• Food and Drug Alert: California Appellate Court Holds That Reproductive Toxicants Can Be Averaged Over Time When Determining Exposure Under Proposition 65
  • March 27, 2015 | Author: Leslie T. Krasny
  • Law Firm: Keller and Heckman LLP - San Francisco Office
  • In Environmental Law Foundation (ELF) v. Beech-Nut Nutrition Corp., (court opinion), the California Court of Appeal for the First Appellate District held that in appropriate circumstances, exposures to reproductive toxicants may be averaged over time under Proposition 65, otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986. As further discussed below, the practical effect of this ruling is that many products that would require a Proposition 65 warning under the interpretation of the law commonly held by the Proposition 65 plaintiffs’ bar will now qualify for an exception to the warning requirement.

    Proposition 65, in pertinent part, prohibits persons “in the course of doing business” from “knowingly and intentionally” exposing any individual to a “chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning.” Cal. Hlth. & Sfty. Code § 25249.6. The more than 800 chemicals known to cause cancer and reproductive toxicity are set forth on a list maintained by California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency that administers Proposition 65 (Proposition 65 list).

    An exception to the warning requirement exists, among others, for insignificant exposures to reproductive toxicants; that is, exposures that will have no observable health effect, assuming exposure at one thousand times the level in question. The level at which no warning is required is called the Maximum Allowable Dose Level or MADL. OEHHA has established many MADLs by regulation. They are expressed as an exposure level in micrograms per day, such as in the case of lead, which has an MADL of 0.5 micrograms per day. Any exposure at or below the MADL does not require a warning.

    Public and private enforcers of Proposition 65, including the California Attorney General, have long advocated that if an exposure exceeded the MADL on any one day and no warning is given, Proposition 65 is violated. The defense bar has advocated that the exposure to reproductive toxicants can be averaged over time when appropriate; typically, when the reproductive harm at issue occurs over a period of time and does not occur over the course of any one day.

    The Beech-Nut case confronted this issue of exposure averaging in the context of fruit products intended for babies and children, such as, juices, fruit cups and baby food. ELF filed suit under Proposition 65 against Beech-Nut and other defendants, alleging that the products at issue exposed consumers to lead without providing a warning. The fact that an exposure to lead occurred was not at issue in the case, as all of the parties agreed that the products caused an exposure. At issue, however, was whether the exposure exceeded the MADL for lead - 0.5 micrograms per day - and triggered the need for a warning. ELF argued that any one exposure above the MADL would cause a product to violate Proposition 65 and that no averaging is permitted under the statute. Defendants countered by arguing that because the relevant reproductive harm caused by exposure to lead occurred over a period of time, it is appropriate to average the exposure over that time period. The court agreed with defendants and the trial court, and now exposure averaging for reproductive toxicants is affirmed.

    The appropriate period to average reproductive toxicants will vary depending on the chemical involved. In Beech-Nut, the court stated that the evidence supported an eight-week period for averaging lead exposures because that was the shortest period during which an exposure to lead at levels detected in the products would be expected to have an adverse reproductive effect. However, because the court only had access to data regarding the consumption of the products over a 14-day period, the exposure averaging was limited to 14-days. It appears that the court would have been willing to permit averaging the exposures over eight weeks, if it had consumption data covering that span.

    An example using a nutrition bar that contains 3.5 micrograms of lead, and that average consumers of such bars eat once per week can illustrate this decision’s impact on Proposition 65 litigation. The plaintiffs’ bar’s previous argument was that Proposition 65 is violated when the MADL is exceeded on any one day (and no warning was given). Thus, each time that bar is sold without a warning, it violates Proposition 65 because the lead content of one bar exceeds the MADL. However, under Beech-Nut, that exposure is averaged over two weeks. In other words, two bars are consumed over 14 days and the seven microgram total exposure level is averaged over those 14 days. Consequently, the average exposure per day is 0.5 micrograms per day and no warning is required.

    Very few Proposition 65 cases make it to trial, but we expect this decision to have a significant impact when the parties to a Proposition 65 case begin settlement discussions. In many cases, defendants will find that they have something they are unaccustomed to in Proposition 65 cases - newfound leverage.