rivers, with delivery to coastal regions by river flow and transfer from those regions to the open oceans. This process can have both natural and anthropogenic components, as can groundwater input. Finally, hydrothermal inputs is another natural source of mercury in the oceans.
The cycling of mercury has existed since prehistoric times, independent of human activity. There is an equilibrium such that the amount of mercury that evades up into the atmosphere matches the amount that is deposited on the earth and aquatic surfaces. Thus, increases of mercury deposits in the oceanic layers will match the increases in atmospheric mercury.
Experts testified that since the industrial revolution, atmospheric mercury has increased by a factor of three (Tuna Companies), or within a spread of two to four (State).
Ionic mercury (mercury II) is the form of mercury that can convert into methylmercury through the process of methylation.[9] Methylmercury is an organic form of mercury in which the element is bound directly to a carbon atom in an organic compound.
2. Methylmercury in Ocean Fish
The world’s oceans are vast. Scientists have classified the oceans into three depth-specific layers. The surface or mixed layer comprises waters that are mixed by the winds to the depth of about 100 meters. The middle layer, from approximately 100 meters to l,000 meters in depth, is the thermocline. Temperatures decrease the deeper one goes and then become roughly constant in the deep ocean, which is about 1,000 to 4,000 meters in depth.
Methylmercury is the major form of mercury found in fish. It bioaccumulates in fish over time. Thus, as fish become larger, the level of methylmercury in the fish increases. All canned tuna contains trace amounts of methylmercury. As well, methylmercury in fish is the main source of human exposure to mercury.
3. Museum Fish Studies
Dr. Francois Morel, an expert for the Tuna Companies on the naturally occurring phenomenon, apprised the court of three studies which compared methylmercury concentrations in museum fish samples with modern fish samples. The premise of these studies was this: If methylmercury was formed in oceanic systems from the deposition of industrial mercury pollution, then there should be a higher concentration of methylmercury in modern fish than in museum fish caught prior to the industrial age.
The three studies—each published in a peer-reviewed journal—demonstrated that methylmercury concentration in ocean fish has not increased over time, notwithstanding increased contributions of mercury into the atmosphere due to manmade pollution. There were weaknesses and limitations in these studies, including the fact that the fish compared in one study were not of the same species and were not caught in the same area. As well, one study of museum and modern fish analyzed a fish that lives 2,000 to 3,000 meters deep in the ocean and has high levels of methylmercury. Anthropogenic pollution would not be expected at such depths because very little of the mercury deposited from the atmosphere into the oceans settles to the deep ocean. Nonetheless, of significance to Dr. Morel was the fact that both samples of fish had very high levels of mercury, and the lack of change was consistent with the idea that the concentration was unaffected by pollution.
4. Kraepiel Study
In 1998, Dr. Morel and his colleagues conducted the “Kraepiel study” to test whether methylmercury concentrations in ocean fish has increased along with global emissions of atmospheric mercury. This study compared yellowfin tuna caught near Hawaii in 1971 and 1998; an article devoted to the research model, findings and conclusions of this study was published in a peer-reviewed scientific journal in 2003. The researchers used a three-box model (or Kraepiel model) to test hypotheses concerning where mercury in the ocean is methylated—in the surface or mixed layer, the thermocline, or the deep ocean. The three boxes represented the three layers of the ocean in the target area. Mercury species were transported from one box to the other by water advection and vertical particulate transport. Dr. Morel testified that although simple, the three-box model was scientifically appropriate and sufficient to provide valid results.
The Kraepiel model was designed to predict the range of increase in methylmercury in the mixed and thermocline layers between 1971 and 1998. Those were the two depth-specific layers in which most scientists hypothesized that methylation of mercury would occur.[10] On the basis of the known increase in global emissions of mercury over the past century and using a simple model of mercury biogeochemistry in the targeted ocean area, the team calculated the range of increase in methylmercury concentration in the surface waters that should have occurred over the 27-year span if methylation occurred in the mixed layer or in the thermocline.
The gist of the study was that if mercury is methylated in the mixed or thermocline layers, and assuming an increase in atmospheric mercury from pollution and a concurrent deposition of mercury on the ocean over the 27-year period, one would expect that the concentration of methylmercury in tuna caught in the same general area would increase between 1971 and 1998.
The assumption that there had been an increase in atmospheric mercury during the period 1971 to 1998 was based on published scientific data. Further, the Kraepiel study took into account whether that increase was linear or exponential, and whether there had been a rise and a stabling.
The results of the study revealed that concentrations of methylmercury were on average slightly less in the 1998 tuna than in the 1971 tuna. From the data the authors rejected the hypotheses that methylmercury was formed in the thermocline or mixed layers, the only two hypotheses that were consistent with an anthropogenic contribution to the formation of methylmercury.


TO BE CONTINUED AS PART II….


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