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California Intends to Add BPA to Prop. 65 List of 'Known Reproductive Toxins'

Jan.31.2013

California's Office of Environmental Health Hazard Assessment (OEHHA) announced on January 25, 2013 that it intends to place bisphenol A (BPA) on the Proposition 65 Governor's List of chemicals known to cause reproductive toxicity. BPA is a chemical used to make polycarbonate plastics, and is typically found in the liners of food and beverage cans and some thermal paper used for transaction receipts. In 2012, the FDA rejected a citizens petition that sought to prohibit the use of BPA in food packaging, citing inadequate supporting data. Subsequently, FDA granted a petition by the American Chemistry Council to modify its food additive regulations to reflect the fact that polycarbonate resins containing BPA are no longer used in manufacturing baby bottles and cups. The American Chemistry Council maintains that BPA is safe at the levels to which people are exposed, and that OEHHA's intention to list BPA is "scientifically unjustified;" however, BPA's safety at low levels of exposure has been controversial.

OEHHA proposes to set a Maximum Allowable Dose Level (MADL) that is considered fairly high—290 micrograms per day—for a purported reproductive toxin. The MADL provides guidance for determining when an exposure is considered "insignificant." The Prop. 65 listing does not constitute a ban of the chemical, but does require the use of warning labels if the potential exposure from a consumer product, by any route (i.e., dermal, inhalation, or ingestion), exceeds the MADL. Notwithstanding the American Chemistry Counsel's opposition to adding BPA on the Proposition 65 list, it has commented that the level proposed by OEHHA creates a sufficient margin of safety to protect consumers, including infants and children, and is consistent with the safe exposure levels cited by numerous other regulatory bodies around the world that have assessed the full body of scientific evidence. These bodies have concluded that BPA is not a risk to human health.

OEHHA's proposed listing appears to be based on a 2008 report by the National Toxicology Program, which concluded that there is "clear evidence" of adverse developmental effects in laboratory animals at "high" levels of exposure. OEHHA is now responding to a petition filed by the Natural Resources Defense Council in July 2009, requesting that BPA be added to the Prop. 65 list. In 2010, the California Environmental Protection Agency put out a call for further data and comment on BPA.

OEHHA is accepting public comments as to whether BPA meets the listing criteria set forth in the Prop. 65 regulations. These comments must be received no later than 5:00 p.m. on March 27, 2013. In addition, OEHHA is accepting comments concerning the proposed MADL of 290 micrograms per day. These must be received by 5:00 p.m. on April 10, 2013.

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For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

Kevin C. Mayer
Partner – Los Angeles, San Francisco
Phone: +1 213.443.5544, +1 415.365.7473
Email: kmayer@crowell.com