By John Edwards and John Hinman
This is about BPA and the emergency regulation that was adopted in May by the California Office of Environmental Health Hazard Assessment (“OEHHA”). Many trade associations, Family Winemakers and the Wine Institute most prominently, have sent bulletins to their members advising them of the new regulation.
Our goal is to pass on the best recommendations for protecting your license against public and potential private enforcement. The penalties if the signage is required and is not up could be as much as $2,500 per day, and in the background loom the plaintiff’s lawyers looking for an easy payday (as happened in the arsenic cases that are now on appeal after being dismissed - see blog).
Who is required to post a sign and where does it have to be posted? Every manufacturer, importer or retailer that sells canned and bottled foods and beverages, including alcoholic beverages, that MAY contain BPA must post the warning at the point of sale. This includes out of state wineries and retailers with customers in California. The point of sale definition includes the check-out page of the seller’s website, as well as winery tasting rooms, bars, restaurants, supermarkets and wine and spirits merchants.
Who does NOT have to post the sign? If the products that you sell do NOT contain BPA, no sign is needed. However to be protected by this exception you must know for certain that no product you sell (or material included in the products you sell) contains BPA. This is difficult to determine because BPA is found in so many different products.
How do you know if the product contains BPA? You ask your vendors or have the products tested. The Wine Institute recommendation is that sellers and manufacturers ask their vendors for affirmative certification that there is NO BPA in their products (“We hereby certify that there is no Bisphenol A (BPA) in [name of] product”). That is prudent advice. If you are a manufacturer you would be asking your product vendors (bottles, capsules, etc.). If you are reseller (such as a retailer) the certification would be asked for from the manufacturer (winery, brewery or distillery) directly or through the wholesaler. Licensees should both require the certification and post the warning statement. The downside of the vendor certification is that if it turns out to be not true the licensee relying on the certification might have a lawsuit against the vendor but is not relieved from liability from the warning statement requirement.
The “Emergency Regulation” and the Warning Statement
On May 16th OEHHA adopted emergency regulations that require manufacturers and retailers of food and beverage containers containing a compound known as Bisphenol A or “BPA” to provide a specific warning about that compound. The Emergency regulation will be in place for an 18-month period while final regulations (probably the same as the emergency regulations) are being drafted and adopted.
OEHHA is the agency responsible for enforcing “Proposition 65,” the California law that requires warnings to the public about compounds that OEHHA determines may cause cancer (carcinogens) or reproductive harm (teratogens).
Typically, the warning requirements are satisfied by posting the signs we see everywhere in California (even in hospitals) warning that a facility or a consumer product contains compounds “known to the State of California” to cause cancer or reproductive harm. Naming all of the listed compounds in the facility is not generally required, which is fortunate, because the list of “known” carcinogens and teratogens contains hundreds of compounds.
The purpose of the emergency regulations is to provide warnings to consumers about BPA either on product labels or at the Point of Sale during the anticipated 18-month interim period. The Regulations require a manufacturer of any canned or bottled beverages that contain BPA either to:
- Place a warning label on the product itself stating: “WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm;” or
- Notify all California retailers of any of its products that may result in an exposure to BPA and provide a sufficient number of compliant Point of Sale warning signs.
The Regulations require retailers to display compliant warnings at each Point of Sale, which includes not only cash registers and checkout lines, but “electronic checkout functions on internet websites.” The warning signs must be at least 5” X 5” and contain the following
WARNING
Many food and beverage cans have linings containing bisphenol A (BPA), a chemical known to the State of California to cause harm to the female reproductive system. Jar lids and bottle caps may also contain BPA.
You can be exposed to BPA when you consume foods or beverages packaged in these containers.
For more information, go to: www.P65Warnings.ca.gov/BPA.
The BPA warning is, of course, in addition to the warning signs that retailers of alcoholic beverages are already required to display, which state:
WARNING: Drinking Distilled Spirits, Beer, Coolers, Wine and Other Alcoholic Beverages May Increase Cancer Risk, and, During Pregnancy, Can Cause Birth Defects.”
These warning signs should soon be going up in tasting rooms, restaurants and retail stores throughout the state. But if the product at issue is shipped to the consumer the “Point of Sale” is considered to be the check-out page of the internet website of the seller.
What is BPA?
BPA is a compound that is used in the manufacture of polycarbonate plastics and epoxy resins. Polycarbonate plastics are used to make bottles, bottle caps, and flasks. Epoxy resins are used to coat metal cans containing food and beverages, and they may also be used to coat metal caps used on glass bottles. Given the widespread use of plastics and epoxy resins in packaging for alcoholic beverages, the new OEHHA regulation affects both manufacturers and retailers of those beverages.
