Emergency Regulation Proposed To Address May 11, 2016 Prop 65 Warning Deadline For Oral Exposure To BPA In Consumer Products
Effective May 11, 2016, companies that manufacture and sell products in California that expose consumers to bisphenol A (BPA) will be required to provide Proposition 65 warnings unless they can affirmatively show that their product does not pose a significant risk of reproductive harm to consumers. BPA is a synthetic compound used in numerous consumer applications, including in certain linings of metal cans and lids of glass bottles containing food and beverages.
In advance of the May 11 deadline, the California Office of Environmental Health Hazard Assessment (OEHHA), the state entity responsible for implementation of Prop 65, has proposed an emergency regulation to allow temporary use of a standard point-of-sale “safe harbor” warning message for oral BPA exposures from canned and bottled foods and beverages. Current safe harbor warning regulations provide general guidance concerning the types of warning methods and content that are deemed “clear and reasonable” for purposes of Prop 65 but do not expressly allow for point-of-sale warnings for consumer products that cause exposures to listed chemicals. Point-of-sale is defined by the proposed regulation as the area within a retail facility where customers pay for food and beverages, as well as electronic check-out functions on Internet websites.
The proposed emergency regulation is noteworthy to any manufacturer, distributor, or retailer of canned and bottled food and beverage products offered for sale in California carrying the potential for exposures to BPA, in part, because public and private parties may bring enforcement actions to force warnings on products for exposures to BPA beginning on the May 11, 2016 effective date. If the proposed emergency regulation is adopted, companies will be in compliance with Prop 65 warning requirements by using the point-of-sale “safe harbor” warning message.
OEHHA has deemed the emergency regulation necessary for several reasons. No Prop 65 warning is required for a product if a company can show that exposure to a listed chemical is below the regulatory safe harbor, also known as the Maximum Allowable Dose Level (MADL). Currently, there is no MADL for BPA. OEHHA does not always set an MADL but generally tries to do so to provide compliance guidance to businesses. OEHHA attempted to set an MADL for oral exposure of BPA that would have been enacted through the normal regulatory process, thereby precluding the need for this emergency action. OEHHA states, however, it was unable to do so in time because of “complicated scientific questions.” OEHHA expects a large series of studies being sponsored by the federal government intended to clarify the effects of BPA at low doses to be completed in 2017 or 2018, which OEHHA hopes will inform the development of an oral exposure MADL.
In the absence of an MADL, businesses must decide on their own whether exposures are high enough to trigger the warning requirement. OEHHA is concerned, therefore, that without the emergency regulation businesses will take inconsistent approaches to compliance for BPA exposures. It fears that some businesses may decide that products causing relatively higher exposures to BPA do not require warnings, while others may decide to place warnings on products causing lower exposures. In addition, some retailers may put warnings on all products with BPA, while others may warn selectively. Consumers could see a warning for a product in one store, and no warning for the same products in another.
In addition, OEHHA acknowledges that some canned food and beverage manufacturers have begun reducing or eliminating the use of BPA, or plan to do so, but any such changes will not affect existing retail inventories as many canned foods and beverages have a shelf life of up to three years. Thus, although businesses have had a year to reduce or remove 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 May 11, 2016. The emergency regulation is designed to be a temporary solution to address these particular products.
As noted, the current regulations do not expressly allow for point-of-sale warnings for consumer products that cause exposures to listed chemicals. Therefore, under current regulations, the most likely way for businesses to ensure that pre-May 2015 products have required 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, most retailers likely would have a plethora of warnings signs displayed in their stores, which is likely to confuse and overwhelm consumers.
Indeed, OEHHA states an emergency exists justifying the proposed regulation “because, if this regulation is not in place by May 11, 2016, consumers will see inconsistent health warnings on canned and bottled food and beverages throughout the state. This situation would cause widespread confusion and undermine the purpose of Proposition 65.”
The proposed safe harbor warning language is as follows:
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 proposed warning language therefore is much more specific than current regulatory safe harbor language and will identify BPA by name and provide supplemental information via a link to OEHHA’s website. These are alterations to the current regulations that are similar to amended regulations currently being proposed by OEHHA for safe harbor warnings for all consumer products in a separate rulemaking process. There currently is an open public comment period on those proposed regulations, which ends April 26, 2016.
