California’s First District Court of Appeal has affirmed a trial court ruling in a landmark Proposition 65 case that may have a profound and lasting impact on future Proposition 65 enforcement actions.
The appellate court opinion affirms Alameda Superior Court Judge Stephen Brick’s 2013 decision that lead levels found in packaged fruit products and baby foods are below levels that would require warning labels under Prop. 65.
Environmental Law Foundation’s (ELF) 2011 lawsuit was closely monitored by the food, beverage and grocery industries which recognized the outcome would have a profound impact on future food litigation brought under Proposition 65. The trade associations and the Attorney General’s Office submitted amicus briefs to the appellate court.
The critical issue in both the trial and the appeal is whether lead exposures from packaged fruit products should be calculated by averaging national consumption data to define an average product consumer or by the highest single exposures—as ELF contends.
The exposure averaging issue was previously addressed by the appellate court in a case involving air exposures to toluene from Bondo Corporation’s auto paint products.
Although very similar issues were involved in a 2005 Proposition 65 trial involving mercury exposure from canned tuna, the appeals court did not consider consumption averaging in its 2009 opinion.
“The decision turned on whether lead exposure should be calculated on the assumption that consumers eat the food on a daily basis,” Robert Falk, a partner at Morrison & Foerster, which defended the sixteen food companies named in the suit told the San Francisco Recorder. Along with veteran litigator Michéle Corash, Falk’s team based their exposure calculations on a study that examined how often consumers eat these products within a two-week period.
“The implications of the Court of Appeal’s decision go beyond the fruit, juice, and baby food products in this case. They may also apply to claims concerning trace levels of arsenic, cadmium and other chemicals, in addition to lead,”Falk said. “In addition to Proposition 65 claims, the Court’s decision also may help to obtain dismissals of other types of lawsuits, including class actions predicated on allegations of failure to disclose the presence of scientifically immaterial trace amounts of lead or other chemicals in a product,” he added.
ELF filed its appeal to Judge Brick’s decision in September 2013, focusing on the exposure assessments presented by expert witnesses for the defense at trial. The organization contends the trial court erred in its determination that the relevant regulations allow defendants to average lead test results over multiple lots, instead of evaluating each lot individually. ELF claims the need for a warning should be evaluated independently for each test result on a product including the single highest one, without regard to the other data in the record on the same product. In support of its contention ELF asserts that the OEHHA “has explicitly rejected Dr. Petersen’s methodology of reducing multiple lots into a single average lead concentration instead of considering the lead concentration of individual lots.”
To support its contention, ELF relies on a passage in OEHHA’s Final Statement of Reasons for Article 8 of the Proposition 65 regulations:
“One commentator recommended that the regulation provide guidance for determining the chemical concentration of a listed chemical, since the level of a listed chemical in a product may fluctuate from unit to unit of production, and specifically recommended that it refer to ‘level in question’ as the mean or average level of a listed chemical unless exposure to the listed chemical produced acute adverse reproductive effects as the result of a brief period of exposure. . . . The Act does not appear to provide a basis for such a distinction. . . . A consistent interpretation of the words ‘level in question’ appears to be much less confusing and more consistent with the Act. Accordingly, this recommendation was not adopted.”
The appellate panel disagreed with ELF’s interpretation of the passage:
“Contrary to ELF’s interpretation, the gist of this passage is not that averaging contaminants over units of production is impermissible. Rather, the passage reflects the agency’s view that lending different meanings to the term “level in question” with respect to chemicals that produce acute adverse reproductive effects, as contrasted with those that produce chronic effects, would be confusing and inconsistent with the Act. Thus, we do not read the passage as stating an agency policy that “oppose[s] the use of averages when determining compliance with food standards,” wrote Justice Robert Dondero for the appellate panel. Dondero was the San Francisco Superior Court Judge that decided the Tri-Union tuna trial where calculating the average consumption of canned tuna over a 60-day period was a critical issue.
