As of August 30, 2018, businesses will are now required to provide revised “clear and reasonable” warnings under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (known as Proposition 65 or Prop 65) if they would like to avail themselves of the safe harbor provided by the implementing regulations of the Office of Environmental Health Hazard Assessment (OEHHA or the Agency). Retailers and manufacturers/distributors alike should ensure that they are in compliance with the new rules, keeping in mind that there are specific requirements related to products sold via the Internet and product catalogs.
Under Prop 65 and the implementing regulations, businesses with 10 or more employees must provide “clear and reasonable” warnings to Californians before exposing them to a chemical listed by OEHHA as a carcinogen or reproductive toxicant (more than 900 chemicals are now on the list). The previous regulations, adopted in 1988, established criteria for what OEHHA considered to be a “clear and reasonable” warning, including specific language that, if used, would be deemed compliant with the regulations (known as “safe harbor” warning language).
In 2016, OEHAA adopted new safe harbor warning regulations that became effective this month. The new regulations place a significantly heavier burden on manufacturers/distributors to provide consumer product warnings. Specifically, manufacturers/distributors must provide revised warnings on the labels of their consumer products or provide notice and materials to retailers so that retailers can post the revised warning on signs or shelf tags at the point of purchase. Manufacturers/distributors must update the notice to retailers periodically and obtain electronic or written confirmation from the retail seller that it received the notice.
Changes to the warning language include the following: (1) addition of a warning symbol consisting of a triangle with an exclamation point (unless an exemption applies), (2) addition of the name of at least one chemical that is a carcinogen and reproductive toxicant that is present in the product, (3) addition of a URL for the new OEHHA Prop 65 warning website. Below is an example of the full warning statement for a general consumer product that contains a chemical which is listed as both a carcinogen and a reproductive toxicant:
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 birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.”
There are modifications to the language for products that contain either a carcinogen or a reproductive toxicant (but not both), as well as for products that contain a chemical listed as a carcinogen and a separate chemical listed as a reproductive toxicant.
For food products, including dietary supplements, the full warning differs slightly in four respects. First, the yellow warning symbol is not required. Second, the warning begins with “consuming this product…” Third, the warning must provide the URL for the new OEHHA Prop 65 website for food and dietary supplement products. Finally, where the warning is provided on the food or dietary supplement label, it must be set off from other, surrounding information and enclosed in a box. Below is an example of the full warning statement for a food product that contains a chemical which is listed as both a carcinogen and a reproductive toxicant:
WARNING: Consuming 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 birth defects or other reproductive harm. For more information, go to www.p65warnings.ca.gov/fact-sheets/foods.”
Again, there are modifications to the language for products that contain either a carcinogen or a reproductive toxicant (but not both), and for products that contain a chemical listed as a carcinogen and a separate chemical listed as a reproductive toxicant.
The regulations also permit use of a new short-form, on-product warning, which omits the chemical name. Below is an example of the short-form warning for a general consumer product that contains a chemical which is listed as both a carcinogen and a reproductive toxicant:
WARNING: Cancer and Reproductive Harm: www.p65warnings.ca.gov.
Yet again, there are modifications to the language for products that contain either a carcinogen or a reproductive toxicant (but not both).
The new regulations also require businesses to provide the Prop 65 warning to consumers prior to completion of online purchases of their products. The regulations note three ways that businesses can satisfy these new website warning requirements. Businesses can (1) include the safe harbor warning statement on the product display page, (2) provide a hyperlink to the warning statement using the word “WARNING” clearly marked on the product display page, or (3) otherwise prominently display the warning statement to the consumer prior to checkout (e.g., through a popup box when the product is added to the consumer’s digital shopping cart). Notably, the short-form warning may be used online only if the short-form warning appears on the product label. Under the regulations, a warning is not “prominently displayed” if the purchaser must search for it on the general content of the retailer’s website. The new regulations also impose a similar requirement that warnings be provided in catalogs.
Another change to the regulations requires businesses to also provide the Prop 65 warning in a foreign language if any other text on the sign, label, or shelf tag is written in that foreign language.
In addition, any product manufactured prior to August 30, 2018 whose warning is compliant under the current regulations will be deemed to have a clear and reasonable warning under the new regulations. Furthermore, warnings under current court-ordered settlements or final judgments will remain compliant under the new regulations.
Finally, in limited situations, the regulations permit product manufacturers, producers, packagers, importers, suppliers, and distributors to transfer the duty to warn to retailers. Specifically, a covered business may follow the specific requirements in the regulations to provide notice and the warning materials to the “authorized agent” of the retail seller and receive an acknowledgment of receipt. The retailer seller is then responsible for the placement and maintenance of the warning materials received from a manufacturer, producer, packager, importer, supplier, or distributor.
Importantly, the new regulations also offer retail sellers the opportunity to cure alleged “failure to warn” violations if they first learn of the need to warn from a 60-Day Notice. Specifically, if retail sellers do not obtain “actual knowledge” of the need to warn from another source (e.g., from a warning on a product label or a notice given by the manufacturer), and first learn of the need to warn from a 60-Day Notice, the retail sellers will have five business days after receiving the Notice to either provide Prop 65-compliant warnings or remove the product from sale in California. While this opportunity to cure can certainly benefit retailers, five business days is an extremely short period of time to determine whether and how to provide warnings or remove products from sale. In the event you receive a 60-Day Notice, please contact the authors so we can address the merits of the Notice and work with you to develop and implement an effective strategy to promptly cure any alleged violations.
Of course, businesses are not required to use OEHHA’s safe harbor warnings. However, declining to do so poses a risk of enforcement action, and businesses will need to defend their warnings as being “clear and reasonable.” Businesses that fail to provide adequate warnings are subject to penalties as high as $2,500 per violation per day.
For help ensuring that your business is compliant with the new regulations, please contact the authors.