Impact of Recent Relisting of BpA as a Source of Developmental Toxicity on SUD Secured by The Vision Council

In April 2020, The Vision Council secured a Proposition 65 Safe Use Determination (SUD) for exposures to Bisphenol A (BpA) from certain polycarbonate eyewear products. The Vision Council is providing members an update on applications of the SUD following California’s Office of Environmental Health Hazard Assessment (OEHHA) recent relisting of BpA as a possible source of developmental toxicity, in addition to its existing listing as a possible source of reproductive toxicity.

Under the terms of the Safe Use Determination (SUD) secured by The Vision Council, members can avoid warning against dermal exposure for BpA in their eyewear products by testing for BpA pursuant to the test protocol in the SUD.

This relisting should not complicate application of the SUD. The maximum allowable dose level (MADL) for reproductive toxicity is three micrograms per day of exposure and was the level against which The Vision Council’s SUD application was measured. To benefit from the SUD, a member’s product must test out at less than three microgram per day using the SUD’s approved test methodology.

In contrast, the BpA data originally reviewed by OEHHA on developmental toxicity showed the level of BpA exposure necessary to trigger a warning for possible developmental toxicity was considerably higher than the three micrograms per day.

The Vision Council encourages members to test their products in accordance with the SUD’s methodology to ensure documentation exists marking products at less than the three microgram per day MADL for reproductive toxicity. While it does not take much time to file a Prop 65 Notice of Action, being able to counter such a notice by producing test results showing less than three micrograms of exposure from BpA should be sufficient for both reproductive and developmental toxicity endpoints.

Any questions about this issue can be directed to Rick Van Arnam, regulatory affairs counsel to The Vision Council, at rvanarnam@barnesrichardson.com, or to Michael Vitale, The Visions Council’s Senior Technical Director and Lens, Lab and LPT Division Liaison, at mvitale@thevisioncouncil.org.