I. Introduction
The Office of Environmental Health Hazard Assessment (OEHHA) is the state entity responsible for the implementation of Proposition 65.1 OEHHA has the authority to adopt and amend regulations to make specific and further the purposes of Proposition 65. OEHHA maintains a list of chemicals known to cause reproductive toxicity or cancer. Proposition 65 requires businesses to provide a warning when they knowingly and intentionally cause an exposure to a listed chemical, and prohibits the discharge of listed chemicals into sources of drinking water.
The current safe harbor warning regulations adopted by OEHHA in Title 27 of the California Code of Regulations, section 25601, provide general guidance concerning the types of warning methods and content that are deemed “clear and reasonable” for purposes of the Act.
On May 11, 2015, bisphenol A (BPA) was added to the Proposition 652 list of chemicals known to cause reproductive toxicity. Effective May 11, 2016, warnings are required for all exposures to BPA unless the person causing the exposure can show that the exposure is 1,000 times below the no observed effect level for the chemical.3 OEHHA is proposing to promulgate an emergency regulation to allow temporary use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages.4
II. BACKGROUND
On May 11, 2015, bisphenol A (BPA) was added to the Proposition 655 list of chemicals known to cause reproductive toxicity. The listing is for the female reproductive toxicity endpoint. Female reproductive toxicity occurs when a chemical damages any aspect of the female reproductive system. BPA is an industrial chemical used to make polycarbonate, a hard, clear plastic, which is used in many consumer products. BPA is also used to make epoxy resins, which act as a protective lining on the inside of some metal-based food and beverage cans and on lids for glass jars and bottles.6 It is approved by the Federal Food and Drug Administration (FDA) for use in food contact applications including food and beverage can linings and seals, except for baby formula.7Due to the Proposition 65 listing, effective May 11, 2016, warnings are required for all exposures to BPA unless the person causing the exposure can show that the exposure is 1,000 times below the no observed effect level for the chemical.8
Currently, the regulations governing Proposition 65 warnings are in Title 27 of the California Code of Regulations, section 25601. These regulations provide general safe harbor guidance concerning the types of warning methods and content that are deemed “clear and reasonable” for purposes of the Act. Under these regulations, a business may provide a warning for an exposure to a listed chemical in a consumer product, including foods, in several ways. Section 25603.1 allows a business to provide the warning on a product’s label or labeling, shelf tags, shelf signs, menus or any combination thereof as long as the warning is prominent and conspicuous. The general safe harbor warning message content for consumer products, including foods, is as follows: “This product contains a chemical known to the State of California to cause reproductive toxicity”. The current regulation does not expressly allow for point-of-sale warnings for consumer products that cause exposures to listed chemicals.
OEHHA understands that many canned and bottled food and beverages can cause exposures to varying amounts of BPA.9 These canned and bottled foods and beverages do not currently carry Proposition 65 warnings because no warning is required for BPA exposures until May 11, 2016. OEHHA also understands that some canned food and beverage manufacturers are moving toward the reduction or elimination of 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. These regulations address the interim period during which manufacturers will take a variety of approaches in response to the new warning requirement.
Proposition 65 is enforced by the Attorney General’s Office, local prosecutors and private citizen enforcers. When the warning requirement goes into effect on May 11, 2016, it is possible that private enforcers may serve a number of 60-notices of intent to sue alleging a failure to warn for BPA exposures from canned and bottled foods and beverages. Given the variety of canned and bottled foods that may cause significant exposures to BPA, and the fact that retailers likely do not know which products currently on their shelves may require warnings, OEHHA is concerned that some retailers will decide to remove canned and bottled food items from store shelves to avoid potential enforcement actions. This could further reduce the availability of nutritious food products in low income communities and locations known as “food deserts” where, because of a lack of available fresh food sources, the population depends heavily on canned food items.10
Widespread Proposition 65 warning signs throughout supermarkets where canned and bottled foods and beverages are sold could also cause some Californians to forego consumption of healthy and nutritionally important vegetable and fruit products. While there would likely be no Proposition 65 warnings required for fresh produce, a significant number of Californians may not view fresh produce as a viable option for several reasons:
Some Californians may have a strong preference for canned vegetables and fruits over fresh produce for various reasons including not having the time or inclination to prepare meals with fresh produce, or simply personal choice.
Canned food is much easier to store, particularly for extended periods of time.
Many low-income Californians live in “food deserts” where fresh produce is not widely available.
Cost is one of the key reasons people buy canned vegetables instead of fresh produce and therefore low-income residents might be unable to switch to fresh produce.
Some low-income families may not have reliable refrigerators.
Widespread Proposition 65 warnings for numerous canned food products may prompt such individuals to reduce, or to forego entirely, purchasing canned or bottled vegetables and fruits, to the detriment of their own health. Proposition 65 warnings typically help consumers make informed decisions about which products to purchase. But BPA warnings will be unusual in that they will apply to a wide range of nutritious canned food products where alternative choices are not always available.
