The Vision Council Succeeds in Efforts to Win an Issuance of a Proposition 65 Safe Use Determination (SUD) for Exposures to BPA from Certain Polycarbonate Eyewear Products

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ALEXANDRIA, Va.—The Vision Council announced that the State of California’s Office of Environmental Health Hazard Assessment (OEHHA) is issuing a Proposition 65 Safe Use Determination (SUD) for exposure to Bisphenol A (BpA) from polycarbonate prescription glasses, non-prescription sunglasses, over-the-counter reading glasses and safety glasses manufactured, distributed or sold by members of The Vision Council. A SUD is a formal opinion issued by OEHHA as to whether a Proposition 65 warning is required for specific exposures. The decision follows several years of work and fulfills The Vision Council's objective to receive a conclusion from OEHHA that BpA in certain optical products is so small that it does not create a health risk requiring a Proposition 65 warning for BpA.

“The OEHHA’s decision to issue this SUD represents a very exciting and significant win for The Vision Council, with far-reaching implications that benefit the vision community,” said Ashley Mills, CEO at The Vision Council. “The issuance is the result of many years of hard work and the tireless efforts of many, which makes it even more thrilling to see our goal realized.”

The process began in December 2016, when The Vision Council submitted its original SUD application.Through ongoing conference calls and in-person meetings with OEHHA, the final application was submitted in July 2018. The application was deemed complete in March 2019, followed by the issuance of a 30-day public notice for comments. In April 2019, the public notice closed.

"The support of The Vision Council’s members was crucial in this process,” said Michael Vitale, The Vision Council’s senior technical director and Lens Division liaison. “Many Vision Council members worked diligently to help us submit samples for testing, which supported our case that our member products show no risk of exceeding the MADL for dermal exposure to BpA.”

Based on the screening level analysis and data provided by The Vision Council in its SUD application, which highlighted worst case dermal exposure scenarios, BpA dermal exposure for TVC member eyewear was found to be at .53 micro grams per day, well within the published safe harbor for BpA of 3 micro grams per day. Thus, OEHHA concluded that this very limited exposure to BpA from use of these eyewear products does not require a Proposition 65 warning for dermal exposure to BpA.

This covers products with acetonitrile extractable concentrations of BpA in the temple, nose pad, frame and lens measured at or below 25 micro grams per gram, 68 micro grams per gram, 120 micro grams per gram, and 302 micro grams per gram, respectively. The notice announcing the issuance of the SUD will appear on the OEHHA website at www.oehha.ca.gov, and in the California Regulatory Notice Register on April 17, 2020.

Proposition 65 has been a California state law since 1986. Passed as the Safe Drinking Water and Toxic Enforcement Act, Prop 65, as it is commonly known, regulates the presence of certain chemical substances found in products sold in California, or present in the workplace in California. The goals of Prop 65 are to protect California's drinking water sources from contamination by these chemicals and to allow California consumers, residents and workers the information necessary to make informed choices so they can take precautions about the products they purchase or exposures they might receive to potentially hazardous chemicals.

If a business sells in California a product containing a substance or substances that are on the Prop 65 list in excess of the de minimis level for that substance, then a "clear and reasonable" warning must be provided to the public. The same is true for environmental or workplace exposures to Prop 65 substances in California, The Vision Council noted.