OEHHA Proposes Significant Changes in Proposition 65 Lead MADL and in Rules for Evaluating Proposition 65 Exposures
The California Office of Environmental Health Hazard Assessment is proposing, in pre-regulatory draft proposals, far-reaching changes in the Proposition 65 warning trigger for lead as a reproductive toxicant (the lead “Maximum Acceptable Dose Level” or “MADL”) and in how exposures to Proposition 65 chemicals should be evaluated. OEHHA will be holding two public hearings: one on October 14, 2015 to discuss revisions to the lead MADL, and one on October 29, 2015 to discuss revisions to related regulations involving exposures to reproductive toxicants and to chemicals in foods. If OEHHA’s draft proposals ultimately are adopted, they are sure to increase litigation and drive companies to provide even more warnings on products in order to avoid litigation.
These draft proposals were instigated in part by the successful defense, upheld on appeal, of a Proposition 65 lawsuit alleging exposures to lead in baby foods, Environmental Law Foundation v. Beech-Nut Corp. That appellate ruling triggered a formal petition submitted on July 3, 2015 by the Center of Environmental Health and other NGOs to OEHHA, seeking the agency to repeal or amend the lead MADL and rules pertaining to the evaluation of exposures to Proposition 65 chemicals.
OEHHA’s draft proposal to amend the lead MADL would establish a tiered set of exposure levels depending on how frequent the exposure is. For example, the lead MADL would be 0.2 micrograms per day for exposures occurring every day. That is less than half of the current lead MADL of 0.5 micrograms per day. The highest lead MADL would be 8 micrograms, for an exposure occurring every 116 or more days. If the proposal is adopted, it would guarantee disputes about the frequency of exposure to lead, with Proposition 65 plaintiffs seeking to push the alleged exposure into the most stringent category possible — and it would guarantee that businesses would opt to provide warnings for lead simply to avoid that dispute.
The same proposal also would “clarify” OEHHA’s intent that all existing MADLs for Proposition 65 reproductive toxicants are set as the highest exposure that can occur in a single day, i.e., no averaging of exposures would be allowed.
OEHHA’s other draft proposals also seek to address issues raised in the Beech-Nut case. For reproductive toxicants, OEHHA proposes that “the reasonably anticipated rate of intake or exposure for average users of the consumer product” be calculated “as the arithmetic mean of the rate of intake or exposures for users of the product.” That is in contrast to the geometric mean, on which the Beech-Nut court in part based its decision. In making this proposal, OEHHA asserts that the geometric mean “underweights the rate of exposure to those people who consume significantly more of a food or product than typical consumers.”
A separate proposal would require the calculation of the average level of a reproductive toxicant in food to be calculated on a per-lot basis, rather than across lots. The proposal, which also defines the term “lot,” would require the concentration of the listed chemical to be determined “using a representative sample or other scientifically valid methodology for ensuring the concentration calculated accurately reflects the average concentration of the listed chemical in the lot.”
In the final draft proposal, and one apparently intended to provide greater certainty to sellers of certain raw foods, OEHHA would establish specific “naturally occurring” concentrations for lead and inorganic arsenic, which would be subtracted out from an exposure calculation when assessing the need to warn. For example, OEHHA proposes that the naturally occurring concentration for inorganic arsenic in brown rice grain be set at 130 parts per billion. Inasmuch as Proposition 65 deals with chemical dose and not chemical concentration, among other things, it is not easy to see how helpful this proposal would be for entities seeking the benefits of a safe harbor.
Taken together, OEHHA’s pre-regulatory draft proposals, if ultimately adopted, will drive even more warnings on products, adding to the warning “noise” in California — precisely the opposite outcome that OEHHA seeks.