Prop 65: How Does It Actually Work?

You have likely heard “Prop 65” (short for Proposition 65) thrown around before, or know it from its ubiquitous warning label. Also called the Safe Drinking Water and Toxic Enforcement Act of 1986, this law sets out several mandates for businesses selling products in California. The reason is that consumers need to make informed decisions about their health and safety. Prop 65 is rooted in this basic consumer right: the right to know about potentially harmful chemical exposures in one’s environment, workplace, or consumer goods.

Who Runs Prop 65, and What Is on the List

The State of California, specifically the Office of Environmental Health Hazard Assessment (OEHHA), spearheaded this initiative, and the California Attorney General’s Office enforces it. For its part, OEHHA administers a list of all substances known (or believed) by the state to be toxic to humans (see California’s Proposition 65 List). Approximately 900 chemicals linked to cancer, birth defects, or other reproductive harm are on this list. Prop 65 does not ban the use of these chemicals, but it does force companies to provide notification when they expose the public to a listed chemical above its legal limit.

The state considers chemicals for placement on the Prop 65 list in four ways:

Scientific committees. Two independent committees of scientists, the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant (DART) Identification Committee, review the most current scientific data available. On behalf of OEHHA’s Science Advisory Board, these committees evaluate chemicals of concern and add them to the list accordingly.
Authoritative bodies. Any organization that the CIC or DART appoints as an “authoritative body” may also identify chemicals that are carcinogens or reproductive toxicants.
Agency requirements. For certain chemicals, such as those in prescription drugs, federal or state agencies will require listing and labeling.
The California Labor Code. Chemicals identified in the California Labor Code as causing cancer, birth defects, or reproductive harm will always appear on the list.

What Businesses Must Do

Once a chemical is listed, warning mandates kick in and businesses have 12 months to comply. While this regulation aims to do good and protect consumer health, its mandates are notably stringent for businesses. Retailers and manufacturers must identify when one or more listed substances is present in their products, facility emissions, or workplace, and the amount of the chemical must be quantifiable enough to trigger a warning label. Under the law, companies also cannot knowingly discharge listed chemicals into the public’s drinking water; once a chemical is listed, businesses have 20 months to comply with this prohibition.

Some argue that what began as a well-intended effort by California voters to make information accessible has led to a practice of “over-warning.” Thirty years on, the bevy of product label warning requirements had proved to be a compliance nuisance, particularly for small businesses. Warning labels are mandatory by law unless a business determines that its product’s expected level of exposure will fall below the legal threshold for the chemical in question. As the party creating the exposure, the manufacturer must always convince the state that no warning label is necessary. The exception is that consumer products do not need to carry a warning when federal law expressly controls exposure. Because companies know firsthand the content and actual exposure levels of their products, they determine whether to affix a label. A business may choose to provide a warning based on that knowledge, or simply on an assumption that a listed chemical is present.

Safe Harbor Levels

“Safe harbors” are another way for businesses to comply with Prop 65 without a warning label. Safe harbor levels include no significant risk levels (“NSRLs”) for cancer-causing chemicals and maximum allowable dose levels (“MADLs”) for reproductive toxicants. A business can put forward a product’s current exposure level along with valid scientific proof that the expected exposure would pose no “significant risk” of cancer or reproductive harm to consumers.

For cancer-causing chemicals, the law does not specify a significant risk level. Instead, it defines “no significant risk” as an exposure level that would cause no more than one extra case of cancer in 100,000 people over a 70-year lifetime. For reproductive hazards, the maximum allowable dose is an exposure level 1,000 times lower than the level at which there is no observable effect. Similarly, state law does not set an observable effect threshold. Manufacturers should not exceed threshold levels for any listed chemicals if they want to remain compliant.

A Hybrid of Postmarket and Premarket Law

Once the FDA approves a given product, the responsible manufacturer must meet specific postmarket requirements. Although we think of Prop 65 as a “postmarket” law, it is a hybrid of postmarket and premarket elements: it burdens product manufacturers and suppliers with deciding whether a warning label is necessary, which is characteristic of a premarket law.

Most postmarket laws ask government regulatory agencies to overextend themselves, forcing agencies to watch for risk or harm, produce data on it, set exposure levels, and demand regulations for products already on the market. All of these tasks are onerous and add unnecessary pressure on the agencies. In this regard, Prop 65 in its current state is no different from other postmarket laws. A more health-proactive and health-protective model would require adequate review and assessment of actual exposure levels before products and substances enter the market.

In his article “Information Generation and Use Under Proposition 65: Model Provisions for Other Postmarket Laws?,” Carl Cranor envisions a fully fledged version of Prop 65 that is more robust and responsive to public health and the environment. Broadly, this model integrates product testing and data gathering straight from the source. It calls on those dealing with potentially hazardous chemicals to take affirmative steps to develop new information. Manufacturers and suppliers would need to be vigilant, directly seeking out data about the safety and effects of their products, as well as any evidence of harm from exposure, and reporting it to the relevant agencies. This change would allow for an ample warning response after products are released.

Enforcement and the Burden of Proof

An overarching concern is that it is almost too easy for private enforcers to bring Proposition 65 enforcement lawsuits. A distinctive feature of Prop 65 is that the accused business bears the burden of proving it complies, while the accuser is not asked to do much. The process works like this: the enforcer detects a listed chemical at even a minute level and advances a plausible route of human exposure. The burden then shifts to the business to prove that the amount of the chemical to which it exposes consumers is below the maximum allowable level. If it cannot meet this standard, the business must provide a warning and pay a fine.

Prop 65 and the First Amendment

People may not realize that the First Amendment also protects businesses’ speech to a certain degree. Laws forcing commercial enterprises to label their products therefore implicate the First Amendment, and Prop 65 is a prime example. It is structurally inconsistent with the First Amendment, which further complicates compliance. The state, and not a private firm, is technically supposed to prove that a compelled consumer product warning meets First Amendment standards. The government cannot establish such a vague standard and expect firms to prove in court that they comply.

David Fischer’s article “Proposition 65 Warnings at 30 – Time for a Different Approach” addresses whether mandated consumer product warnings amount to a First Amendment violation. Fischer points out that consumer product warnings tend to be scientifically questionable, which creates a fundamental flaw. The required warning language, “this chemical is known to cause cancer or reproductive harm,” implies a scientific judgment rather than a purely informative fact. As a result, businesses often believe Prop 65 warnings are misleading, untruthful, or even unnecessary. The government can say what it wants, but there are limits on what it can force businesses to say.

Not every Prop 65 warning automatically violates the First Amendment, however. This debate simply illustrates that a compelled warning label may not be reasonable for a given compound or product, depending on the state’s knowledge or the scientific uncertainty at the time, or on how speculative the risk at issue is.

See Prop 65 tracking inside MatCheck, or see Rumzer's compliance engineering services if you need help evaluating exposure across a complex product line. For the current warning and discharge deadlines, read the quick-reference Prop 65 guide.

Sources

California Office of Environmental Health Hazard Assessment, The Proposition 65 List (2021).
Carl Cranor, "Information Generation and Use Under Proposition 65: Model Provisions for Other Postmarket Laws?," Indiana Law Journal, Vol. 83, Iss. 2, Article 7 (2008). Available at: https://www.repository.law.indiana.edu/ilj/vol83/iss2/7
David B. Fischer, "Proposition 65 Warnings at 30 - Time for a Different Approach," 11 Journal of Business & Technology Law 131 (2016). Available at: http://digitalcommons.law.umaryland.edu/jbtl/vol11/iss2/2

Prop 65: (How) Does It Work?