Environmental Law & Toxic Tort Alert: Court Permits Averaging of Exposure in Prop. 65 Cases

On August 7, 2013, Alameda Superior Court Judge Brick issued a comprehensive decision in Environmental Law Foundation v. Beech-Nut Corporation in which he held that it was appropriate for defendants’ expert to average lead test results to determine the average lead content for their packaged fruit and vegetable products. As a result of the use of the averaging methodology, which assumed that consumption was averaged over time and not measured on a daily basis, defendants’ challenged products were found to have satisfied the regulatory safe harbor level of 0.5 micrograms of lead from those products per day.

The Court thoroughly reviewed the methodology employed by defendants’ expert, Dr. Barbara Peterson, in support of her averaging the consumption data. First, Dr. Peterson started with the test results for all tests of defendants’ products done by plaintiff and defendants. Those test results were averaged. Next, Dr. Petersen obtained consumption data about those products from the NHANES data base and averaged the survey data. She next determined the frequency with which average users consumed each of the products using the NET data base. For each product, she then multiplied the average lead concentration times the amounts eaten per day times the frequency of consumption during a fourteen day period covered by the NET survey data and compared the result with the 0.5 microgram/day standard. In each instance, using Dr. Peterson’s methodology, the products met the exemption from notification standard set forth in section 25801(b)(2).

Plaintiff’s expert was critical of Dr. Peterson’s averaging of test data because of her concern that averaging would tend to mask individual relatively high results. However, she did not contradict Dr. Peterson’s testimony concerning the variability of lead in individual containers of the challenged products. The Court held, “Although averaging will not disclose the results of the individual samples tested, those individual tests are not necessarily representative of the lead content of the container tested. It is only through conducting a sufficient number of individual tests and averaging the results that a reliable estimate of the lead concentration in the food products in this case to which consumers are exposed can be determined.”

Dr. Peterson concluded that the test results were “log normally distributed,” that is most of the data clustered around the same point with a few exceptions that would skew the results of an arithmetic mean. For that reason, she analyzed the data using the geometric mean rather than the arithmetic mean. Plaintiff argued that use of the geometric mean was done in order to get lower results. However, the Court was persuaded by Dr. Peterson’s use of the geometric mean because she made it clear that in each instance she examined the data to determine whether it was normally distributed or log normally distributed, and found that it was log normally distributed. Plaintiff’s expert did not contradict those characterizations of the data.

The penultimate step in Dr. Peterson’s safe harbor analysis (before comparing the numbers she derived to the 0.5 micrograms per day standard), was to determine the frequency with which the products are consumed by average users. Plaintiff argued that because lead is a teratogen, the NHANES data showing amounts consumed per eating occasion and per day should not be averaged, but should be presumed to be consumed daily. Defendants contend that because of the low concentrations of lead in each of their products and because the products are typically not consumed on a daily basis, it is appropriate to consider frequency. In support of their position, plaintiff relied on the testimony of a government witness from the Office of Environmental Health Hazard Assessment (OEHHA), which is tasked with administering the Prop. 65 program.

The witness testified that the OEHHA’s policy is to permit taking frequency of exposure into account for lead only when a defendant seeks to establish a defense under Section 25801(b)(1) but was not when the defense is brought under section 25801(b)(2) as was the case here. The Court ruled that the witness’ testimony was entitled to little weight in interpreting the regulations because the witness’ testimony was not adopted by OEHHA in any formal way nor was his view expressed in the lengthy Final Statement of Reasons or in any other OEHHA publication. Moreover, the witness’ interpretation does not account for the Final Statement’s explanation of section 25821 that: “If it is scientifically more appropriate to evaluate a reproductive toxicant for chronic toxicity, this section does not permit it.”

It is not known whether plaintiff will seek review of the judgment or otherwise object to it. A copy of the decision is available upon request.

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August 28, 2013