The nature and cost of human exposure testing required by Proposition 65 is unlike what is required by many other product safety laws, such as the Consumer Product Safety Act, which states content limits on certain chemicals that are relatively easy to measure and control.
After nearly two years of consideration and multiple public hearings, California has adopted wholesale changes to the Proposition 65 warning regulations that impact companies doing business in California or whose products are sold in California. These new regulations have substantially rewritten the “safe harbor” warning requirements that are a key to compliance with Proposition 65 and essential to avoiding potentially costly enforcement actions brought by private bounty hunters that the statute has empowered.
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, was adopted by California voters with such laudable goals as keeping California’s drinking water safe and giving Californians a right to be informed about exposures to chemicals that cause cancer, birth defects or other reproductive harm. The resulting rules and regulations are complex, and they have just grown more so as a result of the new regulations.
A fundamental precept of the “right to be informed” component of Proposition 65 is that a business with 10 or more employees must give a “clear and reasonable warning” to consumers, employees and others in California before knowingly and intentionally exposing them to any chemical on a list of chemicals maintained by the state that are “known to cause cancer or reproductive toxicity.” The list continues to grow, and it now includes more than 700 chemicals. The net result has been the nearly ubiquitous presence of warning signs on business premises all over the state—and warning labels on consumer products all over the country—because the exposure levels that mandate warnings are so low in some cases that they are difficult to measure. In almost all cases, determining human exposure levels that may trigger a warning requirement involves costly and potentially subjective toxicological testing.
The nature and cost of human exposure testing required by Proposition 65 is unlike what is required by many other product safety laws, such as the Consumer Product Safety Act, which states content limits on certain chemicals that are relatively easy to measure and control. As a result, many businesses have no practical choice but to err on the side of caution and provide Proposition 65 “warnings” for thousands of products and environmental situations that present no known risk of harm.
Among the topics covered by the new warning regulations are the following:
- Complete rewrite of the “safe harbor” warning label text and format, including mandatory use of a warning triangle [ ] and reference to an official Office of Environmental Health Hazard Assessment (OEHHA) website; OEHHA controls the website content and can change it at any time;
- Warnings in some situations must identify a specific chemical that is the subject of the warning for each endpoint (cancer and/or reproductive harm);
- Warnings on a product may be shorter and need not identify a specific listed chemical, but must state “cancer” or “reproductive harm” and refer to the official OEHHA website;
- Warning responsibilities are allocated among manufacturers, producers, packagers, supporters, suppliers, importers, distributors and retailers, with a stated intent to minimize burdens on retailers;
- Retailers are provided a potential escape from liability upon receipt of a 60-day notice of violation if the retailer does not have actual knowledge of the presence of a listed chemical and the retailer, within five days of receiving the 60-day notice, either stops selling the product or begins providing appropriate warnings;
- New requirements are provided for transmitting warnings to consumers for Internet and catalog sales that are intended to communicate warnings before a sale is consummated;
- Emergency rules announced earlier this year for labeling of food and beverage containers containing bisphenol-A (BPA) have been amended and kept in force;
- Warning requirements for environmental and occupational exposures have been revised;
- Retailers must provide public enforcers and private bounty hunters with specified information regarding the manufacturers or suppliers of accused products; and
- New or revised product-specific and situation-specific warning requirements now exist for food, alcoholic beverages, restaurants, medical and dental care, raw wood, furniture, diesel engines, motor vehicles, recreational vessels, enclosed parking facilities, amusement parks, petroleum products, service stations and vehicle repair facilities, and smoking areas, among others.
These new warning requirements were announced by the State of California on September 2, 2016, and will be operative on August 30, 2018.
In the interim period, businesses may continue to comply with the warning regulations now in effect, or they may begin implementing the new regulations. Consumer products manufactured prior to this effective date may be sold with warnings compliant with the existing regulations. A company that is a party to a court-ordered settlement or final judgment regarding Proposition 65 may continue to use the warning methods and content approved by the court for the product categories and listed chemicals covered by the court-ordered settlement or final judgment. Any failure to meet applicable warning requirements may result in businesses’ being targeted by public or private enforcers seeking civil penalties, injunctive relief and attorneys’ fees.
The regulatory text and supporting rulemaking documents can be viewed or downloaded from the State of California OEHHA website.
While the new compliance date is two years away, it may not be too soon to begin planning.