Editor's Note: California's Office of Environmental Health Hazard Assessment (OEHHA) recently posted answers businesses' frequently asked questions about the new Proposition 65 Clear and Reasonable Warning regulation that goes into effect on Aug. 30, 2018. OEHHA announced the final rule for "clear and reasonable warnings" in September 2016.

Learn more about the new Clear and Reasonable Warning requirements at AHPA's July 25 webinar. The webinar provides an opportunity to get your questions answered by an OEHHA official and industry legal experts.


 

Cal EPA Office of Environmental Health Hazard Assessment
July 2017

Modified Article 6 Clear and Reasonable Warnings 

Has the Office of Environmental Health Hazard Assessment (OEHHA) issued new regulations concerning the provision of warnings?
Yes, in August 2016 OEHHA adopted amended regulations for the provision of "clear and reasonable" Proposition 65 warnings in Title 27, California Code of Regulations, section 25600, et seq. 2 The new regulations will be effective on August 30, 2018, although businesses can begin using warnings that conform with the new regulations at any time.
    • Article 6, Subarticle 1 consists of mandatory provisions including definitions of terms that are applicable to all warnings provided under Proposition 65.
    • Article 6, Subarticle 2 provides non-mandatory, "safe harbor" methods and content for giving "clear and reasonable" warnings under Proposition 65. 
2 All further references are to sections of Title 27, California Code of Regulations unless indicated otherwise. 

I have determined that I need to provide a warning. How do I do so? 
Guidance for providing a clear and reasonable warning is available in OEHHA's warning regulations. Warnings can be given by a variety of methods depending on the type of exposure (consumer product, environmental, or occupational). You may find it helpful to refer to the side-by-side comparison of the September 2008 and August 2018 ("new") regulations to consider your options, as either can be used until August 30, 2018. 

What kind of testing does a business have to do in order to meet the safe harbor warning requirements? 
The warnings regulations do not address the question of whether a warning is required; rather, the regulations provide guidance on how to provide a warning once a business has made a determination that a warning is required. The warning regulations do not require a business to perform any testing. 

To guide businesses in determining whether a warning is necessary, OEHHA has developed over 300 regulatory safe harbor levels for Proposition 65 chemicals. A safe harbor level identifies a level of exposure to a listed chemical that does not require a Proposition 65 warning. A business is not required to provide a warning if exposure to a chemical occurs at or below these levels. These safe harbor levels consist of No Significant Risk Levels for chemicals listed as causing cancer and Maximum Allowable Dose Levels for chemicals listed as causing birth defects or other reproductive harm. 

Subarticle 1. General 

When do the new regulations take effect? 
To allow for a reasonable transition period for businesses to begin providing warnings under the new regulatory provisions, businesses can use either the September 2008 or new regulations until August 30, 2018, at which time the new regulations will become operative and the September 2008 regulations will no longer be available as a safe harbor compliance option. 

If I have to provide a warning, am I required to use the safe harbor warning methods and content described in Article 6? 
No. The safe harbor warning methods and content in Article 6 are deemed by OEHHA to be clear and reasonable, and provide a "safe harbor" against enforcement actions for businesses that choose to use them. A business can choose to use other warning methods and content; however, the business might have to defend the warning in legal proceedings if it were challenged by a public or private enforcer as not being clear and reasonable. 

When do I need to provide the new warnings? 
The new warnings become operative on August 30, 2018, at which time the September 2008 safe harbor warning methods and content will no longer be operative. The exceptions involve consumer products manufactured prior to August 30, 2018 and labeled in compliance with the September 2008 warning regulations, and products covered by court approved settlements (Section 25600).


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