Editor’s Note: On August 30, 2018, OEHHA’s amendments to the Proposition 65 clear and reasonable warning regulations became effective. The amendments bring two major changes:
- the first ever allocation of responsibility for warnings, which places the primary responsibility on upstream entities rather than retailers; and
- significant changes to the “safe harbor” warning regulation, including warning content and methods of transmission.
This post focuses on the content of the warning itself; a detailed discussion of supplier and retailer responsibility can be found here. For a look at the impact of the new regulations six months after passage, click here.
The statutory warning requirement
Prop 65 requires that any person in the course of doing business (meaning any private company that employs 10 or more persons) must provide a “clear and reasonable warning” before exposing individuals to listed carcinogens and reproductive toxins in significant amounts. When it first adopted regulations implementing the warning requirement in 1989, the Lead Agency (now the Office of Environmental Health Hazard Assessment, or OEHHA) was faced with turning that language into directions for businesses to follow to comply with the requirement.
The meaning of “clear and reasonable”
The Lead Agency first interpreted the statute to mean that the “clear” part of the warning requirement applied to the language of the message, and the “reasonable” part applied to the method. It decreed that any warning must “clearly communicate that the chemical in question is known to the state to cause cancer, or birth defects or other reproductive harm.” And “the method employed to transmit the warning must be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure.”
The safe harbor
Recognizing that these standards were fuzzy, OEHHA adopted a “safe harbor” approach, providing specified warnings that were “deemed” to be clear and reasonable, although they were not the exclusive methods. The agency has, over the years, provided versions of safe harbor warning methods and messages for exposures to listed chemicals. As noted above, OEHHA substantively amended the safe harbor requirements effective August 30, 2018.
Amended safe harbor–warning location
Warnings must be provided on product labels or at the point of display (product-specific posting or shelf signs). Point of sale signs are not approved safe harbor warning methods.
A retailer may also provide a warning by any electronic device or process that provides the warning prior to or during the purchaser without requiring the consumer to seek out the warning, such as electronic shopping carts, QR Codes, smart phone applications, barcode scanners, and self-checkout registers.
Online and catalog sales
For online transactions, retailers must include either the warning or a clearly-marked hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase. Warnings contained within general website content will not meet the safe harbor method.
For catalogs, warnings must be printed such that they are clearly associated with corresponding products.
OEHHA has stated that online and catalog warnings must be provided even if the product is already labeled with a warning. This appears to be overreach, but unless/until there is litigation over this issue, it remains an area of risk.
Amended safe harbor–warning content for consumer products
A safe harbor warning must include a warning symbol and identification of at least one chemical in the product that is associated with the warning’s toxicological endpoint (cancer or reproductive harm). Warnings must be provided in the same language or languages as any other label, labeling or sign accompanying a product. Examples include:
- Warning for exposures to either a carcinogen or reproductive toxicant
WARNING This product can expose you to [name of one or more chemicals], a chemical [or chemicals] known to the State of California to cause [cancer] [birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov/product.
- Warnings for exposure to both cancer and reproductive toxicity
WARNING This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Amended safe harbor–short form warnings
In circumstances where a standard warning might not be practical (think product or package size), short form warnings on products that do not require chemical identification are permissible:
Note that as of now, the short form warning is not expressly limited to small products/packaging, but we understand OEHHA may soon amend the regulation to limit short for usage due to concerns over misuse.
Amended safe harbor–warning language for specific products
In addition to the general consumer product warnings above, there are product-specific safe harbors that generally tweak the warning language or add additional requirements, including:
- Food and dietary supplements
- Alcoholic beverages
- Food and non-alcoholic beverages in restaurants
- Raw wood
- Prescription drugs and emergency medical or dental care
- Diesel engine exhaust
- Vehicle and RV exhaust
- Parking garages
- Amusement parks
- Petroleum products in industrial settings
- Service stations and automotive repair
- Smoking areas.
Product-specific safe harbor warning samples and translations can be found here.
Do you have to use the safe harbor?
Companies that stray from the safe harbor risk litigation, where the sufficiency of warning language or methods is a question of fact (meaning that it is unlikely to be decided by the court before trial). Common pitfalls:
- A warning that says a product “may contain” a chemical known to the State to cause cancer. Public and private enforcers argue that this is an inadequate warning, because it does not actually provide a warning before exposure to the chemical.
- Not labeling products shipped to non-California locations. Sometimes, companies label only products shipped to California customers or to California warehouses of distributors and retailers, figuring that they don’t need to provide warnings for products shipped to other parts of the country. But multistate retailers and distributors often transship products or fulfill California orders from other warehouses. And customers located throughout the world can sell to resellers in California or to consumers over the internet. All it takes is one product being purchased by an enforcer in California without a warning to subject a company to costly litigation.
- Assuming that changing the label by the date a warning is required is all that is necessary. The law allows a 12-month “grace period” after the listing of a chemical to require a warning. Sometimes, businesses do not account for products offered at retail when the grace period expires. The enforcers are often in stores the next day looking for products that contain listed chemicals and hold both the manufacturer and retailer responsible for such products.