Despite positive reviews from the EPA and European Food Safety Authority, Bisphenol A (BPA), a synthetic compound used to line canned goods and other consumer products, was added to the Proposition 65 list on May 11, 2015, as a chemical known to cause reproductive toxicity. Effective May 11, 2016, private enforcers may bring lawsuits to force warnings on products for exposures to BPA. No warning is required if a company can show that the exposure is below the regulatory safe harbor, also known as the Maximum Allowable Dose Level (MADL), but this defense is difficult in practice because the law places the burden on defendants to demonstrate de minimis exposure, whereas private enforcers need only show the presence of BPA in a product to bring a lawsuit.
In response to the listing, several industry groups met with the California Office of Environmental Health Hazard Assessment (OEHHA) regarding the potential negative impacts the listing would have on businesses and consumers, especially if the listing was enforced absent the adoption of a safe harbor MADL for BPA. Brushing aside these concerns, OEHHA will allow enforcement of the listing.
OEHHA did recently announce two new regulatory measures, one an “emergency regulation” to take effect immediately, relating to the BPA listing, but neither serve to alleviate the concerns raised by various industries:
OEHHA has issued a notice of emergency regulation to allow temporary use of a standard point-of-sale warning signs for BPA exposure from canned and bottled foods and beverages, but no other products.The provision, if adopted, would expressly deem manufacturers or distributors of such products to be in compliance if they provide a specified notice to retailers, as well as providing the retail seller, at no cost, a sufficient number of point-of-sale warning signs, which must meet certain specifications. The emergency regulation would expire after 180 days.
OEHHA has issued a notice of proposed rulemaking to set an MADL for BPA of 3 micrograms per day for dermal exposure from “solid materials.”OEHHA relied primarily on animal studies that reported a subcutaneous “lowest observed effect level” of 0.05 milligrams per kilogram body weight per day. Yet, the data relied upon by OEHHA has recently been called into question because they did not report a No Observable Effect Level (NOEL), which the statute calls for, nor did they consider differing exposure pathways.
Interested parties must provide written comments relating to the emergency regulation to OEHHA immediately. Parties who wish to provide public comment on the dermal BPA MADL proposal must submit them by April 29, 2016. If you have any questions regarding this information or would like to submit comments to OEHHA through counsel, please contact Maria C. Garcia˘, Anthony J. Cortez, or Greg Sperla at Greenberg Traurig.
Maria C. Garcia˘ is a lobbyist who specializes in helping consumer product companies influence legislative and regulatory action in California. Anthony J. Cortez and Greg Sperla are litigation and regulatory attorneys who work with consumer product companies that do business in California.