Regulatory Developments

Proposition 65: OEHHA Releases Pre-Regulatory Proposal for Revised Proposition 65 Warning Regulations

April 1, 2014 PRINT

On March 7, 2014, the Office of Environmental Health Hazard Assessment (OEHHA) released a pre-regulatory proposal for a potential draft regulation amending Proposition 65 regulations. Significantly -- and likely controversially -- the proposal seeks changes to the warning requirements to require more detailed information, including the names of the chemicals covered by individual warnings, the ways that individuals are exposed to these chemicals, and how individuals can avoid or reduce their exposure to these chemicals. The draft regulation and Initial Statement of Reasons are available for public review on OEHHA's website.

OEHHA states that this is only a pre-regulatory proposal and that any potential proposed regulation may change substantially prior to the eventual initiation of a formal regulatory proceeding. Nonetheless, the proposal outlines sweeping changes to Proposition 65, which, if even some version were ultimately implemented, would dramatically change the regulatory landscape in California and likely elsewhere. If OEHHA decides to propose changes to Proposition 65 regulations formally, additional opportunities for public input will, of course, be provided.

Background

On May 7, 2013, Governor Brown released a proposal to reform Proposition 65 to reduce unnecessary litigation and "require more useful information to the public on what they are being exposed to and how they can protect themselves." On July 30, 2013, a public workshop was held and public comments also were submitted. Although the process did not move forward with any suggested language, until now, there was a law (AB 227) enacted in October 2013 very narrow in focus that allows small companies (e.g., restaurants, bars, parking garages) in very limited instances (i.e., only to exposures to chemicals in food, alcohol, vehicle exhaust, and tobacco smoke when such exposures occur on the alleged violator's premises) to cure alleged Proposition 65 violations within a 14-day period.

OEHHA states the pre-regulatory proposal takes into account comments received at the public workshop as well as other comments received to date. The stated purpose of this proposal "is to improve the quality of Proposition 65 warnings while providing both flexibility and certainty for businesses."

Proposal

OEHHA states that many of the proposed revisions are intended to further the "right-to-know" purposes of Proposition 65 by establishing certain standards so that warning language is "clear and reasonable." The following are the minimum required core elements for warnings that this proposal would establish:

  • Pictogram: Proposed Section 25607.2(a)(1) would require the inclusion of the following standard (Globally Harmonized System) pictogram:

    This pictogram would be required on all Proposition 65 consumer product warnings, with limited exceptions for food products, drugs, and medical devices; occupational warnings; and environmental warnings. OEHHA states: "Using a graphic symbol will enhance the effectiveness of the warnings in a manner that is consistent with the requirements of other governmental warning programs including those that were adopted by federal OSHA and the California Division of Occupational Safety and Health Program." Initial Statement of Reasons at 19.
     
  • Warning Signal Word: Proposed Section 25607.2(a)(2) would require that the signal word "WARNING" appear in all capital letters and bold print. While "warning" is already required in the current Proposition 65 regulations, OEHHA states the capital letters and bold print requirements "ensures that consumers will immediately know the information being provided is important and not just informational in nature." Initial Statement of Reasons at 19.
     
  • "Expose": The current warning is: "WARNING: This area contains a chemical known to the State of California to cause [cancer or birth defects or other reproductive harm]." Proposed Section 25607.2(a)(2) would modify this warning to: "WARNING: This product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer or birth defects or other reproductive harm]." OEHHA states: "Since the existing regulation was adopted over 25 years ago, it has become clear that using the word 'contains' does not communicate the fact that individuals will actually be exposed to a chemical if they use a given consumer product." OEHHA believes this change is clearer, consistent with the warning requirements, and clarifies for certain businesses that "a warning is not required for a chemical that is contained in a product in such a way that it cannot foreseeably cause an exposure (e.g. where the chemical is bound in a matrix such as titanium dioxide in paper, or sealed inside the product like a battery that contains lead)." Initial Statement of Reasons at 19.
     
