For over 25 years, those selling products in California have been able to rely on the regulatory “safe harbor” level for lead of 0.5 micrograms per day in order to determine whether they need to provide Proposition 65 warnings for their products. Thanks to the April 11 ruling of the Alameda Superior Court, they can continue relying on that level for the time being. But an appeal looms, and the agency is still considering lowering the level by 60 percent.
With the ruling, businesses can breathe a bit easier that they will not be placed in limbo without a lead threshold specified by law. Because lead is one of the most commonly targeted chemicals in Proposition 65 enforcement actions, the safe harbor level for lead is of particular importance to businesses that rely on it to avoid or minimize costly litigation.
As we discussed previously, the Mateel Environmental Justice Foundation had argued that the agency’s determination of this level in 1989 was based on faulty and outdated science. The California Chamber of Commerce and California Farm Bureau Federation, represented by Arnold & Porter, intervened on the side of the agency to defend the regulation. Although the court declined to dismiss the case on statute of limitations ground, it ultimately ruled on the merits that the agency’s scientific determinations are entitled to deference.
After the lawsuit was filed, another Prop 65 activist group, the Center for Environmental Health, filed an administrative petition with the agency seeking repeal or a reduction in the lead safe harbor level as well as a determination that the level can only be applied on a single-day basis. This would overturn the Beech-Nut decision we discussed here: the Court of Appeal held that, in measuring whether exposures exceed the safe harbor level or not, it is appropriate to average exposures to lead over a period of time greater than a single day for products that are consumed less frequently than every single day.
Attention now shifts to the regulatory process, in which the Office of Environmental Health Hazard Assessment is considering the following issues:
Lead Safe Harbor Revision: OEHHA issued a draft proposal to reduce the lead safe harbor to 0.2 mcg/day on a one-day basis and higher levels when consumption occurs at longer intervals. Comments are closed and OEHHA is considering them but reportedly intends to move forward with a formal proposal on this topic in the next few months.
Averaging: OEHHA’s draft proposal on the lead safe harbor was accompanied by two proposals (here and here) incorporating three revisions to how averaging is done: (1) the arithmetic mean would be used to calculate exposures, instead of the geometric mean approved in Beech-Nut; (2) all existing safe harbor levels set by OEHHA would apply on a single-day basis and cannot be averaged for consumption rates less frequent than daily; and (3) levels of chemicals in food products would have to be averaged only within each “lot” and not across lots. These are also pending review within OEHHA, but they are reportedly moving forward in the next few months despite serious policy and technical concerns expressed by the business community.
Naturally Occurring: OEHHA’s draft proposals also including proposed concentration levels of lead in most foods and arsenic in rice that would be deemed to be naturally occurring and therefore exempt. This proposal responds to repeated requests from the food and agriculture sectors for greater specificity regarding the elusive “naturally occurring” exemption in the regulations. OEHHA is also reportedly planning to move forward on this in conjunction with the other proposals.
Warning Regulations: OEHHA has issued a “near final” set of proposed regulations on safe harbor warnings, which made many substantive revisions to the last proposal. Comments are due on April 26, 2016. This proposal would completely overhaul the way that warnings are provided to California consumers and includes references to a new website managed by OEHHA to provide additional information to consumers under a recent regulation.
The court’s ruling in the Mateel case is rare good news for businesses on Prop 65. But they cannot let down their guard and will need to continue to address challenges on multiple fronts in the coming months.