California Proposition 65 (Prop 65), officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The proposition’s intent is to protect California’s drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform individuals in California about exposures to such chemicals. Prop 65 requires the state to maintain and update a list of chemicals known to the state to cause cancer or reproductive toxicity. Consumer products that contain any of the chemicals on the list must include a warning label that complies with the requirements of Prop 65. By requiring that this information be provided, Prop 65 enables individuals in California to make more informed decisions about their exposure to these chemicals.
To guide businesses in determining whether a warning is necessary, the Office of Environmental Health Hazard Assessment (OEHHA) has developed safe harbor levels for many California Prop 65 chemicals. A safe harbor level identifies a level of exposure to a listed chemical that does not require a California Prop 65 warning. A business is not required to provide a warning if exposure to a chemical occurs at or below these levels. Although a business has the burden of determining if a warning is required, a business is discouraged from providing a warning that is not necessary (i.e., over-warning of hazards). Enforcement of Prop 65 labeling requirements is carried out by the California Attorney General’s office.
The California Attorney General has published a list of frequently asked questions concerning Prop 65:
This site specifies that: “Enforcement is carried out through civil lawsuits brought by the California Attorney General, or by a district attorney or city attorney of a city with a population exceeding 750,000. Private parties acting in the public interest can also bring Proposition 65 lawsuits, but only if two things have happened first:
- They have provided at least 60 days notice of the alleged violation to the business, as well as to the Attorney General and the appropriate district attorney.
- The city attorney, and the Attorney General, district attorney or city attorney has not taken action. The notice must provide adequate information about the alleged violation and comply with the requirements specified in the regulations. (CA Code of Regulations, Title 27, Section 25903, and Title 11, Sections 3100-3102)
If a business is found to be in violation of Proposition 65, a court may order the business to stop committing the violation. The business is also subject to civil penalties of up to $2,500 per day for each violation.”
In response to client requests, IAPMO has worked with industry experts to develop the Conformity Assessment Document for California Proposition 65 Compliance – Products or Materials to further enhance IAPMO’s California Prop 65 services. IAPMO thanks the volunteers for the over two-year commitment to help create the document. It is also important to recognize OEHHA for the valuable public comments they provided on the draft document. The industry experts worked tirelessly to address the plethora of public comments received. The IAPMO conformity assessment procedure will help interested companies ensure that California Prop 65 requirements are met.
The conformity assessment procedure uses a decision tree approach to chart out the steps used to determine if a product or material conforms to California Prop 65 requirements. The first step in the process is to conduct a thorough review of a product’s materials by obtaining detailed information about its ingredients and collecting information about how a consumer will use the product under normal conditions. This information is typically collected from product manufacturers and suppliers to those manufacturers. Chemical ingredients of a product are compared to the California Prop 65 list to determine if further assessment is needed.
If chemical ingredients of a product are on the California Prop 65 list, a thorough exposure assessment is then required. Information collected in the product review step will dictate the exposure assessment, which is intended to characterize the exposure setting (e.g., in a consumer’s home) and the exposed population (e.g., potential vulnerable populations such as babies and pregnant females). The exposure assessment identifies which route(s) of exposure are relevant to the product or material being evaluated (e.g., ingestion, dermal contact, inhalation).
Quantification of the level of a chemical(s) to which a population may be exposed may then be required. Quantification of exposure may be accomplished by laboratory assessment/modeling. The conformity assessment procedure provides general guidance as to which laboratory/modeling methods may be used to quantify exposure.
The next step in the assessment is to determine if safe harbor levels, which includes Maximum Allowable Dose Levels (MADLs) and No Significant Risk Levels (NSRLs), exist for the chemical(s) of concern (those identified as being an ingredient or leachate of the product to which an individual may be exposed at a significant level). Safe harbor levels are used to determine if a warning is required. When safe harbor levels are not available for a chemical on the Prop 65 list, a business has the option of calculating its own level. The conformity assessment procedure provides general guidance for calculating MADLs and NSRLs, including examples for calculating MADLs and NSRLs.
If it has been determined that an individual may not be exposed to a significant level of a chemical on the California Prop 65 list, a Prop 65 warning label is not required. If it has been determined that an individual may be exposed to a significant level of a chemical on the California Prop 65 list, a Prop 65 warning label is required.
Contact IAPMO or download a complimentary copy of the Conformity Assessment Document for California Proposition 65 Compliance – Products or Materials from our website. Several companies offer services to assist manufacturers with Prop 65 compliance. IAPMO Research and Testing will be using this new publication to offer an evaluation for products or materials seeking Prop 65 compliance. IAPMO recognizes that use of the procedure for conformity assessment is not a substitute for legal guidance regarding California Prop 65 warning label requirements.