Audit, Compliance and Risk Blog

Clean Drinking Water and Proposition 65

Posted by Jon Elliott on Tue, Mar 15, 2016

Water_glass.jpgCalifornia is a persistent exception to states’ limited abilities to create long-lasting effects on national environmental health and safety (EH&S) programs. One example, well-known here in California but relatively invisible to EH&S professionals outside the state, is Proposition 65.

What Are Prop 65’s Basic Elements and Approaches?

Proposition 65 (formally the “Safe Drinking Water and Toxic Enforcement Act”) was placed on California’s November 1986 general election ballot, by a coalition of environmental groups dissatisfied with state policies regulating toxic chemicals. It was approved by nearly two-thirds of California’s voters.

Proposition 65’s primary purposes are to:

  • Ensure more public information when especially hazardous chemicals appear in products and locations.

  • Restrict discharges of listed chemicals into sources of drinking water.

  • Strengthen governmental enforcement and empower private litigants.

Listed Chemicals

The primary focus of Proposition 65 is on “chemicals known to the state to cause cancer or reproductive toxicity.” The state’s Office of Environmental Health Hazard Assessment (OEHHA) creates and administers one list of carcinogens and three separate lists for reproductive toxicants (which designate male reproductive toxicants, female reproductive toxicants, and developmental reproductive toxicants).

Proposition 65 requires the state to identify and list such chemicals and to update the list at least annually thereafter. In defining these chemicals, OEHHA considers whether “authoritative bodies” (such as the International Agency for Research on Cancer and the US Environmental Protection Agency) have made similar determinations, and makes independent judgments based on review of the scientific literature. Chemicals are reviewed on an ongoing basis and listings are considered quarterly. OEHHA lists over 500 carcinogens (including some families of chemicals such as cadmium and its compounds) and over 300 reproductive toxicants (which may appear on one, two, or all three sub-lists).

“Persons” subject to Proposition 65

Proposition 65 generally applies to “persons in the course of doing business,” where “person” is defined as an individual, trust, firm, joint stock company, corporation, company, partnership, or association.” This definition excludes:

  • Persons employing fewer than 10 employees.

  •  Public agencies (including publicly owned water systems and publicly owned treatment works (POTWs)).

Warning requirements

Beginning 12 months after listing, no “person in the course of doing business” may knowingly and intentionally expose any individual (e.g., workers, consumers, or the general public) to the chemical without “clear and reasonable warning,” unless the exposure poses no “significant risk.” The state has devised standard “safe harbor” warnings for various situations:

  • Consumer products: “WARNING: This product contains a chemical known to the State of California to cause [cancer] [birth defects or other reproductive harm]”.

  • Fresh fruits, nuts, and vegetables: “WARNING: This product may contain a chemical known to the State of California to cause cancer, or birth defects or other reproductive harm]”.

  • Alcoholic beverages: “WARNING: Drinking Distilled Spirits, Beer, Coolers, Wine and Other Alcoholic Beverages May Increase Cancer Risk, and, During Pregnancy, Can Cause Birth Defects”.

  • Locations: “WARNING: This area contains a chemical known to the State of California to cause [cancer] [birth defects or other reproductive harm]”.

  • Facilities where food is sold or served for immediate consumption: “WARNING: Chemicals known to the State of California to cause cancer, or birth defects or other reproductive harm may be present in foods or beverages sold or served here.”

Businesses can use the applicable “safe harbor” text – which most people agree do not provide very much useful information – or can design and provide alternative language (many businesses actually post the name(s) of listed chemical(s) present, for example). Businesses where employees are exposed to Proposition 65 chemicals must include these warnings when complying with worker protection requirements under the state’s Hazard Communication Standard (HCS).


Proposition 65 provides limited grounds for exempting persons who otherwise would be subject to the warning requirement. The first is preemption by federal laws. However, attempts to claim such exemptions have generally failed, with court decisions denying preemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, the national pesticide law), Hazardous Substances Act, and certain requirements of the Food, Drug, and Cosmetics Act.

