Lead Exposure in Brown Rice Case Dismissed

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California Court Applies Proposition 65 Safe Harbor in Dismissal

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Wednesday, January 10, 2024

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Last month, a California Superior Court dismissed a case against Gulf Pacific Rice Company which alleged that one of their brown rice products contained elevated levels of lead and failed to carry an appropriate warning as required by the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).
Proposition 65 provides a safe harbor where it can be shown that the exposure to the chemical in question is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. These thresholds below which no warning is needed are referred to as “no significant risk levels” (NSRLs) in the case of carcinogens and “maximum allowable daily levels” (MADLs) for chemicals that cause reproductive harm.
The MADL for lead is 0.5 micrograms/day so the question at trial was whether the exposure to lead from consumption of the brown rice product exceeded this level.
The Court agreed with Defendant’s calculations indicating that expected exposure was only 0.01 micrograms/day, well within the safe harbor. In so doing, the Court concluded that:
- It was appropriate to use the geometric mean rather than the arithmetic mean for all calculations, because the geometric mean reduces the effect of outliers and “is the generally accepted scientific method for the determination of the central tendency of a set of data.” The geometric mean is always equal to or less than the arithmetic mean.
- An exposure assessment under Proposition 65 should use consumption data from all groups “and is not limited to any specific subpopulation, ethnicity, gender or other subcategory.”
However, the Court did reject the Defendant’s constitutional challenges to Proposition 65 as well as the argument that Proposition 65 was preempted by the Federal Food, Drug, and Cosmetic Act.