OEHHA continues to review the scientific studies of BPA as they become available and may be able to establish a Maximum Allowable Dose Level (MADL) for oral exposure, such as occurs when food is consumed, that would help businesses determine which exposures are significant enough to require a warning; the timing of that regulatory action is dependent on the availability of necessary scientific information. However, given that a MADL will likely not entirely eliminate the need for warnings for exposures to BPA from all canned foods and beverage, OEHHA also wishes to encourage food manufacturers to reduce or eliminate exposures to BPA by switching to safer alternatives where feasible. Therefore, a reasonable transition period is needed to avoid consumer confusion and at the same time provide the required warning for significant exposures to BPA. This short-term emergency regulation coupled with a regular rulemaking process to adopt an interim regulation would accomplish these purposes.
Emergency Action is Needed
This emergency regulatory proposal is intended to further the purposes of Proposition 65 by promoting the use of a uniform point-of-sale warning message for BPA exposures from canned and bottled foods and beverages. The proposed amendments would:
Avoid consumer confusion by promoting consistent warnings about BPA exposure from canned and bottled foods and beverages prior to exposure, as required by Health and Safety Code section 25249.6.
Avoid a potential misperception on the part of the public that the canned and bottled food supply poses an imminent health threat.
Avoid the reaction of retailers who may pull existing inventories of canned and bottled foods off store shelves in an effort to avoid liability.
Avoid harm to the general welfare of low income communities and populations who live in “food deserts” by potentially significantly limiting availability of necessary food items.
Provide the public with supplemental information via a link to the OEHHA website with fact sheets and links to materials from other authoritative organizations concerning exposures to BPA from canned and bottled foods and beverages to help consumers make informed decisions.
III. Finding of an Emergency
Section 48 Statement
Title 1 of the California Code of Regulations, section 48 requires the following statement:
“Government Code section 11346.1 (a)(2) requires that, at least five working days prior to submission of the proposed emergency action to the Office of Administrative Law, the adopting agency provide a notice of proposed emergency action to every person who has filed a request for notice of regulatory action with the agency. After submission of the of the proposed emergency to the Office of Administrative Law, the Office of Administrative Law shall allow interested persons five calendar days to submit comments on the proposed emergency regulations as set forth in Government Code section 11349.6.”
Facts Constituting the Need for an Emergency Action
The APA defines an "emergency" to mean "a situation that calls for immediate action to avoid serious harm to the public peace, health, safety, or general welfare." (Gov. Code Section 11342.545.) To make a finding of emergency, the agency must describe the specific facts supported by substantial evidence that demonstrate the existence of an emergency and the need for immediate adoption of the proposed regulation. (Gov. Code Section 11346.1(b)(2).) Some factors an agency may consider in determining whether an emergency exists include: (1) the magnitude of the potential harm, (2) the existence of a crisis situation, (3) the immediacy of the need, i.e., whether there is a substantial likelihood that serious harm will be experienced unless immediate action is taken, and (4) whether the anticipation of harm has a basis firmer than simple speculation. Pursuant to these statutes, OEHHA finds that an emergency exists in the present case.
An emergency exists because, if this regulation is not in place by May 11, 2016, manufacturers and retailers may resort to one or both actions described above: the removal of canned and bottled food and beverage items from the shelves, or the placement of multiple and inconsistent warnings on the products and throughout the facility where canned, bottled or jarred foods are displayed. This situation would cause widespread confusion and unnecessary adverse impacts to public access to inexpensive but nutritious food. These impacts would disproportionately harm California’s most vulnerable communities, which rely heavily on canned and bottled food as a main source of nutrition.
The following facts support this finding:
The use of BPA in food and beverage can linings and jar and bottle lids is prevalent, and BPA can migrate into the food or beverage from the linings and lids of cans and bottles.
Since canned and bottled foods have shelf-lives of up to three-years, there are vast inventories of pre-warning canned and bottled food products currently on store shelves.
Currently, warnings are not provided on the cans, bottles or jars that are already in commerce. One option under the existing regulations is for manufacturers or retailers to place warnings signs or shelf tags at each point of display of products that may cause exposures to BPA. Having a large volume of disparate warnings posted throughout a facility may cause consumer confusion and dilute the effectiveness of the warnings being provided.
Under existing regulations, manufacturers and retailers are likely to comply with the new warning requirement in inconsistent ways. These inconsistencies in the marketplace are likely to cause confusion, thwarting the informational purposes of Proposition 65. A uniform point-of-sale warning would avoid public confusion and misconception about the safety of the food supply that could result from inconsistent warning messages about these products.
Canned and bottled foods provide an important source of nutrition, and low income communities and individuals living in “food deserts” in particular rely heavily on access to canned and bottled food.
Action is necessary to ensure an effective transition from the sale of canned and bottled foods without Proposition 65 warnings to providing warnings for significant BPA exposures from food products.
In order to avoid retailers removing canned and bottled food products that have no warnings from store shelves, OEHHA is proposing to temporarily allow for a uniform point-of-sale warning for these products.
