Issuance of Safe Use Determination for Exposures to Bisphenol A from Certain Polycarbonate Eyewear Products Manufactured, Distributed, or Sold by The Vision Council Member Companies

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 ^[1].  OEHHA received a request for a Safe Use Determination (SUD) for exposures to bisphenol A (BPA) ^[2] from certain polycarbonate eyewear products manufactured, distributed, or sold by The Vision Council (TVC) member companies.  The request was made by TVC, pursuant to Title 27 of the California Code of Regulations, section 25204(b)(3).

In accordance with the process set forth in Section 25204(f), OEHHA held a written public comment period on this request from March 8, 2019 to April 8, 2019.  No hearing was requested and no public comments were received.

As provided in Sections 25204(a) and (k), OEHHA is issuing this Safe Use Determination for exposures to BPA from certain polycarbonate prescription glasses and sunglasses, over-the-counter (OTC) reading glasses, non-prescription sunglasses, and safety glasses that are manufactured, distributed, or sold by TVC member companies, with acetonitrile extractable concentrations of BPA (as determined by LC/MS/MS) in the temple, nose pad, frame, and lens at or below 25 micrograms per gram (µg/g), 68 µg/g, 120 µg/g, and 302 µg/g, respectively.

The essential elements and results of OEHHA’s assessment are described in the supporting documentation available at: https://oehha.ca.gov/proposition-65/proposition-65-safe-use-determinations-suds.

Based on OEHHA’s screening-level analysis of the information and data provided by TVC, the upper-end estimate of dermal exposure to BPA for users of certain polycarbonate eyewear products (prescription glasses and sunglasses, OTC reading glasses, non-prescription sunglasses, and safety glasses) manufactured, distributed, or sold by TVC member companies, with acetonitrile extractable concentrations of BPA as specified above, is 0.53 µg/day.  This exposure estimate falls below the "Maximum Allowable Dose Level (MADL)” for BPA (dermal exposure from solid materials) of 3 µg per day ^[3].  The MADL is defined as the level of exposure that corresponds to the “no observed effect level” divided by 1000.  Thus, exposures to BPA from use of such eyewear products, under the conditions described in OEHHA’s assessment, would not require a Proposition 65 warning. 

Questions regarding this notice should be directed to:

Tyler Saechao

Office of Environmental Health Hazard Assessment

P.O. Box 4010, MS-12B

Sacramento, California 95812-4010

P65Public.Comments@oehha.ca.gov

Telephone: (916) 445-6900