California’s “Proposition 65” warning requirements have long been a major concern for businesses that want their products offered for sale in the State’s large marketplace. Businesses whose products contain even a detectable amount of any one of more than 900 chemicals often face enforcement lawsuits brought by for-profit plaintiffs unless their products contain a “clear and reasonable” Proposition 65 warning. Short of eliminating the chemical entirely, the only way for businesses to immunize themselves from such claims has been for companies to label or display their products with a generic warning based on language set forth in the original Proposition 65 regulations. It usually states: “WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.”
Three new developments threaten to make Proposition 65 less predictable and more difficult.
1) New Proposition 65 Warning Regulations Proposed for Adoption: Earlier this year, the California Office of Environmental Health Hazard Assessment (“OEHHA”) formally proposed an extensive set of new rules concerning the requirements for Proposition 65 warnings to be deemed “clear and reasonable.” While Proposition 65’s current regulations allow for compliance with its warning requirements through the type of generic, one sentence statement appearing above, the proposed regulations will, among other things, require:
a. use of a yellow triangle pictogram containing an exclamation point;
b. a more unequivocal warning statement indicating that the product “can expose” a user to chemicals known to the State to cause cancer and birth defects or other reproductive harm;
c. listing particular chemicals if they are among a group of twelve which are the most frequent targets of Proposition 65 litigation;
d. adding a URL to all warnings linking a public website that OEHHA will operate to provide information supplementing the warning for those so interested (see below); and
e. presentation of the warning in languages in addition to English if the product label otherwise uses languages other than English.
The proposed new Proposition 65 warning regulations specify alternative and additional requirements for certain types of products, including for food, restaurants, and several products or facilities that have previously been the subject of enforcement litigation. They also adopt revised and more onerous requirements for warnings for “environmental exposures,” such as for air emissions that arise from the operation of facilities or equipment within the State. As proposed, businesses will have two years from the adoption of a final rule to transition their warnings to meet the requirements of the new regulation, after which they can face enforcement actions and citizen’s suits for products in the California market that still bear the old (or no) warnings.
2) New Proposition 65 Website-Related Requirements Proposed for Adoption: Although not contemplated by the voters when they approved Proposition 65 over twenty-five years ago, OEHHA is also proposing that it operate a website to provide information to the public to supplement and explain the basis for the Proposition 65 warnings given by businesses. Information to be provided on this website may include the routes or pathways by which exposure to a chemical from a product may occur, OEHHA’s quantification of the level of exposure to a chemical presented by a product, and other information that may be of interest to plaintiffs as well as to sensitive consumers and other members of the public.
Significantly, in addition to its potential public education function, the proposed website regulations also empower OEHHA to require that manufacturers, importers, and distributors of products bearing a Proposition 65 warning provide the agency with information if so requested. Such information may include the identities of the chemicals in the product for which a warning is being given, the location or components of a product in which such chemicals are present, the concentration of those chemicals, and “any other information the lead agency deems necessary.” While trade secret protection may be asserted in some circumstances, the requirement to provide information to OEHHA will be enforceable by public prosecutors, including the California Attorney General and District Attorneys.
3) Potential Changes Relative to Proposition 65’s “Safe Harbor” Levels for Chemicals Listed for Reproductive Effects: Lead has been the focus of the vast majority of all Proposition 65 enforcement actions to date and resulted in hundreds, if not thousands, of settlements with national and international implications over the past two decades. Cases have included those concerning trace levels of lead in ceramic tableware, water faucets, candy, mini-blinds, toys, and a wide array of other consumer products and foods. However, in 2013, a trial concerning lead in 100% fruit juices, packaged fruits, and baby foods resulted in a highly significant Proposition 65 defense verdict based on a judge’s finding that the trace levels of lead exposure presented by each of these products was less that the State’s published “safe harbor” warning threshold for lead of 0.5 “micrograms/day.” A California Court of Appeal decision published earlier this year sustained, among other things, the trial court’s finding that it was permissible for defendants’ experts to construct a daily average level of exposure based on real world data concerning the frequency of the consumption of the products at issue over a fourteen day time period. Environmental Law Foundation v. Beech-Nut Corporation, et al., 325 Cal.App.4th 307 (2015).