  • Chemical Name Disclosure: In proposed Section 25605, disclosure of the following 12 chemicals would be required in the text of the warning:
    • Acrylamide;
       
    • Arsenic;
       
    • Benzene;
       
    • Cadmium;
       
    • Chlorinated tris;
       
    • 1,4-Dioxane;
       
    • Formaldehyde;
       
    • Lead;
       
    • Mercury;
       
    • Phthalates;
       
    • Tobacco smoke; and
       
    • Toluene.
    OEHHA states that its decision to limit the requirement to name the substance for which a Proposition 65 warning is required took into account objections by businesses to include chemical names because chemical names could be long and difficult for the average person to understand and also because some warnings would be inordinately long and cumbersome if the names of several chemicals were included. OEHHA also states: "The list of chemicals is not intended to be exhaustive and may be changed over time as the public becomes more familiar with the improved warning format." Initial Statement of Reasons at 12.
     
  • New OEHHA Website: Proposed Section 25604 would require on the label a link to a new OEHHA-hosted website (www.P65Warnings.ca.gov) to allow the public to access more information relating to the warning, including additional chemicals, routes of exposure, and if applicable, any actions that individuals could take to reduce or avoid the exposure. Companies would be required to provide some of this information, but OEHHA states that it may develop additional information to supplement the specific information provided by businesses and OEHHA also may provide links to authoritative entities such as the U.S. Environmental Protection Agency (EPA) or the U.S. Food and Drug Administration (FDA) to provide individuals additional sources to consult for more detailed information concerning a given chemical or exposure. Initial Statement of Reasons at 11. The information to be provided to OEHHA is:
    • The name and contact information for the person providing the warning.
       
    • The name and contact information for the manufacturer of any product the warning is intended to cover.
       
    • The specific products or category of products the warning is intended to cover, including barcodes, if any.
       
    • The type of occupational exposure to a listed chemical the warning is intended to cover, if any.
       
    • The type of environmental exposures the warning is intended to cover, if any, and the affected area.
       
    • The name of the chemical or chemicals for which the warning is being provided.
       
    • Whether the warning is being provided for cancer, or birth defects or other reproductive harm, or both.
       
    • The anticipated route, routes, or pathways of exposure to the listed chemical for which the warning is being provided.
       
    • Reasonably available information concerning the anticipated level of human exposure to the listed chemical, if known.
       
    • Information concerning actions a person can take to minimize or eliminate exposure to the listed chemical, if any.
       
    • Whether the warning is being provided in any language other than English and a copy of the translated warning, if any.
       
    Significantly, a company that provides all this information in the warning would not be required to provide the information to OEHHA, although parties are still "encouraged to do so." OEHHA states that these requirements are needed "to reduce the number of warnings that are being provided for non-existent exposures or in situations where a chemical could be present, but not at a level that requires a warning." OEHHA states further: "This provision clarifies that a business should have a good-faith belief that a warning is required for a given exposure when it provides a warning, thereby reducing the warnings that are provided where businesses have no reasonable belief that one is required." Initial Statement of Reasons at 9.
     
    Businesses that do submit information to OEHHA for its website must also update such information when they become aware of additional chemical exposure(s) for an already reported product, occupational or environmental warning, or other required information change. The updated information must be reported within 30 days of becoming aware of such information.

The proposal also includes the following additional elements, which OEHHA believes will provide the public with better information and businesses with more regulatory certainty, clarity, and additional warning options:

  • Proposed Section 25607.1 sets forth the methods of transmission of warning requirements, including:
    • On-product warnings;
       
    • For Internet purchases, warnings provided on the Internet prior to the time the consumer completes its purchase of the product;
       
    • For catalog purchases, warnings provided in the catalog in a manner that clearly associates it with the item being purchased;
       
    • Product-specific warnings on the shelf-tag or shelf sign; or
       
    • Product-specific warning provided via any electronic device or process that automatically provides the warning to the consumer while the consumer is making a purchase.
       
    OEHHA states it is proposing alternatives such as e-mail (for environmental exposures), as well as automated processes that may be developed in the future, "so long as the person receiving the warning is not required to seek it out." Initial Statement of Reasons at 17. The methods of transmission of occupational exposure warnings and environmental exposure warnings are substantially the same as existing regulations.
     
  • Proposed Sections 25607.3 through 25607.9 provide tailored methods for transmission of warnings and warning language in specific contexts related to food, prescription drugs, medical devices, dental care, and alcoholic beverages. Proposed Section 25607.10 sets forth warning requirements for restaurant warnings not including alcoholic beverages. OEHHA also has developed in proposed Section 25607.17 specific environmental exposure warning requirements for parking facilities; apartments, hotels, and other lodging facilities; and amusement parks. OEHHA has not at this time developed proposed requirements for specific occupational exposures, although OEHHA has included a placeholder section "in the event OEHHA determines that a more specific warning is needed for a certain type of exposure." Initial Statement of Reasons at 30.
     
