A California court has tentatively determined, following a 10-day bench trial, that the levels of lead in canned or packaged fruit, vegetable and grape drink products, or baby foods, are below the regulatory “safe harbor” exposure level under Proposition 65 (Prop. 65) and therefore that the companies which make them are not required to provide Prop. 65 warnings to consumers. Envtl. Law Found. v. Beech-Nut Corp., No. RG11 597384 (Cal. Super. Ct., Alameda Cnty., tentative decision entered July 15, 2013). Because few Prop. 65 cases go to trial, the court was faced with a number of questions of first impression, primary among them application of the “naturally occurring” defense.

The parties did not dispute the presence of lead in the products or that it has been identified as a known carcinogen and reproductive toxin under Prop. 65. Beech-Nut Corp., the original defendant, was joined at trial by a number of other food and beverage manufacturers, including Del Monte Foods; Dole Packaged Foods, LLC; Gerber Products Co.; Seneca Foods Corp.; Tree Top, Inc.; and Welch’s Foods, Inc. They claimed that no warnings were required because they were preempted by federal law, the lead in their products is naturally occurring and does not constitute an “exposure” under Prop. 65, or that they have established that the exposures are below the regulatory “safe harbor” level of 0.5 micrograms per day.

As to preemption, the defendants argued “that requiring their labels to carry a warning to the effect that the products contain lead . . . would be an obstacle to federal objectives and amount to misbranding under the FDCA [Food, Drug, and Cosmetic Act].” Essentially, they contended that the federal government has a policy of promoting the consumption of these foods, and a Prop. 65 warning on product labels would deter consumers from buying the products. The court determined that the defendants failed to identify a federal policy “with which a Prop. 65 warning would be in direct conflict” or to produce evidence that a “warning would result in California consumers eating fewer fruits and vegetables.”

Noting that the “naturally occurring” defense is not a part of the statute, but rather has been adopted through formal rulemaking by the Office of Environmental Health Hazard Assessment (OEHHA), the court also determined that the defendants (i) failed to offer evidence “that the small amounts of lead in their products are present ‘solely as a result of absorption or accumulation of the chemical which is naturally present in the environment’”; and (ii) did not show what portion of the lead in their products was naturally occurring. According to the court, OEHHA’s rule “required Defendants either to establish that the lead in their products was solely geogenic or to establish the proportions that were geogenic. They did neither.”

In ruling that the defendants also failed to demonstrate efforts to achieve the “lowest level currently feasible” as part of the “naturally occurring” defense, the court rejected the plaintiff’s argument that food manufacturers must comply with all of the guidelines of the Codex Alimentarius Commission’s Code of Practice for the Prevention and Reduction of Lead Contamination in Foods. The court noted that the Codex recommendations have not been adopted by the Food and Drug Administration and were, in fact, adopted in 2004, more than 15 years after the implementing regulations were enacted. Thus, in the court’s view, OEHHA could not have had the recommendations in mind when drafting the regulations. The court also stated, “[M]any of the recommendations in the Codex are not realistically achievable and would accomplish very little. For example, the recommendations to test each grower’s soils for lead would require tremendous expenditures and would have little effect on the amount of lead in the products.”

As to its conclusion that the defendants had established the safe harbor defense, the court was persuaded by their primary nutrition expert, Barbara Peterson, who based her finding that the average user who consumed the products was exposed to less than 0.5 micrograms per day of lead, averaged over a scientifically appropriate period of 14 days, on average lead test results for the products rather than evaluating each individual test score separately. She obtained consumption data from the NHANES database and averaged the survey data, analyzing it with a geometric mean rather than an arithmetic mean.

She also did not, as the plaintiff’s expert did, rely on the 85th percentile of the NHANES data as representative of what the average consumer eats on one or more eating occasions on the same day. According to the court, the plaintiff’s expert only did so because counsel asked her to focus on the 85th percentile without explaining why. The court rejected the plaintiff’s reliance on a case involving touch-up paint containing toluene, stating “DiPirro does not stand for the proposition that consumer data at the 85th percentile of consumption data which overstates the amounts of a listed chemical average users are exposed to is an appropriate substitute for actual consumption data to determine intake or exposure for average users.”

The court further rejected the plaintiff’s effort to elevate the views of their OEHHA witness regarding Peterson’s averaging approach to the level of agency policy. According to the court, “on the present record, The Court cannot find that what was said in Dr. Donald’s 1991 declaration constituted a policy of OEHHA, or that the policy he testified to at trial is one which was well known and of longstanding. . . . There is no evidence that Dr. Donald’s declaration performed the function of advising those responsible for compliance with Prop. 65 of any policy of OEHHA regarding averaging or frequency of exposure.” The court also found his “expression of policy” unclear.

The parties have 15 days to file and serve any objections.