Proposition 65

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Prop 65: New Threshold for Calculating Exposure to Chemicals

March 23, 2015

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Environmental Law Foundation v. Beech Nut Nutrition Corp. et al., Case No. A 139821, First Appellate District of California, March 17, 2015

On March 17, 2015, the California Court of Appeal for the First Appellate District upheld a trial court ruling that exposure to a Proposition 65 (Health & Safety Code § 25249.5 et seq.) listed chemical, namely lead, should be measured by an average exposure over time as opposed to a single day exposure. The defendants in this case were manufacturers of food primarily intended for babies and toddlers, such as baby foods, fruit juice and packaged fruit cups. Since the defendants satisfactorily demonstrated that the average consumer's reasonably anticipated rate of exposure to lead from their products fell below the relevant regulatory thresholds, the defendants need not give Proposition 65 warning for their products. The ruling has the effect of determining that the defendants were not in violation of Proposition 65 and its prohibition on exposing consumers to certain chemicals without a reasonable warning.

Proposition 65 states that "no person...shall knowingly or 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...." Health & Safety Code § 25249.6. Lead has been listed by the State of California as both a causing cancer and reproductive toxicity. The state agency which oversees Proposition 65, the Office of Environmental Health hazard Assessment (OEHHA), has set by regulation the method for calculating the exposure to a chemical in food by first quantifying the chemical concentration of the listed chemical and then multiplying that concentration by the reasonably anticipated rate of exposure for an individual. The rate of exposure is based on the pattern and duration of exposure that is relevant to the reproductive effect. 

If the defendant can show that the exposure will have no observable effect assuming exposure to one thousand times the level in question for substances known to cause reproductive toxicity, then no warning is required. H&S Code § 25249.10(c). The no observable effect level or "NOEL" is determined through a scientific inquiry and assessment. The NOEL is divided by one thousand to arrive at the maximum allowable dose level or "MADL." OEHHA has determined the MADL for lead to be 15 micrograms per day for carcinogenicity and 0.5 micrograms per day for reproductive toxicity.   

The Environmental Law Foundation (ELF) filed suit under Proposition 65, alleging that defendants intentionally and knowingly exposed consumers to lead in food without providing reasonable warnings. Prior to trial, the parties stipulated that ELF had met its burden on its affirmative case. The parties did not dispute that the products contained small amounts of lead. The defendants raised three issues at trial: 1) that any Proposition 65 warning were preempted by federal law; 2) that lead in their products is naturally occurring; and, 3) that the exposures fall below the regulatory “safe harbor” level of 0.5 micrograms per day.

The parties submitted by declaration and cross and redirect examination the expert testimony of seven different experts. ELF’s experts testified that it was necessary to determine the exposure by measuring a single daily dose of lead. The defendants’ experts testified that the correct measure of exposure should be based upon an average dose over time. 

The trial court held that the defendants had not established that federal preemption applied or that the regulatory “naturally occurring” defense was applicable. The trial court did find that the expert testimony presented by defendants was more persuasive than the ELF analysis. The trial court specifically rejected ELF’s expert’s use of a database that assumes each product was eaten once every two days as a proxy for amounts consumed by the average user. Instead, the trial court accepted the defense expert’s average consumption per day calculations over a longer period of time.

On appeal, the court first looked at whether the OEHHA regulations prohibited the averaging of data to determine the amount of exposure. The court concluded that, although the Statement of Reasons for the regulations addressed the level in question and did not adopt a distinction based on the mean or average level of a listed chemical, this was to prevent confusion between chronic and acute levels and did not mean the use of averages was impermissible. Nor was there an issue with using methods of averaging across lots for a single product. The court noted the issue of product lots was specifically aimed at adulterated food, which was not an issue before the court. The ELF, the court stated, failed to refute the fact that samples of defendants’ products showed various levels of lead not just across units but within each individual unit. ELF also attacked the defense methodology, arguing that the defense expert used insufficient representative samples. The court, after determining that that issue was not timely raised, concluded that the ELF expert relied on the same sample results as the defense expert and that this anecdotal evidence is insufficient to demonstrate unreliability.   

The court then rejected ELF’s contention that the exposure analysis should be based on acute toxicity that assumed that lead levels in the defendants’ products would be higher than those actually found. ELF also contended that the defendants’ failure to evaluate short-term exposure to higher levels of lead was fatal to the defense use of safe harbor. The court disagreed and stated that prior Proposition 65 case law envisioned a case-by-case approach taking into account the totality of the quantitative risk assessment evidence.

The evidence showed that the products were not eaten more than four times per month and each side agreed that the window of susceptibility to lead was over an eight week period, that is eight weeks is the shortest period of time in which a product would be expected to have an adverse reproductive effect. It was undisputed that the products were not eaten every day. Based upon the defense analysis, the level of exposure when averaged over time would not exceed the NOEL; therefore, no warnings are needed and no violation of Proposition 65 has occurred.

The case can be submitted to the California Supreme Court for review, but assuming it is not accepted, it is now the law in California that exposure to listed chemicals under Proposition 65 can be based on the average exposure over time.

For more information, please contact:

Michael Van Zandt

415-995-5001 Direct Phone
415-995-3566 Fax

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