BPA is also used in the manufacture of carbonless copy paper—including the paper used in printed sales receipts. For this reason the BPA warning requirement is particularly relevant to retailers and in tasting rooms.
Why do the agencies think that BPA is bad?
BPA has been accused of causing fetal and developmental abnormalities, endocrine systems abnormalities, and cancer. The compound has been studied extensively, with inconclusive results. The FDA has concluded that the use of BPA at current levels in the nation’s food supply is safe and has approved the use of BPA in food and beverage containers (except for baby formula), notwithstanding that minute amounts of BPA may leach from the container into the contents. The EU has reached the same conclusion. On the federal level, the only substantive action has been a ban on the use of BPA in baby formula cans, baby bottles and toddler cups.
In 2009, the California OEHHA unanimously decided that BPA would not be listed as a “known” teratogen. In 2015, however, the OEHHA reversed that decision and decided that the State now “knows” that BPA causes reproductive harm.
Prop 65 provides a year for compliance after a compound is listed, because listing imposes an arduous process on affected businesses. Each business must determine whether any of its products expose individuals to the compound above a regulatory safe harbor, if any has been set. If so, the business must then provide the generic warning conspicuously on the label, shelf tags, menus or any combination of those. Identification of the specific compound in the product is not generally required.
OEHHA decided that emergency action was needed in the “unique” situation of BPA because:
- BPA was widely used in food and beverage containers prior to the 2015 listing. Many of those containers are still in the stream of commerce and have no warnings at all. Removal of these items from commerce because of enforcement concerns could jeopardize the food supply.
- OEHHA has not set a safe harbor for oral exposure to BPA, because there is no consensus on the Maximum Allowable Dose Level for that exposure. OEHHA expects to have the results of federally-sponsored research on that issue by late 2017 or 2018.
- The listing of BPA could cause a plethora of warnings on products and shelves that might alarm or confuse consumers.
- The general Prop 65 warning could create “a uniquely high potential for confusion” about BPA.
- Interim regulations will inform and protect the public and allow manufacturers to reduce or eliminate BPA exposure.
OEHHA will replace the emergency regulations with likely identical interim regulations, which will are expected to be in effect for about 18 months.
What does OEHHA want to accomplish with these Emergency Regulations?
Keeping in mind that the OEHHA already “knows” that alcohol itself can be a carcinogen (if abused) and a teratogen, you may ask what the OEHHA hopes to accomplish by duplicating the existing warning with one specifically targeting minute amounts of BPA that may have leached from the container. Frankly, we can only guess at the end-game, and our best guess starts with the phrase “regulatory overkill.”
A Current BPA Issue —Sales Receipts and “Unclean Hands”
As noted above, the OEHHA has not yet been able to set a Maximum Allowable Dose Level for oral consumption of BPA. It has, however, set a Maximum Allowable Dose Level for dermal exposure to BPA from solid materials at 3 micrograms/day, and that level goes into effect in October of this year (2016). Once in effect, potential higher exposure will trigger a warning requirement for dermal exposure.
BPA is being used in carbonless copy paper, which is used to make the multiple copies of receipts that emerge from cash registers and charge card readers. One of the “private enforcers” of Prop 65 has already raised a new issue of concern to on-site sellers of alcohol: dermal exposure to BPA from sales receipts.
Even before the OEHHA had announced its 3 mg./day Maximum Allowable Dose Level for dermal exposure to BPA, an “environmental advocacy group” had issued a Notice of Violation to a fast food restaurant, alleging that its sales receipts violated Prop 65 because of dermal exposure to BPA.
No one knows whether that group can prove that a sales receipt results in dermal exposure to more than 3 mg. of BPA per day or whether that Notice portends additional action relating to BPA in copy paper. If it does, printing the notice, “WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm” on the receipt will likely be the result. We can only imagine what the credit card equipment manufacturers will do with such a requirement.
We recommend that:
- Manufacturers selling products in California analyze their packaging or require certifications about BPA content from their suppliers. Ongoing monitoring is required to protect against suppliers that change their formulas or their own suppliers and thereby introduce BPA where none existed before. If BPA is being or has been used on products in retailers’ inventories, manufacturers should immediately notify their California retailers and provide the required Point of Sale warning signs.
- Retailers should post the required BPA warning, unless they have certifications from every supplier that none of the products in their inventories contain BPA, which is an unlikely occurrence. Retailers with a large number of items in inventory (including items made before May 2016) and suppliers from outside California are unlikely to have the certainty that their products are free from BPA. Providing the warning is a prudent protective measure.
- Our final recommendation is that all affected sellers spend some quality time with their trade associations to see if some sanity can be brought into the OEHHA system of regulation. BPA may be a problem, but there should be a better way to address it than to require extensive warning signage that most consumers (if they read it) will ignore.