California court affirms Prop 65 lead MADL at 0.5 mcg per day

California court affirms Prop 65 lead MADL at 0.5 mcg per day

Appeals Court rejects lawsuit challenging established standard for Proposition 65 warnings

Published: Tuesday, July 24, 2018

On June 5, 2018, the California Court of Appeal ruled against private plaintiff Mateel Environmental Justice Foundation (Mateel) and upheld the current 0.5 microgram per day safe harbor for lead, as set in 1989 by the predecessor agency to the Office of Environmental Health Hazard Assessment (OEHHA). The ruling has since been finalized by the Court. Mateel had sought to force OEHHA to repeal the regulations for setting a “maximum allowable dose level” (MADL) for lead as a reproductive toxicant and to revoke the safe harbor for lead.

This ruling has particular significance for the dietary supplement industry, as the main focus of Proposition 65 notices and settlements for supplement products has been related to trace levels of lead in these products.

“Prior to this challenge by Mateel, it’s inconceivable that anyone would have considered maintaining the unreasonably low limit for lead of 0.5 mcg/day to be anything to celebrate,” said AHPA’s Director of Program Development, Jane Wilson. “But if the plaintiff had been successful the likely proliferation of Proposition 65 warnings would have made this well-intentioned but impractical law even less meaningful to California consumers.”

Some positive highlights of the ruling are as follows:

  • It recognizes that setting a safe harbor level using “evidence and standards of comparable scientific validity” to the science on which the Proposition 65 listing is based is different from using only the same science on which the listing is based.
  • It recognizes that the regulations on how to set a MADL are intended to be defaults, and other scientific approaches can be utilized as long as they are defensible.
  • It states, for the first time in a binding legal opinion, that postnatal exposures are not covered by Proposition 65. This was a regulatory interpretation issued soon after the implementation of Proposition 65 -- that “reproductive harm” only covers prenatal exposures to the fetus and harm to the male or female reproductive systems.
  • The opinion repeats a key quote from a prior Supreme Court decision in a product liability case, and notes that overwarning would “invite mass consumer disregard and ultimate contempt for the warning process.”

AHPA continues to maintain its long-time attention to Proposition 65 issues, including the changes to warning requirements that will become effective on August 30, 2018. AHPA’s Guidance on Proposition 65 and herbal products and other information for industry can be accessed here.

The final California Court of Appeal decision can be accessed here.


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