The California Attorney General’s Office submitted an amicus brief on behalf of ELF that argued Proposition 65’s regulations prohibit the trial court from allowing defendants to average lead exposure from consumption of their products over a defined time period before comparing the exposure to the 0.5 microgram per day regulatory MADL.
The Attorney General asserts that a defendant that relies on a regulatory MADL must accept a single-day exposure period, contending that defendants are prohibited from averaging the single-day maximum exposure of 0.5 micrograms over 14 days.
The Attorney General’s rationale appears to be that OEHHA did not independently determine a MADL based on an average exposure over an extended and defined period of time. Instead the agency calculated a daily Safe Harbor Limit. However, support for this argument is tenuous at best.
The Attorney General’s tenuous support is the testimony of OEHHA Chief of Toxicology James Donald, Ph.D, who testified at trial that the policy of OEHHA permits taking frequency of exposure into account for lead when a defendant seeks to establish a defense under section 25801(b)(1) of the regulations, but not when, as in this case, the defense is based upon section 25801(b)(2). The Attorney General’s amicus brief contends the trial court erred by improperly declining to give deference to his testimony.
The appellate panel’s opinion suggested Donald’s testimony received the deference it deserved from the trial court. None.
“Although administrative agencies’ interpretation of their regulations and language is entitled to great weight, we will not defer when the construction is unauthorized, unreasonable, or clearly erroneous. As the trial court noted, the evidence supplied by Donald was insufficient to demonstrate that his views represent the authorized, formal policy of the OEHHA. We concur with that assessment,” Justice Dondero wrote.
ELF had relied on another passage from OEHHA’s Final Statement of Reasons to support its daily exposure theory:
“Since some reproductive effects, such as teratogenic responses or birth defects, may reflect an acute response during a brief period of intrauterine exposure, exposure to
chemicals producing such effects should be assessed on the basis of short term exposure. Therefore, when one evaluates such a reproductive toxin, one needs to view the exposure as the one that may cause the acute effect. For example, if a food is eaten once per week, and if that food contains a teratogen, a proper assessment would require the assumption that ingestion of that food will occur on any day and, hence, every day) of the pregnancy. In other words, averaging to a daily intake would be inappropriate, since the embryonic response ought to be assumed to occur on the day of the ingestion of that food.”
Judge Brick in his trial court decision wrote: “ELF’s argument that the Statement supports a ‘no averaging’ position would be stronger if the Statement stopped there. However in the very next sentence the Statement makes clear that: ‘If it is scientifically more appropriate to evaluate a reproductive toxicant for chronic toxicity, this section does permit it. The food manufacturers took advantage of the option to establish a more scientifically appropriate method to evaluate the potential reproductive effects of lead in the products, engaging a well know toxicologist and an equally distinguished nutritional expert. “’
The appellate panel agreed with the trial court that the method used by the food companies to evaluate lead exposure was scientifically appropriate, finding that there was sufficient evidence to establish the defense’s exposure assessment, and the data and methodology the expert relied upon was sufficient to meet the requirements of Proposition 65 and the California Evidence Code.
Robert Falk, who, with Michèle Corash, lead the trial team which included trial litigators Linda Shostak and James Schurz and former appellate Justice Miriam Vogel. The trial team represented 16 food manufacturers in the case, including Beech-Nut, Del Monte, Dole, Gerber, Hain-Celestial, J.M. Smucker, Seneca, and Welch’s.
“The Court of Appeal’s decision supports that sound science and real world data on a product’s content and use characteristics should be the basis for requiring warning labels. We are pleased that the Court of Appeal has signaled that enforcement should not fall to the extremes and require the use of unrealistic default assumptions,” said Falk.
Michèle B.Corash was recognized by Law.com as Litigator of the Week following the publication of the Court of Appeal’s Opinion.
The Cases cited by this article are: Environmental Law Foundation v. Beech-Nut (Alameda Sup. Ct. Case No. RG11597384) and CA1 Case No. A139821.