California Doubles Down on Proposition 65 Regulations; OEHHA Issues Pre-Regulatory Proposals That Harm Existing Defenses

Late last week, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) released several new pre-regulatory draft proposals regarding Proposition 65 (“Prop 65”). With one possible exception, the pre-regulatory draft proposals double down on the existing Prop 65 burden for companies doing business in California, and would make defending a Prop 65 action even more costly. In an era when more should be done to curb Prop 65 abusive lawsuits, it is unfortunate to see proposals from OEHHA that further complicate the already difficult Prop 65 defense options.

New Safe Harbor Level for Lead: In response to a petition filed by a well-known Prop 65 plaintiff to repeal or amend the Maximum Allowable Dose Level (“MADL”) for the chemical lead, OEHHA has proposed a modified calculation method that considers exposure limits over various time periods. For instance, instead of the current MADL of 0.5 micrograms per day (“µg/day”) for lead, the limit would be lowered to 0.2 µg for exposure that occurs in a single day, but would increase it to 1.0 µg/day for an exposure that occurs only once a week. Remarkably, OEHHA also proposes adding language to the regulations that state that safe harbor levels for other chemicals (not lead) causing reproductive toxicity would be limited to a single day, i.e., not averaged over time. Applying this single-day exposure limit to the MADLs established for other reproductive toxicants is inconsistent with the existing law. Further, OEHHA has not provided any science to support the proposed blanket limitation for all other reproductive toxicants. OEHHA is holding a public workshop on these proposals on October 14, 2015, and written comments are due by October 28, 2015.

Averaging Rate of Exposure: Under Prop 65’s current regulations, the level of exposure to consumer products is calculated using the reasonably anticipated rate of intake for average users of the product. A recent case approved calculation of the reasonably anticipated rate of intake of exposure using the geometric mean. See Envtl. Law Found. v. Beech-Nut Corp., 235 Cal. App. 4th 307 (2015). OEHHA’s proposed changes to the regulations would require that the rate of exposure be calculated using the arithmetic mean of the rate of intake or exposure, not the geometric mean, contrary to Beech-Nut. OEHHA is holding a workshop on this proposal on October 19, 2015, and requiring written comments by November 2, 2015.

Averaging Concentrations in Food Products: Also contrary to Beech-Nut, OEHHA proposes a change to the regulations that would require that the “level in question” of a reproductive toxicant in foods be based on a single lot of the final product, and would prohibit averaging chemical concentrations across lots. OEHHA’s proposal defines “lot” as a “quantity of a food offered for consumer products having uniform characteristics and quality that is generated by one producer during a single production run, on a single processing line.” It is holding a workshop on this proposal on October 19, 2015, and requiring written comments by November 2, 2015.

Naturally Occurring Allowances for Lead and Arsenic in Unprocessed Foods: In a proposal that may be welcome by some agribusiness companies, OEHHA has provided for levels of arsenic and lead that will be considered “naturally occurring” in certain foods. For white rice grain, inorganic arsenic will be considered naturally occurring at 60 parts per billion (“ppb”); for brown rice grain, inorganic arsenic will be considered naturally occurring at 130 ppb. Lead in raw leafy vegetables will be considered naturally occurring at 8.8 ppb, and lead in raw non-leafy vegetables, fruit, meat, seafood, eggs, and fresh milk will be considered naturally occurring at 6.2 ppb. These levels are extremely low and the regulations do not address other products, such as dietary supplements, which sometimes also have naturally occurring levels of these chemicals. The regulations likewise do not address other chemicals that are commonly found in food products, such as cadmium. Nonetheless, it is positive that OEHHA has acknowledged that these chemicals are naturally occurring for certain products and that OEHHA is willing to establish some default levels. Whether the levels proposed are reasonable and reflect current science will likely be discussed at the OEHHA workshop on this proposal, on October 14, 2015, and in written comments due October 28, 2015. It is anticipated that plaintiffs’ organizations will oppose any efforts by OEHHA to set these or any naturally occurring default levels under Prop 65.

If you have questions concerning the content of this alert, please contact Melissa Jones.