Recent action by the California Office of Environmental Health Hazard Assessment (OEHHA) regarding BPA exposures will impact manufacturers, packagers, importers, distributors, and retailers of canned and bottled beverage and food products. The recent actions are:
- An emergency rulemaking that allows manufacturers, packagers, importers, and distributors of canned and bottled beverage and food products to comply with the Proposition 65 warning requirements that become effective May 11, 2016 through providing point-of-sale warnings to retailers and allows retailers to use specific point-of-sale warnings.
- A notice of proposed rulemaking to set a Maximum Allowable Dose or safe harbor level for dermal exposure to BPA from solid materials.
Point-of-Sale Warnings for BPA Exposures from Canned and Bottled Food and Beverage Products
Why Emergency Action?
On May 11, 2015 OEHHA added BPA to the list of chemicals known to the State of California to cause reproductive toxicity, with the Proposition 65 warning requirements becoming effective 12 months later. Beginning May 11, 2016, a business exposing consumers to BPA consumer products, including foods, must provide a “clear and reasonable” warning on “labeling, shelf tags, shelf signs, menus or any combination thereof” unless the business can show that exposure is “1,000 times below the no observed effect level” for BPA.
The existing Prop 65 regulations did not explicitly allow for point-of-sale warnings. On April 1, 20161, OEHHA issued a Notice of Emergency Action to temporarily allow use of a standardized point-of-sale warning message for BPA exposures from canned and bottled beverages and food. In proposing the emergency regulations OEHHA specifically noted the possibility of inconsistency in labeling and consumer confusion that would arise given the lack of an OEHHA-established Maximum Allowable Dose Level (MADL) for oral exposure to BPA. The Office of Administrative Law approved the emergency regulations April 18.
The absence of a reference to a specific NOEL raises the likelihood of legal action based on a range of values including those accepted by the US Food and Drug Administration and the European Food Safety Authority and those espoused by activist groups, including litigation from private enforcers based on the most conservative NOEL values thus far discussed, unless Prop 65 warnings are provided. OEHHA is concerned that retailers, unsure of which food products require a BPA exposure warning, and wary of private enforcement actions, could potentially remove all canned and bottled beverage and food items from their shelves or place warnings throughout their stores in order to avoid a private enforcement action. OEHHA further believes that these actions could either reduce access to nutritious food products or cause consumers to avoid purchasing them due to confusion over an excessive number of warning signs. Therefore, OEHHA proposed the emergency regulations.
How do the Emergency Regulations impact the warning?
The regulations allow manufacturers, packagers, importers, and distributors of canned and bottled beverages and food to meet the Proposition 65 warning requirement by providing written notice directly or through an authorized agent or trade association to the retailer or the retailer’s agent. The notice must: (1) state that the canned or bottled food or beverage may result in an exposure to BPA; (2) include the name or description of the food or beverage such as a UPC or other designation; and (3) offer to provide to the retailer at no cost point-of-sale warning signs in sufficient quantities. Alternatively, manufacturers, packagers, importers, and distributors may choose to affix labels to their products that meet the Proposition 65 regulatory requirements.
How long will the Emergency Regulations be in place effective and what are OEHHA’s plans for additional regulations?
The emergency regulations became effective April 18, 2016 and will expire October 18, 2016. OEHHA has stated that it plans to adopt an MADL for oral exposure to BPA; however OEHHA noted that its scientists had found the issues surrounding an oral MADL to be “technically complex.” OEHHA has stated that research expected to be completed in the next one to two years may help resolve these issues.
Our concerns regarding what data OEHHA will rely on to establish an MADL are heightened by its recent response to comments by the Can Manufacturers Institute (CMI). CMI urged OEHHA to establish an MADL based on the Delclos (2014) study performed at FDA’s National Center for Toxicological Research. OEHHA declined to do so, stating that:
The Proposition 65 exemption from the warning requirements requires the establishment of the level requiring no warning “based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing.” The CMI proposal is inconsistent with this requirement.
Safe Harbor Levels for Dermal Exposure to BPA
OEHHA also has issued a notice of proposed rulemaking to establish a Maximum Allowable Dose Level (MADL) of 3 micrograms per day for dermal exposure to BPA from contact with solid materials, such as paper and plastics. OEHHA based this MADL on findings from a 2014 study relied on by the Developmental and Reproductive Toxicant (DART) Identification Committee in determining that BPA causes reproductive toxicity. This study found a subcutaneous lowest observable effect level (LOEL) of 0.05 milligrams BPA per kilogram of body weight per day for female reproductive toxicity in animal subjects.
Under the regulations implementing Prop 65, OEHHA may establish MADLs, which are safe harbor levels for products found to cause reproductive toxicity. If exposure is at or below the MADL, no warning is required. Comments on this proposed MADL rule must be submitted by May 16, 2016.