CA Agency to Initiate Rulemaking to Update Proposition 65 "Safe Harbor" Level for Lead

2 min

CA Office of Environmental Health Hazard Assessment Responds to Center for Environmental Health Petition for Administrative Rulemaking

Earlier this week, the California Office of Environmental Health Hazard Assessment (OEHHA) responded to a July 3, 2015 petition filed by the Center for Environmental Health (CEH), in which CEH requested Administrative Rulemaking to repeal and/or amend Proposition 65 (Prop 65) regulations pertaining to the Maximum Allowable Dose Level (MADL) "safe harbor" for lead. In short, OEHHA determined that it will initiate a rulemaking to update the existing MADL for lead set out in Title 27, Cal. Code of Regs. (C.C.R.), section 25805(b), and will hold a hearing on the petition on October 9, 2015. The rulemaking could have a significant impact on the dietary supplement industry, as it could mean that products would need to have even lower levels of lead or include a Prop 65 warning. Such a rule would necessarily impact companies' choices of suppliers, affect product formulation decisions, and could impose significant costs on companies (e.g., the costs to revise product labels to include the Prop 65 warning).

CEH contended in its petition to OEHHA that the existing MADL for lead of 0.5 microgram per day (µg/day) is too high to protect Californians from the "well-established reproductive effects of lead that can and do occur at levels below 500 micrograms per day (1000 times the 0.5 µg/day level)." Accordingly, CEH contends that OEHHA should repeal 27 C.C.R. Section 25805(b)'s MADL for lead, to protect Californians, including workers, children, and pregnant women, from "unwarned exposures" to lead above those permitted by Prop 65. Ultimately, CEH is asking OEHHA to promulgate a regulation to clearly establish that the lead MADL is a single-day exposure limit and that averaging over time is not permitted when assessing compliance with the regulatory MADL.

OEHHA’s October 9, 2015 hearing on the CEH petition will take place at 10:00 a.m. in the Sierra Hearing Room at the CalEPA Headquarters building at 1001 I Street in Sacramento, CA. Further information and materials related to the hearing will be posted on the OEHHA website prior to the hearing date, which we will continue to monitor. Companies should consider submitting comments to OEHHA, particularly any data or analyses that might inform the appropriate "safe harbor" level for lead.

If you have questions regarding the issues raised in this alert, or would like to submit comments to OEHHA, please contact one of the authors.