  • Proposed Section 25601(b) would allow businesses to propose tailored warning methods and content for chemical-, product-, or area-specific scenarios for adoption into regulations. OEHHA states this provision is "intended to encourage business to work with OEHHA to develop a tailored warning method or message where the existing regulatory provisions are not sufficient." Initial Statement of Reasons at 7.
     
  • Proposed Sections 25606(a) and (b) are intended to clarify that the primary responsibility for providing warnings for consumer products, including foods, is with the manufacturer, distributor, producer, or packager of those products (although the retail seller must cooperate with the manufacturer, distributor, producer, or packager to ensure that the required warning is provided).
     
  • Proposed Section 25603 would recognize warnings covered by existing court-approved settlements. Specifically, the regulations would state that the new requirements in the regulations do not apply to the parties to settlements that have been approved by a court prior to January 1, 2015. OEHHA states that this provision would be "limited to the parties to the settlement so that any provisions in the original settlement that are not consistent with the new regulations do not carry over to the whole industry in perpetuity." Initial Statement of Reasons at 8.
     
  • Importantly, to avoid frivolous litigation, proposed Section 25607 includes a new "Opportunity to Cure" provision that would provide small retailers (establishments with 25 or fewer employees) an opportunity to cure certain minor warning violations (e.g., a short-term absence of a sign or inadvertent obstruction of a warning label or sign) if the retailer was previously in compliance; the violation is not due to intentional neglect or disregard of the regulations, not avoidable using customary quality control or maintenance; and the violation is corrected within 24 hours of discovery or notification, or within 14 days where software equipment must be repaired or replaced.

Next Steps

OEHHA will hold a pre-regulatory public workshop on April 14, 2014, to discuss the potential regulatory action to change the existing regulations governing Proposition 65 warnings. If a regulation is eventually adopted, it would replace the existing OEHHA regulations. OEHHA is encouraging parties to submit written comments via e-mail, rather than in paper form by May 14, 2014. All comments received will be posted on the OEHHA website at the close of the public comment period.

OEHHA has stated its intent to propose formal regulations in early summer 2014 and adopt final regulations in early summer 2015. There also are plans to develop a website concurrent with the regulatory process.

Commentary

The proposed changes provide additional guidance regarding Proposition 65 warnings (e.g., recognizing warnings covered by existing court-approved settlements) that may help some in industry and expand provisions to prevent frivolous lawsuits beyond those already enacted with AB 227. The proposal also, however, includes game-changing additional warning requirements that are sure to inspire controversy for companies that manufacture, distribute, or sell consumer products with Proposition 65 warnings.

OEHHA states its proposal "is designed to provide more meaningful information for individuals in Proposition 65 warnings, facilitate the public's understanding of these warnings and make the warnings more consistent." Since the proposal requirements would significantly increase the mandatory elements of a warning, create different warning requirements for a multitude of specific circumstances, and require companies to compile and report burdensome exposure information, it is reasonable to conclude that contrary to making warnings more consistent as OEHHA intends, the regulations could also create more compliance and consistency issues while also causing confusion for the general public.

The development of an OEHHA website to provide additional information to the public is another potentially challenging aspect of these regulations. OEHHA intends the website to be as comprehensive as possible, but it may be challenging and costly to develop, and keep updated, a user-friendly website for all the information it is expected to receive, while also determining what additional information it will post. If the provisions regarding an OEHHA-hosted website were issued in final, similarly situated companies may wish to consider collaborating on the information to be provided to OEHHA.

It also is important to note that these proposed regulations address mostly warning requirements and only modestly address litigation reform issues. There are other sections of Proposition 65 reform that were debated when Governor Brown initiated reform efforts in 2013, but have not been incorporated into this pre-regulatory draft, including additional revisions to limit private enforcement and stop frivolous and shakedown lawsuits as well as how OEHHA determines safe harbor levels. OEHHA states that there are other elements of the Governor's proposed reforms that will require legislation. Whether some of these additional changes can be accomplished through regulatory revisions or legislative reform, it will be interesting to see whether and how some of these additional issues are addressed along with the pre-regulatory proposal.

Companies should review carefully the proposal and how the significant changes to the warning requirements will affect its cost and compliance capabilities. Comments should be submitted by May 14, 2014.


 
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