OEHHA attempted to address the emergency situation through non-emergency regulations, but encountered technical and practical problems with that approach. OEHHA attempted to develop a MADL for oral exposure that would have been enacted through the normal regulatory process. In the course of that process, OEHHA scientists found that the issue was technically complex. At the same time, the federal government is sponsoring a large series of studies intended to clarify the effects of BPA at low doses. Some of these studies, expected to be complete in 2017 or 2018, could form the basis of an oral MADL.
As the May 11, 2016 deadline for warnings has approached, OEHHA also became aware that some manufacturers and retailers are concerned about litigation risk and are considering different approaches to addressing the risk. Some businesses may provide warnings on labels, shelf signs or tags; others may provide point-of-sale warnings, and others may choose to provide no warning at all. The location, design, and content of these warnings may all vary. These potentially inconsistent approaches could lead to public confusion, and could also result in retailers deciding the most prudent path to avoid legal liability is to pull their canned food and beverage products from store shelves, and this type of reaction could adversely impact consumers, including some of California’s most vulnerable communities.
Canned food and beverage products can provide important options for a nutritious diet. If retailers react to the current warning requirement by pulling cans from the shelves, consumers would have fewer food choices, and, because many communities in California already lack sufficient access to healthy foods, the further reduction in choices would disproportionately impacts certain communities. These underserved communities, often referred to as “food deserts,” include poor inner-city neighborhoods and rural communities where residents live far from the closest grocery store or supermarket.11 Small corner stores and fast-food outlets may be the only sources of food within these communities.12 Confusion regarding canned and bottled foods could further limit healthy choices for low-income families.
OEHHA has concluded that both the public and the food manufacturing and retail industries would benefit from the clarity a uniform point-of-sale warning regulation would provide. The proposed emergency regulation would expire after 180 days. During that period, OEHHA will commence a regular rulemaking process to adopt the regulation as an interim measure for a one-year period from date of adoption. 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 for oral exposures to BPA, which would further clarify which products require a warning.
Need for the Proposed Regulation to Effectuate the Statute
Proposition 65 was enacted to protect the public from exposures to chemicals that cause cancer, birth defects, or reproductive harm by informing the public about exposures to these chemicals. As is discussed above, this proposed emergency regulation is necessary to avoid potential consumer confusion and dilution of the effectiveness of Proposition 65 warnings to the public that could result from inconsistent messages.
IV. TECHNICAL, THEORETICAL, AND/OR EMPIRICAL STUDY, REPORTS, OR DOCUMENTS RELIED UPON
Citations to the documents relied on for this proposal are provided in this document. No other technical, theoretical or empirical material was relied upon by OEHHA in proposing the adoption of this regulation.
V. AUTHORITY
Health and Safety Code section 25249.12(a)
VI. INFORMATIVE DIGEST
Background (see Section II, above)
Specific Benefits of the Proposed Regulations
This regulatory proposal is intended to further the purposes of Proposition 65 by ensuring use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages. (See Sections II and III, above.)
No Inconsistency or Incompatibility with Existing Regulations
OEHHA has conducted an evaluation and has determined that this would be the only regulation concerning Proposition 65 BPA Warnings. Therefore, the proposed regulation is neither inconsistent nor incompatible with any other existing state regulations. The proposed regulation does not change the existing mandatory requirements on businesses subject to Proposition 65, state or local agencies and does not address compliance with any other law or regulation.
Local Mandate/Fiscal Impact.
Because Proposition 65 by its terms13 does not apply to local agencies or school districts, OEHHA has determined the proposed regulatory action would not impose a mandate on local agencies or school districts; nor does it require reimbursement by the State pursuant to Part 7 (commencing with Section 17500) of Division 4 of the Government Code. OEHHA has also determined that no nondiscretionary costs or savings to local agencies or school districts will result from the proposed regulatory action. Also, the proposed action will not create any cost or saving to any state agency, and will not create any cost or savings in federal funding to the state.
Costs of Savings to State Agencies
Because Proposition 65 by its terms14 does not apply to any state agency and this regulation is simply a clarification of existing procedures, OEHHA has initially determined that no significant savings or increased costs to any state agency will result from the proposed regulatory action.
Efforts to Avoid Unnecessary Duplication of Conflicts with Comparable Federal Regulations
Proposition 65 is a California law that has no federal counterpart. OEHHA has determined that the regulations do not duplicate and will not conflict with federal regulations.
VII. FISCAL IMPACT
Costs to Local Agency or School District
Because Proposition 65 by its terms15 does not apply to local agencies or school districts, OEHHA has determined the proposed regulatory action would not impose a mandate on local agencies or school districts; nor does it require reimbursement by the State pursuant to Part 7 (commencing with Section 17500) of Division 4 of the Government Code. OEHHA has also determined that no nondiscretionary costs or savings to local agencies or school districts will result from the proposed regulatory action. Also, the proposed action will not create any cost or saving to any state agency, and will not create any cost or savings in federal funding to the state.
Cost of Savings to State Agencies
Because Proposition 65 by its terms16 does not apply to any state agency and this regulation is simply a clarification of existing procedures, OEHHA has initially determined that no significant savings or increased costs to any state agency will result from the proposed regulatory action.
Source:OEHHA