New BPA Prop 65 emergency regulations

After several false starts, Proposition 65 warnings will be required for exposures to bisphenol A (BPA) starting on May 11, 2016. Because of tremendous uncertainty regarding the amount of BPA exposure that will require a warning, as well as the ubiquitous nature of the chemical, on March 17, 2016, California's Office of Environmental Health Hazard Assessment announced an emergency rulemaking for temporary use of a point-of-sale warning for BPA exposures from canned and bottled foods and beverages, and a proposed safe harbor level for dermal exposure to BPA of 3 micrograms/day.

Background

On May 11, 2015, OEHHA placed BPA on the Proposition 65 list. BPA is used in a variety of products including hard plastics and polycarbonate, metal cans for food and beverage, epoxies, and electrical equipment.

Under Proposition 65, products containing newly listed chemicals require a warning starting 12 months after the listing. This means that effective May 11, 2016, warnings will be required for products containing BPA that cause significant exposures.

Emergency point-of-sale warnings

OEHHA determined that an emergency regulation is needed to address BPA 's widespread use in epoxy resins. These resins serve as protective linings on the inside of some metal-based food and beverage cans and on the lids for glass jars and bottles. BPA can migrate from these linings into food. Even though reformulation away from BPA is expected, these products can have a shelf life of up to three years. OEHHA seeks to provide some certainty for consistent warnings that manufacturers could use during the interim period while reformulating or labeling newly-produced products with warnings. OEHHA also aims to avoid a situation in which retailers remove products from sale due to fear of enforcement actions. This could decrease the availability of food in areas that depend on canned food. OEHHA is also concerned that widespread warnings on canned food products could result in negative health effects if consumers avoid purchasing these products.

The regulation requires warnings be provided either by on-product labeling or by point-of-sale signage for BPA in cans, bottles and jars. For warnings where the manufacturer elects to use a point-of-sale sign, the regulation requires a 5×5-inch sign with the following language:

WARNING: Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is known to the State of California to cause harm to the female reproductive system. For more information, go to www.oehha.ca.gov/BPA.

The regulation splits responsibility between manufacturers and retailers. Manufacturers must provide written notice of the need to post warning signs to retailers directly or through an authorized agent or trade association, and must provide signs. Retailers are required to post and maintain the signs at a point-of-sale (each cash register or check-out line, or electronic check-out functions on Internet websites).

The proposed emergency regulation would expire after 180 days, although OEHHA expects to adopt the regulation as an interim measure for at least one year. According to OEHHA:

This time period should be sufficient to ensure an orderly transition to providing warnings for BPA exposures, and for manufacturers to reduce or eliminate exposures to BPA by switching to safer alternatives where feasible. It will also allow for additional time for OEHHA to evaluate the emerging science for potentially establishing a MADL [safe harbor level] for oral exposures to BPA, which would further clarify which products require a warning.

Proposed safe harbor level

OEHHA has also proposed a safe harbor level (maximum allowable dose level or MADL) for BPA of 3 micrograms/day. This safe harbor would apply to "dermal exposure from solid materials," such as hard, clear plastics and polycarbonate.

OEHHA has not set a safe harbor level for oral exposures, calling the issue very complex and deferring to a series of federal studies intended to clarify the effects of BPA at low doses. According to OEHHA, some of those studies are expected to be complete as early as 2017, and could form the basis of an oral MADL.

Implications

Manufacturers and retailers are greatly concerned about the ubiquitous nature of BPA in canned food and other products, and the near-certainty that private enforcers will be issuingnotices of violation immediately upon the warning effective date. The allocation of warning responsibility between manufacturers and retailers is similar to what OEHHA has proposed in pending revisions to the Proposition 65 warning regulation, and it is expected that while many retailers will provide these warnings, others may not due to logistical difficulties in ensuring consistent display of point-of-sale warnings. Of particular interest is OEHHA's explicit sanctioning of a warning sign that does not specifically identify the products to which it applies. OEHHA apparently recognizes that product-specific signs are infeasible given the thousands of potentially impacted products from dozens of separate suppliers in a typical retail store.

OEHHA's adoption of a dermal MADL is not expected to significantly impact companies determining whether and how to provide a warning for BPA exposure, except for those products manufactured from polycarbonate plastic, where BPA exposure is expected to be mostly dermal. In the absence of an oral MADL, manufacturers seeking to assess whether potential exposure to BPA from food or hand-to-mouth contact would need to develop their own determination of the "no observable effect level," and then compare that level to the "reasonably anticipated rate of intake and exposure." Experience has shown that most companies are likely to either warn or reformulate away from BPA rather than attempting to prove that exposure is 1,000 times below the "no observable effect level." Defending such exposure assessments is extremely expensive and risks potentially crippling civil penalties and attorney's fees awards to private enforcers if unsuccessful.

We anticipate continued uncertainty regarding BPA over the coming weeks and months, even with OEHHA's emergency rulemaking.