California Proposition 65 (Prop 65) is the Safe Drinking Water and Toxic Enforcement Act of 1986 published as Section 25249.7 of California's Health and Safety Code. Proposition 65 is administered by the Cal/EPA Office of Environmental Health Hazard Assessment (OEHHA) and is enforced by California Department of Justice, Office of the Attorney General. Proposition 65 is intended to warn consumers of potential exposures to chemicals that are recognized by the State as carcinogens and reproductive toxins. Prop 65 applies to all consumer goods sold within the state and impacts all importers, domestic manufacturers, and retailers of these items. Compliance with the law often is difficult due to the lack of OEHHA exposure guidelines for many of the listed chemicals. Additional ambiguity regarding compliance is created because most of the legal activity is not initiated by the State but rather by private law firms and consumer advocacy groups acting in the public interest.
Berkeley Analytical, as a California-based laboratory, is well informed regarding Proposition 65 issues and tracks legal activities filed with the State Attorney General that are impacting the industries we serve. A number of our analytical testing services can be used to address Prop 65 issues. Our phthalate and SVOC testing often is used to measure the content of specific Prop 65 phthalate esters and halogenated flame retardant chemicals in products. Such testing is particularly useful for quality control programs. Manufacturers potentially can limit liability by monitoring the content of listed chemicals in the components they are purchasing, such as flame retardants in flexible foam used for seating products. BkA's VOC emission testing generates information that can be used to evaluate potential inhalation exposures to listed chemicals. In addition to our regular testing services, we can create testing protocols for estimating the decay in the emissions of chemicals over long time periods that are of interest with respect to cancer effects and other chronic exposure issues. Our network of qualified toxicology professionals can develop risk assessments needed to determine if Prop 65 labeling is required and to defend against Prop 65 lawsuits.
The six phthalate esters contained in Proposition 65 have generated considerable attention. Prop 65 Safe Harbor values for exposure and the numbers of 60-day notices filed in 2015 for these compounds are shown.
An overview of the law is provided below. It has two components that substantially impact companies doing business in California, the Prop 65 List and the Prop 65 Labeling Requirements. Prop 65 Enforcement results in substantial financial costs to businesses each year. Prop 65 Section 6 on clear and reasonable warnings is in the process of being revised. The proposed changes will provide specific guidance on labeling.
The law requires the State to publish a list of chemicals that are known to cause cancer or birth defects or other reproductive harm. This list is updated at least annually and has grown since first publication in 1987 to include over 900 chemical substances. The list contains a wide range of synthetic and naturally occurring chemicals. These chemicals include ingredients and additives in products that are commonly used and contained in homes, schools and offices such as personal care products, household cleaners, furniture, and building and construction products. Chemicals are nominated for inclusion in the list by different mechanisms. There are two independent committees appointed by the governor as the state's qualified experts. Either of these committees can recommend a chemical for inclusion based on current scientific literature. In this case, OEHHA compiles the evidence for the committee to review and publishes the document for public comment. OEHHA also considers several other governmental agencies as authoritative bodies and adopts their assessments of chemicals for cancer and developmental effects. The designated authoritative bodies are the U.S. EPA, the U.S. FDA, NIOSH, the National Toxicology Program, and IARC.
Proposition 65 is a product labeling law related to potential consumer exposures. It is not a product content law. Companies doing business in California are required to provide a "Clear and Reasonable Warning" before knowingly and intentionally exposing anyone to a listed chemical over defined levels. Once a chemical is listed, companies have 12 months to comply with the warning requirements. The warning can be delivered to consumers in various ways. For goods sold to consumers, the warning typically consists of an on-product label. Retailers operating in California often post signs at their places of business. The current prescribed warning is generic and provides very little information to consumers. It simply states — "WARNING: This product contains a chemical known to the State of California to cause cancer (and/or birth defects or other reproductive harm)."
For listed carcinogens, a "No Significant Risk Level" or NSRL is defined as an exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime. For reproductive toxicants, a "no observable effect level" or NOEL that has been shown not to pose any harm to humans or laboratory animals is determined. A Maximum Allowed Dose Level or MADL is established as 1/1000 of the NOEL. If exposures are likely to exceed an NSRL or MADL, then a product warning is required. OEHHA develops numerical "Safe Harbor Numbers" for exposures that provide risk-based guidance on labeling. To date, there are about 300 safe harbor levels. If there is no safe harbor level, a significant amount of chemical exposure often is interpreted broadly as any detectable amount. Alternately, businesses may choose to perform specific risk assessments typically by consulting with qualified toxicologists.
Proposition 65 is not directly enforced by a regulatory agency. Instead, the California Attorney General's Office enforces the law as may any district or city attorney of cities with populations >750,000. Significantly, any individual acting in the public interest also may enforce the law by filing a lawsuit against a business for allegedly violating the law. This latter path is being pursued by consumer advocacy groups and law firms and is how most of the legal cases are initiated. In this circumstance, the public interest party first sends the business a 60-day notice of the violation before filing a lawsuit. Upon receiving a 60-day notice, many businesses choose to seek legal advice. Most of these public interest cases do not go to trial but rather are settled out of court by agreements. In 2014, the Proposition 65 settlements totaled $29.5M, with 17% as civil penalties, 12% as payments in lieu of penalties, and 71% ($21.0M up from $15.6M in 2012) as attorney fees and costs.
OEHHA has proposed extensive revisions to Proposition 65 Section 6 on Clear and Reasonable Warnings. The proposed revisions to Section 6 are intended to further the “right-to-know” purposes of the law and to provide specific guidance on the content of safe harbor warnings for a variety of exposure situations, and on the corresponding methods for providing those warnings. The proposed revisions also make clear distinctions between the responsibilities of manufacturers and their supply chains versus the responsibilities of retailers. The revisions are intended to become effective in 2016 with a two-year phase-in period.
The current Prop 65 warnings are generic and do not list chemical names. The text of the proposed new warnings requires that at least one chemical name be listed. If multiple chemicals result in the requirement for a warning label, the manufacturer may list all of the chemicals but only is required to list one. The new labels will state “This product can expose you to [name of one or more chemicals] a chemical [or chemicals] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/product.”
OEHHA lists the following benefits of the proposed new Prop 65 Section 6 regulations: