California appellate court ruling paves the way for using average exposure calculations to determine applicability of Proposition 65 “safe harbor.”

  • Proposition 65 is a “right to know” California statute that requires companies to provide warning statements where their products cause an “exposure” to carcinogens and/or reproductive toxicants.  California’s Office of Environmental Health Hazard Assessment (OEHHA) maintains an up-to-date list of the chemicals (>800) that trigger warnings.  The warning requirements do not apply where a particular exposure falls within the “safe harbor,” which is defined by reference to:
    • the no significant risk level (NSRL) for listed carcinogens, which is the level of a chemical calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime (70-year) exposure to the chemical at the level in question; or
    • the maximum allowable dose level (MADL) for reproductive toxicants, which is the level at which a chemical would have no observable effect assuming exposure at 1,000 times that level.
  • In the instant case, plaintiff – the Environmental Law Foundation – sued Beech-Nut Nutrition and other food manufacturers, distributors, and retailers, alleging that their fruit and fruit juice products, intended primarily for babies and toddlers, contain amounts of lead sufficient to trigger warnings under Proposition 65, based on the amount of lead in a product consumed in a single day.  Among other arguments, the defendants asserted that their products result in lead exposures that fall within the “safe harbor” based on the average consumer’s reasonably anticipated rate of exposure to lead from their products, including frequency of use over the relevant susceptibility time period for the reproductive toxicant.  The appellate court now has affirmed the trial court’s ruling in favor of the defendants.
  • Prior to this decision, plaintiffs in Proposition 65 litigation routinely asserted that an exposure in excess of the MADL on even a single given day triggers the warning requirement and that averaging is not permitted for reproductive toxicants.  The appellate court found no formal OEHHA policy that prohibits averaging exposure over time, even for reproductive toxicants, and further found that the defendants’ experts had used sufficiently reasonable and valid scientific methods to support their “safe harbor” conclusion.  This ruling marks a significant victory for companies who market products that contain chemicals listed under Proposition 65 as reproductive toxicants; it paves the way for companies to use appropriate averaging and rules of reason when determining the application of the “safe harbor.”