In response to a petition from the Center for Environmental, the California Office of Environmental Health Hazard Assessment will initiate a rulemaking to update the current 0.5 µg/day safe harbor level for lead. The implications are huge, as years of Prop 65 settlements over lead have been premised on the existing safe harbor level. CEH argues in its petition that there is no safe level for lead – if OEHHA agrees with this position, any amount of lead in any consumer product would require a warning and could lead to a Prop 65 lawsuit.
CEH’s petition is largely seen as a response to the decision in ELF v. Beech-Nut, in which the California Court of Appeal affirmed a lower court decision permitting averaging of exposures. CEH argues that averaging lead exposures over a 14-day period equates to increasing the safe harbor level to 7 µg/day (7 µg/day averages over 14 days is 0.5 µg/day). CEH also asserts that since OEHHA set the safe harbor level in 1989, it should have reevaluated, and lowered, that exposure rate when it changed the basis for the listing of lead in 2013.
We expect OEHHA to consider four regulatory proposals, including revising the safe harbor level, adopting naturally occurring allowance levels for agricultural products, permitting averaging in food products only across the same lot, and clarifying that the average rate of exposure is based on the arithmetic mean.
- Revising the safe harbor level: preliminary indications are that OEHHA will revise the lead safe harbor level based on the frequency of exposure. This will address the averaging issue raised in Beech-Nut. Under the approach, the one-day safe harbor level could be reduced to 0.3 µg/day, with an increase to approximately 3.0 µg/day at and above 10 days.
- Naturally occurring allowances: to account for background levels of lead in soil and uptake by plants, OEHHA will seek to define naturally occurring allowances in agricultural products grown in California. Only lead above these allowances would count toward the safe harbor level.
- Averaging across lots: OEHHA would only permit averaging of lead across the same lots of a food product, meaning that a producer could establish compliance with the safe harbor level for a given lot by averaging representative samples from that lot.
- Average rate of exposure: OEHHA would establish that average rate of exposure is based on the arithmetic mean, and not the geometric mean or other approaches to averaging.
A long process
OEHHA will hold a public hearing on October 9, 2015 to discuss the petition. It will publish information on the potential changes on the OEHHA website in advance of the hearing. Given the magnitude of these issues and the controversy involved, these approaches could change significantly. We expect a lengthy process and a long road to a final rule.