FAQs Regarding the BpA Safe Use Determination

FAQs Regarding the BpA Safe Use Determination

04/14/2020

Last week, California's Office of Environmental Health Hazard Assessment (OEHHA) issued 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. Following this monumental announcement, The Vision Council has received several questions from members and has answered them, below.

1. When can we rely on the SUD?

The SUD is scheduled for publication on April 17, 2020. Until then, we are advising everyone to retain the status quo and not drop or change their Prop 65 warnings.

2. Does this mean we do not need to provide Prop 65 warnings for our products anymore?

Not necessarily. The SUD only covers BpA in polycarbonate eyewear products. It is important to know which chemicals are in your products. If your products have other substances that require a Prop 65 warning, then you must continue to warn for those other substances.

Also, the SUD is limited to eyewear products made of polycarbonate. Therefore, if your products are made of something other than polycarbonate and have BpA in them or are not eyewear products and have BpA in them, then you need to continue to warn for BpA.

3. Are spectacle frames included in the SUD?

Yes, they were tested as components of prescription eyeglasses, as were lenses and nose pads. So long as a polycarbonate temple or a polycarbonate frame (i.e. the front) has a maximum BpA concentration of 25 micrograms/gram and 120 micrograms/gram, respectively, the spectacle frame would be within the scope of the SUD. Likewise, maximum BpA concentration for nose pads is 68 micrograms/gram and for lenses it is 302 micrograms/gram.

4. How can I determine whether my polycarbonate temples, frame fronts, nose pads or lenses are below the maximum BpA concentrations allowed for those components?

Have a testing laboratory conduct an acetonitrile extraction test on each component to determine how much BpA leached out and compare those results to the maximum limits for each component set out in the answer to question three of this FAQ.

5. Does the SUD cover possible workplace exposure?

Not necessarily. The SUD addresses dermal exposure to consumers of eyewear products. If you are providing occupational warnings to your California employees because they are coming in contact with polycarbonate eyewear products in the course of their employment, or if those employees could be exposed to polycarbonate other than through dermal contact (such as inhaling ground polycarbonate), then you should continue to post the occupational warning as to BpA exposure.

More information on Proposition 65 Safe Use Determination (SUD) can be found here on The Vision Council's website.

Any further questions can be directed to Rick Van Arnam, The Vision Council's regulatory affairs counsel, at rvanarnam@barnesrichardson.com or Michael Vitale, The Vision Council's senior technical director and Lens Division liaison, at mvitale@thevisioncouncil.org.

Categories: 
Government and Regulatory Affairs
General Updates from The Vision Council
Divisions: 
Sunglass & Reader Division
Lens Division
Lab Division
Lens Processing Technology Division
Low Vision Division
Optical Retail Division
Eyewear & Accessories Division