California Proposition 65 Update: BPA - End of the 1-year Grace Period

08 Apr 2016

OHHEA plans to impose temporary emergency regulations for canned food retailers due to possible BPA-related litigation concerns.

The one-year grace period for the Bisphenol A (BPA) listing is ending on May 11, 2016, which means that after this date, enforcement action can be taken against companies that expose individuals to BPA through their products (if  they contain BPA and do not provide a warning). BPA is used in a wide-range of products and this listing will affect numerous industries doing business in California.  BPA is also a component of the epoxy lining of some cans and bottles used in food and beverage packaging.

As the grace period ends, OEHHA is concerned that food retailers, fearing litigation risks, will pull bottled/canned foods/beverages from shelves, which would reduce access to healthy food to Californians, especially vulnerable populations in "food deserts" (locations with limited access to fresh food/produce).

As such, OEHHA is proposing emergency (temporary) regulations for retailers of canned/bottled food and beverages to allow for uniform point-of-sale warning messages in hopes to keep retailers from pulling these products from shelves.

Here is the proposed warning text:

Generally, warnings are only required when exposure to the individual is above the safe harbor level (SHL) for that chemical.  OEHHA has not published an oral-route SHL for BPA  yet (although they have just published a proposed dermal SHL of 3 µg/day) so companies need to derive one themselves or put a warning on the product.

However, deriving an oral SHL for BPA is a hugely complex issue, as this chemical has been extensively evaluated with a wide range of standardized and non-standardized testing methods (various in vitro assays, animal models, epidemiological evaluation in humans) that all need to be considered.

Having published an oral MADL for BPA and then retracting it, OEHHA hinted that additional investigations are now underway to evaluate the safety of oral exposure to BPA at low doses, which may play a role in deriving an MADL. In their proposed rule-making notice, it suggested that these evaluations may be completed in 2017 or 2018. Therefore, the task of individual companies trying to address this requirement will be daunting, essentially forcing companies to add warning labels where they may not be required. However, “over-warning” may expose them to additional scrutiny with the impending lead agency website going live on April 1, 2016, which requests additional data from companies providing warnings to be published on a new OEHHA website (more on this later).

Californians may see these warnings at grocery stores/retailers near them soon, which could unjustifiable scare consumers despite the fact that the safety of the exposure has not been evaluated in relation to Prop 65. I can appreciate that retailers pulling canned foods in fear of litigation could be terrible for vulnerable populations but these warnings may just add to the confusion of this "right-to-know" legislation. It's a difficult situation either way.

Various agencies including U.S. FDA, Health Canada, European Food Safety Authority (EFSA) have evaluated estimated exposures to BPA from food packaging and determined them to be safe but our understanding of the science is not yet complete.

At this point, companies doing business in California would be wise to conduct comprehensive evaluations of their products and supply chain to evaluate what their potential litigation risks are in relation to BPA. If your product cannot withstand having a Prop 65 warning on the label, you will need to seek packaging without BPA or conduct the investigations into the derivation of an oral MADL and conduct exposure assessments to evaluate whether you actually need a warning.

If you have any questions regarding Intertek's comprehensive Proposition 65 compliance services please contact me directly. We will be following these developments closely.

To learn more about our Prop 65 services, feel free to contact our scientific & regulatory experts at food.sci-reg@intertek.com.

Blogger:

Tom Jonaitis,
Scientific and Regulatory Associate, Intertek