Proposition 65 (Prop 65) is a controversial California health law enacted in 1986 as the Safe Drinking Water and Toxic Enforcement Act. The law—which purports to protect consumers from exposure to substances known to the State of California to cause cancer, birth defects, or reproductive harm—mandates the placement of consumer warnings on products containing any of nearly a thousand different chemicals. In turn, Prop 65 is administered by the Office of Environmental Health Hazard Assessment (OEHHA), part of the California Environmental Protection Agency.
The confusion surrounding compliance with Prop 65 is pervasive and persistent. For starters, neither the regulators, businesses, plaintiff lawyers, or the courts can seem to agree on what products are affected and what warnings are required. In a recent high-profile case involving the sale of coffee, the court ruled that ready-to-drink and ready-to-prepare coffee products must be accompanied by a warning because coffee contains high levels of acrylamide, a chemical known to the state of California to cause cancer and reproductive harm. Following the ruling, OEHHA proposed new coffee regulations that would exempt coffee products from the warning requirements. Meanwhile, after plaintiff lawyers successfully argued that cereal products required warnings because of the presence of acrylamide, a California appeals court overturned the ruling.
In addition to the confusion being sown by the regulators and courts, the federal government is threatening to become involved as well. Recently introduced federal legislation, the Accurate Labels Act (ALA), would demand any food product warning requirements (i.e., those mandated by Prop 65) be subjected to rigorous evidence-based review supported by the best available science. More importantly, ALA would shift the burden of proof from the defendant to the party (government or private plaintiff) bringing any enforcement action.
Revised Warning Requirements
Recent changes to the Prop 65 regulations have also arguably increased the levels of confusion surrounding Prop 65 compliance. Historically, Prop 65 warnings were merely required to notify consumers if a chemical capable of causing cancer or reproductive harm might be present. That began to change in 2016, when OEHHA significantly revised the warning requirements. After a two-year phase-in, the new OEHHA warning revisions went into effect on Aug. 30, 2018. Even though the revisions do not substantively change the purpose of Prop 65, they have nonetheless generated significant confusion regarding how to best comply and are widely expected to lead to an increase in litigation.
Among other things, the new regulations require that any products needing a warning must now identify the specific chemical that may be present in a product. The regulatory changes shift responsibility for warnings further upstream in the supply chain, giving manufacturers the primary responsibility for providing Prop 65 warnings. Manufacturers can either affix warning labels to their products, or provide written notice to retailers that a product requires a warning, provide the warning materials, and obtain confirmation retailers received the notice.
The revisions also substantially modify the guidance relating to the form and content of the warnings. It should be noted that the precise format of the warnings is not mandated by the law. Rather, the warnings must simply be “clear and reasonable.”
The definition of what it means to be “clear and reasonable,” however, can and does vary greatly between, for instance, a commercial business and a plaintiff’s lawyer. To address this issue, the law gives manufacturers the option to use a form-template “safe harbor warning.” Warnings that meet the safe harbor warning requirements are deemed to be clear and reasonable.
To meet the safe harbor requirements, Prop 65 warnings for food products must: 1) contain the word “WARNING” in all capital letters and in bold print; 2) state whether the product contains a carcinogen, reproductive toxicant, or both; and, 3) reference the Prop 65 warning food website. If the warning is placed on the product label, it must be set off from other surrounding information and enclosed in a box. If the warning is in a language other than English, the warning must be in that language as well. Here is an example of the new warning:
“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/or (as appropriate) [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/food.”
The amended regulations also allow the use of a “short-form” warning. This warning must appear in a size no smaller than the largest font size used for other consumer product information affixed to the product and must be at least 6-point type. A short-form warning label may be used on any size product. Here is an example:
“WARNING: Cancer and Reproductive Harm—For more information, visit www.P65Warnings.ca.gov.”
The warnings must be provided on the food product label (enclosed in a box) or on a product sign, label, or shelf tag at the point of display of the product. The new requirements are applicable to all modes of purchase and distribution, including online/internet and catalog purchases as well as direct-import and drop-ship delivery, and require an understanding of the chemical constituents of all products sold or distributed in the state of California.
Prop 65 Compliance Questions
While the new regulatory changes on their face appear to be relatively straightforward, achieving compliance may remain elusive for many companies. Since there are nearly 1,000 chemicals on the Prop 65 list, how are food companies going to be able to determine which chemicals may (or may not) be present? The problem extends much further up the supply chain, as well, because a food company’s ingredient suppliers may not know either. Some suppliers may not have even heard of Prop 65.
Additionally, some chemicals, like acrylamide, may not be present when the product is sold, but are created when the consumer cooks the product at high temperatures. Under these circumstances, a warning may be required, so food product manufacturers may need to do substantial additional testing.
The placement and type of warnings may create confusion as well. What happens when a product manufacturer chooses not to place the warning on its product, but elects instead to send separate product warnings to their customers instructing them to place the warning on store shelves, and those instructions are not followed? Even if they were followed, since there is no minimum size warning for shelf warnings, who will determine whether the warnings are sufficient. Often, retailers and plaintiff lawyers will disagree.
So, when it comes to Prop 65 compliance, certainty is fleeting. The one thing that is (and will likely remain) certain, however, is Prop 65 is officially a law known by the State of California, and now the rest of the world, to create chaos and confusion.
Stevens, a food industry attorney, is a founding member of Food Industry Counsel, LLC. Reach him at firstname.lastname@example.org. Chappelle is also a food industry lawyer and consultant at the same organization. Reach him at email@example.com.
AUTHORS DISCLAIMER: This article is intended only to offer a broad overview of recent changes to Proposition 65. Businesses should consult with experts or attorneys to evaluate their responsibilities under Prop 65 and protect themselves from any potential claims.