Notice of Proposed Rulemaking Title 27, California Code of Regulations Maximum Allowable Dose Level for Bisphenol A (Dermal Exposure from Solid Materials)

California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed to establish a Proposition 65Maximum Allowable Dose Level (MADL) for bisphenol A (BPA) (dermal exposure from solid materials) of 3 micrograms per day by amending Section 25805(b) of Title 27 of the California Code of Regulations. The proposal is open for public comment until 16 May 2016. All comments received will be posted on the OEHHA website at the close of the public comment period. This proposed regulation sets forth a MADL for adoption into Section 25805 that was derived using scientific methods outlined in Section 25803. The proposed regulation would adopt the following MADL for dermal exposure from solid materials to BPA, by amending Section 25805 as follows (addition in underline):

 

Chemical Name Level (Micrograms/day)
Bisphenol A (BPA) 3 (dermal exposure from solid materials)

 

OEHHA reviewed the transcript of the 7 May 2015 meeting of the DARTIC and the hazard identification materials reviewed by the DARTIC at that meeting. 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 relied on the study by Veiga-Lopez et al. (2014) that provides a subcutaneous LOEL of 0.05 milligrams BPA per kilogram body weight per day (mg/kg-day), for female reproductive toxicity. Additional relevant studies were identified and reviewed by OEHHA. This is discussed in more detail in the initial statement of reasons for this proposed regulatory amendment.

 

Anticipated Benefits of the Proposed Regulation: Some businesses may not be able to afford the expenses of establishing a MADL and therefore may face litigation for a failure to warn or for a prohibited discharge of the listed chemical. Adopting this regulation will save these businesses those expenses and may reduce litigation costs. In addition, by providing a 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.

 

No Inconsistency or Incompatibility with Existing Regulations

OEHHA has conducted an evaluation for whether there are any other regulations on this matter and has found that these are the only regulations dealing with BPA for exposures via the dermal route, for purposes of compliance with Proposition 65. Therefore, OEHHA has determined that the proposed regulation is neither inconsistent nor incompatible with existing state regulations because it provides compliance assistance to businesses subject to the Act, but does not impose any mandatory requirements on those businesses, state or local agencies and does not address compliance with any other law or regulation.

 

This notice and the Initial Statement of Reasons will be provided to the Developmental and Reproductive Toxicant Identification Committee for scientific peer review and comment.

Further information on the proposal is available at: http://www.oehha.ca.gov/prop65/CRNR_notices/NPR_BPA_MADL031716.html

OEHHA, 17 March 2016 ;http://www.oehha.ca.gov ;