In advance of the May 11, 2016 effective date of the Proposition 65 warning requirement for bisphenol A (BPA), the California Office of Environmental Health Hazard Assessment on March 17, 2016 proposed a safe harbor warning for BPA in canned and bottled foods and beverages through an emergency rulemaking procedure. OEHHA also separately has proposed a Maximum Acceptable Dose Level (MADL) for dermal absorption of BPA from solid materials of 3 micrograms per day. These regulatory actions are expected to provide guidance to the regulatory community and deter unnecessary and frivolous Proposition 65 enforcement actions involving BPA.
On May 7, 2015, the Developmental and Reproductive Toxicant Identification Committee identified BPA as a Proposition 65 reproductive toxicant based on its purported effects on the female reproductive system. BPA was placed on the Proposition 65 list on May 11, 2016, and the warning requirement becomes effective one year later, i.e., May 11, 2016. BPA is widely used in the manufacture of polycarbonate materials and in the manufacture of epoxy resins. Epoxy resins can be used as a protective coating inside metal food and beverage cans, and on lids for glass jars and bottles. These coatings protect the contents from contamination.
Safe Harbor Warning for Canned and Bottled Foods and Beverages
Acknowledging the widespread use of BPA in protective coatings for canned and bottled foods and beverages, and the potential harm that may ensue to consumers and businesses if the agency does not provide clarity on Proposition 65 warnings for BPA, OEHHA has proposed through an emergency regulation a safe harbor warning for BPA in these products. This regulatory process bypasses the usual public comment procedure and fast tracks the final promulgation of the proposed rule.
The safe harbor warning would be provided at point-of-sale locations by posting a sign no smaller than 5 by 5 inches within a retail facility where customers pay for food and beverages. Significantly, a manufacturer’s obligation to provide warnings would be discharged by providing notifications to retail sellers if such notifications meet specific requirements. The safe harbor warning text would read as follows:
WARNING: Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is a chemical known to the State of California to cause harm to the female reproductive system. For more information go to: www.P65warnings.ca.gov/BPA.
This proposed emergency regulation will become effective when the California Office of Administrative Law (OAL) approves it and files it with the California Secretary of State. OAL is required to make a decision to approve or not no later than ten days after the agency submits the proposed regulation to OAL. Presumably, the safe harbor warning regulation would be in place and effective by the time the warning requirement for BPA also becomes effective.
BPA MADL for Dermal Absorption from Solid Materials
In separate rulemaking also published on March 17, 2016, OEHHA proposes a MADL of 3 micrograms per day for BPA through the dermal exposure route from solid materials. (At this time, OEHHA has not proposed a MADL for the oral exposure route.) The proposed MADL is based on a study report stating that prenatal treatment with BPA, through subcutaneous injections, disrupted ovarian follicular dynamics in sheep. In calculating the MADL, OEHHA also assumed that the dermal absorption factor for BPA is 10%. This value is based on the review by the European Food Safety Authority of certain studies using human and pig skin.
OEHHA is proposing this BPA MADL through its regular rulemaking process. Comments on the proposed MADL are due by May 16, 2016. Of course, that is after the effective date of the BPA warning requirement. And, the proposed MADL would not cover alleged exposures to BPA through the oral route (including the hand-to-mouth route highly favored by private enforcers when they allege Proposition 65 violations). However, even a proposed MADL, and even one with a narrowly defined exposure route, may deter private enforcers from pursuing frivolous enforcement actions — an important outcome, given the prevalence of polycarbonate plastics in a large variety of consumer products.