California’s Office of Environmental Health Hazard Assessment (OEHHA) has published a Notice of Emergency Action to amend section 25603.3 Title 27, California Code of Regulations Warnings for Exposures to Bisphenol A From Canned and Bottled Foods and Beverages. On 11 May 2015, bisphenol A (BPA) was added to the Proposition 65 list of chemicals known to the state to cause reproductive toxicity based on the female reproductive endpoint. Female reproductive toxicity occurs when a chemical damages any aspect of the female reproductive system. BPA is commonly used in certain linings of metal cans and lids of glass bottles containing food and beverages. Under Proposition 65, one year after the listing, beginning 11 May 2016, warnings are required for all exposures to BPA unless the person causing the exposure can show that the exposure when multiplied by 1,000 times has no observable effect.Businesses make the decision whether to provide a warning and have options for the content of the warnings.A product does not require a warning simply because it contains a chemical that is listed under Proposition 65. A warning is required only when a business knowingly and intentionally causes an exposure to a listed chemical. The business that is responsible for the product must make several decisions:
- First, the business should determine whether its products are likely to expose individuals to any listed chemicals.
- Second, if the product causes an exposure to a listed chemical, the business should determine whether OEHHA has identified a regulatory safe harbor level for the chemical. An exposure below a safe harbor level (for reproductive toxicants, also known as a Maximum Allowable Dose Level, or MADL) is exempt from the warning requirement.
- Third, if there is no regulatory safe harbor level for a listed reproductive toxicant, a business that knowingly exposes individuals to that chemical is generally required to provide a Proposition 65 warning, unless the business can show that the exposure to the chemical, when multiplied by 1,000, has no observable effect. Determining this threshold level for the chemical and the exposure caused by the product can be complex.
- Fourth, if a business decides that a warning is required, OEHHA’s safe harbor regulations on warnings allow the business several options. A business may provide the warning on a product’s label, shelf tags, shelf signs, menus or any combination thereof as long as the warning is prominent and conspicuous. OEHHA regulations also provide for a general safe harbor warning for consumer products, including food, that states: “This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.” Thus, there is currently no statutory or regulatory requirement for a Proposition 65 warning to actually identify the chemical at issue. Also, the current regulation does not expressly allow for point-of-sale warnings for consumer products that cause exposures to listed chemicals.
Maximum Allowable Dose Levels can clarify when a warning is required, but none exists for oral exposure to BPA at this time
Because Proposition 65 requires businesses, rather than OEHHA, to determine when warnings are required, some businesses may make their own determination that the BPA exposures that they are causing are too low to require a warning, even though the BPA exposures from their products may be comparable to, or even greater than, exposures from other products that carry warnings. OEHHA generally tries to avoid such situations by establishing MADLs. Businesses over the years have relied on MADLs and related guidance in determining when they need to provide warnings. Unfortunately, there is currently no MADL for oral exposure from food and beverages to BPA. 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.
Many canned and bottled food and beverages sold throughout California are likely to require warning
The listing of BPA under Proposition 65 will have widespread impacts on food and beverages sold across the state. BPA is used to make epoxy resins, which act as a protective lining on the inside of many (though not all) metal-based food and beverage cans and on lids for glass jars and bottles. It is approved by the U.S. Food and Drug Administration (FDA) for use in food-contact applications including food and beverage can linings and seals, except for baby formula. Many canned and bottled food and beverages can cause exposures to varying amounts of BPA. OEHHA understands that some canned food and beverage manufacturers plan to reduce or eliminate the use of BPA, or have recently done so, and the need for warnings for these products will likely decrease over time. Any changes made by manufacturers will not immediately affect existing retail inventories, however, because many canned foods and beverages have a shelf life of up to three years. Thus, although businesses have had a year to remove or reduce BPA from their products, many products produced prior to or immediately after the May 2015 listing of BPA are still in the stream of commerce and will require warnings beginning in May 2016.
Emergency action is needed
Given this situation, OEHHA is concerned that businesses will take inconsistent approaches to compliance, particularly in the time period immediately following 11 May, when the warning requirement begins. For example:
- Products that contain relatively high amounts of BPA may have no warning at all. In the absence of a MADL, businesses must decide on their own whether the BPA exposures their products cause are high enough to trigger the warning requirement. This is a complex decision by individual businesses that involves not only scientific interpretation of the health effects of BPA, but also the use of the business’ own information on the frequency that consumers use their products and how much they consume. Some businesses may decide that products causing relatively high exposures to BPA do not require warnings, while others decide to place warnings on products causing lower exposures to BPA. Consumers will have no immediate way of distinguishing between them. Some may incorrectly assume that a product with no warning has no BPA.
- Some retailers may put warnings on all products with BPA, while others warn selectively. Consumers could see a warning for a product in one store, and no warning for the same products in another. Ubiquitous warnings may undermine the effectiveness of Proposition 65, as some consumers are alarmed by them and others disregard them as meaningless and uninformative. Under the current Proposition 65 warning regulation, the most likely way for businesses to ensure pre-May 2015 canned and bottled food and beverage products have warnings is for retailers to post shelf signs with warnings for each individual canned and bottled food product that may require a warning. Until pre-May 2015 products are no longer in the stream of commerce, it is likely that most retailers would have a plethora of warning signs wherever canned and bottled food and beverage products are displayed in their stores. The relatively sudden appearance of a large number of warning signs referring to a multitude of food and beverage products is likely to confuse and overwhelm consumers. Some consumers might become overly alarmed, while many consumers would dismiss them as uninformative. Neither outcome furthers the purposes of Proposition 65.
- Currently there is no statutory or regulatory requirement for Proposition 65 warnings to name the chemical of concern or the health effect associated with it. While some businesses may choose to name BPA and provide supplemental information about it in its warning, OEHHA anticipates that most warnings will simply say the food or beverage product “contains a chemical known to the State of California to cause birth defects or other reproductive harm.” Consumers seeing these warnings will not know what chemical they are being warned about or how they could reduce their exposure to it. While this has been the case with the majority of Proposition 65 warnings over the years, the multitude of warnings for foods and beverages combined with a lack of information creates a uniquely high potential for confusion that does not serve the public interest and should be avoided. Rather than address these problems, OEHHA could do nothing and simply assume that enforcement actions will eventually resolve uncertainty about what products require warnings and the adequacy of the warnings. But litigation will not provide clear guidance for businesses attempting to prepare for May 11. Nor will it help consumers and businesses faced with these problems in the period immediately following 11 May.
The proposed emergency regulation will 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. The proposed safe harbor warning for canned and bottled foods and beverages will identify BPA by name, and disclose that it causes harm to the female reproductive system. The warnings will also provide the public with supplemental information via a link to OEHHA’s website, which will contain fact sheets and links to informational materials on BPA from other authoritative organisations. Moreover, because it will be limited in duration, businesses that have not already switched to safe alternatives will have a strong incentive to do so before the regulation expires. At that time, OEHHA will attempt to have completed a MADL so that businesses have guidance on the amount of BPA exposure that does not require a warning under Proposition 65. Further information is available on the OEHHA website.
OEHHA, 19 April 2016 ;http://www.oehha.ca.gov ;