In anticipation of this type of appellate decision, earlier this year, one of the most historically active Proposition 65 plaintiff’s groups, the Mateel Environmental Justice Foundation, filed a lawsuit seeking a writ of mandate and declaratory relief challenging the 0.5 microgram/day “safe harbor” for lead. Mateel contends that California’s published threshold for lead was not set consistently with Proposition 65’s 1,000-fold safety factor requirement for reproductive toxicants. It therefore argues that this longstanding Proposition 65 safe harbor threshold should be declared illegal and inoperative despite it having been published more than 25 years ago and relied on for thousands of settlements and warning decisions. Mateel further argues in its case that OEHHA should be ordered to promptly establish a dramatically more stringent safe harbor level for lead based on updated science concerning trace level exposures to lead. It also seeks to have OEHHA ordered to adopt a rule precluding the averaging of exposure across multiple days in relation to the lead safe harbor level. A second prominent citizen’s group, the Center for Environmental Health, which also focuses on Proposition 65 enforcement, submitted an administrative petition to OEHHA in early July seeking relief parallel to that sought by Mateel, regardless of the outcome of the lawsuit.
OEHHA has just announced that, in response to this petition, it will soon initiate a rulemaking to update the existing Proposition 65 safe harbor for lead and several related Proposition 65 regulations. The proposals include several major changes in the way the extent of exposure is calculated and how Proposition 65’s regulatory exemption for “naturally occurring” exemption for foods is determined. OEHHA’s new proposals essentially seek to nullify the important Beech-Nut precedents and will likely make it even more difficult for businesses to defend Proposition 65 claims about lead and the nearly 300 other chemicals listed for reproductive effects, especially those that may be present as trace contaminants in food products. OEHHA’s proposals include the following four elements:
A. Revised Safe Harbor for Lead and Other Chemicals. OEHHA proposes to repeal the current safe harbor level for lead (the Maximum Allowable Dose Level or MADL). In its place, OEHHA proposes multiple levels that depend on the frequency of exposure, from exposure once per day to once every 116 or more days. OEHHA asserts that the once-per-day figure should be reduced from 0.5 to 0.2 micrograms/day and that the existing 0.5 microgram/day level should instead apply only to exposures that occur no more than once every third day. For exposures that would occur only once every 6 to 9 days, the lead safe harbor figure would rise to 1.0 microgram/day and to higher amounts as exposure intervals become more infrequent. Plaintiffs’ groups contend that the lead safe harbor should be an order of magnitude lower at 0.03 micrograms per single day and do not want any alternative levels based on frequency of exposure over time. Despite its proposal for lead, as to all other chemicals listed for reproductive effects OEHHA proposes to eliminate any consideration of the frequency of exposure when safe harbor levels are applied.
B. Naturally Occurring Allowances for Lead and Arsenic in Some Foods. OEHHA also proposes to adopt specific naturally occurring allowances for lead and arsenic (but not other chemicals such as cadmium) in some specific types of food ingredients/products. The allowances for arsenic are 60 ppb and 130 ppb for white and brown rice respectively. For lead, they are 8.8 ppb for raw leafy vegetables and 6.2 ppb for raw non-leafy vegetables, fruit, meat, seafood, eggs, and fresh milk. The agency bases its proposal on data regarding background levels of lead in soil in California as well as rates of uptake by relevant plants.
C. Averaging of Product Samples. OEHHA further proposes to expressly prohibit averaging lead or other contaminant levels across different lots of a food product in the final form it will be purchased by a consumer. It would instead require that the level of a contaminant in a lot of food be determined by “representative sampling” from within a particular lot. OEHHA also would define a “lot” on a production basis, apparently by reference to date or production codes, which could significantly increase the amount of testing required. Testing on this scale may be infeasible for most businesses.
D. Average Rate of Exposure. Finally, OEHHA proposes to dictate that, as to any Proposition 65-listed chemical (lead or otherwise), the “average rate of exposure” must always be calculated based on the arithmetic mean and not a geometric mean or some other measure of the central tendency of a data set. OEHHA’s proposal flies directly in the face of the scientific testimony that prevailed in Beech-Nut and the prior position of the California Attorney General’s office on this issue.
OEHHA has scheduled public hearings to further discuss its new proposals on October 14 and 19, 2015. It is also inviting written public comment on the lead safe harbor issue until October 28, 2015, and on the averaging issues until November 2, 2015.