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Averaging to Determine Exposure under California's Prop 65 Allowed, Says Court

March 24, 2015

The Court of Appeal of the State of California affirmed on March 17, 2015, a lower court's ruling that food companies may average exposures over time to determine if levels of reproductive toxicants in their products are sufficiently low to exempt them from the need to provide a warning under Proposition 65. The ruling stems from a complaint the Environmental Law Foundation (ELF) filed in 2011 against Beech-Nut Nutrition Corporation and other companies seeking enforcement of the provisions of California's Safe Drinking Water and Toxic Enforcement Act of 1986 with respect to lead content in certain food products. The Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65, prohibits a company from knowingly exposing any individual to a listed chemical, such as lead, without first providing a "clear and reasonable warning"" to such individual. The law provides an exemption from the need to provide a warning where exposures are below a "safe harbor"—an established no significant risk level (NSRL) for a carcinogen or a maximum allowable dose level (MADL) for a reproductive toxicant.

In Environmental Law Foundation v. Beech-Nut Nutrition Corp., et al., ELF had argued to the trial court that a single exposure to lead above the 0.5 microgram per day MADL would cause a product to violate Proposition 65. The trial court disagreed. ELF maintained on appeal that the trial had erred in permitting defendants to average the level of exposure to lead over multiple days instead of looking at exposure that occurred on the day the food was actually consumed. A question on appeal was whether the Proposition 65 regulations administered by California's Office of Environmental Health Hazard Assessment (OEHHA) prohibit the averaging of exposures. The appeals court agreed the defendants and affirmed the trial court's conclusions with respect to averaging. As a practical matter, the court's ruling, in asserting that "Proposition 65 ‘envisions a case-by-case approach which takes into account the totality of the quantitative risk assessment evidence presented,'" means that under certain circumstances it is appropriate to average exposures to reproductive toxicants for purposes of determining whether a warning is required.