California Prop 65

The Vision Council Wins an Issuance of a Proposition 65 Safe Use Determination (SUD) for Exposures to Bisphenol A (BPA) from Certain Polycarbonate Eyewear Products

On April 7, 2020, the State of California’s Office of Environmental Health Hazard Assessment (OEHHA) announced it would issue 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.

For more information, read The Vision Council’s press release. To read the source documents issued by California advising on the SUD and its analysis of the data, click here.

Background Information on Prop 65

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.

Civil actions based on Prop 65 violations can be brought by the California Attorney General or District Attorney; however, Prop 65 includes a private right of action that may be brought by "any person in the public interest." Because of this, tort lawyers in California look for and litigate Prop 65 claims against companies believed to be in violation of the law. Over the past couple of years, several cases have been brought based on allegations that certain eyewear, including sunglasses and reading glasses, are in violation of Prop 65, resulting in several members of The Vision Council being subject to such suits. For more information, read the original memorandum that was issued to members of The Vision Council warning of these legal actions (October 31, 2013).

Prop 65 Definitions

  • Chemical Substances Covered
    • Prop 65 requires the Governor of California to publish a list of chemical substances that are known to the State of California to cause cancer, birth defects or other reproductive harm. The list contains a wide range of chemicals, including phthalates, dyes, solvents, pesticides, drugs, food additives, byproducts of certain processes, or specialty chemicals used in industrial applications and may be naturally occurring or synthetic. The list is updated periodically so businesses that are subject to Prop 65 should review it on a regular basis to ensure that they are compliant.
    • Even if a substance is listed, however, Prop 65 will not be triggered if the amount of the substance is below a designated minimum amount. Information on the de minimis levels for each chemical may be found at using the link provided above. However, not all substances have a safe harbor level, and if you intend to rely on a safe harbor defense you need to have toxicology testing to validate your decision. 
  • Companies Subject to Prop 65
    • Prop 65 applies to retail, mail order or internet sales of products in California. If you operate in California, or simply sell your products in California, then you are subject to this law. Any company with ten or more employees that operates within the State or sells products in California, must comply with the requirements of Prop 65.
  • Violation Penalties
    • The penalties for violations of Prop 65 are not insignificant: any business that violates or threatens to violate Prop 65 is liable for a civil penalty not to exceed $2,500 per day for each violation. You can also be liable for attorney and expert witness fees.

Necessary Actions

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 law allows for the warning to be provided by a variety of means, such as direct labeling of the product, posting signs at the workplace, or publishing notices in a newspaper, depending on the circumstances and provided the warning is clear and reasonable. The current version of the warning requirements for consumer products can be found here.

 

Resources

Download the June 2018 Mandatory Warning Labels Guide (pdf)

Download the September 2020 Guide to California Prop 65 for Ophthalmic Suppliers (pdf)

Proposition 65 Website

Of Special Interest to Optical Laboratories: "California Proposition 65 - The Safe Drinking Water and Toxic Enforcement Act of 1986 Guide for Optical Laboratories"

This version of The Vision Council's guidance document on Prop 65 is intended for the Optical Laboratories Division members, particularly those labs physically located in California.

Questions

Members with questions on this topic should contact Rick Van Arnam, The Vision Council's regulatory affairs counsel, at rvanarnam@barnesrichardson.com or 212.725.0200, or Michael Vitale, The Vision Council's senior technical director and lens division liaison, at mvitale@thevisioncouncil.org.