California's Proposition 65 warning requirement for Bisphenol A (BPA) comes into force on 11 May 2016. The Office of Environmental Health Hazard Assessment (OEHHA) published two notices for BPA compliance on 17 March 2016 for public comment. This includes a notice of emergency action to provide a warning sign at each point-of-sale for oral exposures to BPA from canned and bottled foods and beverages, a revised notice issued on 1 April 2016 to supersede the previous one, and a notice of proposed rulemaking to establish a BPA dermal exposure level (i.e. 3 µg/day from solid materials).
Bisphenol A (BPA) was added to the Proposition 65 list of chemicals known to cause reproductive toxicity on 11 May 2015. 1 year later, on 11 May 2016, warnings are required for all exposures to BPA unless the person responsible can show that the exposure when multiplied by 1,000 times has no observable effect (NOEL or No Observable Effect Level) (i.e. the "maximum allowable dose level" or "MADL"). The MADL is also called “Safe Harbor Level” for reproductive toxicants.
Unfortunately, there is no MADL for oral exposure from food and beverages to BPA currently. OEHHA is waiting for research sponsored by the federal government that may resolve complicated scientific questions that would enable OEHHA to establish a MADL for BPA oral exposures. The research is expected to be completed in late 2017 or early 2018.
BPA is an industrial chemical used to make certain plastics such as polycarbonate and also used to make epoxy resin, which act as a protective lining and has been used extensively in metal-based food and beverage cans and on lids of glass jars / bottles. Many canned and bottled food and beverages can cause exposures to varying amounts of BPA.
Proposition 65 is enforced by the Attorney General’s office, local prosecutors and private citizen enforcers. When the warning requirement goes into effect on 11 May 2016, private enforcers may serve a number of 60-day notices of intent to sue alleging a failure to warn for BPA exposures from canned and bottled foods and beverages. In the absence of a guidance level for warning requirements currently, industry faced a difficult situation on compliance. It is possible that manufactures or retailers will decide to remove canned and bottled food items from store shelves to avoid any potential enforcement actions; or post disparate warnings throughout a facility inconsistently that may cause consumer confusion and reduction in the availability of nutritious food products for certain groups of California citizens who rely heavily on canned and bottled foods.
Under this situation, OEHHA finds that there is an emergency need for action to provide a reasonable transition period to help avoid consumer confusion and at the same time provide consistent, informative, and meaningful warnings to consumers about significant exposures to BPA, particularly in the time period immediately following 11 May 2016 when the warning requirement begins. Although industries are moving towards the reduction or elimination of BPA in canned food and beverage, this may not help existing retail inventories immediately as many canned foods and beverages have a “shelf life” of up to three years.
OEHHA announced two proposals for BPA compliance, in terms of oral and dermal exposures.
1. Oral exposure – a proposed rule on the responsibility to provide warnings for BPA exposures in canned and bottled foods and beverages
Manufacturer, producer, packager, importer or distributor shall either affixes a warning label on the canned/bottled foods and beverages or provide written notice to the retail seller
The retailer shall then post a warning sign at each point-of-sale (including area within a retail facility where customers pay for foods and beverages, such as the cash register or check-out line and electronic check-out functions on Internet websites) in the retail facility and responsible for the placement and maintenance of the warning signs
Content of the proposed warning sign (size at least 5 by 5 inches and the words should be conspicuous):
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.
2. Dermal exposure
OEHHA proposes to establish a MADL (dermal exposure from solid materials) for BPA and comments have to be provided on or before 16 May 2016.