OEHHA believes that both the public and the food and beverage businesses would benefit from the clarity that a uniform point-of-sale warning regulation for BPA would provide. The proposed emergency regulation would expire after 180 days. During that period, OEHHA will commence a regular rulemaking process to adopt a regulation as an interim measure for a one-year period from date of adoption. OEHHA hopes to have available the results of the current BPA studies by the end of that interim period in order to establish an MADL at that time.
It should be emphasized that the proposed regulation applies only to oral exposure to BPA by way of canned and bottled foods and beverages. OEHHA has initiated a separate rulemaking process to set an MADL of 3 micrograms per day for dermal exposures from solid materials containing BPA. Comments on the proposed MADL are due to OEHHA May 16, 2016. Note that this means that the proposed MADL for dermal exposures will not be finalized until after the May 11, 2016 trigger date for warnings. OEHHA expects, however, that the proposed MADL will provide sufficient guidance to businesses because it is not likely to change much, if at all.
The Prop 65 warning requirement for BPA was triggered by OEHHA’s controversial May 11, 2015 listing of BPA as a reproductive toxicant to be added to the list of chemicals subject to Prop 65. Once a chemical is added to the list, companies only have 12 months to comply with Prop 65’s “clear and reasonable” warning requirement. OEHHA’s decision to list BPA was controversial because health experts, including the U.S. Food and Drug Administration and European Food Safety Authority, have consistently concluded through research that exposure to BPA is safe in typical dosage levels. (The FDA did ban BPA from baby bottles and sippy cups in 2012, a move it said it took as a precaution.) Furthermore, BPA is prevalent in many of the most common plastic products – such as water bottles, food containers and many construction products – and therefore, the warning requirements threaten to impose a substantial burden on companies that manufacture and sell such products.
Aside from assessing Prop 65 warning obligations and litigation risks, businesses should also keep in mind that BPA may become subject to California’s Safer Consumer Products Act (SCPA). The SCPA seeks to transform the way manufacturers, importers, and retailers conduct business in California, with the goal of creating a comprehensive list of toxic chemicals used in consumer products and then eventually replacing them with “safer” and “greener” alternatives. The Department of Toxic Substances Control (DTSC) is responsible for identifying and prioritizing products to undergo the regulatory process. DTSC identifies a list of chemicals of concern from a broader list of “candidate chemicals,” and these chemicals of concern serve as the basis for selecting priority products. BPA currently is among the 2,300 chemicals found on the DTSC’s candidate chemical list, and has been identified by DTSC as an “emerging chemical of concern.” Accordingly, BPA may well be on its way to becoming a chemical of concern and consequently serve as a basis for selecting priority products. Indeed, the listing of BPA under Prop 65 likely is a precursor to BPA becoming a chemical of concern under the SCPA.
There will be a five-day comment period on OEHHA’s proposed emergency Prop 65 regulation for BPA exposures after it is filed with the Office of Administrative Law (OAL). OEHHA must wait five working days after providing notice of the proposed emergency action to the public before filing the proposed regulation with the OAL. Notice was issued to the public on April 1, 2016. Accordingly, OEHHA may file the proposal with OAL as early as Friday, April 8.
If you wish to comment on proposed emergency regulations, you must submit the comment directly to OAL within five calendar days of when OAL posts the proposed emergency regulations on the OAL web site at http://www.oal.ca.gov/Emergency_Regulations_Under_Review.htm.
Submit comments to:
OAL Reference Attorney
by mail to:
300 Capitol Mall, Suite 1250
Sacramento, California 95814
by fax to: (916) 323-6826
or by e-mail to: firstname.lastname@example.org.
Please also send a copy of your comments to OEHHA at:
Monet Vela Office of Environmental Health Hazard Assessment
Street Address: 1001 I Street, 23nd Floor
Sacramento, California 95814
Mailing Address: P.O. Box 4010
Sacramento, California 95812-4010
For more information and a copy of the draft proposed emergency regulations, please visit http://www.oehha.ca.gov/prop65/CRNR_notices/040116BPAEmergencyAction.html.