Last week, the lead agency responsible for implementing California’s Proposition 65, the Office of Environmental Health Hazard Assessments (OEHHA), completed a series of four workshops on proposed regulatory changes that would, if adopted, significantly impact the food industry and others. These proposed regulations follow two other rulemakings OEHHA initiated in January to overhaul the Proposition 65 warning regulations and to create a Proposition 65 website, which were described in a prior alert here. Both of those rulemakings were met with industry opposition and, at this month’s workshops, the regulated community expressed concern with the new draft regulations as well.
OEHHA released the four pre-regulatory draft proposals in response to the seminal decision by the California Court of Appeal in Environmental Law Foundation (ELF) v. Beech-Nut Nutrition Corp., et al. (Case No. A139821). ELF alleged that certain defendants’ foods including baby food and fruit juices caused exposure to lead at levels requiring a clear and reasonable warning under Proposition 65. Defendants prevailed at trial. The trial court concluded that defendants had no duty to warn because the average consumer's reasonably anticipated rate of exposure to lead from the products fell below the warning level. On appeal, the State of California supported ELF. Nonetheless, the trial court’s verdict was affirmed. OEHHA has expressly acknowledged that its proposed regulations aim to limit the precedential effect of portions of the Beech-Nut decision.
- Under current regulations, no Proposition 65 warning is required for consumer products that cause an exposure to 0.5 micrograms of lead per day or less. This is the “safe harbor.” In Beech-Nut, the trial court averaged a typical consumer’s exposures to lead in the products over a 30-day period and determined that the average daily exposure did not exceed the 0.5 ug safe harbor. In response, prolific plaintiff Center for Environmental Health petitioned OEHHA to repeal the safe harbor for lead. OEHHA now proposes to reduce the safe harbor level for lead. Specifically, OEHHA’s proposal would set a range of maximum allowable dose levels that range from 0.2 micrograms for daily exposures to 8.0 micrograms for an exposure that occurs only once every 116 or more days (an average exposure of 0.07 ug/day or less). OEHHA also proposes that no other reproductive toxicant could be averaged over time, although no scientific rationale is set forth to support such a sweeping and rigid limitation.
- Proposition 65 does not require warnings for exposures to naturally occurring chemicals in foods. In litigation, the defendant bears the burden of proving that this exemption applies and the amount of the chemical that is “naturally occurring.” This burden is heavy; other than the case of mercury in canned tuna, no defendant has ever succeeded at trial in establishing a naturally occurring defense (although there are settlements including negotiated naturally occurring allowances). Notably, the trial court in Beech-Nut did not find that the lead in the foods at issue was naturally occurring. OEHHA proposes to set concentration limits for naturally occurring inorganic arsenic in white rice grain (60 ppb) and brown rice grain (130 ppb) and for lead in raw leafy vegetables (8.8 ppb) and non-leafy vegetables, fruit, meat, seafood, eggs and fresh milk (6.2 ppb). These levels are low and as proposed, apply only to unprocessed foods.
- OEHHA proposes that the concentration of a chemical in a food be based on a single “lot” of the finished product. Under OEHHA’s proposal, the average concentration of the listed chemical in the lot should be determined using representative sampling. However, averaging test data across lots, as the defense did in the Beech-Nut case, would be prohibited. OEHHA’s proposal does not expressly require a plaintiff issuing a Proposition 65 notice letter to adhere to the same rules in determining whether there has been an actionable exposure. Given the defendants’ burdens of proof in Proposition 65 cases, this could lead to over warning on lots for which a warning may not actually be required. At the workshop last week, industry representatives also noted that OEHHA’s definition of a “lot” as “that quantity of a food product offered for consumer purchase having uniform characteristics and quality that is generated by one producer during a single production run, on a single processing line” is inconsistent with some existing food processing and realities of the marketplace. OEHHA did not advance a scientific justification for its position.
- Under Proposition 65, the level of exposure to a chemical from a consumer product is determined by looking at the reasonably anticipated rate of intake for average users of the consumer product. In Beech-Nut, the Court relied upon the geometric mean (or average) rate of intake instead of the arithmetic mean because expert testimony established that the former was more appropriate than the latter given the distribution of the data being averaged. OEHHA’s final proposal requires that, in all cases, regardless of the data set involved or the scientific correctness of the expert analysis, the rate of intake must be calculated using thearithmetic mean. Use of the geometric mean would be banned.
These are material proposals with enduring impacts on persons subject to Proposition 65. Time remains to submit written comments. Comments are due by October 28, 2015 on the first proposal, by November 12, 2015 on the second proposal and by November 17, 2015 on the third and fourth proposals. Because these are “pre-regulatory draft” proposals, there is greater ability now to shape the text which ultimately evolves into OEHHA’s official regulatory proposals.