Prop 65 Update – The addition of BpA to the list

By Christie Walker

Back in 1986, Californians passed the Safe Drinking Water and Toxic Enforcement Act known as "Prop 65." The Act was meant to regulate the presence of certain chemical substances found in products sold in California, or present in the workplace in California. The purpose of Prop 65 was to protect California's drinking water sources from contamination by chemicals and to give California consumers, residents and workers the information necessary to make informed decisions about chemicals in products they may purchase or exposure to chemicals at places of business.

Over the past couple of years, tort lawyers have been looking for and litigating Prop 65 claims including several cases that were based on allegations that certain eyewear, including sunglasses and reading glasses, were in violation of Prop 65, resulting in several optical industry companies being subjected to such law suits. Prop 65 does not ban these chemicals from being used, it only mandates that a warning be issued.

On May 11th, 2015, the state of California added Bisphenol A (BpA) to the Prop 65 list of substances known to the state to cause birth defects or reproductive toxicity. Bisphenol A is one of the chemicals used in the making of polycarbonate with trace elements found in polycarbonate lenses.

Just because a substance is listed, doesn’t necessarily mean that Prop 65 will be triggered. If the amount of the substance is below a designated minimum amount (safe harbor) it does not come under Prop 65 regulations. Unfortunately, not all substances have a safe harbor level. At the time of this writing, California had not yet published a safe harbor level for BpA; therefore any product containing BpA (read all polycarbonate lenses and swarf) must have a Prop 65 warning or run the risk of being the basis for a Prop 65 lawsuit.

Until a safe harbor is established for BpA, all polycarbonate lenses currently in or coming into the state of California are subject to this regulation. This includes products that are already "on the shelf," or in inventory in California. In addition, this will include areas where polycarbonate is processed (read optical labs) and dispensed (read ECP offices, retail outlets), and where employees or customers are working with or in contact with polycarbonate lenses (labs, retailers, ECP offices). For optical labs, this includes the disposal of polycarbonate swarf.

Enforcement of this requirement commenced on May 11, 2016.

The Vision Council has been watching these developments carefully and has a number of documents available for review on The Vision Council website: www.thevisioncouncil.org.  You must be a Vision Council member to access this information.  The Vision Council also hosted the annual California Optical Laboratories Association meeting (COLA) in Temecula, California, this past April, where The Vision Council regulatory counsel, Rick Van Arnam, Esq., provided information on how to comply with the new regulation, which is where the information for this article was gathered.

FAQ ABOUT PROP 65

Answers provided by:  Rick Van Arnam, Esq. The Vision Council regulatory counsel

Q - Do I have to comply with the warning requirements?

A - Letter of the law, yes.  But it’s a business decision.

 

Q - If I sell to an entity that is exempt from Prop 65, am I exempt too?

A - No. 

 

Q - Are my internet sales exempt from Prop 65?

A - No.  Must post warning on website.  True for companies with no physical presence in California.

 

Q - Am I covered by a retailer’s warning sign posted at its door?

A - Not likely.  To be effective, warning signage must be associated with your product.

 

Q - Can I use point-of-sale warning signs.

A - Yes, but must be associated with your product.  Highly subjective.

 

Q - How big does the product warning have to be?

A - Clear and Reasonable

 

Q - Then how do I get the retailer (or OD/Dr) to provide the warning?

A - Engage them and explain the ramifications. Consider legally sufficient point-of-sale signage option.

 

Q - Should I warn for cancer, and reproductive toxicity?

A - Warn for what is in your product.  BpA must warn for “birth defects and other reproductive harm.” State frowns on over warning.

 

Q - If we provide sufficient warnings, or fall into a safe harbor, are we insulated from law suits?

A - Theory, yes; application, no.  Make it hard for the bounty hunters looking for easy targets.

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Labtalk May/June 2018