No warning is required, however, if a business can show that the actual exposure poses no “significant risk” of cancer or reproductive toxicity. OEHHA provides for a two-step process to determine this level. First, the general standard is that the exposure should not be larger than 1/1,000 times the No Observable Effect Level (NOEL) calculated for a reproductive toxicant or higher than the exposure calculated to produce 1 additional cancer per 100,000 exposed individuals for a carcinogen. Second, the business must convert these limits into actual quantities or concentrations to compare them with its activities. OEHHA sets safe harbor levels for some listed chemicals, which it refers to as “no significant risk levels” (NSRLs) for carcinogens and “maximum allowable dose levels” (MADLs) for reproductive toxins. OEHHA also makes advisory safe use determinations at the request of individual businesses. However, the lack of detailed scientific information precludes this process for most listed chemicals.

OEHHA also exempts some “naturally occurring” quantities, including listed chemicals in food products (this does not include food additives or process-created chemicals such as alcohol in alcoholic beverages) and ambient exposures to chemicals in the air, water, or soil. OEHHA also exempts exposures to listed chemicals already present in water received for drinking or process water, and exposures that result from emergency medical or dental care.

Discharge Prohibitions

Beginning 20 months after listing, Proposition 65 prohibits businesses from releasing significant amounts of listed chemicals “into water or onto or into land where such chemical passes or probably will pass into any source of drinking water,” except at levels below these risk levels. OEHHA defines a significant amount as the quantity that would create a significant risk as defined above.

Penalties and Agency/Private Enforcement

Proposition 65 provides for injunctive relief and civil penalties of up to $2,500 per day per violation of warning and discharge restrictions. Proposition 65 reverses the traditional burden of proof by requiring the defendant business to prove that its activities do not violate these restrictions. These provisions are enforceable by the state Attorney General, a country District Attorney, a City Attorney, or by any person. Penalties collected through successful prosecutions are allocated 50% to the state, 25% to the local Certified Unified Program Agency (CUPA) with authority over hazardous materials and waste regulation, and 25% to the successful public agency prosecutor or individual plaintiff – this last is often referred to as Proposition 65’s “bounty hunter” provision.

Alternatively, many cases end not in a formal finding but in a settlement, in which the defendant company typically pays the plaintiff attorneys’ fees in addition to making changes in notice or discharge practices. To avoid oppressive litigation, the Attorney General is assigned to receive copies of plaintiffs’ filings and settlements, and to evaluate them for validity.

Why Should People Outside California Care?

These provisions are clearly important inside California. In addition, state courts and federal Occupational Safety and Health Administration (OSHA) have upheld the incorporation of Proposition 65 warnings into worker information provided under HCS.

OSHA voided California’s requirement that non-California manufacturers include Proposition 65 information on their material safety data sheets (MSDSs; since replaced with Safety Data Sheets (SDSs)). However, many manufacturers and importers of chemicals do identify constituents list by Proposition 65 when they produce MSDSs and SDSs, so at the very least information is available throughout the U.S. and employers should be ready to explain the Proposition 65 reference on their chemical safety documents.

More subtly, manufacturers from around the world have reformulated products to facilitate sales into California’s important market, and then sell these reformulated products to all markets. For example, wine bottles now come with plastic foil instead of lead, and nail polish remover no longer contains acetone. Many of these changes are invisible to consumers, but tend to reduce exposure risks.

Self-Evaluation Checklist

Does the organization manufacture, import, sell or use products with any chemical constituents listed under Proposition 65?

Does the organization provide “clear and reasonable warning” of any listed constituents?

Does the organization limit its discharges of listed chemicals?

Does the organization identify Proposition 65-listed chemicals in its Hazard Communication Standard program?

Where Can I Go For More Information?

Specialty Technical Publishers (STP) provides a variety of single-law and multi-law services, intended to facilitate clients’ understanding of and compliance with requirements. These include:

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About the Author Elliott is President of Touchstone Environmental and has been a major contributor to STP’s product range for over 25 years. He was involved in developing 12 existing products, including Environmental Compliance: A Simplified National Guide and The Complete Guide to Environmental Law.

Mr. Elliott has a diverse educational background. In addition to his Juris Doctor (University of California, Boalt Hall School of Law, 1981), he holds a Master of Public Policy (Goldman School of Public Policy [GSPP], UC Berkeley, 1980), and a Bachelor of Science in Mechanical Engineering (Princeton University, 1977).

Mr. Elliott is active in professional and community organizations. In addition, he is a past chairman of the Board of Directors of the GSPP Alumni Association, and past member of the Executive Committee of the State Bar of California's Environmental Law Section (including past chair of its Legislative Committee).

You may contact Mr. Elliott directly at:

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Tags: OSHA, California Legislation, EHS, Hazcom, MSDS