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March 25, 2015

OEHHA Proposes MADL For BPA (Dermal Exposure From Solid Materials), And Other Recent Endocrine Disruptor Developments

The ACTA Group

OEHHA Proposes MADL For BPA (Dermal Exposure From Solid Materials): On March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed a maximum allowable dose level (MADL) for bisphenol A (BPA) (dermal exposure from solid materials) of three micrograms per day. OEHHA states that it reviewed the transcript of the May 7, 2015, meeting of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) and the hazard identification materials reviewed by the DARTIC at that meeting. According to OEHHA, these hazard identification materials included numerous studies of the effects of BPA on the female reproductive system, including in vivo studies in experimental animals and in vitro studies that provide additional evidence of female reproductive toxicity. OEHHA states that it relied on the study by Veiga-Lopez, et al. (2014) “that provides a subcutaneous [lowest observed effect level (LOEL)] of 0.05 milligrams BPA per kilogram body weight per day (mg/kg-day), for female reproductive toxicity.” OEHHA identified and reviewed additional relevant studies. In the notice announcing the proposed MADL, OEHHA states that “by providing a[n] MADL, this regulatory proposal may encourage businesses to lower the amount of the listed chemical in their products to a level that does not require a warning. This in turn may reduce exposures to BPA and reduce resident, worker and environmental exposures to chemicals that cause reproductive toxicity.” OEHHA will schedule a public hearing on request. Hearing requests must be made no later than May 2, 2016, which is 15 days before the close of the comment period. Written comments must be received by OEHHA on May 16, 2016.

OEHHA Proposes Emergency Regulation For Standard Warning For Exposures To BPA From Canned And Bottled Foods And Beverages: OEHHA issued on April 1, 2016, a notice of emergency action to amend Section 25603.3 of Title of the California Code of Regulations regarding warnings for exposures to BPA from canned and bottled foods and beverages. This notice supersedes OEHHA’s March 17, 2016, notice on the same emergency action. Effective May 11, 2016, warnings are required for all exposures to BPA, unless the person causing the exposure can show that the exposure is 1,000 times below the no observed effect level (NOEL) for the chemical. OEHHA proposes to promulgate an emergency regulation to allow temporary use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages. The current regulation does not expressly allow for point-of-sale warnings for consumer products that cause exposures to listed chemicals. According to OEHHA, some canned food and beverage manufacturers plan to reduce or eliminate the use of BPA, or have recently done so, and the need for warnings will likely decrease over time. OEHHA notes that any changes made by manufacturers will not immediately affect existing retail inventories, however, because many canned foods and beverages have a “shelf life” of up to three years. OEHHA acknowledges that when the warning requirement goes into effect on May 11, 2016, private parties may bring suits alleging a failure to warn for BPA exposures from canned and bottled foods and beverages. OEHHA states that, given the variety of canned and bottled foods that may cause significant exposures to BPA, and the fact that retailers may not know which products currently on their shelves may require warnings, OEHHA is concerned that businesses will take inconsistent approaches to compliance, particularly in the time period immediately following May 11, 2016, when the warning requirement begins According to the notice, “the federal government is currently sponsoring a large series of studies intended to clarify the effects of BPA at low doses. Some of these studies, expected to be complete in 2017 or 2018, could inform the development of an oral MADL that will provide clarity for consumers and businesses.” Until then, OEHHA has concluded that both the public and the food and beverage businesses would benefit from the clarity that a uniform point-of-sale warning regulation would provide. OEHHA states that the proposed emergency regulation would expire after 180 days. During that period, OEHHA will commence a rulemaking process to adopt a regulation as an interim measure for a one-year period from date of adoption. According to OEHHA, this time period “should be sufficient to ensure an orderly transition to providing more product-specific warnings for BPA exposures, and for more manufacturers to reduce or eliminate exposures to BPA by switching to safer alternatives where feasible. It will also allow additional time for OEHHA to evaluate the emerging science that, if sufficient, would support a MADL for oral exposures to BPA, which would further clarify which products require a warning.”