Regulatory Developments

Proposition 65:  OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations

September 22, 2016

On August 28, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering "clear and reasonable warnings" requirements.

Bergeson & Campbell, P.C. (B&C®) prepared a memorandum discussing OEHHA's November 27, 2015, proposed rule, Proposition 65: OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations, and the March 25, 2016, revisions to those proposed changes, Proposition 65: OEHHA Proposes Revisions to Its Proposed Proposition 65 Warning Regulations. Other information related to OEHHA's past actions modifying Prop 65 warning regulations is available on our website, key phrase Proposition 65.

The final regulations are effective on August 30, 2018. In the interim, businesses may comply with the regulation that came into effect on August 30, 2016, or the provisions of the revised regulation. For the next two years, companies have the choice of whether to comply with the clear and reasonable warning requirements that will be operative until August 30, 2018, or the clear and reasonable warning requirements that must be operative by August 30, 2018.

Considering the substantive and controversial revisions in the final regulations applicable to Prop 65 warning requirements, as identified in this side by side comparison of the old and new regulations, and also considering production and distribution chain challenges and logistics, companies should not delay reviewing current warning practices and determining when and how these changes are to be implemented. Specific areas of focus include:

  • Consumer Product Exposure Warnings -- Content: The most obvious changes are those required to the warning language, including but certainly not limited to adding a new pictogram and referencing OEHHA's new website, www.P65Warnings.ca.gov/product. Title 27, California Code of Regulations Section 25603. Also significantly, companies will need to identify the name of one or more of the listed chemicals for which the warning is being provided. When the warning is being provided for more than one endpoint (cancer and reproductive toxicity), the warning must include the name of one or more chemicals for each endpoint, unless the named chemical is listed as known to cause both cancer and reproductive toxicity and has been so identified in the warning. Companies must review all the products for which they provide warnings and determine how they will meet this new regulatory requirement on a product by product basis depending on whether there is one or more chemicals for which warning is required and the bases for each such warning.
     
  • Consumer Product Exposure Warnings -- Method of Transmission: Companies also must review the methods of transmission they currently use for warnings and determine whether those methods are still valid and/or whether they wish to employ a new method of transmission. Section 25602. While the revised regulations expand the list of acceptable methods for providing a warning via electronic means, the revised regulations also make clear that the warning must be provided to the purchaser "prior to or during the purchase of the product, without requiring the purchaser to seek out the warning." Warnings provided with internet purchases also must be provided to the purchaser prior to completing the purchase (e.g., clearly marked hyperlink using the word "WARNING"). Companies considering this new method of transmission must be careful to ensure that requirements related to the timing of the warning are satisfied. Even warnings that are not relayed via electronic means or internet sales should be reviewed as to when that warning is still compliant, as the revised regulations no longer contain any language that would permit a warning that would be read and understood under customary conditions of use.
     
  • New Specific Product, Chemical, and Area Exposure Warnings: There are new regulations providing tailored methods for transmission of warnings and warning language for several products, chemicals, and area exposures:
     
    • Food (including dietary supplements);
       
    • Alcoholic beverages;
       
    • Food and non-alcoholic beverages in restaurants;
       
    • Prescription drugs;
       
    • Dental care and emergency medical care;
       
    • Raw wood;
       
    • Furniture;
       
    • Diesel engines;
       
    • Passenger vehicles or off-road vehicles;
       
    • Recreational vessels;
       
    • Parking garages;
       
    • Amusement parks;
       
    • Petroleum products;
       
    • Service stations and vehicle-repair facilities; and
       
    • Designated smoking areas
       
    Sections 25607-25607.29. Any company that has warning obligations related to any of these scenarios must review and ensure compliance with the specific warning requirements.
     
  • Warning Responsibility: The revised regulations limit the circumstances when the retail seller is responsible for providing the warning requirement. Section 25600.2. Any company with an arrangement to have a retail seller or other entity provide a Prop 65 warning for its product(s) must review that arrangement and determine if current procedures comply with the revised regulations.

 
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